Business briefs: GSK, Otsuka, Roche and Gilead
GSK said it is seeking an additional indication for Votrient (pazopanib) as a maintenance therapy for advanced ovarian cancer. The additional indication will be for the treatment of women with Stage II-IV ovarian, fallopian tube or primary peritoneal cancer who have not responded to first-line chemotherapy treatment. The drug maker also said it received FDA approval to ship its four-strain (quadrivalent) influenza vaccine to HCPs.
Rep. Jason Chaffetz (R-UT) introduced a bill in the house Friday that would change the way submission and approval of certain combination drug products would be conducted. The bill, dubbed the Combination Drug Development Incentive Act of 2013, would seek to amend the five-year new chemical entity exclusivity (NCE) provisions requiring that each of “the active moieties in the drug product must be new,” or not previously approved. The proposed act would amend the statute to allow for exclusivity for a new combination of drugs even if both were previously approved separately, reported FDA Law Blog.
An FDA advisory committee voted 9-6 not to approve Otsuka Pharmaceuticals's tolvaptan for the treatment of Autosomal Dominant Polycystic Kidney Disease. The FDA accepted Otsuka's NDA for tolvaptan earlier this year and granted it priority review status with a goal date of September 1, 2013.
The UK's National Institute for Health and Care Excellence (NICE) said breast cancer drug Perjeta isn't worth its price tag. A NICE independent appraisal committee said the drug is not recommended as a routine treatment because clinical data presented to the committee would not predict how long it might extend people's lives vs. current National Health Service treatments. NICE is currently evaluating whether it should fund Perjeta when used in combination with Herceptin and docetaxel for HER-2 positive tumors.
The Indian government said yesterday that Roche lost a bid to secure additional patents for Herceptin due to “procedural lapses,” in how they were filed. According to a press release issued by the regional patent office in Kolkata, Roche failed to meet legal deadlines and executives were not present to attend hearings.
China revoked Gilead's patent protecting Viread—a treatment for HIV and hepatitis B. In dismissing the patent, authorities said the drug “lacked novelty and was not entitled to protection,” according to one analyst, as reported by Bioworld, adding that the move could be part of a greater effort by Chinese regulators to exert a stronger position in pricing negotiations.