I am teaming up with the great staff of http://www.drunktrader.com/ in search of some missing IT ware. Both DT and me plus our staff have co-operated in the past on several ventures and to hear that Isis has pulled this type of behavior is unacceptable. We will be joining forces both online and in person to see this injustice is dealt with.
It's quite possible that the entire team of BT101 will be summoned to a fact finding mission to Chicago in the coming days. Please understand that while clinical trial data and biotech stocks are our top priority, one must always step up when a friend is in need. I will keep you updated.
Thursday, July 31, 2008
Monday, July 28, 2008
Amgen Still Rolling on results
Amgen Inc. led drug stocks higher early Monday, as the biotech giant gained on a report of progress with an osteoporosis drug candidate, denosumab.
Late Friday, Amgen released favorable data for denosumab, a product many investors are hoping can jump-start the biotech group's top line. Amgen's financial performance has been lackluster this year, due largely to weakened sales for its flagship anemia drugs Aranesp and Epogen amid heightened safety concerns.
Late Friday, Amgen released favorable data for denosumab, a product many investors are hoping can jump-start the biotech group's top line. Amgen's financial performance has been lackluster this year, due largely to weakened sales for its flagship anemia drugs Aranesp and Epogen amid heightened safety concerns.
Amgen is slated to release its second-quarter earnings report after the market closes on Monday.
I'll get some info on denosumab (another monoclonal antibody therapy) and get another post up with an explanation. Stay tuned.
AMGN is trading at 60.58, +6.67, +12.4% in afternoon action.
Tuesday, July 22, 2008
BioTech Market Update:
The staff at Bio took the day off today and hit up Where the Surf Meets the Turf at Del Mar. The racing was good, the betting better and the scenery the best. Nothing like hanging out by the Pacific, beautiful women and men and the best jockeys the sport has to offer. Did I mention they have beer?
Here's what happened whilst 101 staff was gambling away their salaries:
Biotech stocks got a nice boost early Monday from news that Swiss drugmaker Roche plans to buy the remaining 44% of Genentech Inc. that it doesn't already own for $43.7 billion.
The Amex Pharmaceutical Index was down marginally at 306.0 while the Amex Biotechnology Index, of which Genentech is a component, jumped 3% to 819.5.
Genentech shares soared 14% to $93.52, notably above Roche's bid price of $89 a share, indicating investors may be anticipating a counter-offer.
Early Monday, Roche announced its bid, stating the merger would stream-line drug discovery and increase productivity. The deal would also give Roche total control over Genentech's marketed products, which include such oncology drugs as Avastin, Herceptin and Rituxan.
Genentech is a leading marketer of biologic oncology drugs. Roche sells Genentech's products overseas, while the biotech group markets them in the U.S.
Shares of partners Merck & Co. and Schering-Plough Corp. fell on news that they were delaying release of their respective quarterly financial reports, which were expected early Monday morning, until after market close.
The companies attributed the postponement to the expected release of new data on their controversial cholesterol drug Vytorin at 1:00 p.m. ET.
Sales of Vytorin have been in the dumps since this winter, when a medical study showed the drug wasn't any more effective in battling heart disease than generic versions of Merck's cholesterol drug Zocor. Vytorin is a combination of Zocor, which lost patent protection in 2006, and a newer drug called Zetia.
Biogen Idec shares were up 5% at $67.95. The biotech, which is slated to roll out its earnings report early Tuesday, co-markets Genentech's blockbuster oncology drug Rituxan.
Also climbing was Biogen partner Elan Corp. Elan and Biogen market the multiple sclerosis therapy Tysabri.
Here's what happened whilst 101 staff was gambling away their salaries:
Biotech stocks got a nice boost early Monday from news that Swiss drugmaker Roche plans to buy the remaining 44% of Genentech Inc. that it doesn't already own for $43.7 billion.
The Amex Pharmaceutical Index was down marginally at 306.0 while the Amex Biotechnology Index, of which Genentech is a component, jumped 3% to 819.5.
Genentech shares soared 14% to $93.52, notably above Roche's bid price of $89 a share, indicating investors may be anticipating a counter-offer.
Early Monday, Roche announced its bid, stating the merger would stream-line drug discovery and increase productivity. The deal would also give Roche total control over Genentech's marketed products, which include such oncology drugs as Avastin, Herceptin and Rituxan.
Genentech is a leading marketer of biologic oncology drugs. Roche sells Genentech's products overseas, while the biotech group markets them in the U.S.
Shares of partners Merck & Co. and Schering-Plough Corp. fell on news that they were delaying release of their respective quarterly financial reports, which were expected early Monday morning, until after market close.
The companies attributed the postponement to the expected release of new data on their controversial cholesterol drug Vytorin at 1:00 p.m. ET.
Sales of Vytorin have been in the dumps since this winter, when a medical study showed the drug wasn't any more effective in battling heart disease than generic versions of Merck's cholesterol drug Zocor. Vytorin is a combination of Zocor, which lost patent protection in 2006, and a newer drug called Zetia.
Biogen Idec shares were up 5% at $67.95. The biotech, which is slated to roll out its earnings report early Tuesday, co-markets Genentech's blockbuster oncology drug Rituxan.
Also climbing was Biogen partner Elan Corp. Elan and Biogen market the multiple sclerosis therapy Tysabri.
Saturday, July 19, 2008
Off topic...But well worth it
GOOG once again was in left field concerning it's 2Q earnings report. Check this youtube video:
http://www.youtube.com/watch?v=mJXxmiKv3hw
http://www.youtube.com/watch?v=mJXxmiKv3hw
Friday, July 18, 2008
PPHM---Peregrine Pharma
I'm looking at them carefully. I can post some of their "promising" pipeline drugs, if there are any at 37 cents a share.
Might have to pick up some shares and anticipate a bump up the closer fall comes. Stay tuned.
Might have to pick up some shares and anticipate a bump up the closer fall comes. Stay tuned.
Sunday, July 13, 2008
The Market is down: There is still action to be had in BioTech
Check out what happened in biotech on friday just before market close. ANDS had a nice spike right before the market closed jumping up 66 cents a share to close at $2.97. This should be a reaction to the news that they are returning to Hep C treatment with their drug termed ANA598:
Anadys Pharmaceuticals, Inc., a biopharmaceutical company, engages in developing medicines in the areas of hepatitis C and oncology. It develops ANA598, a small-molecule non-nucleoside inhibitor of the NS5B polymerase for the treatment of hepatitis C; and ANA773, an oral toll-like receptor 7 agonist prodrug for cancer. The company was founded in 1992. It was formerly known as ScripTech Pharmaceuticals, Inc. and changed its name to Scriptgen Pharmaceuticals, Inc. in 1994. Later, the company changed its name to Anadys Pharmaceuticals, Inc. in 2000. Anadys Pharmaceuticals is headquartered in San Diego, California.
Anadys Pharmaceuticals, Inc., a biopharmaceutical company, engages in developing medicines in the areas of hepatitis C and oncology. It develops ANA598, a small-molecule non-nucleoside inhibitor of the NS5B polymerase for the treatment of hepatitis C; and ANA773, an oral toll-like receptor 7 agonist prodrug for cancer. The company was founded in 1992. It was formerly known as ScripTech Pharmaceuticals, Inc. and changed its name to Scriptgen Pharmaceuticals, Inc. in 1994. Later, the company changed its name to Anadys Pharmaceuticals, Inc. in 2000. Anadys Pharmaceuticals is headquartered in San Diego, California.
Thursday, July 03, 2008
Illumina hits record high....Nice time to be in their ESPP
Illumina shares reach record high as analysts reaffirm positive sales outlook
NEW YORK (AP) -- Shares of genetic analysis instrument maker Illumina Inc. reached an all-time high Wednesday as analysts reaffirmed a positive sales outlook for the company.
Shares reached $91.41 during the trading session, before retreating. The stock maintained a gain of $1.55, or 1.8 percent, to close at $90.10.
Goldman Sachs analyst May-Kin Ho raised her second-quarter profit forecast for the company to 30 cents from 29 cents per share and counted Illumina among biotech companies that will excel because of sales. For the year, she expects profit of $1.23 per share, up from prior forecasts for $1.19 per share.
The company, meanwhile, expects second-quarter profit of 37 to 40 cents per share, topping the 28 cents per share expected by analysts surveyed by Thomson Financial.
During the first quarter, Illumina swung to a profit as analytic instrument sales more than doubled with the help of its Genome Analyzer and Genome Analyzer II systems.
Ho previously said the company's profit could increase by about 32 percent per year over the next few years. She and others view the company's Genome Analyzer II system as a key player in pushing the company's profit.
More tomorrow and just what this Analyzer thing is. check back.
NEW YORK (AP) -- Shares of genetic analysis instrument maker Illumina Inc. reached an all-time high Wednesday as analysts reaffirmed a positive sales outlook for the company.
Shares reached $91.41 during the trading session, before retreating. The stock maintained a gain of $1.55, or 1.8 percent, to close at $90.10.
Goldman Sachs analyst May-Kin Ho raised her second-quarter profit forecast for the company to 30 cents from 29 cents per share and counted Illumina among biotech companies that will excel because of sales. For the year, she expects profit of $1.23 per share, up from prior forecasts for $1.19 per share.
The company, meanwhile, expects second-quarter profit of 37 to 40 cents per share, topping the 28 cents per share expected by analysts surveyed by Thomson Financial.
During the first quarter, Illumina swung to a profit as analytic instrument sales more than doubled with the help of its Genome Analyzer and Genome Analyzer II systems.
Ho previously said the company's profit could increase by about 32 percent per year over the next few years. She and others view the company's Genome Analyzer II system as a key player in pushing the company's profit.
More tomorrow and just what this Analyzer thing is. check back.
Tuesday, July 01, 2008
Biotech Market update: 1 July 2008
BioTech/Big Pharma stocks in the news, 10am PST.
Drug stocks slipped in early action Tuesday, but shares of Myriad Genetics rebounded from a sell-off in the previous session over its move to discontinue development of its Alzheimer's disease drug candidate Flurizan.
