Tuesday, February 24, 2009

MAP Pharmaceutical shares fall after asthma drug candidate fails late-stage study

MAP Pharmaceuticals, Inc., a development stage company, focuses on developing drug candidates to treat local respiratory and treatable diseases. It develops inhalable drug particles to facilitate pulmonary delivery.

The company's proprietary product candidates in clinical development include Unit Dose Budesonide, a nebulized version of budesonide for the treatment of pediatric asthma in children; and MAP0004, an orally inhaled version of dihydroergotamine for the treatment of migraine. Its product portfolio also includes the earlier stage product candidates, which include MAP0005, an inhaled corticosteroid and beta-agonist for the treatment of asthma and chronic obstructive pulmonary disease; and MAP0001, a formulation of insulin for the treatment of Type 1 and Type 2 diabetes through pulmonary delivery using Tempo inhaler.

The company has a research and development, license, and supply agreement with Eiffel Technologies Limited to develop certain methods for manufacturing formulations of beta-agonists, alone or with steroid, steroids, or insulin; and a license agreement with Nektar Therapeutics UK Limited to develop and commercialize various formulations of a form of dihydroergotamine for administration by inhalation using a device.

NEW YORK -- Shares of MAP Pharmaceuticals Inc. fell in premarket trading, after the drug developer said its experimental treatment for children with asthma failed to meet its main goal in a late-stage study.

The stock fell as low as $4.20 in premarket trading, after closing at $11.03 during the regular session Monday. Shares have traded between $1.75 and $14.97 over the last 52 weeks.
Late Monday, the Mountain View, Calif.-based company said a Phase III trial studying two doses of Unit Dose Budesonide showed the drug, which is a fine mist version of the steroid budesonide, didn't control asthma better than placebo. The study assessed changes from baseline in nighttime and daytime symptom scores, including cough, wheeze and shortness of breath.
The study included 360 children ages 12 months to eight years who had never taken steroids, and who received either 0.25 of a milligram of the drug, 0.135mg, or a placebo twice a day for 12 weeks.

MAP's partner on the drug candidate is AstraZeneca PLC.
Deutsche Bank-North America analyst David M. Steinberg downgraded shares of MAP to "Hold" from "Buy" and cut the price target to $5 from $15.

"Out of MAP's two Phase 3 pipeline products, the UDB program had been the one that offered lower risk along with higher potential peak sales," he said, in a note to investors.
Though another late-stage program, focusing on chronic migraines, could still generate more than $250 million in annual revenue, he added, the company's current value is not justified and the development risks have increased.

"This negative result is quite surprising given the overall positive results for the previously conducted Phase 2 trial, AstraZeneca's recently signed lucrative partnership for this compound, and the long track record of the base molecule budesonide," he said.

The stock ended trading today valued at $2.65. Cash value?

an explanation of the drug and how it works coming in the am.

No comments: