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

changfa

5/2/2010 4:34 AM ET 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. H.P. Acthar gel is an injectable drug that is approved in the U.S. by the FDA for the treatment of certain disorders with an inflammatory component, including the treatment of exacerbations associated with multiple sclerosis and to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that is due to lupus erythamatosus. Pursuant to guidelines published by the American Academy of Neurology and the Child Neurology Society, many child neurologists use Acthar to treat infants afflicted with infantile spasms. Two times over the past three years, the FDA has turned down Questcor's supplemental New Drug Application for H.P. Acthar Gel. Questcor initially submitted its supplemental New Drug Application for H.P. Acthar Gel to the FDA in June 2006 and was issued a "not approvable" letter" by the regulatory agency in May 2007. The company resubmitted its supplemental New Drug Application for H.P. Acthar Gel in December 2008 and completed its filing in March 2009. However in May 2009, the FDA requested the company to include additional statistical analysis relating to data from one secondary study. Following the FDA's request, the company resubmitted its filing to the FDA for its supplemental New Drug Application again for H.P. Acthar Gel last October. The FDA accepted the company's supplemental New Drug Application for H.P. Acthar Gel for review late last December and decided to convene an Advisory Panel meeting to obtain independent expert advice on specific aspects of the supplemental New Drug Application. As mentioned earlier, the FDA panel will review the supplemental New Drug Application for H.P. Acthar Gel for infantile spasms on May 6 and the FDA is expected to make a final decision on June 11. Sabril is the first and the only FDA-approved drug for infantile spasms. The drug developed by Danish pharmaceutical company H.Lundbeck A/S (HLUKY.PK) was approved as recently as August 21, 2009 for that indication. The drug was launched in the U.S. last September with an extensive REMS (Risk Evaluation Mitigation Strategy) program as required by the FDA. QCOR has gained nearly 23% over the past five trading days in anticipation of the regulatory decision on the supplemental New Drug Application for H.P. Acthar Gel. The stock touched a new intraday high of $9.98 on Friday before closing the day's session at $9.77. Bayer AG's (BAYRY.PK) estradiol-based oral contraceptive (estradiol valerate/dienogest) is yet another new drug, on which the FDA will make a decision this coming week. The company submitted a New Drug Application for estradiol valerate/dienogest in July 2009 seeking approval for the indications oral contraception and treatment of heavy and/or prolonged menstrual bleeding. Based on the standard 10-month review, the FDA is expected to make a decision by May 8. The new oral contraceptive has been available in several European countries since May 2009 under the tradename Qlaira for the indication oral contraception.

changfa

ITMN may have a good chance.

xxtrader

QCOR 机会非常小，可以空
BYM 问题不大