Myriad shares were up 4% at $47.30.
Myriad reported disappointing Phase III clinical results for Flurizan early Monday, an event that had been widely predicted by industry watchers on Wall Street. The company had been developing the compound for the treatment of mild cases of Alzheimer's disease.
Drug stocks slipped in early action Tuesday, but shares of Myriad Genetics rebounded from a sell-off in the previous session over its move to discontinue development of its Alzheimer's disease drug candidate Flurizan.
Myriad shares were up 4% at $47.30.
Myriad reported disappointing Phase III clinical results for Flurizan early Monday, an event that had been widely predicted by industry watchers on Wall Street. The company had been developing the compound for the treatment of mild cases of Alzheimer's disease.
Myriad's bad news appeared to ripple over into shares of other drugmakers working on Alzheimer's medications.
Monday, June 30, 2008
Glutoxim (NVLS) Lead Candidate
Glutoxim is a representative of thiopoietins, a new class of pharmaceuticals possessing a
modulating effect on intracellular processes of thiol metabolism [SH groups containing sulfur and hydrogen atoms]playing an important role in the regulation of genetic and metabolic processes in cells and tissues.
The drug’s mechanism of action consists in regulated escalation of redox state of cells. The new
level of redox systems and of dynamics of phosphorylation of signal-transmitting system key
proteins and transcription factors, primarily of immunocompetent cells, determines the
immunomodulating and systemic cytoprotective effect of the drug. [It keeps the inside of the cell in a reduced state, ready to lose electrons and bind up free radicals]
Glutoxim acts differently on normal cells, where it stimulates proliferation and differentiation [growth and growing into a specialized cell that cannot change again],
and on transformed ones, where it induces apoptosis (genetically programmed cell death). The
main immunophysiological properties of the drug include its high tropism to the cells of central
immunity organs and of the lymphoid tissue system, enhancement of spinal hemopoiesis
(erythropoiesis, lymphopoiesis and granulocyto-monocytopoiesis)[formation of new cells, red blood cells, white blood cells], activation of the phagocytosis [cell eating]
system (including cases of immune deficiency), restoration of neutrophil, monocyte and
lymphocyte count in peripheral blood and of tissue macrophage functional activity. The most
important immunobiochemical effects of the drug include stimulation of cascade mechanisms of
phosphate modification of the signal-transmitting system key proteins, initiation of the cytokine
system, [communication between cells--cytokine are small proteins that elicit very specific cellular reactions] including endogenous synthesis of interleukine 1, interleukine 6, tumour necrosis factor, interferons, erythropoietin, and reproduction of interleukine 2 effects by inducing expression of its receptors.
NVLT closed down 3 cents in today's trading to 0.50 cents per share in relatively normal trading volume.
Note: NVLT today announced that it was issued U.S. Pat. No. 7,371,411 by the U.S. Patent and Trademark Office extending the composition and method of use claims relating to NOV-002, Novelos’ lead compound in an ongoing pivotal Phase 3 trial for non-small cell lung cancer under a Special Protocol Assessment (SPA) and Fast Track. NOV-002 has also demonstrated positive results in Phase 2 trials for other oncology indications.
Novelos has a commanding intellectual property position around its oxidized glutathione-based product platform, which currently includes 6 issued U.S. patents, 2 European patents (that have gone national) and 1 Japanese patent. Overall, Novelos filed more than thirty patent applications worldwide. Together, these will provide broad and long-lasting coverage, up to at least 2019, encompassing composition of matter, method of use and manufacturing for Novelos’ compounds.
modulating effect on intracellular processes of thiol metabolism [SH groups containing sulfur and hydrogen atoms]playing an important role in the regulation of genetic and metabolic processes in cells and tissues.
The drug’s mechanism of action consists in regulated escalation of redox state of cells. The new
level of redox systems and of dynamics of phosphorylation of signal-transmitting system key
proteins and transcription factors, primarily of immunocompetent cells, determines the
immunomodulating and systemic cytoprotective effect of the drug. [It keeps the inside of the cell in a reduced state, ready to lose electrons and bind up free radicals]
Glutoxim acts differently on normal cells, where it stimulates proliferation and differentiation [growth and growing into a specialized cell that cannot change again],
and on transformed ones, where it induces apoptosis (genetically programmed cell death). The
main immunophysiological properties of the drug include its high tropism to the cells of central
immunity organs and of the lymphoid tissue system, enhancement of spinal hemopoiesis
(erythropoiesis, lymphopoiesis and granulocyto-monocytopoiesis)[formation of new cells, red blood cells, white blood cells], activation of the phagocytosis [cell eating]
system (including cases of immune deficiency), restoration of neutrophil, monocyte and
lymphocyte count in peripheral blood and of tissue macrophage functional activity. The most
important immunobiochemical effects of the drug include stimulation of cascade mechanisms of
phosphate modification of the signal-transmitting system key proteins, initiation of the cytokine
system, [communication between cells--cytokine are small proteins that elicit very specific cellular reactions] including endogenous synthesis of interleukine 1, interleukine 6, tumour necrosis factor, interferons, erythropoietin, and reproduction of interleukine 2 effects by inducing expression of its receptors.
