Biotech Values

[ghmm]

Here is the PR from the FDA website.

Thelin seems dead in the US. In addition to my thinking they won't be able to recruit patients for another trial some posters on iVillage pointed out several other reasons including: lack of funds/would be a couple years behind Letairis. The only chance I'd see for it if it is co-formulated with another class of drugs for PAH (the most likely candidate would be a longer acting PDE5 but Thelin is daily and Revatio and Cialis seem to have different dosing regimins).

From Gilead's PR, conference call yesterday and more so their Goldman Sachs call a couple days ago they seem all set for a launch and head-to-head competition with Tracleer/Actelion. I found it interesting they note the percent of patients not needing additional therapy after 1 year. Actelion has Ventavis (Inhaled Prostacylin) and was also studying both with PDE5's. I think it is more marketing/hype as most PAH opinion leaders think combination therapy is where treatment paradigms are heading.


http://www.fda.gov/bbs/topics/NEWS/2007/NEW01653.html

FDA News

FOR IMMEDIATE RELEASE
P07-104
June 15, 2007


Media Inquiries:
Sandy Walsh, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension

The U.S. Food and Drug Administration (FDA) today approved Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension, a rare, life-threatening condition characterized by continuous high blood pressure within the arteries of the lungs.

"Letairis represents a valuable addition to the treatment alternatives for this orphan disease," said John Jenkins, M.D., director of FDA's Office of New Drugs. "Letairis is similar to an existing drug, but offers the potential for fewer drug interactions."

In pulmonary arterial hypertension, the small arteries in the lungs become narrowed or blocked, and the heart must work harder to pump the blood through them. Over time, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs. Symptoms include shortness of breath, fatigue, chest pain, dizzy spells and fainting. About 100,000 people in the United States have pulmonary arterial hypertension.

Letairis, a new drug not previously approved in the United States, was granted a priority review by FDA. A priority review designation is intended for those products that address unmet medical needs. For priority drug applications, FDA sets a target date of six months after the date of receipt for the agency to complete all aspects of a review and to take action.

The safety and effectiveness of Letairis were demonstrated in two international clinical trials involving 393 patients. Letairis significantly improved physical activity capacity compared with a placebo, as shown by a six-minute walk, a standard test. Letairis also delayed the worsening of the pulmonary hypertension.

The most common side effects in patients using Letairis included swelling of legs and ankles, nasal congestion, sinusitis, and getting red in the face (flushing).

Letairis should not be used by women who are pregnant or may become pregnant because the drug may cause birth defects. Patients taking Letairis must have monthly blood tests to check for potential liver injury.

Letairis will be available in five-milligram and 10-milligram once-daily tablets.

Letairis was granted orphan drug status by FDA because it treats a rare disease and meets other criteria. Orphan designation qualifies the drug's sponsor for a tax credit and marketing incentives.

Letairis is manufactured by Gilead Sciences, Inc., Foster City, Calif. Gilead acquired the U.S. rights to ambrisentan when it acquired Myogen, Inc. in 2006. GlaxoSmithKline holds rights to ambrisentan outside of the United States.

For more information:

The Orphan Drug Act
www.fda.gov/orphan/

National Heart Lung and Blood Institute – What is Pulmonary Arterial Hypertension?
www.nhlbi.nih.gov/health/dci/Diseases/pah/pah_what.html