Glenmark gains favourable arbitration ruling in crofelemer case with Napo
This article was originally published in Scrip
An international arbitrator has ruled in favour of Glenmark Pharmaceuticals upholding, among others, the Indian firm's commercialisation rights to Napo Pharmaceuticals' anti-secretory gastrointestinal agent, crofelemer
Glenmark informed the Bombay Stock Exchange that the International Centre for Dispute Resolution (ICDR) had, in an interim award, held that the firm's exclusive rights to commercialise and distribute crofelemer include an exclusive right to distribute the product through relief agencies into the 140 countries that form part of its territory.
About a year ago, Glenmark filed an arbitration claim with the American Arbitration Association, of which the ICDR is a part, aimed at safeguarding its exclusive rights to crofelemer (scripintelligence.com, 9 August 2011).
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 the 140 countries in its territory. Napo was also pulled up for breach of the collaboration agreement by disclosing confidential information concerning the manufacture of crofelemer to Aptuit Laurus. The ICDR has enjoined Napo from disclosing such confidential information to third parties and from purchasing or obtaining crofelemer from Aptuit, a statement from Glenmark said.
Napo's claim of Glenmark having materially breached the collaboration pact by failing to, among others, commercialise crofelemer in the 140 countries and to manufacture a pediatric formulation for crofelemer was also rejected. The ICDR noted that Glenmark had complied with all of its obligations under the collaboration deal.
Glenmark said that although the current ruling addressed the issues presently before the ICDR, certain other issues had been deferred to a second phase. Some analysts think, that with the current ruling having addressed the key issues, the residual issues may not be significantly material.
Glenmark also continues to progress its 700-patient Phase III study in India and Bangladesh with crofelemer in patients with acute watery diarrhoea and cholera, though all eyes on the new Prescription Drug User Fee Act (PDUFA) date for crofelemer. The US FDA had earlier extended the PDUFA date, originally set for 5 June to 5 September. The agency's priority review of the crofelemer NDA is for the indication of chronic diarrhoea in people living with HIV/AIDS who are on anti retroviral therapy.
Napo had earlier terminated its deal with both its partners – Salix and Glenmark – the latter over alleged "material breaches" of the pact by the Indian firm (scripintelligence.com 14 December 2011). Earlier this year Napo claimed victory after Salix filed a voluntary motion requesting the dismissal of a June 2011 lawsuit, in which it had sought access to Napo's financial books and records (scripintelligence.com, 13 January 2012). Napo had also filed a lawsuit against Salix seeking damages in excess of $150 million for breach of contract (scripintelligence.com, 9 May 2011).
Crofelemer had been licensed to Salix for the treatment of chronic diarrhoea in people living with HIV, and the additional indications of pediatric diarrhoea and acute infectious diarrhoea, in North America, Europe (excluding Iceland, Liechtenstein, Norway and Switzerland) and Japan. Salix also has a worldwide licence to all other possible human indications, including irritable bowel syndrome. Glenmark has the exclusive licence to commercialise crofelemer in 140 rest-of-world territories including India for indications related to HIV and acute adult and pediatric diarrhoea. Glenmark and Salix have also entered into a supply agreement for crofelemer's active pharmaceutical ingredient.