NVLT closed down 3 cents in today's trading to 0.50 cents per share in relatively normal trading volume.
Note: NVLT today announced that it was issued U.S. Pat. No. 7,371,411 by the U.S. Patent and Trademark Office extending the composition and method of use claims relating to NOV-002, Novelos’ lead compound in an ongoing pivotal Phase 3 trial for non-small cell lung cancer under a Special Protocol Assessment (SPA) and Fast Track. NOV-002 has also demonstrated positive results in Phase 2 trials for other oncology indications.
Novelos has a commanding intellectual property position around its oxidized glutathione-based product platform, which currently includes 6 issued U.S. patents, 2 European patents (that have gone national) and 1 Japanese patent. Overall, Novelos filed more than thirty patent applications worldwide. Together, these will provide broad and long-lasting coverage, up to at least 2019, encompassing composition of matter, method of use and manufacturing for Novelos’ compounds.
Sunday, June 29, 2008
I'm having some down time..
Our mascot, UGA VI died yesterday. It's a sad time and it's right before the season kicks off.
RIP UGA.
more NVLT tomorrow.
RIP UGA.
more NVLT tomorrow.
Update: NVLT
I'm in the process of legging the ground work of NVLT's product pipeline. I can get more in depth tomorrow when I can gain access to scientific journals at work.
Some Background First:
The Company was incorporated in June 1996 as AVAM International, Inc. In October 1998, Novelos Therapeutics, Inc., a newly incorporated entity, merged into AVAM, and the name of AVAM was changed to Novelos Therapeutics, Inc. In 2005, the Company completed a two-step reverse merger with Common Horizons, Inc., and its wholly-owned subsidiary Nove Acquisition, Inc. Following the merger, the surviving company was Novelos Therapeutics, Inc. The Company is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. NOV-002, its lead compound, is currently in Phase 3 development for lung cancer under a Special Protocol Assessment and Fast Track. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer, and is also being developed for acute radiation injury. NOV-205, the Company's second compound, is in Phase 1b development for chronic hepatitis C non-responders. Both compounds have completed clinical trials in humans and have been approved for use in Russia where they were originally developed.
Ok, so what does glutathione based compounds mean?
IN the body, glutathione acts much like a scavenger, finding and neutralizing free oxygen species, such as hydrogen peroxide. It's a small molecule produced in every cell of the body. It has three amino acids. It originates from three primary amino acids in the body: glutamate, cysteine and glycine. Glutathione is actually a tripeptide made up the amino acids gamma-glutamic acid, cysteine, and glycine. The primary biological function of glutathione is to act as a non-enzymatic reducing agent to help keep cysteine thiol side chains in a reduced state on the surface of proteins. Glutathione is also used to prevent oxidative stress in most cells and helps to trap free radicals that can damage DNA and RNA. There is a direct correlation with the speed of aging and the reduction of glutathione concentrations in intracellular fluids. As individuals grow older, glutathione levels drop, and the ability to detoxify free radicals decreases.
NOV-002: (from Novelos website: www.novelos.com)
NOV-002, the lead compound, acts as a chemoprotectant and a chemopotentiator. NOV-002 was approved in Russia where it is marketed by PharmaBAM under the trade name Glutoxim®. NOV-002 has already been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in combination with cisplatin-based chemotherapy increased the one-year survival of advanced NSCLC patients from 17% to 63% (p < href="http://www.glutoxim.ru/" target="_blank">Glutoxim®. NOV-002 has already been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in combination with
Post is getting long. Repost with more info shortly. Reading the mechanism of action now.
Some Background First:
The Company was incorporated in June 1996 as AVAM International, Inc. In October 1998, Novelos Therapeutics, Inc., a newly incorporated entity, merged into AVAM, and the name of AVAM was changed to Novelos Therapeutics, Inc. In 2005, the Company completed a two-step reverse merger with Common Horizons, Inc., and its wholly-owned subsidiary Nove Acquisition, Inc. Following the merger, the surviving company was Novelos Therapeutics, Inc. The Company is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. NOV-002, its lead compound, is currently in Phase 3 development for lung cancer under a Special Protocol Assessment and Fast Track. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer, and is also being developed for acute radiation injury. NOV-205, the Company's second compound, is in Phase 1b development for chronic hepatitis C non-responders. Both compounds have completed clinical trials in humans and have been approved for use in Russia where they were originally developed.
Ok, so what does glutathione based compounds mean?
IN the body, glutathione acts much like a scavenger, finding and neutralizing free oxygen species, such as hydrogen peroxide. It's a small molecule produced in every cell of the body. It has three amino acids. It originates from three primary amino acids in the body: glutamate, cysteine and glycine. Glutathione is actually a tripeptide made up the amino acids gamma-glutamic acid, cysteine, and glycine. The primary biological function of glutathione is to act as a non-enzymatic reducing agent to help keep cysteine thiol side chains in a reduced state on the surface of proteins. Glutathione is also used to prevent oxidative stress in most cells and helps to trap free radicals that can damage DNA and RNA. There is a direct correlation with the speed of aging and the reduction of glutathione concentrations in intracellular fluids. As individuals grow older, glutathione levels drop, and the ability to detoxify free radicals decreases.
