FDA Calendar Updates: 3-Month Delay for Nuvo, Covidien's Pennsaid

Written by Mike Havrilla

Tuesday, 04 August 2009 13:16

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 286 entries as of 8/4/09. The calendar was originally created by Mike Havrilla 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) (NRIFF.PK) 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.

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