Ranbaxy Laboratories says that its recently-extended R&D pact with GlaxoSmithKline is already bearing fruit and the firms have identified a promising compound that has the potential to treat respiratory inflammation.
The Indian drugmaker claims it has achieved “a significant milestone in its collaboration with GSK” and researchers from the two companies have approved the candidate selection of a compound for respiratory inflammation. Under the terms of the multi-year R&D pact, initiated in 2003 and expanded in February, Ranbaxy will further profile the drug candidate through pre-clinical studies and be responsible for conducting Phase I and Phase II trials through to proof of concept. After that, GSK will have the option to conduct further development through to final commercialisation.
The alliance is looking at a wide range of therapeutic areas of interest, including anti-infectives, metabolic disorders and oncology, as well as respiratory products. The revised agreement also means that Ranbaxy could receive over $100 million in potential milestone payments for any product subsequently launched by GSK in multiple indications and up to double- digit royalties on worldwide net sales.
Supreme Court rejects Ranbaxy's Lipitor challenge
Less good news for Ranbaxy came with the announcement that it has lost an appeal to the US Supreme Court in an attempt to sell its generic version of Pfizer’s blockbuster cholesterol drug Lipitor (atorvastatin). Ranbaxy had alleged that the New York-based behemoth had forfeited its right to a patent extension blocking generic sales of the drug through March 2010, because it failed to disclose information to the US Patent and Trademark Office. However, a federal judge said the information that Pfizer withheld was "immaterial."
An appeals court had previously upheld Pfizer's basic patent for the compound last year and the company got a six-month extension to the aforementioned March 2010 date thanks to paediatric exclusivity.