NOV-002: (from Novelos website: www.novelos.com)
NOV-002, the lead compound, acts as a chemoprotectant and a chemopotentiator. NOV-002 was approved in Russia where it is marketed by PharmaBAM under the trade name Glutoxim®. NOV-002 has already been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in combination with cisplatin-based chemotherapy increased the one-year survival of advanced NSCLC patients from 17% to 63% (p < href="http://www.glutoxim.ru/" target="_blank">Glutoxim®. NOV-002 has already been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in combination with
Post is getting long. Repost with more info shortly. Reading the mechanism of action now.
Wednesday, May 14, 2008
F*** off Virus!
Im back!!! A very long illness but I'm back in the game. Now let me see if I can get this thing updated.
Friday, February 29, 2008
Evil Alcohol
The update on NVLT is on it's way, but I went through a week of a binge vodka tonic action. Not good and got some sort of evil death virus. I'm on the rebound now so check back soon. Thanks.
Thursday, February 21, 2008
Coming Today: NVLT
NVLT:
Novelos Therapeutics, Inc., a biopharmaceutical company, commercializes oxidized glutathione-based compounds for the treatment of cancer and hepatitis in the United States. Its products in development include NOV-002, which acts as a chemoprotectant and an immunomodulator; and NOV-205, which acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-002, a small-molecule formulation of a natural metabolite, is in Phase III development for lung cancer, as well as in Phase II development for chemotherapy-resistant ovarian cancer and early-stage breast cancer. NOV-002 is also being developed for acute radiation injury. NOV-205, a small-molecule formulation of oxidized glutathione and inosine, is in Phase Ib development for the treatment of chronic hepatitis C. Novelos Therapeutics is based in Newton, Massachusetts.
I need to do some research on the compounds--eg how they work etc, and will post. Very interesting mechanisms of action.
Novelos Therapeutics, Inc., a biopharmaceutical company, commercializes oxidized glutathione-based compounds for the treatment of cancer and hepatitis in the United States. Its products in development include NOV-002, which acts as a chemoprotectant and an immunomodulator; and NOV-205, which acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-002, a small-molecule formulation of a natural metabolite, is in Phase III development for lung cancer, as well as in Phase II development for chemotherapy-resistant ovarian cancer and early-stage breast cancer. NOV-002 is also being developed for acute radiation injury. NOV-205, a small-molecule formulation of oxidized glutathione and inosine, is in Phase Ib development for the treatment of chronic hepatitis C. Novelos Therapeutics is based in Newton, Massachusetts.
I need to do some research on the compounds--eg how they work etc, and will post. Very interesting mechanisms of action.
Saturday, January 26, 2008
I'm Back! Amgen reports lower sales
Amgen Inc. reported flat fourth-quarter earnings attributable to a 25% drop in sales for one of its top-selling products, the anemia drug Aranesp.
The Thousand Oaks, Calif., biotechnology giant also issued an updated financial forecast.
Amgen shares closed up 4.7% at $48.28 in after-hours trading.
Amgen earned $835 million, or 76 cents a share, in the quarter compared with $833 million, or 71 cents, in the year-earlier period. Average shares outstanding fell 7.1% to 1.09 billion.
Both periods reflected various charges. Adjusted earnings were $1 a share versus 90 cents.
Revenue declined 2% to $3.75 billion from $3.84 billion.
Still, Amgen's results topped Wall Street expectations. A poll of analysts by Thomson Financial pegged the results at 97 cents a share of earnings on $3.54 billion of revenue.
The company said it now expects to earn an adjusted $4 to $4.30 a share on revenue of $14.2 billion to $14.6 billion in 2008. A Thomson Financial poll has Amgen earning $4.37 a share on revenue of $14.49 billion.
Sales of Amgen's top-selling Aranesp dropped to $827 million. Epogen, a forerunner to Aranesp, also saw sales decline, down 3% to $638 million. The drugs, which are based on the hormone erythropoietin, are used to treat anemia associated with either kidney failure or chemotherapy.
Last year "was Amgen's most challenging year," Chairman and Chief Executive Officer Kevin Sharer said in a statement. "Despite the unexpected reduction in revenues of our erythropoietin products, we delivered earnings per share very close to the low end of our original guidance."
Sales of both drugs have been under pressure following changes in Medicare reimbursement policy and a move by the Food and Drug Administration in November to strengthen safety warnings in the drugs' prescribing information. The drugs are also beginning to face competition from generic versions overseas.
Amgen said Thursday that it is still in talks with the FDA about further revisions to the products' labels. It added it was also discussing labeling changes with European regulators.
On a conference call with investors Thursday night, Amgen management said that going into 2008, Aranesp sales appeared to be "flat but stable."
They said the introduction of generic versions of the drug overseas has so far resulted only in "mild price erosion" for Aranesp. They added, however, than any additional labeling or reimbursement changes could further hurt sales.
