Thursday, November 30, 2006

Arpida Shares Surge On Positive Superbug Drug Trial

- Swiss biotech company Arpida said on Thursday its superbug drug iclaprim had proved to be as efficient as Pfizer's (PFE.N: Quote, Profile, Research) rival drug in a late-stage trial, sending Arpida stock up over 14 percent.

By 1241 GMT, the shares were up 13 percent at 30.50 Swiss francs per share on 9 times average daily volume, making Arpida the top gainer in the Swiss market and the second most actively traded stock. Arpida's value has almost doubled in 2006.

"Iclaprim demonstrated a clinical cure rate which was statistically non-inferior to that of (Pfizer's) linezolid ... thereby achieving the primary endpoint of the trial," Arpida said in a statement.

The Phase III trials were designed to compare the efficacy and safety iclaprim in the treatment of skin infections with that of market leader linezolid, marketed by Pfizer Inc. as Zyvox. Iclaprim is designed to treat severe hospital-acquired infections including superbug MRSA.

"The safety profile of iclaprim was excellent and here we believe that iclaprim offers a significant benefit over Zyvox which causes myelosuppression requiring weekly blood counts," Brian White, analyst at Deutsche Bank, said in a note.

What is it?
Iclaprim is a broad-spectrum antibiotic targeting severe infections including those caused by methicillin-resistant Staphylococcus aureus (MRSA) which is predominantly caught in hospitals.

Hollis-Eden Pharma Present Positive Data

Hollis-Eden Pharmaceuticals presented positive data from an animal trial on an experimental drug for rheumatoid arthritis.
The new synthetic steroid hormone, HE3286, showed a dramatic benefit in rodents with collagen-induced arthritis when compared with a placebo, reducing the severity of the disease. Results from the trial are being presented at a conference in Italy.

Hollis-Eden will also present data showing how the drug helps to keep the immune system from attacking the body itself, which is the cause of autoimmune diseases like rheumatoid arthritis. The drug will be compared to the effects of treatment with the steroid dexamethasone.

At a previous scientific meeting, the company presented early data showing that HE3286 improved glucose tolerance in early insulin resistant type 2 diabetes.

"The observed ability, in these preclinical models, of immune-regulating hormones to have potent anti-inflammatory properties without side effects such as immune suppression and bone loss commonly associated with corticosteroids, provides the potential opportunity to use these compounds in a broad array of inflammatory conditions," said Richard Hollis, the company's chairman and CEO.

How does the synthetic hormone work?
Specifically, these second-generation compounds regulate NF-kappaB, a protein that plays a key role in cellular signaling. NF-kappaB activation leads to the production of inflammatory mediators such as TNF-alpha, IL-6, and IFN-gamma, and controls various other cellular functions. Thus, NF-kappaB is an important pharmaceutical target for treatment of inflammatory and metabolic disorders. It is the universal protein regulator of inflammation such that if inhibited, the body cant mount an immune response against itself.

HEPH: Shares were up 4.1% to $5.56 Thursday.

Wednesday, November 29, 2006

Interesting mover in after hours: ENDP

Endo Pharmaceuticals closed the market at 27 but is down 61 cents in after hours. I saw large blocks being traded at 26 and the news was not released until market close. Interesting.

FYI- Endo researches and markets pain medications such as Percocet, Percodan, and OxyContin.

After Hours: 26.39 0.61 (2.26%)

Dynavax Shares Rise as Hepatitis B Shot Beats Glaxo's

--Dynavax Technologies Corp. said its experimental vaccine gave greater protection against the liver disease hepatitis B in two doses than GlaxoSmithKline Plc's did in three. Dynavax shares jumped 31 percent in late trading.

Two doses of Dynavax's Heplisav protected more than 98 percent of patients, compared with 25 percent who were protected by two shots of Glaxo's Engerix-B and 73 percent who were helped by three, Dynavax Chief Executive Officer Dino Dina said in an interview today. The company is now talking with Glaxo, Merck & Co. and other potential partners about possible deals, he said.

The study results position Heplisav to compete with Glaxo in the $1 billion Hepatitis B vaccine market, said Katherine Xu, an analyst with Pacific Growth Equities in San Francisco. Glaxo's vaccine dominates the market with $450 million in annual sales, followed by Merck's Recombivax with $270 million, she said.

``It's very powerful data,'' Xu said in a telephone interview today.

Glaxo spokeswoman Jennifer Armstrong and Merck spokeswoman Janet Skidmore both said they were unfamiliar with the new study results and could not comment about possible deals.

Invalid Patents

Glaxo and Merck hold patents in the U.S. covering Hepatitis B vaccines that Berkeley, California-based Dynavax believes are invalid, Dina said. Those patents have already been invalidated in Europe, he said.

``It's our hope that we can sort this out in a collaboration rather than a fight,'' Dina said. ``I think there's a very good chance of that happening.''

The possibilities include a licensing deal, a co-marketing agreement and the sale of either the drug or the company, Dina said.

``We're not ruling anything out,'' he said.

Dynavax plans to seek clearance to sell a two-dose regimen of Heplisav and will begin trials on that approach in Europe, Canada and the U.S. before the end of the year, Dina said. The company also plans to begin trials in people with kidney failure who are undergoing kidney dialysis, he said.

Heplisav works by stimulating the innate immune response to trigger the immune system to kill viral infected cells. It does this by stimulating Toll like receptor 9 which in turn activates T cells that will activate cascades leading to virally infected cell death.

Dynavax shares jumped to $9.73 at 7:28 p.m. in late trading after closing at $7.40 in Nasdaq Stock Market composite trading.

Tuesday, November 28, 2006

Commonwealth Biotech shares soar on Mimotopes buy

SAN FRANCISCO-- Commonwealth Biotechnologies Inc. shares soared 67% to $3.52 in Tuesday morning trade after the Richmond, Va.-based company said late Monday it has agreed to acquire Australia-based Mimotopes Pty Ltd, a unit of PharmAust Chemistry Ltd., which is itself a subsidiary of PharmAust Ltd. Under the terms of the deal, Commonwealth will issue 2.15 million shares of its common stock to PharmAust Chemistry. As a result, PharmAust, through its PharmAust Chemistry unit, will hold a 39.5% equity position in Commonwealth.

About CB-Commonwealth Biotechnologies, Inc., a contract research organization, provides research and development services to the biotechnology industry, academic institutions, government agencies, and pharmaceutical companies worldwide. It offers various services relating to the design, synthesis, purification, and analysis of peptides, proteins, and oligonucleotides, as well as creates assay and detection methods.

Anika Therapeutics Stock blowing up: Gets conditional FDA nod for wrinkle filler

NEW YORK, Nov 28- Anika Therapeutics Inc. said on Tuesday it received conditional approval from U.S. health regulators for its injectable filler for facial wrinkles.

The company said it expects final approval from the Food and Drug Administration by the end of this year, sending Anika shares more than 21 percent higher.

Anika did not specify what conditions the FDA had set before the agency will give its outright approval for the sale of the cosmetic tissue augmentation treatment.

ANIK is trading substantially up today at $14.81; that's up 3.25 or 29%.

Anika Therapeutics, Inc. engages in the development, manufacture, and commercialization of therapeutic products for tissue protection and healing. Its products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. HA is one of them simplest of the glycosaminoglycans which is a repeating sugar molecules up to 25,000 units. It is thought to play a role in resisting compressive forces in tissues and joints.

CytRx Phase IIa Arimoclomol Data to Be Presented at the 17th International Symposium on ALS/MND

LOS ANGELES--CytRx Corporation a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that Merit Cudkowicz, M.D. and Jeremy Shefner, M.D. will be presenting previously-released data from the Company's Phase IIa trial with its lead small molecule product candidate arimoclomol for the treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) at the 17th International Symposium on ALS/MND being held November 30 through December 2, 2006 in Yokohama, Japan. Drs. Cudkowicz and Shefner are co-principal study investigators of the trial.

A poster presentation titled "A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS" will be available on Thursday, November 30, and on Saturday, December 2. Dr. Cudkowicz will deliver a 15-minute closing slide presentation on the same topic beginning at 2:15 p.m. local time.

In September 2006, CytRx announced that primary endpoints were met in its Phase IIa double-blind, placebo-controlled, clinical trial of the safety and tolerability of arimoclomol compared with placebo over 12 weeks of treatment in patients with ALS. Initial Phase IIa data suggests the achievement of a secondary endpoint that includes drug absorption, distribution and elimination. Subject to U.S. Food and Drug Administration (FDA) approval, CytRx plans to initiate a Phase IIb clinical trial with arimoclomol for the treatment of ALS in the 3rd quarter of 2007.

Arimoclomol is one of CytRx's three orally-administered, small molecule compounds. This small molecule drug candidate is believed to function by stimulating a normal cellular protein repair pathway through the activation of "molecular chaperones." Since damaged proteins called aggregates are thought to play a role in many diseases, CytRx believes that activation of molecular chaperones could have therapeutic efficacy for a broad range of diseases. This is a normal biological process used for clearing dead cells, wounds, etc.
The FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS.


Nasdaq:CYTR is trading at $1.68, down 3 cents or 1.7% this morning.

Monday, November 27, 2006

Biotechnology Index down as well today:


Biotechnology
Composite Value: 1099.2
Today's Change: -1.11%
Not bad considering the NASDAQ finished down over 2%.

Targeted Genetics' stock skyrockets

Shares in Targeted Genetics Corp. shot up more than 60 percent in early trading Monday, but company officials say they don't know why the stock price is rising so rapidly.
"We don't have any announcements, and I don't have any rumors," said Stacie Byars, director of communications for the Seattle biotech.

She did point out that earlier this month Targeted Genetics reduced its debt to Biogen Idec, as the Massachusetts company took a larger ownership stake in the Seattle biotech.

In May, Targeted Genetics enacted a one-for-10 reverse stock split, which raised the company's stock price from the 35-cent-per-share range to more than $3 per share. In Monday's early trading, shares in Targeted Genetics shot up from $3.84 per share to about $6.30.

NASDAQ: TGEN - In late afternoon trading, TGEN is still up 1.99 at 5.79.

About TGEN- Targeted Genetics Corporation was incorporated in the state of Washington in 1989. They develop gene therapy products and technologies for treating both acquired and inherited diseases. The Company's gene therapy product candidates are designed to treat disease by regulating cellular function at a genetic level. Gene therapy products involve the use of delivery vehicles, called vectors, to place genetic material into target cells. Total revenue in 2004 was $9.7 million, compared to $14.1 million in 2003.

Genzyme Begins Phase 2 Pivotal Study of Clolar(R) in Adult Acute Myelogenous Leukemia

CAMBRIDGE, Mass.--Genzyme Corporation announced today that it has begun treating patients in a phase 2 clinical trial examining the safety and effectiveness of Clolar® (clofarabine) in previously untreated, older adult patients with acute myelogenous leukemia (AML) who are unlikely to benefit from standard induction therapy. This is Genzyme's second pivotal clinical study of clofarabine in adult patients with AML to commence this year, and it is expected to provide substantial support for expanding the current product label.

