The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
1.) Roche (RHHBY.PK): Highly anticipated clinical trial results for Avastin missed their main goal of preventing the recurrence of colon cancer in patients who have undergone surgery for tumor removal. Shares of Roche in Europe (ROG.VX) are down by 9% today, representing a loss in market value of about $10B (all currency amounts reflect U.S. Dollars in this article).
Avastin was a key element and growth driver behind Roche's decision to buy the remaining stake in Genentech for $46.8B. Sales of Avastin have grown rapidly to $4.4B and analysts predicted the possibility of rapidly doubling this figure if the trial was successful. However, the head of pharmaceuticals at Roche, Bill Burns, predicts that Avastin sales will reach $8B-9B by 2011 despite the disappointing clinical trial results for colon cancer announced today.
2.) Watson Pharma (WPI) confirmed today that it has filed two ANDAs with the FDA seeking generic approvals for Reckitt Benckiser's (UK: RB.L) (US ADR: RBGPF.PK) over-the-counter cough and cold medications, Mucinex and Mucinex DM, which posted U.S. sales in 2008 of $106M and $85M, respectively, according to IMS Health data.
Reckitt Benckiser filed a lawsuit against Watson earlier this week to prevent generic competition for the products until their patents (U.S. patent numbers 6,372,252 and 6,955,821) expire – resulting in a stay of final FDA approval of the two ANDAs for up to 30 months or until the litigation is resolved. Watson believes it is the first-to-file for generics of the two products, an it may be eligible for 180 days of market exclusivity if the ANDAs are approved.
3.) Genzyme (GENZ) reported its quarterly results today and issued the following guidance for its development programs, which include about 100 active clinical trials and multiple pending FDA applications for new drug approvals and label expansions for its existing products.
- expects a FDA decision to expand the use of cancer drug Clolar as a first-line therapy for adult acute myeloid leukemia during 2H09.
- completed enrollment in the first of two Phase 3 trials of alemtuzumab as a new treatment for multiple sclerosis and expects to complete enrollment in second trial by year-end with a goal of FDA approval in 2012
- topline Phase 3 clinical trial results expected during 2Q09 along with Isis Pharma (ISIS) for mipomersen in patients with homozygous familial hypercholesterolemia (a genetic condition resulting in very high cholesterol levels)
- plans to initiate two phase 3 studies of GENZ-112638 by mid-2009 as an oral treatment for Gaucher disease (a rare enzyme disorder) with one trial including untreated patients and the other as a switch trial in patients who have achieved their therapeutic goals with Cerezyme (imiglucerase for injection)
- along with Osiris Therapeutics (OSIR), enrollment has been completed in two Phase 3 clinical trials of Prochymal for graft vs. host disease with data expected 2H09
- ataluren is an oral treatment for genetic disorders with a pivotal phase 2b trial in patients with Duchenne muscular dystrophy fully enrolled with expected results 1H10 and a Phase 3 clinical trial in cystic fibrosis expected to begin during 2Q09
- began a pivotal trial of an advanced phosphate binder for patients with renal disease which is expected to represent an improvement in potency over existing therapies while maintaining all the benefits of sevelamer with an expectation of FDA approval at the time of expiration for the core patent estate of sevelamer (marketed as Renagel and Renvela with combined sales of $170.6M during 1Q09) in 2014
Disclosure: No positions.