Earlier this week, Johnson & Johnson which markets Epogen under the names Procrit and Eprex, reported fourth-quarter sales of those drugs also were down 25% from the previous year.
In August, Amgen said it planned to slash 14%, or about 2,600, of its workers because of a slowdown in sales for its anemia drugs.
Sales of Amgen's other drugs were mixed.
Combined sales of Neulasta and Neupogen showed solid growth, rising 9% to $1.12 billion from a year earlier. The drugs help ward off infection in patients undergoing chemotherapy.
Sales of Amgen's new colorectal-cancer drug Vectibix, however, saw sales dip to $33 million from $41 million in third-quarter 2007. Amgen attributed the slide to a decline in segment share and size.
The Thousand Oaks, Calif., biotechnology giant also issued an updated financial forecast.
Amgen shares closed up 4.7% at $48.28 in after-hours trading.
Amgen earned $835 million, or 76 cents a share, in the quarter compared with $833 million, or 71 cents, in the year-earlier period. Average shares outstanding fell 7.1% to 1.09 billion.
Both periods reflected various charges. Adjusted earnings were $1 a share versus 90 cents.
Revenue declined 2% to $3.75 billion from $3.84 billion.
Still, Amgen's results topped Wall Street expectations. A poll of analysts by Thomson Financial pegged the results at 97 cents a share of earnings on $3.54 billion of revenue.
The company said it now expects to earn an adjusted $4 to $4.30 a share on revenue of $14.2 billion to $14.6 billion in 2008. A Thomson Financial poll has Amgen earning $4.37 a share on revenue of $14.49 billion.
Sales of Amgen's top-selling Aranesp dropped to $827 million. Epogen, a forerunner to Aranesp, also saw sales decline, down 3% to $638 million. The drugs, which are based on the hormone erythropoietin, are used to treat anemia associated with either kidney failure or chemotherapy.
Last year "was Amgen's most challenging year," Chairman and Chief Executive Officer Kevin Sharer said in a statement. "Despite the unexpected reduction in revenues of our erythropoietin products, we delivered earnings per share very close to the low end of our original guidance."
Sales of both drugs have been under pressure following changes in Medicare reimbursement policy and a move by the Food and Drug Administration in November to strengthen safety warnings in the drugs' prescribing information. The drugs are also beginning to face competition from generic versions overseas.
Amgen said Thursday that it is still in talks with the FDA about further revisions to the products' labels. It added it was also discussing labeling changes with European regulators.
On a conference call with investors Thursday night, Amgen management said that going into 2008, Aranesp sales appeared to be "flat but stable."
They said the introduction of generic versions of the drug overseas has so far resulted only in "mild price erosion" for Aranesp. They added, however, than any additional labeling or reimbursement changes could further hurt sales.
Earlier this week, Johnson & Johnson which markets Epogen under the names Procrit and Eprex, reported fourth-quarter sales of those drugs also were down 25% from the previous year.
In August, Amgen said it planned to slash 14%, or about 2,600, of its workers because of a slowdown in sales for its anemia drugs.
Sales of Amgen's other drugs were mixed.
Combined sales of Neulasta and Neupogen showed solid growth, rising 9% to $1.12 billion from a year earlier. The drugs help ward off infection in patients undergoing chemotherapy.
Sales of Amgen's new colorectal-cancer drug Vectibix, however, saw sales dip to $33 million from $41 million in third-quarter 2007. Amgen attributed the slide to a decline in segment share and size.
Saturday, November 03, 2007
Slow Posting on my part
I had a death in the family and have not thought about posting. I realize some of you come here to read daily, and I'm trying to get back to posting daily, but instead of quantity i'll give you quality. Thank you for stopping by and updates [I'm planning] will resume on Monday, Nov. 5.
Friday, October 12, 2007
Wyeth gets hit with multi million dollar verdict
A Nevada jury awarded $134.5 million to three women who claimed Wyeth's hormone-therapy drugs caused their breast cancer.
Jurors awarded compensatory damages to plaintiffs Arlene Rowatt, Jeraldine Scofield and Pamela Forrester after finding Wyeth was negligent, that its drugs were defective and that the company concealed a material fact about the products' safety. All these issues were a cause of injury or damage to the women, the jury said.
The jury, which also found that Wyeth acted with malice or fraud, awarded damages of $43.5 million to Ms. Scofield, $47.5 million to Ms. Forrester and $43.5 million to Ms. Rowatt.
A Wyeth spokesman declined to comment because the case "is not yet complete," citing a hearing on punitive damages scheduled for today. The plaintiffs' law firm also declined comment, citing today's hearing.
The suit, filed in Washoe County District Court in Reno, is one of some 5,300 hormone-replacement cases filed against Wyeth on behalf of 7,900 plaintiffs, according to the pharmaceutical maker. The complaints allege personal injury as a result of the plaintiffs' use of one or more of Wyeth's hormone- or estrogen-therapy products, including Prempro and Premarin, used to treat menopausal symptoms.
