FDA Calendar Updates: Advanced Life Sciences, AstraZeneca, Bristol-Myers

Includes: ADLS, AZN, BMY
by: Mike Havrilla

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 293 entries as of 7/31/09. I originally created the calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/31/09, AstraZeneca (NYSE:AZN) and Bristol-Myers (NYSE:BMY) received FDA approval for a new diabetes drug called Onglyza. The Agency will require the companies to conduct a post-approval study to evaluate the drug's cardiovascular safety in higher-risk patients, but Onglyza was not linked to increased heart problems in low-risk diabetics according to the FDA.

The following is the previous FDA Calendar entry for Onglyza: BMY and AZN have a pending NDA for Onglyza (saxagliptin oral tablets), which is a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor for Type 2 Diabetes. On 4/1/09, the FDA panel voted 10 to 2 that the clinical data for the drug rule out the risk that the drug hastens heart attack, stroke and other problems. On 4/23/09, the FDA extended the PDUFA decision date by three months to 7/30/09.

On 7/31/09, Advanced Life Sciences (OTC:ADLS) announced that it received a complete response letter (CRL) from the FDA for the Company's New Drug Application (NDA) for Restanza (cethromycin) for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP). ADLS.OB will continue to pursue approval of Restanza in CAP and believes that an additional well-controlled clinical study designed to demonstrate efficacy in a more severe CAP population will likely be required for the approval of Restanza. In parallel, the Company will continue to advance Restanza as a bio-defense agent against anthrax, plague and tularemia.

On 6/2/09, the FDA Anti-Infective Drugs Advisory Committee voted that Restanza demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP, but voted that Restanza did not demonstrate efficacy in the treatment of CAP. The committee's negative vote on the drug candidate's efficacy followed a discussion that the Restanza NDA included data on patients with mild-to-moderate disease and that the new draft guidance for developing treatments for CAP, released in March, 2009, requires the enrollment of moderate-to-severe CAP patients for approval in the mild-to-moderate CAP indication. Advanced Life Sciences' pivotal Phase 3 program included in the NDA was designed and conducted under prior FDA guidance and before the new draft guidance was released.

ADLS.OB is moving expeditiously to develop a protocol for an additional Phase 3 trial that is designed to satisfy the FDA's request for additional efficacy information and expects to start the additional Phase 3 program during 1H10. On 7/31/09, ADLS.OB announced that it expects to report key data from the Company's ongoing pivotal studies in plague and tularemia by the end of 2009. ADLS.OB plans to submit an NDA amendment seeking marketing approval for the bio-defense indications during 1Q10.

Disclosure: No positions

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