GlaxoSmithKline, Pernix Therapeutics deal

Pernix said the closing of a deal granting GlaxoSmithKline U.S. rights to Treximet sumatriptan/naproxen was delayed due to a short-term “supply constraint” for the product. Early last month, Pernix announced the delay and said it was working with GSK to ensure sufficient supply to meet anticipated demand, and that the company and its lenders were also performing additional due diligence related to this supply issue. The deal was previously slated to close by Aug. 1; it closed on Aug. 20 (see BioCentury, May 19).

On a conference call to discuss its 2Q14 earnings, Pernix said the delay was caused by batch failure and a “low inventory situation.” GSK said it identified a cosmetic issue with the “fast-dissolving coating process” for Treximet and added that there was no issue with safety. By year end, Pernix plans to submit a request to FDA for pediatric exclusivity for Treximet. The request will trigger an additional $17 million payment to GSK from Pernix. Pernix said GSK will continue to manufacture Treximet until patent expiration, which will be August 2017 or February 2018 if Pernix obtains the pediatric exclusivity. ...