The Reno case is the seventh to reach a verdict since trials began last year. Three of the other six trials resulted in verdicts in favor of Wyeth. Of those favoring plaintiffs, one was overturned and judgment entered in favor of Wyeth, and verdicts in the two others were thrown out and new trials ordered by judges. None of the victorious plaintiffs in those cases had been awarded damages greater than $3 million.Three other cases also have been dismissed by courts on summary judgment, and a dozen other cases that had been set for trial were voluntarily withdrawn by plaintiffs before trial.
Wall Street didn't appear rattled by the verdict. Wyeth's shares, which have been in a slump lately for reasons related to the company's pipeline and generic drugs, were down 38 cents to $45.78 in 4 p.m. composite trading on the New York Stock Exchange.
Deutsche Bank drug analyst Barbara Ryan said that it is too early in the string of litigation to presume this case would be the start of a trend, and that in general the hormone-replacement cases appear tougher for plaintiffs to win than past "fen-phen" diet-drug litigation against the company. Wyeth is an investment-banking client of Deutsche Bank.
Lawyers for the Madison, N.J., drug maker have argued that the company clearly warned users that there was a slightly increased risk of breast cancer from taking Prempro, which was first marketed in 1995. In a recent filing with the Securities and Exchange Commission, the company said it hasn't established any litigation-reserve fund for its hormone-therapy litigation.
Howard Erichson, a professor at Seton Hall law school in New Jersey, said it is common for surprisingly large damage awards to be lowered. But, he added, "With thousands of cases remaining to be tried, it's a scary thing to know that juries don't like your argument."
Another, "I don't want to take responsibility for my actions" lawsuit(s) there has been research since the 1980's that suggested estrogen therapy has an incidence of breast cancers. This settlement is ridiculous.
Jurors awarded compensatory damages to plaintiffs Arlene Rowatt, Jeraldine Scofield and Pamela Forrester after finding Wyeth was negligent, that its drugs were defective and that the company concealed a material fact about the products' safety. All these issues were a cause of injury or damage to the women, the jury said.
The jury, which also found that Wyeth acted with malice or fraud, awarded damages of $43.5 million to Ms. Scofield, $47.5 million to Ms. Forrester and $43.5 million to Ms. Rowatt.
A Wyeth spokesman declined to comment because the case "is not yet complete," citing a hearing on punitive damages scheduled for today. The plaintiffs' law firm also declined comment, citing today's hearing.
The suit, filed in Washoe County District Court in Reno, is one of some 5,300 hormone-replacement cases filed against Wyeth on behalf of 7,900 plaintiffs, according to the pharmaceutical maker. The complaints allege personal injury as a result of the plaintiffs' use of one or more of Wyeth's hormone- or estrogen-therapy products, including Prempro and Premarin, used to treat menopausal symptoms.
The Reno case is the seventh to reach a verdict since trials began last year. Three of the other six trials resulted in verdicts in favor of Wyeth. Of those favoring plaintiffs, one was overturned and judgment entered in favor of Wyeth, and verdicts in the two others were thrown out and new trials ordered by judges. None of the victorious plaintiffs in those cases had been awarded damages greater than $3 million.Three other cases also have been dismissed by courts on summary judgment, and a dozen other cases that had been set for trial were voluntarily withdrawn by plaintiffs before trial.
Wall Street didn't appear rattled by the verdict. Wyeth's shares, which have been in a slump lately for reasons related to the company's pipeline and generic drugs, were down 38 cents to $45.78 in 4 p.m. composite trading on the New York Stock Exchange.
Deutsche Bank drug analyst Barbara Ryan said that it is too early in the string of litigation to presume this case would be the start of a trend, and that in general the hormone-replacement cases appear tougher for plaintiffs to win than past "fen-phen" diet-drug litigation against the company. Wyeth is an investment-banking client of Deutsche Bank.
Lawyers for the Madison, N.J., drug maker have argued that the company clearly warned users that there was a slightly increased risk of breast cancer from taking Prempro, which was first marketed in 1995. In a recent filing with the Securities and Exchange Commission, the company said it hasn't established any litigation-reserve fund for its hormone-therapy litigation.
Howard Erichson, a professor at Seton Hall law school in New Jersey, said it is common for surprisingly large damage awards to be lowered. But, he added, "With thousands of cases remaining to be tried, it's a scary thing to know that juries don't like your argument."
Another, "I don't want to take responsibility for my actions" lawsuit(s) there has been research since the 1980's that suggested estrogen therapy has an incidence of breast cancers. This settlement is ridiculous.
Thursday, September 20, 2007
FDA approves label expansion for medimmune's flumist
MedImmune, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the expanded use of FluMist(R) (Influenza Virus Vaccine Live, Intranasal) in children two to five years of age. FluMist is now approved for active immunization for the prevention of disease caused by influenza A and B viruses in individuals two to 49 years of age. Only one manufacturer had previously been licensed in the United States to produce influenza vaccine for children under four years of age.
FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
MedImmune is wholly owned by AstraZeneca. AZN ended today's trading all square at 48.21 a share.
FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
MedImmune is wholly owned by AstraZeneca. AZN ended today's trading all square at 48.21 a share.
Wednesday, September 19, 2007
Stocks soar on fed news....Will BioTech take advantage?