"We are very pleased to begin treatment in this clinical study as we seek to expand Clolar therapy to adult patients," stated Mark Enyedy, senior vice- president and general manager of Genzyme Oncology. "Significant data from investigator-sponsored clinical trials have already been presented regarding the use of Clolar in adult AML and show very encouraging results. The start of this new clinical study is another important step in our plan to broaden Clolar's label to benefit a larger patient population and address multiple lines of adult AML."

The trial is designed to address a high unmet medical need among older AML patients who currently have limited treatment options. According to the American Cancer Society, each year approximately 6,500 people over the age of 60 are diagnosed with AML in the U.S. The median survival for those receiving therapy can vary from one to thirteen months, and the five-year survival rate over the past three decades remains at less than 15 percent. Standard therapy is poorly tolerated and early induction mortality exceeds 30 percent in patients with poor risk factors.

"While the outlook for children and young adults with AML has improved during the last three decades due to advances in chemotherapy and bone marrow transplant, the majority of AML patients are over the age of sixty years and not able to tolerate these curative approaches," stated Harry Erba, M.D., Ph.D., of the University of Michigan Comprehensive Cancer Center. "This Genzyme-sponsored trial of clofarabine represents an attempt to develop a new effective therapy for this aggressive leukemia that can be tolerated by older patients."

Hagop M. Kantarjian, M.D. of The University of Texas M. D. Anderson Cancer Center, added that complete remission and response rates remain low among older AML patients. "Standard therapies for AML in this population are unsatisfactory. Older patients are often faced with treatment choices at either end of the spectrum: either toxic combination chemotherapy that has a high chance of treatment-related morbidity and mortality despite a low chance of cure, or very shortened survival with supportive care alone."

The clinical trial, known as CLASSIC II, builds on promising results from two phase 2 studies of clofarabine in previously untreated older patients with AML deemed unfit for chemotherapy. These studies were conducted by Alan Burnett, M.D., of Cardiff University in the United Kingdom. Dr. Burnett will present updated results from his UK clinical trials at the annual American Society of Hematology meeting taking place next month in Orlando, Florida.

How does clofarabine work?
Clofarabine is a purine nucleoside antimetabolite; which means it mimics one of the sugars in the DNA backbone. It is converted to it's toxic form once inside the body and inhibits DNA synthesis, such that cancer cells cannot replicate and grow. Side effects include tumor lysis syndrome which is the body's reaction to dead cells in the blood.


Genzyme Biotechnology (Nasdaq:GENZ) is trading down this morning 94 cents or 1.4% at 64.23.

Sunday, November 26, 2006

Off Topic: Stocks Expected to move on Monday

Among the companies whose shares are expected to see active trade in Monday's session are Donaldson Co., McKesson Corp. and Family Dollar Stores Inc.
Donaldson is expected to report earnings per share for the first quarter of 43 cents, according to analysts polled by Thomson First Call.


On Friday, AMR Corp. parent company of No. 1 U.S. carrier American Airlines, said 18% of the value of debt it offered to redeem was tendered by Wednesday in a purchase offer. AMR said $276.5 million of $338.4 million in debt securities will remain outstanding.
Bombardier Inc.'s Aerospace unit said M1 Travel Ltd. has ordered two Q400 turboprop airliners, and taken options on an additional four. The order is worth $51 million, and the Q400 aircraft will be operated by Flybaboo SA.

Companhia Vale do Rio Doce said it has signed a new 15-year contract with ThyssenKrupp Steel AG to supply iron ore and pellets to ThyssenKrupp CSA Companhia Siderurgica, which is a joint venture between ThyssenKrupp and CVRD. CVRD will supply 2.7 million tons of pellets and 5.9 million tons of iron ore per year to CSA.

Dearborn Bancorp Inc. declared a stock dividend of one share of its common stock for each 20 shares owned by stockholders of record as of Dec. 8. The stock dividend will be distributed on Dec. 22.

The chief executive of Deutsche Bank, Josef Ackermann, has agreed with state prosecutors to pay a 3.2 million euro fine in connection with the approval of bonuses to Mannesmann officials in 2000. The bonus award came after the mobile phone company's board approved its takeover by Vodafone Group. Judges will decide whether the settlement will be accepted next week.

Family Dollar said it won't file its annual report by the Friday extended deadline due to its continuing investigation into stock options.

Fossil Inc. said it has received a Nasdaq non-compliance notice over the company's failure to file its Form 10-Q for its third quarter ended Oct. 7. The watchmaker plans to request a hearing before a Nasdaq panel to request continued listing on the exchange.

McKesson said it has renewed its supply agreement with Wal-Mart Stores Inc.

Wal-Mart Stores, McKesson said the renewal extends a distribution agreement that dates back to 1988, and maintains McKesson as the primary supplier of brand pharmaceuticals for Wal-Mart stores in the U.S.
Odyssey Re Holdings Corp. said Patrick Kenny has been elected a director. He has been appointed to its Audit, Compensation, and Transaction Review committees. Frank Bennett has resigned from the board.

Quest Software Inc. said M. Brinkley Morse, the company's senior vice president of corporate development, has resigned after he declined to be interview by a special committee investigating the company's historical stock option grant practices.

Saturday, November 25, 2006

Amylin Pharmaceuticals to Present at Piper Jaffray Healthcare Conference

SAN DIEGO-- Amylin Pharmaceuticals, Inc. will be presenting at the Piper Jaffray Healthcare Conference on Friday, December 1, 2006 at 12:00 p.m. ET in New York. Mark G. Foletta, Senior Vice President, Finance and Chief Financial Officer of Amylin Pharmaceuticals, will be providing a corporate overview.

The live presentation and breakout session will be webcast, and a recording will be made available following the event. The webcast and recording will be accessible through Amylin's corporate website, located at www.amylin.com. To access the live webcast, please log on to Amylin's site approximately fifteen minutes prior to the presentation to register and download any necessary audio software.


AMLN biopharmaceuticals closed friday's half day down 51 cents (~1%) to 41.04.

Friday, November 24, 2006

More Biotechnology Stocks up on Friday:

BioMimetic Therapeutics' (BMTI) shares rose after an analyst at AG Edwards increased his price target on the stock. Pharmaceuticals analyst Jan Wald now sees a 2006 loss of $1.27 a share on sales of $3.6 million in 2006, improved from his previous expectations of a $1.95 loss per share on sales of $3.5 million. For 2007, he expects a loss of $1.33 on sales of $5.7 million, up from a $2.42 loss on sales of $5.9 million. Accordingly, he increased his price target on the stock to $18 from $11. BioMimetic shares were up 39 cents, or 3.9%, to $11.90.

Among other health care stocks rising Friday were PDL BioPharma (PDLI), up 2.6% to $23.09, Encysive Pharmaceuticals (ENCY), gaining 8.9% to $6.87, Labopharm (DDSS), 3.7% higher to $6.10, Iomai (IOMI), whose shares were boosted 5.9% to $5.17 and Sangamo Biosciences (SGMO), up 5.1% to $7.90.

Pharmaxis stock soars on fast track approval

Shares of drug developer Pharmaxis soared 20% after the company said it was granted fast track status by the Food and Drug Administration for its cystic fibrosis drug Bronchitol. The designation, which is granted for experimental drugs intended to address unmet medical needs, allows an expedited FDA review of its marketing application through a rolling submission, instead of submission of the entire application at once. The drug has already been granted orphan drug status for rare diseases, which waives the company's application fee and allows for certain tax benefits and marketing exclusivity.
Shares of Pharmaxis recently changed hands at $42, up $7.


What exactly is bronchitol and how does it work to be granted fast track?

Cystic fibrosis is the abnormal production and ineffective clearance of mucus in the lungs. Bronchitol restores the ability of patients’ lungs to clear mucus by promoting salt and water movement through airway cells.
Bronchitol is produced form a naturally occurring sugar called mannitol. The mannitol is formulated into a dry powder with a particle size small enough to allow it to be inhaled the lungs.
Bronchitol is thought to increase mucus clearance by changing the viscosity of the mucus and by acting like salt in the lung to draw water out of airway cells. It also stimulates the cough reflex to clear the excess mucus. If this works, it could really help the lives of people suffering from CF.

PXSL soared today with the NASDAQ composite about to close, is up 6 dollars (17%) to $41.22.

Thursday, November 23, 2006

Breaking News: Bayer sells Starck to Advent, Carlyle for $908 mln

German drugs and chemicals group Bayer said it planned to sell unit H.C. Starck to a consortium formed by Advent International and the Carlyle Group for 700 million euros ($908 million) plus debt.

Bayer said in a statement on Thursday the sale of one of its chemicals businesses, including debt of about 450 million euros, would help pay for its 17 billion euro acquisition of rival Schering .
The company aims to create a healthcare group with sales of around 15 billion euros with the Schering acquisition, enabling the merged entity to compete better with big global drugmakers.

Shares in Bayer were up 0.6 percent at 39.98 euros by 1448 GMT, outperforming a flat German blue-chip DAX .

"Bayer has fetched a good and fair price for the business," said Silke Stegemann, an analyst at Landesbank Rheinland-Pfalz.
Bayer said the Starck sale, which is expected to close early next year, would cut its net debt by about 1 billion euros and lead to a book gain of 150 million euros. Bayer's net debt stood at 19.95 billion euros at the end of June.

The Starck unit, which makes powders of metals such as molybdenum, tungsten and tantalum as well as ceramic powders, had sales of 920 million euros in 2005, up from 703 million euros a year earlier.
Bayer, which announced the planned sale in March this year, said the buyers intended to continue developing Starck with the aim of positioning the company for a stock market listing in three to five years.
A German newspaper reported last month that Bayer had received three bids for Starck. They were from Advent and Carlyle in a team, Belgian metals maker Umicore and financial investor Bain Capital.
Bayer has also sold its diagnostics business to engineering conglomerate Siemens for 4.2 billion euros to help pay for Schering.

Analyst says Sangamo BioSciences could be target

NEW YORK- Sangamo BioSciences Inc. which is developing products for congestive heart failure and HIV, could become a takeover target for big pharmaceutical companies, an analyst said on Wednesday.

Navdeep Jaikaria, a biotech analyst with Rodman & Renshaw believes Sangamo is just the kind of company "with novel science behind their products," that the drug companies would be interested in acquiring, according to BusinessWeek magazine.

Meanwhile, Pamela Bassett, of Cantor Fitzgerald, told the magazine that Sangamo's stock could rise to $17 in the next 12 months. It closed on the Nasdaq on Wednesday at $7.52.

In September the company that a protein it developed appeared to make human immune system cells permanently resistant to HIV infection.

Sangamo officials couldn't be reached immediately for comment.

NASDAQ:SGMO closed wednesday's after hours trading up 19 cents to $7.71 (2.5%).

