Replies to post #95065 on Biotech Values

[skitahoe]

The company has previously indicated a plan to partner, if they've now indicated otherwise I question whether they either couldn't find anyone interested that was willing to pay their price, or they intend to dilute dramatically to afford the effort. If they don't partner or contract for assistance, they'll be undertaking a job that they'll find overwhelming. I'm talking about dealing with the foreign equivalents of the FDA to gain approvals. Certainly many countries may approve based on FDA actions, but others won't. They will also be burdened with the logistics of distribution and sales worldwide which have extra burdens because of personalizing the drug for every patient.

I'm not a DNDN investor, but if you're correct, I believe much of the price growth that could have been expected from U.S. sales and partnering will be burned in gaining approvals elsewhere, and setting up a worldwide organization. Long term the profit may be greater, but will investors want to wait.

I may be wrong in terms of what they're doing, but then I wasn't wrong about the drugs ability to be approved. I urged caution in 2007 and was correct about that, but then I indicated I thought it would be approved on the new data, but admittedly thought it might be delayed. I'm happy the FDA didn't further delay it with some silly question, as they've been known to do, but then they did delay roughly 3 years. Perhaps some Change has come to the FDA, far more is needed IMHO.

Gary

[zigzagman]

FDA/Panel Decision Alert: InterMune, Questcor, Bayer:

5/2/2010 4:34 AM ET

InterMune Announces Top-Line Results From Phase 2b Study Of Danoprevir In Patients With Chronic Hepatitis C - Quick Facts

(RTTNews) - The U.S. Food and Drug Administration delivered its decision on three new drugs last week without missing the review deadline.

While Dendreon Corp.'s (DNDN) breakthrough prostate cancer vaccine Provenge and Pozen Inc.'s (POZN) arthritis drug Vimovo were able to cross the regulatory finish line.

Bristol-Myers Squibb Co.'s (BMY) kidney transplant drug Belatacept was issued a complete response letter.

Let's take a look at the drugs whose fate will be decided this coming week:

InterMune Inc.'s (ITMN) idiopathic pulmonary fibrosis drug Esbriet faces final FDA decision on May 4. Esbriet is expected to be a blockbuster if approved.

Idiopathic pulmonary fibrosis, or IPF, which results in a progressive scarring of the lungs with no known cause, is a rare and fatal lung disease. There are no approved drugs in the U.S. or Europe to treat IPF, a disease, which is characterized by shortness of breath. The disease affects about 200,000 people in the U.S. and Europe.

According to the National Heart, Lung, and Blood Institute, most patients are diagnosed with IPF in their 50s and 60s, and many people live only three to five years after being diagnosed. Only lung transplants have been found to be a viable treatment option to improve survival in patients with IPF.

On March 9, the Pulmonary-Allergy Drugs Advisory Committee of the FDA, which reviewed the New Drug Application for Esbriet voted 9-3 to recommend approval of the drug for the treatment of patients with idiopathic pulmonary fibrosis to reduce decline in lung function. The panelists also voted 7-5 that the drug provides a "clinically meaningful benefit".

The regulatory agency usually follows the recommendations of its panels, though not mandatory.

Since the panel's recommendation on March 9, ITMN gained as much as 110% when it touched a new 52-week intraday high of $49.05 on April 13. The stock closed Friday's trading session at $42.51, which is 13% down from its 52-week intraday high.

Questcor Pharmaceuticals Inc.'s (QCOR) supplemental New Drug Application to market H.P. Acthar Gel (repository corticotrophin injection) for the treatment of infantile spasms is scheduled to be reviewed by the FDA panel on May 6.

Infantile spasm, or IS, is a seizure disorder of early childhood also known as West Syndrome. The onset is predominantly in the first year of life, typically between 3 to 6 months. The typical pattern of IS is a sudden bending forward and stiffening of the body, arms, and legs; although there can also be arching of the torso.

http://www.rttnews.com/ArticleView.aspx?Id=1288892