A jubilant Wall Street barreled higher Tuesday after the Federal Reserve cut its benchmark interest rate by a larger-than-expected half percentage point. The Dow Jones industrial average reacted by surging 335 points -- its biggest one-day point jump in nearly five years.
Although some investors hoped for a rate cut of that magnitude, most were betting on a smaller, quarter-point cut in the federal funds rate. The Fed responded to the spilling of credit market problems into the rest of the economy by saying, "the tightening of credit conditions has the potential to intensify the housing (market) correction and to restrain economic growth more generally."
The Fed lowered the benchmark fed funds rate to 4.75 percent after keeping it unchanged for more than a year and not lowering the rate since 2003. It also reduced the discount rate -- what it charges banks borrowing from its discount window -- by a half percentage point to 5.25 percent. On Aug. 17, the central bank lowered the discount rate by a half-point to help keep cash moving in the U.S. banking system.
The central bank's decision and the wording of its accompanying economic assessment gratified a market that plunged during August amid fears that credit market tightness, spawned by a continuum of mortgage defaults and delinquencies, would send the economy toward recession.
There was no direct signal in the Fed's statement that it would make further rate cuts. It said "some inflation risks remain" and that it will keep monitoring inflation developments. Still, it did not call inflation its "predominant policy concern" as it did after holding rates steady in early August.
"What it says to me is you had a major shift in the last couple of months from a Fed that was very concerned about inflation to one that is concerned about the health of the financial months from a markets, the availability of liquidity," said Jerry Webman, chief economist at Oppenheimer Funds Inc.
Big Pharma has a lot of cash, will they spend it? ANDS sure could use a bolster of milestone payments for it's pipeline.
I love the quote "last couple of months from a Fed that was very concerned about inflation to one that is concerned about the health of the financial months from a markets, the availability of liquidity,"
I've been trying to get to full liquidity for a long, long, time.
Although some investors hoped for a rate cut of that magnitude, most were betting on a smaller, quarter-point cut in the federal funds rate. The Fed responded to the spilling of credit market problems into the rest of the economy by saying, "the tightening of credit conditions has the potential to intensify the housing (market) correction and to restrain economic growth more generally."
The Fed lowered the benchmark fed funds rate to 4.75 percent after keeping it unchanged for more than a year and not lowering the rate since 2003. It also reduced the discount rate -- what it charges banks borrowing from its discount window -- by a half percentage point to 5.25 percent. On Aug. 17, the central bank lowered the discount rate by a half-point to help keep cash moving in the U.S. banking system.
The central bank's decision and the wording of its accompanying economic assessment gratified a market that plunged during August amid fears that credit market tightness, spawned by a continuum of mortgage defaults and delinquencies, would send the economy toward recession.
There was no direct signal in the Fed's statement that it would make further rate cuts. It said "some inflation risks remain" and that it will keep monitoring inflation developments. Still, it did not call inflation its "predominant policy concern" as it did after holding rates steady in early August.
"What it says to me is you had a major shift in the last couple of months from a Fed that was very concerned about inflation to one that is concerned about the health of the financial months from a markets, the availability of liquidity," said Jerry Webman, chief economist at Oppenheimer Funds Inc.
Big Pharma has a lot of cash, will they spend it? ANDS sure could use a bolster of milestone payments for it's pipeline.
I love the quote "last couple of months from a Fed that was very concerned about inflation to one that is concerned about the health of the financial months from a markets, the availability of liquidity,"
I've been trying to get to full liquidity for a long, long, time.
Tuesday, September 11, 2007
Imclone clinical trial endpoint met, Stock gains momentum
NEW YORK - Positive results from a study involving Imclone Systems Inc.'s cancer drug Erbitux is raising the company's market value by nearly a quarter Tuesday, but some think it will take a lot longer before any effect is seen on the company's bottomline.
A study released this morning from Imclone's overseas marketing partner for Erbitux, Merck KGaA (MRK.XE), met its primary endpoint of increased survival rates in treating advanced non-small cell lung cancer when used in combination with chemotherapy. That type of lung cancer currently has limited treatment options and would add another market for the drug.
Remember that Erbitux was one of the first targeted drug therapies using monoclonal antibodies. Erbitux is targeted to the epidermal growth factor receptor family of proteins that are located on the cell surface. Once bound, the antibody neutralizes the signaling pathways that the receptors use to tell the cell to grow.
IMCL stock closed trading today +6.97 or 18% in afternoon trading and another 23 cents upward in after hours trading.
A study released this morning from Imclone's overseas marketing partner for Erbitux, Merck KGaA (MRK.XE), met its primary endpoint of increased survival rates in treating advanced non-small cell lung cancer when used in combination with chemotherapy. That type of lung cancer currently has limited treatment options and would add another market for the drug.
Remember that Erbitux was one of the first targeted drug therapies using monoclonal antibodies. Erbitux is targeted to the epidermal growth factor receptor family of proteins that are located on the cell surface. Once bound, the antibody neutralizes the signaling pathways that the receptors use to tell the cell to grow.
IMCL stock closed trading today +6.97 or 18% in afternoon trading and another 23 cents upward in after hours trading.
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