Some info on the company: Sangamo Biosciences, Inc. engages in the research, development, and commercialization of DNA binding proteins for the therapeutic regulation and modification of disease-related genes. Its technology platform is based on the engineering of a class of proteins known as zinc finger DNA-binding proteins (ZFPs). The applications of the company’s technology include pharmaceutical protein production, development of human therapeutics, and plant agriculture. It has also initiated preclinical animal studies of ZFP therapeutics in congestive heart failure, nerve regeneration, and neuropathic pain; and has research-stage programs in human immunodeficiency virus, X-linked severe combined immunodeficiency, hemophilia and hemoglobinopathies, and cancer and cancer immunotherapy.
Interesting ideas and science.

Wednesday, November 22, 2006

Nasdaq , S & P end at multiyear highs, Biotechnology finishes down

The Nasdaq composite surged to its highest point in nearly six years Wednesday, after Dell's upbeat earnings helped spark a rally in technology.

But the blue-chip averages meandered the day before Thanksgiving, with investors distressed by a slump in GM shares on news that one of its major shareholders has substantially cut its stake in the automaker.

The Nasdaq composite (up 11.14 to 2,465.98) added almost 0.5 percent ending at its highest point since February 2001.

The Dow Jones industrial average (up 5.36 to 12,326.95) ended the session just above unchanged. The blue-chip barometer briefly hit a record trading high of 12,360.52 in the first minutes of trade, before retreating.

The broader S&P 500 (up 3.28 to 1,406.09) index added 0.2 percent and closed at a six-year high.

An Appropriate Term Of The Day 11/22/06: Turkey

Slang for an investment that yields disappointing results or
turns out worse than expected. Failed business deals, securities
that realize significant losses and unsuccessful IPOs could
all be called "turkeys". Biotechnology always seems to serve up some of these it seems on a monthly basis. Not so much for big Pharma.

For an individual investor, a turkey could be a speculative
equity investment in a startup technology company that
subsequently goes bankrupt. For a corporation, a turkey could
be the purchase of a smaller company that ends up producing
much less revenue than anticipated, making it an investment
that gobbles up the company's profits.

PDL BioPharma, Inc. Announces Roche To Discontinue Co-Development Of Daclizumab

FREMONT, Calif.-- PDL BioPharma, Inc. announced that Roche will discontinue its agreement with PDL to jointly develop and commercialize daclizumab for organ transplant patients on longer-term maintenance therapy. Roche made this decision subsequent to a periodic internal review of its development programs. This decision follows another decision by Roche earlier this year to discontinue its involvement in the co-development of daclizumab for the treatment of asthma. The co-development agreement between PDL and Roche will formally terminate in May 2007.

As a result, PDL will hold exclusive development and commercial rights to daclizumab for transplant maintenance, which has shown potential in both the transplant maintenance and asthma indications based on earlier clinical trials. In a separate collaboration, Biogen Idec and PDL are developing daclizumab in multiple sclerosis and indications other than transplant and respiratory diseases.

"We are evaluating the overall transplant maintenance indication opportunity for daclizumab, while we continue to support the ongoing studies of daclizumab in relapsing/remitting multiple sclerosis, and anticipate results from the ongoing Phase 2 CHOICE study, which is testing daclizumab in combination with beta-interferon, during 2007," said Mark McDade, Chief Executive Officer, PDL BioPharma. "In the meantime, efforts are ongoing to evaluate partnership opportunities for this important drug in asthma."

WHAT IS DACLIZUMAB AND HOW DOES IT WORK?
Daclizumab is an immunosuppressive that inhibits the immune system from invading the transplant site thus helping to prevent rejection. It is a humanized monoclonal antibody that binds to the interleukin 2 receptor (CD25). The end result is that when bound to the IL2 receptor, the lymphocyte cannot proliferate and grow. These T lymphocytes are responsible for organ rejection. Daclizumab is mainly indicated in kidney transplant, but has entered clinical trials for MS.
It is prescribed under the brand name zenapax.


(PDLI)Biopharmaceuticals is trading today down 40 cents to 22.27$ on the nasdaq exchange.

Tuesday, November 21, 2006

Pharmacyclics, Inc. Announces Presentation Of Pooled Analysis Of Xcytrin(R) For Lung Cancer Brain Metastases

SUNNYVALE, Calif.-- Pharmacyclics, Inc. announced the presentation of pooled results from two randomized Phase 3 clinical trials, which indicate that Xcytrin(R) (motexafin gadolinium) Injection combined with whole brain radiation therapy (WBRT) significantly prolonged time to neurologic progression in non-small cell lung cancer (NSCLC) patients with brain metastases. The presentation took place at the Society for Neuro-Oncology's 11th Annual Meeting being held this week in Orlando, FL.

"These data demonstrate that Xcytrin, used in combination with whole brain radiation therapy, may significantly improve neurologic outcomes in patients with brain metastases from non-small cell lung cancer," said William R. Shapiro, M.D., chief of the Neuro-Oncology Division of Neurology at the Barrow Neurological Institute, and presenter of the pooled Phase 3 results. "These two large studies both used an innovative and clinically meaningful endpoint and reveal consistent benefit in this patient population."

Brain metastases occur when cancer cells spread to the brain and grow, causing major neurologic complications. Patients with brain metastases usually suffer serious deterioration of neurologic and neurocognitive function such as loss of short-term memory, compromised verbal skills and fine motor coordination, and reduction in cognitive performance. Most patients with brain metastases are treated with WBRT.

Pharmacyclics is developing Xcytrin as an anti-cancer agent with a novel mechanism of action that is designed to selectively concentrate in tumors and induce apoptosis (programmed cell death). Xcytrin is a redox-active drug that has been shown to disrupt redox-dependent pathways [how cells control reactive radicals inside the cell such as O 2]in cells and inhibit oxidative stress related proteins. Its multifunctional mode of action provides the opportunity to be used in a broad range of cancers.


PCYC pharmaceuticals closed trading today on the NASDAQ exchange up 5.2% (31 cents) to $6.21.

Vion Pharmaceuticals shares up 13% today

Vion has entered phase III trial with it's anti cancer drug Cloretazine in combination with cytarabine in the treatment of relapsed acute myelogenous leukemia.

Cloretazine is a DNA alkylating agent that transfers an alkyl group to it's target within the cell. This leads to DNA strand breakage especially in cells that are replicating (cancer cells) and leads to cell death. These cells seem to lose the ability to initiate DNA repair as well.

VION is trading at $1.79. I could see this stock reaching 5 dollars.

About VION:
The Company is a development stage company engaged in the development of novel therapeutics for the treatment of cancer. Its portfolio of potential products consists of two distinct small molecule anticancer agents in clinical development, and additional small molecules and a drug delivery system in preclinical development. The Company's product development programs are based on technologies that it licenses from Yale University and other cancer research centers. The Company's product development strategy consists of two approaches. First, it engages in product development with respect to novel anticancer therapeutics through in-house preclinical and clinical development and through collaboration with academic institutions. Second, depending on financial and pharmaceutical market conditions and required resources, the Company determines the method and/or partnership to develop, and eventually market, its products.

Monday, November 20, 2006

Cardica shares soar in FDA approval of C-Port xA system

SAN FRANCISCO-- Cardica Inc. shares rocketed up 68% to $8.80 in Monday morning trade after the Redwood City, Calif.-based company said it has received 510(k) clearance from the Food and Drug Administration to market its C-Port xA distal anastomosis system in the U.S. The company said the C-Port xA system automates the creation of anastomoses, or attachments of blood vessels and grafts, such as those in coronary artery bypass graft surgeries.

What is an anastomosis? It's the literal stitching together of two blood vessels done by the surgeon. It is time consuming and tedious. This machine then does the ligation of two blood vessels together by inserting minute staples into the vessel walls. The resulting junctions are leak proof and can fluctuate with blood flow. It will mainly be used in coronary atertery diseased patients and graft insertions. Very Cool indeed.!

CRDC shares shot up 36% today to close at $7.17 on heavy trading.

Biocryst Pharmaceuticals' Fodosine Gets Orphan Status Designation in Europe

BIRMINGHAM, Ala.-- Biocryst Pharmaceuticals Inc. said Monday European regulators granted its developing leukemia treatment Fodosine orphan drug status.
The designation by the European Medicines Agency gives the drug 10 years of market exclusivity if it is approved. It also holds the potential for agency assistance with clinical development, a research grant and reduction in regulatory fees.

Fodosine is currently in midstage to late stage studies aimed at testing its effectiveness against a specific type of leukemia, called T-Cell acute lymphoblastic leukemia.

What is Fodosine?
Fodosine is a transition state purine nucleoside phosphorylase (PNP) inhibitor, which functions by blocking the DNA synthesis machinery of the body's T-cells. It is specific for immune cells. The small molecule drug is being developed for treatment of T-cell mediated cancers, and has been designated an "Orphan Drug" for several indications, including T-cell leukemia, cutaneous T-cell lymphoma (CTCL), chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL).

The U.S. Food and Drug Administration granted the drug orphan status in 2005 for several types of leukemia.

Biocryst shares added 27 cents, or 2.3 percent, to $12 in premarket electronic trading, from their close Friday at $11.73 on the Nasdaq.

Sunday, November 19, 2006

Advanced Magnetics, Inc. announces results From Phase III Study Of Ferumoxytol; Shares R

CAMBRIDGE, Mass.,-- Advanced Magnetics announced positive results from a Phase III clinical trial of ferumoxytol as an intravenous (IV) iron replacement therapeutic that is being presented at the American Society of Nephrology's Renal Week 2006 Annual Meeting in San Diego, CA. A poster entitled "Ferumoxytol as Intravenous Iron Replacement Therapy in Chronic Kidney Disease (CKD) Patients Not on Dialysis -- Evaluation of Safety and Efficacy in Two Phase III Studies" is being presented today at 10:00 am PT. The study enrolled 304 non dialysis-dependent chronic kidney disease patients (NDD-CKD) who were randomized to receive either two 510 mg doses of ferumoxytol within one week or 200 mg of oral iron daily for three weeks. The study demonstrated a statistically significant achievement of all the primary and secondary endpoints. Additionally, all primary and secondary endpoints were statistically significant in both patients on erythropoiesis stimulating proteins (ESP) and those not on ESPs.

So what does this say?:
Anemia is common in patients with advanced chronic kidney disease (CKD) and can lead to a variety of detrimental effects. In addition to the direct effects of anemia on performance and ischemic symptoms, it has also been suggested that mortality and major complications during end-stage renal disease (ESRD) are associated with anemia that develops early in the course of CKD. Correcting anemia before the initiation of renal replacement therapy (RRT) may improve health outcomes.
Iron deficiency is treatable and failure to replete iron stores may result in resistance to erythropoietin.

AMAG closed friday trading up up $13.10 dollars per share or 29%. In after hours trading the trend continued as it went up another 45 cents to close at $57.45. I'm keeping my eye on this company for the letter of approval from the FDA in the future. I will post if I pull the trigger on the stock.

