Schering/Migenix Sign Deal For PEG-Intron Hepatitis C Combo Study

Schering-Plough gains right to negotiate a licensing agreement for Migenix’ hepatitis C therapy celgosivir (MX-3253). Schering will provide pegylated interferon alfa-2b and ribavirin to Migenix for a Phase II combination study.

Schering-Plough will have the option to negotiate a licensing agreement for Migenix' Phase II hepatitis C therapy celgosivir (MX-3253) under a deal announced by Vancouver, B.C.-based Migenix July 13.

Schering will supply Migenix with a bundled peginterferon alfa-2b/ribavirin product for a Phase II combination study with Migenix' celgosivir. Schering will also lend technical and laboratory support.

The Schering product used in the study will be Pegetron , co-packaged pegylated interferon alfa-2b/ribavirin sold in Canada. In the U.S., Schering markets PEG-Intron (pegylated interferon alfa-2b) and Rebetol (ribavirin) as stand-alone products.

In exchange, Schering will receive "limited periods of exclusivity" for data review of the clinical trial results and for the negotiation of a licensing agreement with Migenix for celgosivir.

The 12-week study, which is expected to start during the third quarter, will randomize 60 patients into one of three treatment groups: celgosivir plus peginterferon alfa-2b plus ribavirin; celgosivir plus peginterferon alfa-2b; or peginterferon alfa-2b plus ribavirin.

Celgosivir is an oral alpha-glucosidase I inhibitor and a prodrug of castanospermine, a natural product derived from the Australian Black Bean chestnut tree, Migenix said. Celgosivir is currently in Phase II as a monotherapy hepatitis C treatment.

Combination therapy with peginterferon alfa-2b and ribavirin could yield greater efficacy results than celgosivir monotherapy, Migenix said.

"In preclinical studies, celgosivir has demonstrated strong synergy with interferon-alpha plus ribavirin and has the potential to be included as part of a combination approach to therapy to improve efficacy," the company said.

- Kate Rawson