NEW YORK (AP) – Pharmasset Inc. and Johnson & Johnson said on July 6 that they will combine their hepatitis C drug candidates in a mid-stage clinical trial.
The study, which will begin later in 2011, will test Pharmasset’s PSI-7977 and Johnson & Johnson’s TMC435 as a treatment for chronic hepatitis C. The regimen will be tested on patients who have not been helped by standard treatments. Some patients will take ribavirin pills in addition to PSI-7977 and TMC435. The trial will evaluate the safety and effects of the regimen after 12 and 24 weeks.
The companies did not disclose terms of the collaboration.
PSI-7977 is seen as a promising treatment for hepatitis C, although it is still in mid-stage testing and is several years away from any potential approval. TMC435 was developed by Tibotec Pharmaceuticals, a unit of Johnson & Johnson.
Medivir AB, a Swedish company that helped develop TMC435, said on July 6 that the FDA granted fast track status to the drug. The FDA’s decision allows Johnson & Johnson to submit its marketing application step by step instead of all at once, and means the drug is eligible for a six-month review instead of the usual 10 months.
Johnson & Johnson is also responsible for European marketing of Vertex Pharmaceuticals Inc.’s hepatitis C drug Incivek. U.S. regulators approved Incivek in May, but the drug has not been approved in Europe.
The Associated Press
Filed Under: Drug Discovery