Saturday, November 18, 2006

.FDA Approves First-Time Generic:

ALTANA Inc. and the FDA announced friday that Sulfacetamide Sodium Topical Suspension USP, 10%, will be available as generic.

Drug name Plexion is indicated for the treatment of acne and rosacea.
Plexion TS Emulsion is a sulfonamide antibiotic and keratolytic. It works by killing bacteria and shedding the top layer of skin to help treat acne.

The generic is made by Altana, Inc. and trades on the New York Stock Exchange under the ticker symbol AAA. AAA was down at friday's close to 57.91.

I would have assumed that a first time generic would have had a bigger impact on the trading price. The generic drug is made by Altana's generic department under the name fougera.

Friday, November 17, 2006

Duramed Pharmaceuticals, Inc. Plan B(R) OTC Now Available In Pharmacies Nationwide

NEW YORK, Nov. 17-- The new dual-label Plan B(R) (levonorgestrel) emergency contraceptive arrives in pharmacies this week. To help patients, pharmacists, and healthcare providers understand how this unprecedented product status - Rx and Over-the-Counter (OTC) - will work, Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., will launch the CARE (Convenient Access Responsible Education) Program, a comprehensive education program for healthcare professionals and consumers.

Approved on August 24, 2006, the new dual-label Plan B(R) is an OTC product for consumers 18 years of age and older and prescription only for women 17 and younger. It is marketed as a single package, which allows for a prescription label to be adhered to the package when dispensed to women age 17 and younger.

"We are pleased with the FDA's historic decision, which gives women more timely access to Plan B(R) emergency contraception," said Amy Niemann, Vice President of Marketing-Proprietary Products at Duramed Pharmaceuticals, Inc. "We are committed to educating consumers on the facts about Plan B(R), as well as how they can purchase the product depending on their age."

Plan B works in the same way a regular daily birth control pill works.
It consists of two tablets of 0.75 mg levonorgestrel (synthetic estrogens), that prevent ovulation or fertilization; it may also inhibit implantation. Once implantation occurs, Plan B(R) is not effective.


BRL ended today's trading largely unchange at $49.52

Good Trend

Genentech breast-cancer drug gets FDA OK

Shares of Genentech Inc. rose 77 cents Friday, a day after the Food and Drug Administration approved its Herceptin drug as part of a breast-cancer regimen.
South San Francisco-based Genentech said late Thursday the drug was OK'd for women with early-stage breast cancer who have had surgery, with or without radiation therapy.

The treatment is designed to reduce the risk of cancer recurrence or the occurrence of metastatic disease.

The FDA approval was based on data from an interim joint analysis of more than 3,500 patients enrolled in two third-phase clinical trials., which showed that the addition of Herceptin to standard adjuvant therapy significantly reduced the risk of breast cancer recurrence, Genentech said.

Remember that Herceptin is a humanized monoclonal antibody to the epidermal growth factor family member, Her2. It keeps the receptor from signaling.

In midday trading, shares were at $81.49 after closing the day before at $80.72.

Thursday, November 16, 2006

Antigenics Data Shows Vaccine Oncophage Produces Immune Response in Nerve Cancer Patients

ORLANDO, Fla. (AP) -- Biotech drug developer Antigenics Inc. said Thursday its cancer vaccine Oncophage produced a specific immune response to cancer of the nervous system.
In a early-to-midstage clinical trial, six patients with high-grade glioma given Oncophage showed an immune reponse specific to their tumors. Glioma is a cancer that affects the connective tissue cells that surround and support nerve cells.

"This is the first documentation of a glioma-specific immune response after vaccination with Oncophage," said Dr. Andrew T. Parsa, a principal investigator in the trial.

Oncophage uses material from an individual's tumor to reprogram the body's immune system to attack target cells with similar genetic material.

Antigenics shares rose 6 cents, or 2.6 percent, to $2.37 in afternoon trading on the Nasdaq.

Biotech's Business Models Evolve as Industry Matures

San Diego- Cautious optimism reigned at the inaugural BIOCOM San Diego Investor Conference, both for the future of the fledgling event and for the availability of financing as biotech business models continue to mature.

Biotech once held the monopoly on cutting-edge scientific innovation, but pharmaceutical companies have developed massive research and development engines, thereby invading the historical biotech territory, and they are doing so with R&D budgets that dwart what biotech can afford.
So what's to do?

Former executive chairman fo Biogen Idec Inc. William Rastetter, who also is a new partner at Venrock Associates, addressed those issues in his plenary breakfast speech. He advised applying many of the same principles that helped him gorw Idec Pharmaceuticals from a San Diego based start up to a multibillion dollar powerhouse, eventually merging with Biogen Inc, to form the world's third largest biotech. His tips included protecting assets with strong intellectual property, fostering an environment of collaborative inquiry and implementing a focused strategy.

Rastetter also advised companies to become the best in the world at something the "establishment" doesnt like or understand. At Idec's inception, that was monoclonal antibodies-specifically using a single antibody to treat a broad patient population. Today, he sees regenerative medicine as an area in which biotech may be able to exel while pharmaceutical companies hang back.

Drug stocks end with gain, biotechs slip

Drug stocks ended Thursday in positive territory while a Food and Drug Administration panel met to discuss the safety review of 16 drugs in children.
The FDA panel will make recommendations that may include changes to some of the drugs' labels.
The drugs being discussed range from Wyeth's Rapamune, which helps to prevent the rejection of kidney transplants, to Abbott Laboratories's HIV treatment Norvir and Pfizer Inc.'s cholesterol drug Lipitor.

Shares of GlaxoSmithKline PLC ended the session with a slight gain. The FDA gave priority review to Tykerb for use in connection with Xeoloda to treat metastatic or advanced breast cancer in women who have received prior therapy.

Industry bellwether Merck & Co. Inc.'s shares ended up more than 1%. The drugmaker said it has inked an agreement with India's Advinus Therapeutics Ltd. for the development of drug candidates for metabolic disorders.
Zoll Medical Corp. shares, meanwhile, rocketed higher by more than 28% after the maker of resuscitation devices and software reported fiscal fourth-quarter net earnings of $5.4 million, or 55 cents a share, up from $2.24 million, or 23 cents a share, in the year-ago period. Revenue rose to $72.3 million from $57.1 million.
The DJ Wilshire Pharmaceuticals Index added 16.54 points to close at 2360.65. The DJ Wilshire Biotechnology Index, meanwhile, slipped 2.30 points to close at 3269.19.

Shares of Dendreon Corp. ended down 11% after the company said it has agreed to sell 9.89 million shares to institutional investors for $45 million, before deducting fees and expenses.

But shares of Neurocrine Biosciences Inc. closed with a more than 5% rise after being upgraded to peer perform from underperform at Bear Stearns. The brokerage firm said the regulatory strategy for the company's insomnia drug candidate, Indiplon, removes an overhang on the stock.

GlaxoSmithKline Wins Priority Review For Tykerb Cancer Drug

LONDON, Nov 16- GlaxoSmithKline Plc's new breast cancer pill Tykerb will receive a priority review from U.S. regulators in a move that should speed its path onto the world's biggest drugs market next year, it said on Thursday.

GSK.L closed trading thursday at $51.97 or up 42 cents.

Another run at a Dow record

Blue-chip average in record territory on mild inflation, merger news; techs hurt by Dell, AMAT; oil turns lower.

NEW YORK-- The Dow industrials flirted with a new high near midday Thursday due to a mild inflation reading and a pair of big corporate deals, but tech stocks struggled after discouraging news from Dell and Applied Materials.

The Dow Jones industrial average (up 38.02 to 12,289.73, Charts) rose 0.3 percent around 2-1/2 hours into the session, briefly touching a new record trading high, before scaling back a bit. The blue-chip barometer ended the previous session at a record high for the 16th time since Oct. 3.

The broader S&P 500 (up 3.46 to 1,400.03, Charts) index added 0.3 percent after ending the previous session at its highest level since Nov. 9, 2000.

The tech-fueled Nasdaq composite (down 1.42 to 2,441.33, Charts) was little changed after ending the previous session at its highest level since Feb. 15, 2001.

"The CPI report was good news for investors, in that it shows inflation pressures continue to abate," said Alan Gayle, senior investment strategist at Trusco Capital Management.

"But the market has had a strong run and has already prices in a lot of good news," he said. "So this CPI report doesn't have the positive impact it used to."

Since bottoming in July, the major gauges have been on an upswing, as investors have reacted well to a bevy of supportive factors. They include: lower oil prices, improved quarterly earnings, a Federal Reserve that has halted its interest rate campaign, and bets that inflation is moderating and the economy has avoided a so-called "hard landing."

Roche and FDA issue warning on tamiflu: YIKES!

Tamiflu (oseltamivir phosphate)

Audience: Pediatric and primary care healthcare professionals and patients

Roche and FDA notified healthcare professionals of revisions to the PRECAUTIONS/Neuropsychiatric Events and Patient Information sections of the prescribing information for Tamiflu, indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days and for the prophylaxis of influenza in patients 1 year and older.There have been postmarketing reports (mostly from Japan) of self-injury and delirium with the use of Tamiflu in patients with influenza. People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior. A healthcare professional should be contacted immediately if the patient taking Tamiflu shows any signs of unusual behavior.

It works by stopping the virion particle from separating itself from human cells and proliferating.

Roche is a leading healthcare company with a uniquely broad spectrum of innovative solutions. For more than 100 years, we have been active in the discovery, development, manufacture and marketing of novel healthcare solutions. Our products and services address prevention, diagnosis and treatment of diseases, thus enhancing well-being and quality of life.

Wednesday, November 15, 2006

DOW scores record close today

NEW YORK-- Wall Street rallied again Wednesday, with the Dow Jones industrials scoring another record close as investors grew more confident that the Federal Reserve has inflation in hand. An $8 billion bid from US Airways Group Inc. for Delta Air Lines Inc. added to the market's momentum.

Minutes from the Fed's Oct. 24-25 meeting showed the central bank's governors remain more worried about inflation than the risk the economy would slow too quickly under higher interest rates. Investors seemed to be buying on the notion that the Fed had struck a balance between taming inflation and keeping the economy from falling into recession.

Investors also cheered the possibility of consolidation in the airline industry and remained upbeat following sharp gains Tuesday.

"I think the case for a soft landing is building," said Stuart Schweitzer, global markets strategist at JP Morgan Asset and Wealth Management. "It looks as though the Fed is bringing the economy in for a true soft landing with growth slowing down but not too much."

The Dow rose 33.70, or 0.28 percent, to 12,251.71, moving further into record territory. The Dow set a new trading high of 12,291.73. The energy, industrials and consumer staples sectors led the advance.

Broader stock indicators also gained. The S&P advanced 3.35, or 0.24 percent, to 1,396.57 and passed the 1,400 mark during the session for the first time since 2000. The S&P's record high of 1,527.46 came in the spring of 2000.

