Boston, MA 04/10/2014 (wallstreetpr) – Reports in India indicate that Natco has formally asked the patent office in India, to deny U.S Gilead Sciences, Inc. (NASDAQ:GILD) patent for its Hepatitis C drug Sovaldi. The move if successful, would clear path for the Indian government to launch a generic drug for the illness. Natco is filling a ‘pre-grant’ opposition with the authority, according to sources who have declined to be named as the information has not yet been made public.
India’s patent laws are unique as they allow third parties to dispute the awarding of patents. The source claims that Natco is opposed to Sovaldi, as it perceives it as not being “inventive” enough. Gilead is thought to be planning to license the drug to three or four Indian generic manufacturers, a move that could pave way for the medicine to be sold at lower prices.
Gilead Granted Review by the FDA
Gilead Sciences, Inc. (NASDAQ:GILD) has announced it has been granted a priority review by the Food and Drug Administration FDA for a combination of its NS5A inhibitor ledipasvir 90mg and nucleotide analog polymerase inhibitor sofosbuspir 400mg. The combination is aimed at treating chronic hepatitis C genotype 1 infection in adults. Gilead had filed for the approval back in February 10, 2014 with the FDA setting target action date for October 10, 2014.
Gilead Sciences, Inc. (NASDAQ:GILD) also received the much needed boost by the FDA essentially assigning LDV/SOF a breakthrough therapy, the treatment is seen as having the potential of offering advanced treatment over existing options. Gilead received approval after submitting data from three, Phase 3 studies. The data supports the use of LDV/SOF on adults with HCV infection genotype 1 for a duration of between 8 and 12 weeks
LDV/SOF Being Evaluated by EMA
LDV/SOF is already under review by the European Union for marketing applications as it has already been validated by the European Medicines Agency (EMA). Gilead has also been granted its request of having the drug review process accelerated.
LDV/SOF is still an investigational product whose safety and efficacy levels have not yet been established, awaiting further testing and approvals. This could be the biggest hurdle that Gilead Sciences, Inc. (NASDAQ:GILD) will have to pass.
