Glenmark’s collaborative partner, Salix Pharmaceuticals announced that the Food and Drug Administration has advised the company that the New Drug Application (NDA) for Crofelemer 125 mg tablets, indicated for symptomatic relief of non-infectious diarrhoea in patients with HIV/AIDS on anti-retroviral therapy, is still under review and that a final action will not be taken by the scheduled Prescription Drug User Fee Act (PDUFA) goal date of September 5, 2012. Glenmark has exclusive rights for Crofelemer in diarrhoea indications in nearly 140 countries including India and is the sole API supplier globally for Crofelemer (ex-China).
Salix, stated in its note, “The FDA continues to work collaboratively with Salix to progress this important product through its full review. By taking no action at this time, the FDA has allowed for the currently ongoing dialogue between Salix and the FDA to continue. The continuing dialogue should allow further collaboration between Salix and the Agency, a collaboration that has resulted in substantial progress in handling topics important to crofelemer and botanical products in general. The primary topic is the production and control of the crofelemer active pharmaceutical ingredient, a complex mixture that is the first botanical product to be reviewed by the Agency for oral use. This focus is needed to ensure compliance with the manufacturing and product quality requirements of the Food, Drug & Cosmetic Act. Both Salix and FDA are committed to a robust level of cooperation and data exchange with the goal of providing crofelemer to patients suffering from this very important unmet need. Salix looks forward to this continuing collaboration and anticipate an action by FDA by the end of the first quarter of 2013.”
As reported earlier in Express Pharma, the International Centre for Dispute Resolution (ICDR) ruled in favour of Glenmark on the arbitration claim it filed on August 8, 2011 against Napo Pharmaceuticals seeking, among other things, a ruling that Glenmark’s exclusive rights to develop, commercialise and distribute Crofelemer in 140 countries for treatment of diarrhoeal diseases. The claim also includes the exclusive rights to distribute though relief agencies in these countries and an injunction prohibiting Napo from sharing confidential information concerning the manufacture of Crofelemer.
The ICDR ruled that Glenmark’s exclusive rights to commercialise and distribute Crofelemer include the exclusive right to distribute Crofelemer through relief agencies to 140 countries that comprise the Glenmark territory. The ICDR also ruled that Glenmark has two years from the time Crofelemer is approved in India (on an indication by indication basis) to file for regulatory approval in 140 countries in its territory.
Finally, the ICDR found that Napo breached the collaboration agreement by disclosing confidential information concerning the manufacture of Crofelemer to Aptuit Laurus and enjoined Napo from disclosing such confidential information to third parties and from purchasing or obtaining Crofelemer from Aptuit.
EP News Bureau