The Nasdaq composite index rose 12.09, or 0.50 percent, to 2,442.75, its highest level in 5 3/4 years.

FDA Allows Resumption Of Immunomedics, Inc. Lupus Trials With Epratuzumab

MORRIS PLAINS, N.J.-- Immunomedics, Inc. , a biopharmaceutical company focused on developing therapeutic monoclonal antibodies, today announced that their partner, UCB , has received notification from FDA that the clinical hold on existing trials with epratuzumab in patients with lupus has been lifted.

"We are pleased that the FDA has agreed to remove the clinical hold status of the trials, and we plan to continue to work closely with UCB to make epratuzumab available to patients who were in the suspended trials, and who remain in urgent need," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics.

Protocol amendments will now be submitted to Institutional Review Boards to seek approval to treat patients who remain on the currently suspended studies, and who are in need of re-treatment.

Epratuzumab is a monoclonal antibody that is specific for CD22. CD22 is a designation for a protein on B cells of the immune system. When this antibody binds to [B lymphocyte adhsesion molecule] the B cell cannot be activated, thus halting self antibody production, of which consitutes lupus. FYI, the most common auto antibody in lupus is specific for double stranded DNA.

IMMU closed today's trading on the NASDAQ exchange at 2.46 or up 1 cent per share.

Acorda Therapeutics Added to NASDAQ Biotechnology Index

HAWTHORNE, N.Y.--Acorda Therapeutics, Inc. today announced that it has been selected for addition to the Nasdaq Biotechnology Index, which will be effective at the market's opening on Monday, November 20, 2006. "We are very pleased to be included in the NASDAQ Biotechnology Index and believe that our selection to this index is recognition of Acorda's consistent progress and achievements," said Ron Cohen, M.D., President and CEO of Acorda. "We are committed to delivering on our mission to develop therapies to restore neurological function to people with spinal cord injury, multiple sclerosis and other disorders of the nervous system."

The NASDAQ Biotechnology Index was launched in 1993 and includes contains securities of NASDAQ-listed companies that meet minimum requirements, including market value, average daily share volume, and seasoning as a public company, among other criteria. The index is ranked on a semi-annual basis in May and November and serves as the basis for the iShares NASDAQ Biotechnology Index Fund (Amex: IBB - News). For more information about the NASDAQ Biotechnology Index, including eligibility criteria, visit www.nasdaq.com.

ACOR is trading up 65 cents or 4.4% at $15.27 in afternoon trading.

Early Asian Update: Taiwan leads advance; Japan's Canon also rises

HONG KONG-- Asian stocks mostly rose Wednesday, with Taiwan leading the gainers on strength in technology shares such as Taiwan Semiconductor Manufacturing Co., following strong gains in the technology-oriented U.S. Nasdaq index.
Taiwan's Weighted Price Index gained 0.5%.
Japan's Nikkei 225 Average ended lower, but broader losses in the index were cushioned by gains in consumer electronics makers such as Canon Inc. on expectations of upbeat holiday season sales after U.S. retailers reported strong results.
Tokyo's Nikkei 225 Average ended 0.3% lower to 16,243.47. The broader Topix index fell 0.3% to 1,592.00.
U.S. stocks rose Tuesday, sending the Dow Industrials to a record close, as investors cheered data showing a greater-than-expected fall in core U.S. producer prices, while a separate report showed consumer retail spending, although easing, held up better than had been expected.
Elsewhere in the region, Australia's S&P/ASX 200 fell 0.1%. Singapore's Straits Times Index rose 0.4% while Malaysia's KLSE Composite traded flat fell 0.4%. South Korea's Kospi rose 0.3% while New Zealand's NZX-50 Index ended 0.2% lower. Share indexes in Thailand traded flat. Shanghai's Composite Index rose 1.2%.
Hong Kong's Hang Seng Index ended the morning session up 0.6% to 18,990.22, led by gains in selected China-related stocks and property shares.
The China Enterprises Index, a gauge of China-incorporated shares listed in Hong Kong, rose 1%.
"The U.S. producer price data came as a surprise and the threat of inflation in the U.S. seems to subsiding," said Marco Mak, head of research at Tai Fook Securities in Hong Kong. "The Hong Kong index is still on the uptrend as investors have become more convinced interest rates will fall going forward."

Tuesday, November 14, 2006

Anadys Pharmaceuticals Stock jumps

Up today 98 cents or 25%. Investors are cashing in on upcoming data to be presented over the next couple of months. ANDS volume nearly tripled from the 3 month average.

Anadys, a biopharmaceutical company, engages in discovering, developing, and commercializing small molecule medicines for the treatment of viral diseases and cancer. The company has core expertise in structure-based drug design coupled with medicinal chemistry and Toll-Like Receptor-based small molecule therapeutics. Its clinical development program includes ANA380 for the treatment of HBV, currently in mid-stage clinical development. Anadys Pharmaceuticals also focuses on the development of the ANA975 program for the treatment of HCV and HBV. In addition, it has an oncology program with the oral TLR-7 agonist, ANA773; a direct antiviral HCV program around a series of non-nucleoside NS5B inhibitors; a program with the oral TLR-7 agonist with potential utility in viral and non-viral applications; and a HIV program focused on viral entry in pre-clinical development.

Biotechnology Stocks Finish up $4.4% today...


Let's hope it keeps building momentum through the holidays.

Allo Therapeutics stock Up on Tuesday Afternoon

WESTMINSTER, Colo.-- Allos Therapeutics, Inc. announced the presentation of updated safety results from its Phase 1/2 trial of PDX (pralatrexate) in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Hodgkin's disease.

PDX is a dihydrofolate reductase inhibitor, a folic acid dependent enzyme that is essential in the replication of DNA in rapidly proliferating cells. Inhibiting DHFR has been drug targets in biopharmaceutical companies for a long time being targets of bacterial infections, cancer, viral infections and so on.

Allos Therapeutics is up ~16% to $5.75 in afternoon heavy trading. The stock was also recently up-graded to "buy" by Reit.

Monday, November 13, 2006

Asian Stocks Up

HONG KONG-- Asian stocks were higher early Tuesday, with Japan's Nikkei 225 index leading the region after stronger-than-expected gross domestic product data inspired buying in blue-chip stocks such as Mitsubishi UFJ.
Japan's economy expanded 0.5% in the three-months ending in September from the previous quarter, its seventh straight quarter of expansion, the government said shortly before the start of trading.

Tokyo's Nikkei 225 Index gained as much as 1.7% to 16,286.81. The broader Topix index rose 1.7% to 1,595.85.

Elsewhere in the region, Australia's S&P/ASX 200 rose 0.4%. Singapore's Straits Times Index was up 0.5% while South Korea's Kospi added 0.5%. Taiwan's Weighted Price Index rose 0.7% and Malaysia's KLSE composite rose 0.4%.
Shares of Mitsubishi UFJ , Japan's largest bank by assets, rose as much as 3.6%

Biotechnology and Drug Stocks Mixed Today

The Amex Pharmaceutical Index edged up 0.4% to close at 325.47 and the Amex

Biotechnology Index fell 1.8% to 666.50.

Biotech index component Vertex (VRTX : Vertex Pharmaceuticals Inc) skidded 7% to $34.82. After market close Tuesday, the anti-viral drug developer reported a quarterly net loss of $50.1 million, or 47 cents a share. This compared to a net loss of $44.7 million, or 56 cents a share, last year.

Biogen Idec dipped as low as $42.52 before closing down marginally at $44.07.
For the first quarter, Biogen posted earnings of $123 million, or 36 cents a share. The Cambridge, Mass.-based company netted $43 million, or 12 cents a share, in last year's corresponding period. Revenue climbed 4% to $611 million, from $588 million last year, but still fell short of Wall Street expectations.

Discovery Laboratories was on the rebound, after sinking over 50% on Tuesday on news that manufacturing problems were delaying approval of its pediatric respiratory treatment Surfaxin.
Shares of Discovery shot up 17% to close at $2.58.

Also climbing was German drugmaker Bayer AG, up 3% at $43.70. The FDA awarded its drug candidate Nexavar orphan drug status in the treatment of liver cancer, meaning that if it receives approval, it will enjoy seven years of market exclusivity for that condition. Nexavar is already approved in the U.S. for the treatment of kidney cancer.
Gilead Sciences tumbled 7% to close at $57.31. The HIV drug developer announced on Tuesday that it had closed on a $1.3 billion sale of convertible senior notes.

Illumina to buy Solexa for about $600M

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Illumina Inc. said Monday it will buy Solexa Inc. for about $600 million.
San Diego-based Illumina is offering about $14 a share in its stock for every share of Hayward-based Solexa (NASDAQ:SLXA - News).

At Solexa's Friday closing price, the offer represents a 44 percent premium. Solexa shot up to $12.90 in midday trading upon the news. Illumina stock was down about 8 percent to $40.36.

In addition to the stock, Illumina has agreed to invest $50 million in Solexa in exchange for newly issued Solexa shares, subject to customary closing conditions.

Along with its Hayward headquarters, Solexa has operations in Cambridge, England. The company developed a genetic analysis system for use in whole genome sequencing, targeted resequencing, digital gene expression and microRNA analysis.

The companies said the market opportunity in sequencing is estimated at $1 billion, creating a market opportunity for the combined company in excess of $2.25 billion.

Illumina said it expects to maintain Solexa's operations in both California and Cambridge, and two members of Solexa's board will join the Illumina board.

Solexa Monday reported it narrowed its third-quarter loss to $9.9 million, or 27 cents per share, for the third quarter ended Sept. 30, compared with a net loss of $10.8 million, or 43 cents per share, for the same quarter in 2005.

Analysts polled by Thomson Financial expected a loss of 23 cents per share.

Total revenue for the quarter was $569,000, compared with revenue of $844,000 a year earlier.

The San Diego based Biotechnology company closed trading today (NASDAQ:ILMN) down 11.5%.

Pancreatic Islet Picture



Pancreatic islet stained for insulin (green), glucogen (red) and DNA (blue).
The rest of the blue only cells are surrounding cells of the pancreas. Glucogen is the precursor of glucose.

Novartis International AG Diabetes drug Delayed--Shares Down

ZURICH - A U.S. decision on approving Novartis AG's key diabetes drug Galvus has been delayed by three months after the firm asked the Food and Drug Administration to consider new clinical trials data, sending its shares sharply lower.

Galvus (vildagliptin) works by stimulating the cells (islet) in the pancreas to be more responsive to glucose, thus lowering blood glucose. Specifically, it is DPP4 inhibitor. DPP4 inhibitors prolong the half-life of incretins such as GLP-1 and GIP resulting in increased insulin secretion, decreased glucagon secretion, delayed gastric emptying, and reduced food intake. Several drugs of the DPP4 inhibitor class have been shown to improve blood glucose.

Novartis Pharmaceuticals division is trading down almost $1 to 58.44 just before market close.

