FDA Calendar Updates: SNTS, CEPH, AZN, DNDN, GILD, NVO

Written by Mike Havrilla

Monday, 06 April 2009 10:42

Below is a summary of updates to the BioMedReports.com database of 239 entries included in the FDA and Clinical Trial Calendars. You can also follow me on Twitter at http://twitter.com/mikehavrilla

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 112 entries through 4/6/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.

The Clinical Trial Calendar includes 127 entries through 4/6/09 and 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.) Santarus (SNTS): On 4/6/09, SNTS filed a NDA for a new tablet formulation of its Zegerid family of branded prescription pharmaceutical products. The expected PDUFA decision date by the FDA is 12/4/09.

2.) Cephalon (CEPH): On 4/6/09, CEPH announced positive Phase 3 clinical trial results for Nuvigil (armodafinil) Tablets [C-IV] as a treatment for excessive sleepiness associated with jet lag disorder. CEPH plans to launch Nuvigil (as the longer-acting isomer of Provigil) during 3Q09 and also plans to submit a sNDA to the FDA in the same quarter to expand Nuvigil's label to include the treatment of jet lag disorder.

3.) AstraZeneca (AZN) received a complete response letter (CRL) today from the FDA, which is requesting additional data for the Company's inhaled asthma treatment Symbicort for young children. The use of Symbicort for the long-term maintenance treatment of asthma is already approved for patients aged 12 and over in the U.S. and AZN is trying to expand the label to include children age 6-11.

4.) Dendreon (DNDN): Shares of DNDN have soared by about 50% since mid-day on Friday 4/3/09 as investors anticipate the possible release of late-stage data for the Company's prostate cancer vaccine Provenge. DNDN has provided guidance of releasing the results before the end of the month and is scheduled to make a late-breaker presentation at the American Urological Association meeting on April 28 in Chicago.

5.) Gilead Sciences (GILD) reported positive Phase 3 clinical trial results on 4/3/09 for the Company's endothelin receptor antagonist darusentan in the treatment of resistant hypertension. The drug met its co-primary efficacy endpoints of change from baseline to week 14 in trough sitting systolic blood pressure and trough sitting diastolic blood pressure. A second Phase 3 study of the drug is about 90% enrolled and is expected to be completed by year-end.

6.) Novo Nordisk (NVO): Last week, a FDA advisory panel had a split vote (6-6) on whether the drug should be approved in the face of evidence it caused cancerous thyroid tumors in rats and mice. The panel voted 8 to 5 that liraglutide did not appear to hasten heart attack and other problems seen with similar drugs in recent years.

Liraglutide is an injectable treatment being developed for use by millions of patients with type 2 diabetes. The drug has demonstrated the ability to control blood sugar levels while reducing weight, whereas many other diabetes drugs and insulin therapy typically causes weight gain.

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