FDA Backlog Leaves Biotech Stocks in Limbo

The most important thing coming out of the U.S. Food and Drug Administration these days is what's not coming out of the agency.

I'm talking about on-time delivery of drug approval decisions.

Top brass at the FDA have given drug reviewers permission to slow down decisions on new drugs. The move comes after the FDA has already missed drug approval deadlines because of a lack of resources -- i.e., too few drug reviewers handling too many drug reviews.

The delays have prompted John Jenkins, the FDA's director of the Office of New Drugs, to ease back on drug approval deadlines by giving reviewers the freedom to take more time, if necessary. The RPM Report, a drug industry trade newsletter, broke the story about Jenkins' decision.

"We will still strive to meet our PDUFA goals whenever we can, however, in some cases we may not be able to meet PDUFA goals, and managers have been given the discretion to make those decisions," Jenkins told The RPM Report.

"PDUFA" stands for the Prescription Drug User Fee Act, which is the federal law that sets out the fees drug companies must pay to the FDA to subsidize new drug reviews. In return, the FDA is supposed to meet certain drug approval timelines, which call for a six-month review time for an accelerated drug approval and a 10-month period for a standard review.

"In the short term, our ability to meet PDUFA goals is expected to decrease," Jenkins said in the report. "In some cases we may have to cut back on work by declining requests from sponsors for guidance (e.g., meetings, multiple cycle SPA reviews) and in other cases we may decide to go past the PDUFA goal date for review of an application. In cases where we decide to go past the PDUFA goal date the sponsor will be notified by the division management of that plan."

For investors, the news is clearly troubling. Investing in biotech or drug companies with drugs pending approval is hard enough; now, the endeavor gets even more difficult since drug approval deadlines are going to be fluid.

Cardiome ( CRME) and CV Therapeutics ( CVTX) have already been hit with FDA delays. The FDA was supposed to act on Cardiome's heart drug IV vernakalant on Jan. 19; the company is still waiting for the FDA to make a decision.

Last week, the FDA informed CV Therapeutics that the review of its cardiac imaging agent regadenoson was taking longer than expected.

In December, I posted a chart of pending drug reviews in front of the FDA this year. I've updated that list below to include all drug reviews now at the FDA with approval dates expected in 2008. The list was compiled with help from BioMedTracker.com and company reports.

Included on the list are also two upcoming FDA advisory panel meetings, one for Lev Pharmaceuticals' ( LEVP.OB) drug Cinryze scheduled for May 2, the other for Cephalon ( CEPH) and its pain drug Fentora on May 6.

Given the new FDA fluidity when it comes to PDUFA dates, don't be surprised to see some missed deadlines on the list below.

Some highlights from the updated list:

  • Gilead Sciences' (GILD) aztreonam lysine for cystic fibrosis has an FDA approval decision date of Sept. 16.
  • AMAG Pharmaceuticals (AMAG) expects to hear from the agency on ferumoxytol, a new intravenous iron treatment for kidney disease patients, on Oct. 19.
  • Discovery Labs (DSCO) will look for redemption in May when the FDA makes a decision on Surfaxin for the treatment of infantile respiratory distress syndrome. Management mistakes and manufacturing problems have significantly delayed the Surfaxin program, so this may be Discovery's last shot at a turnaround.
  • Indevus Pharmaceuticals (IDEV) should be able to make a big dent in the growing "manopause" market, with its long-acting testosterone replacement therapy, Nebido. The FDA decision date is June 27.
  • Expected FDA decision date Company Drug Indication Status
    1/13/2008 Biogen Idec/Elan Tysabri Crohn's Disease Approved
    1/17/2008 ZymoGenetics rThrombin Hemostasis Approved
    1/18/2008 Johnson & Johnson TMC125 HIV/AIDS Approved
    1/19/2008 Cardiome Pharma Vernakalant IV Acute Atrial fibrillation Delayed
    1/30/2008 Lev Pharmaceuticals Cinryze Hereditary angioedema (HAE) Complete Response Letter
    2/2/2008 Abbott Labs Humira Psoriasis Approved
    2/23/2008 Genentech Avastin Breast Cancer Approved
    3/7/2008 Spectrum Pharmaceuticals ISO-Vorin Bone Cancer Approved
    3/14/2008 CV Therapeutics regadenoson Heart Imaging Agent Delayed
    04/01/2008-04/24/2008 Amgen Nplate Immune Thrombocytopenic Purpura (ITP)
    04/01/2008-04/30/2008 Axcan Pharma Ultrase Capsules Exocrine Pancreatic Insufficiency
    04/01/2008-04/31/2008 Merck & Co. Cordaptive Dyslipidemia/Hypercholesterolemia
    4/15/2008 Pozen Trexima Migraine Headaches
    4/30/2008 Progenics Pharmaceuticals Methylnaltrexone Opioid Induced Constipation (AMI)
    5/1/2008 Discovery Laboratories Surfaxin Respiratory Distress Syndrome (RDS)
    5/2/2008 Lev Pharmaceuticals Cinryze Hereditary angioedema (HAE) Advisory Panel Meeting
    5/6/2008 Cephalon Fentora Chronic/breakthrough pain Advisory Panel Meeting
    5/10/2008 Adolor Corporation Entereg Postoperative Ileus
    06/01/2008-06/30/2008 Eurand Zentase Exocrine Pancreatic Insufficiency
    6/20/2008 Millennium Pharmaceuticals Velcade Multiple Myeloma (First line)
    6/26/2008 Eli Lilly & Company Prasugrel Acute Coronary Syndrome (ACS)
    6/27/2008 Indevus Pharmaceuticals Nebido Hypogonadism
    7/21/2008 Theravance Telavancin Skin and Skin-Structure Infections
    7/27/2008 Vanda Pharma/ Titan Pharma Iloperidone Schizophrenia
    8/1/08-8/31/2008 BioDelivery Sciences Int'l BEMA Fentanyl Pain Indications
    8/11/2008 Gilead Sciences Viread Hepatitis B
    8/29/2008 Johnson & Johnson Paliperidone palmitate Schizophrenia
    9/13/2008 Cephalon Fentora Chronic/breakthrough pain
    9/16/2008 Gilead Sciences Aztreonam lysine Cystic Fibrosis
    10/4/2008 Johnson & Johnson Ustekinumab Psoriasis
    10/19/2008 AMAG Pharmaceuticals Ferumoxytol Anemia Due to Chronic Renal Failure
    10/31/2008 Cephalon Treanda Non-Hodgkin's Lymphoma (NHL)
    Source: BioMedTracker, company reports
    Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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