Sunday, November 12, 2006

Barr Pharmaceuticals Receives Approval for generic Zydis

WOODCLIFF LAKE, N.J. -- Barr Pharmaceuticals, Inc. announced that its subsidiary, Barr Laboratories, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly and Company's ZYPREXA(R) Zydis(R) (Olanzapine) Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg. The Company anticipates receiving final approval following the expiration of the 30-month stay in April 2007.

The patent listed in the Orange Book for ZYPREXA Zydis expires on April 23, 2011. Barr's Abbreviated New Drug Application (ANDA) alleges that the Orange Book listed patent is invalid, unenforceable and/or would not be infringed by Barr's product.

Barr filed its ANDA containing a paragraph IV certification for a generic ZYPREXA Zydis product with the FDA in August 2004, and received notification of the application's acceptance for filing in September 2004. Following receipt of the notice from the FDA, Barr notified Lilly Industries Limited, the patent owner, and Eli Lilly & Company, the New Drug Application (NDA) holder. On December 1, 2004, Lilly Industries Limited and Eli Lilly & Company filed suit in U.S. District Court, Southern District of Indiana to prevent Barr from proceeding with the commercialization of its product, formally initiating the patent challenge process under the Hatch-Waxman Act.

ZYPREXA (olanzapine) is indicated for the treatment of schizophrenia and for the short-term treatment of acute manic episodes associated with Bipolar I disorder. The product had annual sales of approximately $246 million for the twelve months ended September 2006, based on IMS sales data.

The big disadvantage of olanzapine is weight gain.
Barr Pharmaceuticals is down 42 cents today.

Friday, November 10, 2006

Geron Corporation Presents Early Clinical Trial Data For Its Telomerase Inhibitor Cancer Drug

MENLO PARK, Calif.--(BUSINESS WIRE)--Geron Corporation today announced the presentation of the first clinical trial data for its telomerase inhibitor cancer drug, GRN163L, at the 18th EORTC-NCI-AACR International Conference on “Molecular Targets and Cancer Therapeutics” in Prague.

Presented by Laurence Elias, M.D., Geron’s vice president, oncology clinical development, the data demonstrate the safety, tolerability and predicted pharmacokinetics in low-dose cohorts from a Phase I/II trial in patients with chronic lymphocytic leukemia (CLL) and a Phase I trial in patients with solid tumors.

“The early clinical data are very encouraging,” said Alan Colowick, M.D., Geron’s president, oncology. “This is the first time telomerase inhibition has been tested in cancer patients. The excellent tolerability and pharmacokinetics observed so far enable us to advance to the therapeutic dose cohorts, where we hope to demonstrate safe, sustained telomerase inhibition in the targeted tumor cells.”


WHAT IS TELOMERASE?
The therapeutic target, telomerase, is in all cells. It is an enzyme that adds back G rich sections at the end of the chromosome that did not fully replicate during mitosis. Telomerase then comes in and fills in the gaps. Normally, cells lose a bit of these G rich sections every time the cell duplicates. When it gets to some point of shortness, the cell recognizes this, stops growing and dies. In cancer cells it is thought that telomerase is very active and extends the life of the cell, and with other events, eventually becomes a cancer. It's long been a drug target.

Geron Corporation (Nasdaq:GERN) closed trading today up 20 cents or 2.38%.

AVANIR Pharmaceuticals (AVNR) Cuts 16% Jobs, Halts Zenvia Commercial Plans

SAN DIEGO--AVANIR Pharmaceuticals announced today that it has taken several steps intended to significantly reduce ongoing operating expenses. Effective immediately the Company has suspended all commercial initiatives focused on Zenvia(TM) for the treatment of involuntary emotional expression disorder (IEED) and has reduced research and development expenses including placing on hold activities associated with the selective cytokine inhibitor clinical development program. These actions have led to a 16% reduction in the Company's current workforce. The Company has implemented these changes to reduce its cash burn rate to a goal of approximately $10 million per quarter, before estimated severance costs of approximately $800,000.

These actions were taken following receipt of an Approvable Letter from the U.S. Food and Drug Administration (FDA) for Zenvia. Since that time, the Company has assembled a team of professionals dedicated to addressing the Agency's concerns. The Company has added to Dr. Randall Kaye's responsibilities by appointing him as the new head of clinical development. Dr. Kaye, Vice President of Medical Affairs, and his team are dedicated to developing a comprehensive plan intended to address the concerns expressed by the FDA in its Approvable Letter. Once prepared, the Company will request a formal meeting with the FDA to ascertain the appropriate next steps required to pursue marketing approval for Zenvia. The Company currently believes that this meeting will most likely take place within the next 60 days.

Zenvia is dextromethorphan, an cough suppressent derived from opioids. It inhibits the NMDA receptors in the brain that induce the cough reaction. It is approved for the treatment of involuntary emotional expression disorder ("IEED").

The biotechnology company (NASDAQ:AVNR)is trading at $2.89 or up 4 cents afternoon trading.

Thursday, November 09, 2006

EntreMed Up on Preclinical Cancer Data


ROCKVILLE, Md. — Shares of EntreMed Inc. jumped Thursday after the drug developer said its experimental cancer drug showed activity against tumors in preclinical studies.

EntreMed shares rose 8 cents, or 3.9 percent, to $2.15 in morning trading on the Nasdaq. Shares have traded between $1.43 and $2.99 over the past 52 weeks.

The company said preclinical results for its cell cycle inhibitor MKC-1 showed that the compound interfered with tumor cells in models of lung cancer and pancreatic cancer when used by itself and with the cancer drug Tarceva.

Data showed that MKC-1 binded to tumor cells and destabilized structural components within the cells.

What is MKC-1 and how does it work?
Specifically, MKC-1 has been shown to inhibit mitotic spindle formation, prevent chromosome segregation in the M-phase (mitosis) of the cell cycle, and induce apoptosis or cell suicide, in multiple cell lines. These effects are consistent with a mechanism resulting from MKC-1 binding to its intracellular targets, tubulin and the importin beta proteins. The importin beta family of proteins plays a critical role in nuclear transport and cell division.
Tubulin is a constituent of microtubules. Microtubules are like cables inside the cell that help pull apart the chromosomes after they replicate such that each daughter cell receives an exact copy.

In the picture above the microtubules are green, attached to the chromosomes, blue, to pull the duplicated copies apart into each new cell.

The biotechnology company ENMD is slightly down in afternoon trading 5 cents to $2.02 with triple the normal volume.

Wednesday, November 08, 2006

New stem cell trial for heart attack patients

LONDON- British doctors said on Wednesday they plan to inject stem cells into heart attack patients in an experimental treatment aimed at preventing heart failure and deaths.

About 100 patients will receive stem cells from their own bone marrow -- or a placebo -- within five hours of a heart attack in the study, expected to begin early next year.

"We are hoping that the patients will have an increased quality of life six months after the procedure," said Professor John Martin, of University College London who will conduct the trial.

Stem cells are master cells that can turn into any cell or tissue type. Scientists believe they could act as a type of repair system and offer new treatments for illnesses ranging from heart disease and diabetes to Alzheimer's and multiple sclerosis.

Embryonic stem cells have the most potential but their use is controversial because they are derived from early embryos. Adult stem cells have a more limited range. But cells taken from the patients themselves overcome the ethical concerns and reduce the risk of their being rejected by the body.

"All other studies have put cells into the heart in small groups of patients several days or weeks after the heart attack," Martin told Reuters.

The British study will combine the normal treatment for a heart attack, along with the stem cell therapy.

The scientists believe that if the therapy is delivered quickly after an attack it can stop the damage to the heart. Earlier stem cell studies have tried to repair the heart after it has been damaged.

This has a lot of potential. Potential is the key regardless of political affiliations. All I'm saying is it's not as easy as putting in cells and curing disease. The public perception needs to be addressed.

Biotechnology Stocks Rally Tuesday Afternoon

BOSTON-- Drug stocks rallied Tuesday afternoon, but shares of Adolor Corp. fell for the second straight day following news that the Food and Drug Administration needs additional data before it can approve its drug candidate Entereg.

The Dow Jones Wilshire Pharmaceutical Index was up 0.9% at 2423.50, while the Dow Jones Wilshire Biotechnology Index advanced 1.1% at 3300.60.
Shares of Adolor were down more than 5% at $7.28, extending their losing streak from Monday. The sell-off was prompted by an FDA request a 12-month safety study be conducted on Entereg, which is used to treat bowel problems associated with the use of powerful painkillers. The agency issued an approvable letter for the drug, meaning it believes it can still be approved if certain conditions are met.
Early Tuesday, analysts at RBC Capital cut their rating of Adolor to sector perform, dropping their price target to $10 from $16 a share.
Adolor developed Entereg with U.K. drugmaker GlaxoSmithKline. Shares of Glaxo were up 1% at $54.22.

Shares of Neurocrine Biosciences Inc. were higher as well, gaining nearly 9% at $8.46 after the company was upgraded to neutral from underperform at Robert Baird on the belief that downside may be limited.

Charles River Labs shares moved up 3% to $43.88. The biotechnology company late Monday that said it swung to a loss in the latest quarter but backed its full-year 2006 forecast for both earnings and revenue.
MedImmune shares hopped 4% to $33.51. Analysts at FBR Research upgraded their rating of the stock to outperform, with a price target of $40 a share.

Positive data from Antisoma's AS1404 lung cancer trial presented at conference

New tumour progression findings complement data showing extended survival
London, UK, and Prague, Czech Republic: 8 November 2006 - Cancer drug developer Antisoma plc (LSE: ASM, US OTC: ATSMY) announces that the final data from its phase II trial of AS1404 in non-small cell lung cancer are presented today at the EORTC-NCI-AACR meeting in Prague by Professor Joachim von Pawel of Asklepios Hospital, Gauting, Germany, one of the leading investigators in the trial. Final time to tumour progression data are included in the presentation along with the updated survival and safety data released during October.

Key findings from the trial are:

* Patients who received AS1404 in addition to standard chemotherapy had a median survival 5.2 months longer (14.0 vs 8.8 months) than that of patients who received standard chemotherapy alone. This is one of the largest differences in survival ever reported from a trial combining a novel agent with first-line chemotherapy for lung cancer. Addition of AS1404 reduced the risk of death by 27%.

* Patients who received AS1404 in addition to standard chemotherapy had 23% increases in both median (5.4 vs 4.4 months) and mean (6.3 vs 5.1 months) time to tumour progression compared with patients on standard chemotherapy, according to an updated and final assessment by trial investigators. This analysis was conducted after follow-up of all patients for at least 12 months and shows a greater delay in progression with AS1404 than that reported at ASCO in June based on interim data from the trial.

