FDA Calendar Updates: Covidien, Dynavax, Nuvo Research

Includes: DVAX, MDT, NRIFF
by: Mike Havrilla

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 286 entries as of 8/4/09. 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, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 8/4/09, Covidien (NYSE:COV) and Nuvo Research [NRI.TO] (OTCQX:NRIFF) announced that the FDA issued a new PDUFA action date for Pennsaid (diclofenac sodium) topical solution 1.5% of 11/4/09. During the review process, Nuvo provided the FDA with supplemental information, which the Agency determined to be a major amendment to the Pennsaid New Drug Application (NDA). As a result, the FDA has extended its action date by three months to provide time for a full review of the submission.

On 6/16/09, Nuvo announced a deal with COV which granted exclusive rights to market and sell Pennsaid, and its follow-on product, Pennsaid Plus, in the U.S. Pennsaid and Pennsaid Plus are Nuvo's topical non-steroidal anti-inflammatory drug (NSAID) candidates that deliver diclofenac through the skin directly to the site of pain. Nuvo receives an up-front, non-refundable payment of US$10M and is also eligible to receive a US$15M milestone payment on Pennsaid's approval by the FDA, which will increase to US$20M if certain labeling criteria are agreed to by the FDA.

In addition, Nuvo will receive royalties on net U.S. sales of Pennsaid and Pennsaid Plus and is also eligible to receive additional escalating sales milestone payments for the products totaling up to US$100M. COV assumes responsibility for all future development activities and expenses for Pennsaid Plus, including two Phase 3 clinical trials that are expected to begin in 2010.

On 8/4/09, Dynavax (NASDAQ:DVAX) announced that the Company met with the FDA to discuss plans to resume development of Heplisav, which is the Company's Phase 3 investigational hepatitis B vaccine. DVAX proposed the continued clinical development of Heplisav in populations that are less responsive to current licensed hepatitis B vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and other groups such as individuals infected with HIV or diagnosed with chronic liver disease. The FDA expressed a general agreement that these populations are appropriate for further clinical development, pending the review of the study protocols and additional supportive data.

DVAX plans to submit this information to the FDA in August 2009 with a goal of having the agency remove the clinical hold in September 2009. The Company is prepared to restart clinical trials in individuals with chronic kidney disease upon removal of the clinical hold. Phase 3 data from the PHAST clinical trial demonstrate subjects over 40 years of age receiving two doses of Heplisav over one month achieved a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over six months. Over 2,500 individuals have been vaccinated with Heplisav to date. Dynavax has worldwide commercial rights to Heplisav, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

Disclosure: No positions