AS1404 or it's chemical name, dimethylxanthenone acetic acid, may stop the growth of tumor cells by blocking blood flow to the tumor. It works by intiating cytokine release (manily TNF), that recruits other immune cells to the tumor. The TNF also causes necrosis of the surrounding blood vessels that feed the tumor, leading to tumor reduction.
Preliminary findings from a phase II trial in non-small cell lung cancer show that patients receiving AS1404 in addition to standard chemotherapy have a higher frequency of tumour responses than patients receiving chemotherapy alone, while side effects are consistent in the two groups.

The biotechnology company is up almost 8% in Europe.

Colorectal Cancer, NSCLC, Breast and Ovarian Cancer Represent the Most Common Indications Targeted By Drugs in Development


The biotechnology index for the last 5 days.


The Cancer Market Outlook To 2011

DUBLIN, Ireland-Nov 8, 2006 - Research and Markets has announced the addition of The Cancer Market Outlook to 2011 to their offering.

Innovation is the key driving force in the cancer market, creating strong opportunities for biotech and pharma companies to launch new products and benefit from high volume sales and a strong competitive position.

'The Cancer Market Outlook to 2011' provides detailed analysis on 9 indications in the cancer market, identifying growth brands, key drug classes and leading companies.

The 6-year epidemiology and product sales forecasts detailed in this report will enable you to evaluate the changes in the competitive positions of leading companies in the cancer market and ensure your R&D pipeline is aligned with future market opportunity to sustain revenue growth.

Use this report to benchmark the strategies behind the market-leading products of today and identify which products will be best positioned for growth over the period 2006-2011.

Key findings of the report...

-- New launches such as Erbitux, Avastin and Tarceva are set to continue to drive the rapid growth of the innovative market due to their utility across multiple indications, and superior efficacy profiles.

-- Colorectal cancer, NSCLC, breast and ovarian cancer represent the most common indications targeted by drugs in development, with an increasing focus also around indications such as renal cell carcinoma and NHL, which while offering a small patient base pose significant incentives if molecules are granted orphan drug status.

-- The cytostatic hormonals market, which has benefited from strong growth over the previous five years, no longer appears to be the growth driver it once was, as generic competition and a lack of innovation reduces prospects for growth.

-- Product and development failure, low investment in emerging technologies and various R&D pipeline constructs are forecast to catalyze a shift in the top players over the forecast period. While Roche is forecast to extend its leading position within the cancer market through strong sales of MabThera, Avastin, Herceptin, Pegasys and Tarceva, increasing genericization is expected to cannibalize AstraZeneca's cancer franchise.

Tuesday, November 07, 2006

Targeted Genetics shares jump on debt deal with Biogen Idec

SAN FRANCISCO-- Targeted Genetics Corp. shares jumped 22% to $2.62 in Tuesday morning trade after the Seattle-based biotech company said it has agreed to restructure repayment of $8.15 million of debt with Biogen Idec. Inc. Under the terms of the new deal, Biogen has agreed to convert $5.65 million of debt into 1 million shares of Targeted Genetics common stock. Targeted Genetics said it will pay $500,000 of the remaining debt immediately, with the remaining $2 million to be paid on a new repayment schedule. As a result of the agreement, Biogen's stake in Targeted Genetics will increase to 19.9%.

Targeted Genetics Corporation, a clinical-stage biotechnology company, engages in the research and development of gene therapy products and technologies for the treatment of acquired and inherited diseases. Its products include tgAAC94, a Phase I/II trial product for the treatment of inflammatory arthritis and other inflammatory diseases; and tgAAC09, a Phase II clinical product, which is used for the treatment of HIV/AIDS. The company also engages in the development, manufacture, and clinical evaluation of AAV-based therapies with Celladon’s portfolio of genes and cardiovascular expertise for the treatment of congestive heart failure. In addition, Targeted Genetics provides novel therapies for the treatment of Huntington's disease, an incurable neurodegenerative disorder.

Gene therapy gets a ton of funding right now for the treatment of just about any disease that a gene has been identified and located. Remember there are lots of forms of gene therapy, such as gene disruption by RNAi; DNAi, or over-expression of a functional gene to overcompensate for the disease causing gene.

tgAAC94 is a special delivery vector for the expression of genes (they are using it by introducing it intra-articular [injection directly into the joint space] to express the TNF receptor ( a cytokine the immune system naturally makes) for arthritis.

TGEN finished after hours trading up another 5% to close up the day at $3.05.

Lots of approvals today: Will get the info posted later today.

ANA975 in a New 13-Week Pre-Clinical Toxicology Study Using Crystalline Form

A Key Step Towards Objective of Re-initiating Clinical Trials :

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS - News) announced today that it has initiated in collaboration with Novartis Pharma A.G ("Novartis") a new 13-week pre-clinical toxicology study of ANA975 to assess safety and tolerability in animals. The recently initiated study, which utilizes a new crystalline form of ANA975 developed by Novartis, should further the understanding of the toxicology profile of ANA975.

"The Anadys and Novartis joint development team has been working diligently over the summer to gain a better understanding of what occurred in the initial 13-week toxicology study in animals," said Steve Worland, Ph.D., Anadys' President, Pharmaceuticals. "While lymphocyte proliferation is an expected consequence of TLR7 activation, we wish to better understand the extent of this proliferation and its reversibility. This new study, which will explore proliferation and reversibility at multiple doses, should provide information helpful to our objective to resume dosing ANA975 in clinical trials."

In June 2006, Anadys suspended dosing in its ANA975 Phase 1b trial in patients with chronic hepatitis C pending additional analysis of recently obtained information from pre-clinical 13-week toxicology studies in animals. Preliminary analysis of that information revealed various new observations which appear consistent with intense immune stimulation in animals. Subsequently, the ANA975 IND was put on full clinical hold by the U.S. Food and Drug Administration. There have been no serious adverse events in humans during the Phase 1b trial. All adverse events have been mild to moderate and have not posed any safety concerns to date, and there were no clinical findings that contributed to the decision to suspend the Phase Ib trial.

TLR's, from an earlier post, are part of the passive immune system. TLR-7 is a receptor that activates this passive immune reaction. Activation of innate immunity is known to be an important component of the human immune defense. ANA975 has been administered to more than 90 healthy volunteers in three completed Phase I trials (501, 502, and 503) and 14 HCV infected patients prior to the suspension of the Phase 1b trial (504), without serious adverse events.

ANDS is Bio/Pharmaceutical company and is trading at $3.72 or up 2 cents in afternoon trading.

Monday, November 06, 2006

Accentia Biopharmaceuticals (ABPI) Commences Fast-Tracked Phase 3 Clinical Trial Of SinuNase For The Treatment Of Chronic Sinusitis

Accentia Biopharmaceuticals will begin enrolling patients for its Phase 3 study of SinuNase™ in November and will include patients with severe chronic sinusitis refractory to sinus surgery. The Company believes that SinuNase, which has been Fast Tracked by the Food and Drug Administration (FDA), is the first product candidate to be in a Phase 3 trial for chronic sinusitis. Despite the fact that there are 31 million affected U.S. patients, and that chronic sinusitis is by far the most common chronic respiratory disease with a market twice the size of asthma, there is currently no approved prescription pharmaceutical for chronic sinusitis.

If this takes off, it will make BILLIONS! I need it right now with these crazy Santa Ana winds!

ABPI Pharmaceuticals is trading (NASDAQ) at $3.29 or down 3 cents per share.

CombinatoRx Arthritis Drug Shows Results

CombinatoRx Says Arthritis Medication Shows Promising Early Phase II Trial Data

CAMBRIDGE, Mass.-- Drug maker CombinatoRx Inc. said Monday that early data in a midstage clinical trial for its experimental arthritis medication showed it reached both primary and secondary endpoints.
Shares jumped $1.45, or 20.6 percent, to $8.50 in premarket activity on the INET electronic exchange, after closing at $7.05 Friday on the Nasdaq. Shares have traded between $5.50 and $14.50 over the past 52 weeks.

In a Phase II clinical trial, rheumatoid arthritis patients were given either study drug CRx-102 or a placebo, and all patients were given an unnamed disease-modifying anti-rheumatic drug.

The primary endpoint looked for the presence of C-reactive protein, which is associated with the inflammation in rheumatoid arthritis. Patients in the CRx-102 group had an average 50 percent reduction in the protein after 42 days compared with 19 percent in the placebo group.

CRx-102 and CRx-139 are oral synergistic combination drug candidates with novel mechanisms of action targeting multiple biological pathways simultaneously. Synergistic combinations are comprised of two compounds acting together to provide a novel therapeutic effect which neither compound can achieve alone. CRx-102 contains the cardiovascular drug dipyridamole [a drug used in coagulation disorders]and an unconventionally low dose of the steroid prednisolone. CRx-139 contains paroxetine, an SSRI,[selective serotonin reuptake inhibitor] and a low dose of the steroid prednisolone. The goal here is to slow down or stop the immune system from attacking the body without immune comprimise in chronic inflammation.



In secondary endpoints, 63 percent of CRx-102 users had at least a 20 percent improvement in their tender and swollen joint count, compared with 30 percent of patients in the placebo group.

CRXX is up almost 15% in afternoon trading on the NASDAQ exchange.

Saturday, November 04, 2006

Exelixis, Inc. Announces November 9 Webcast Of Clinical Investigator Discussions Of XL999, XL880, XL820 And XL184 Data

A continuation and new results from November 2 post.

SOUTH SAN FRANCISCO, Calif.-- Exelixis, Inc. announced that clinical investigators will discuss clinical data on XL999, XL880, XL820 and XL184 in conjunction with data presentations at the 18th EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer Therapeutics" to be held in Prague, Czech Republic at 6:00 p.m. (local time) / 12:00 p.m. (ET) / 9:00 a.m. (PT) on Thursday, November 9, 2006.

So what are these XL... drugs and what do they do?

XL999 is an inhibitor of a receptor tyrosine kinase called VEGF, (vascular endothelial growth factor) which tells cells for form new blood vessels. It also inhibits other receptors that tells cells to grow.

XL880 stops VEGFR2 (vascular endothelial growth factor receptor 2) anther receptor that is overexpressed and upregulated in tumor cells that are growing rapidly and need to feed themselves with new blood vessels.

XL820 is a inhibitor of mutationally activated forms of KIT found in human cancers. In tumor models of breast carcinoma, glioma and leukemia the compound exhibits dose-dependent growth inhibition and has been shown to cause tumor regression.
KIT is another receptor tyrosine kinase that binds and signals when stem cell growth factor binds to it. In tumors, it is mutated such that it continually sends signals to the nucleus.

XL184 inhibits VEGFR2 and Met, key drivers for tumor formation and growth. MET receptor is a tyrosine kinase that transduces motility, proliferation, and morphogenic signals of scatter factor/hepatocyte growth factor in epithelial cells.

(EXEL) closed up 35 cents friday, at $8.56. I'm watching this one and may get in before the data is announced.

U.S. stocks set for choppy week

Investors expected to continue locking in recent gains

U.S. stocks are expected to come under pressure next week as investors await the outcome of the midterm elections and consolidate gains that have pushed the major indexes close to multiyear highs.
The voting public will have their say on Tuesday on a wide variety of issues in races around the country. Political strategists expect Democrats to gain seats in the House and Senate, but Republicans have been working to ensure that they don't lose more than the 15 House seats or six Senate seats needed to cede control of the chambers to the opposition.
"The market is still going to be choppy and on a downward note regardless of what the outcome is," said Barry Hyman, equity market strategist at EKN Financial Services. Success by the Republicans may lead to an upside pop in stocks in the middle of the week but "within a day or two that would be reversed," said Hyman. Read Election Trading Strategies.
The calendar of economic data will be light, with figures due on consumer credit and sentiment, trade, import prices and wholesale inventories. Most of the reports are slated for release on Thursday.
Hyman said stocks are likely to struggle as traders go back to worrying that the economy is heading for a recession after softer data this week. Last Friday's weaker-than-expected gross domestic product number set the tone for a weak performance on Wall Street, with the major indexes all losing ground.
The market found some support Friday after the Labor Department said the U.S. unemployment rate unexpectedly dropped to a 5 1/2 year low of 4.4%.

A lot of clinical data came out yesterday; going through it now and will post relevant material soon.

Friday, November 03, 2006

AVANIR Pharmaceuticals (AVNR) Announces $15 Million Sale Of Common Stock

SAN DIEGO--Avanir Pharmaceuticals (NASDAQ:AVNR) announced that it has entered into definitive purchase agreements with institutional investors for the offering of approximately 5,265,000 shares of Class A common stock at a price of $2.85 per share. As part of the offering of the common stock, the purchasers will also receive warrants to purchase 1,053,000 shares of Class A common stock at an exercise price of $3.30 per share. The warrants become exercisable six months after the closing and then remain exercisable for a period of six months. The gross proceeds of the offering are expected to be approximately $15 million, before offering expenses and commissions, and the net offering proceeds are expected to be approximately $14.4 million. The securities are being sold by AVANIR. The offering is expected to close on or about November 6, 2006.

I may have to get in on some of this action. I will post when of if I decide to pull the trigger.
AVNR stock trading in the biotechnology was down 20 cents to close at $3.10.

Biotechnology Sector finishes down Friday, 3 points

Index Value: 1,102.91
Trade Time: 4:15PM ET
Change: 3.68 (0.33%)
Prev Close: 1,106.60
Open: 1,105.57
Day's Range: 1095.96 - 1107.33

NovaDel Pharma (NVD) Receives FDA Approval Of NitroMist(TM)

FLEMINGTON, N.J.--(BUSINESS WIRE)--NovaDel Pharma Inc. (AMEX: NVD - News) today announced that NitroMist(TM) (Nitroglycerin Lingual Aerosol) has been approved by the U.S. Food and Drug Administration (FDA) for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. NitroMist(TM) is NovaDel's first product approval utilizing its proprietary oral spray technology. The North American commercial rights for NitroMist have been licensed to Par Pharmaceutical Companies, Inc. (NYSE: PRX - News).

"The FDA's approval of NitroMist(TM) is a major milestone for NovaDel, as it represents the first approval of a drug using our proprietary oral spray technology. This achievement also further validates our ability to develop innovative drugs and gain FDA approval using the 505(b)(2) regulatory pathway," commented Jan Egberts, M.D., President and CEO of NovaDel. "With this approval, we will now focus our resources on the rapid advancement of our pipeline of compounds that promise to provide faster onset of action and more patient-friendly dosing. We are particularly excited about the potential of Sumatriptan Oral Spray and Zolpidem Oral Spray, which respectively target patients suffering from migraines and insomnia."

"We are very pleased that our partnership with NovaDel has successfully delivered an additional treatment option for those patients who suffer from acute angina," stated Paul Campanelli, Senior Vice President, Business Development & Licensing at Par. "At this time, we are finalizing our commercialization strategy for the product."

NitroMist is an oral spray formulation of the drug most often used to treat angina pectoris, nitroglycerin. Angina is pain in the chest due to lack of blood and oxygen supply to the heart muscle resulting from an acute coronary syndrome and must be treated emergently. Nitroglycerin is most often, until now, placed as a dissolving pill under the tongue. It's mechanism of action is by relaxing the smooth muscle surrounding the arteries in the heart as well as reducing the volume of blood in the heart. Its effects are very short, 20 minutes, and is not indicated for maintenance therapy. This is a novel mechanism of delivery. I am keeping an open eye on this stock

The biotech/pharmaceutical company NVD is trading up 7% to $1.34.

Viacell up on new analyst ratings

UBS rates VIAC as buy.

3-Nov-06 UBS Upgrade FROM: Reduce TO: Buy


ViaCell, Inc., a biotechnology company, engages in the research, development, and commercialization of cellular therapies in the United States and Singapore. It develops a pipeline of proprietary umbilical cord blood-derived and adult-derived stem cell product candidates as treatments for cancer, cardiac disease, and diabetes. The company conducts a Phase I clinical trial of CB001, its lead umbilical cord blood-derived stem cell therapy product candidate as a treatment for hematopoietic stem cell reconstitution in patients affected by various cancers. It also sells ViaCord, a product offering through which expectant families can preserve their baby’s umbilical cord blood for possible future medical use. In addition, the company develops ViaCytesm, its investigational product candidate that intended to expand reproductive choices for women through the cryopreservation of human unfertilized eggs. It has an agreement with Stem Cell Internal Venture of Centocor Research & Development, Inc. to collaborate on studying a treatment for cardiac disease.

VIAC is trading up 7% to $4.22 in afternoon trading with double volume.

Thursday, November 02, 2006

InterMune, Inc. Teams With Roche Milestone Payments Could Reach $470M

BRISBANE, Calif., Nov. 2-- InterMune, Inc. (Nasdaq: ITMN - News) announced today that on October 30, 2006, it successfully closed its Exclusive License and Collaboration Agreement with Roche for the exclusive worldwide development and commercialization of InterMune's hepatitis C virus (HCV) protease inhibitor program. The parties received notice of early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976, on October 30, 2006.

Having closed the transaction, InterMune will receive an upfront payment of $60 million. Roche is now funding 67% of the global development costs associated with ITMN-191, InterMune's lead HCV protease inhibitor drug candidate. Assuming the successful development and commercialization of ITMN-191 in the U.S. and other countries, InterMune could receive up to $470 million in milestones, including a potential $35 million within the next 12 months.

The NASDAQ traded company closed at $21.72, down 37 cents.
InterMune, Inc., a biotechnology company, engages in the research, development, and commercialization of therapies in pulmonology [Lung] and hepatology [liver]. The company has a product portfolio addressing idiopathic pulmonary fibrosis (IPF) [scarring of the lung] and Hepatitis C Virus (HCV) infections. Its pulmonology portfolio includes two compounds in phase III development for IPF, a disease characterized by progressive scarring of the lungs for which there are no FDA-approved treatment options.

Australian Market on fire at this hour!

Asian shares were mixed in early trading Friday, as Australia's benchmark stock index rose to a record high after the nation's biggest lender, National Australia Bank, reported earnings, while South Korea's leading index fell back, pacing weakness on Wall Street.

Markets in Japan were closed for a public holiday.
Australia's S&P/ASX 200 was up 0.1% to 5,413.10, after touching an intraday record of 5,426.70 earlier in the session.
Elsewhere around the region, South Korea's Kospi rose 0.1%, Taiwan's Weighted Price Index was up 0.7% and Malaysia's KLSE Composite Index was up 0.1%. Singapore's Straits Times Index fell 0.5%.

Shares of National Australia Bank rose 2.3%.
The resource sector lost ground, pacing declines in crude oil and natural resource prices. Miner BHP Billiton fell 0.8% while Woodside Petroleum fell 0.7%. End of Story

Wall Street Extends Its Decline After Flat Productivity Report, Mixed October Sales Report

Wall Street Extends Its Decline After Flat Productivity Report, Mixed October Sales Report


NEW YORK (AP) -- Wall Street extended its decline Thursday, dipping lower after the Labor Department said productivity was flat in the third quarter while wages rose nearly 4 percent. The data touched off concerns that the Federal Reserve will continue to wrestle with inflation, possibly raising interest rates again.

The Dow Jones industrial average posted its first five-day consecutive decline since June 2005 following the economic news and amid mixed reports from retailers on October sales, including Wal-Mart Stores Inc., which had disappointing results last month and warned that November sales would also come in below expectations.

The economic data, which showed wage pressure was increasing at the fastest rate in more than 20 years, rattled investors who have grown concerned that the economy might be slowing too quickly. Wall Street wants a gradual slowdown so the Fed will cut interest rates.

One market observer wasn't worried, noting that the decline was modest. "In the grand scheme of what's happened today and this week I'd say the markets are hanging in there," said Brian Williamson, an equity trader at The Boston Company Asset Management.

Exelixis, Inc. Suspends Enrollment Of New Patients In XL999 Phase II Clinical Trial Program

Exelixis, Inc. today announced that it has suspended enrollment of new patients in the XL999 clinical trial program until further data have been collected and analyzed. The company currently anticipates that it will incur a delay in the clinical program for XL999 of between two weeks and three months. Exelixis suspended enrollment after a preliminary review of patient data relating to cardiovascular adverse events for the month of October. Through the end of September, 117 patients had been dosed with XL999, of whom 12 (10.3%) experienced serious adverse cardiovascular events. However, 4 of the 14 patients enrolled during October also experienced such events, which raised a concern with the company's internal safety monitoring committee. The company therefore decided to suspend enrollment of new patients pending further review of the data. Because 115 of the 131 subjects enrolled in the XL999 clinical program to date have received repeated doses of XL999 (every week or every other week) ranging from 2 doses (2 weeks) to 53 doses (approximately 2 years) with no reported cardiac toxicities, the company has elected to allow patients already enrolled to continue to receive XL999.

"The apparent increase in the frequency of cardiovascular events during October concerns us," said George A. Scangos, PhD, president and chief executive officer of Exelixis. "These are recent observations, and we are in the process of collecting and analyzing all of the relevant primary data. Our primary responsibility is the safety of the patients in the trial, and so we are suspending the enrollment of new patients until we have had a chance to analyze the data. Since all but one of the events occurred on first administration of XL999, we are continuing to treat those patients presently enrolled in the trial. We will of course keep you informed as we go forward analyzing the data."

WHAT is XL-999?
XL999 is a potent inhibitor of key receptor tyrosine kinases [receptors on the cell surface that transmit signals to the nucleus such as to grow] implicated in the development and maintenance of tumor vasculature and in the proliferation of some tumor cells. It inhibits the FGFR, VEGFR and PDGFR RTKs and also is a potent inhibitor of FLT3, an important driver of leukemia cell proliferation in some patients with acute myelogenous leukemia (AML). Those receptors are all growth oriented telling the cell to grow, put out new vessels to feed the tumor and to divide.


The Biotech/pharmaceutical company trades on the NASDAQ and closed down 12% today to $8.21