Napo terminates crofelemer collaboration pact with Glenmark
Glenmark denies breaches to agreement alleged by Napo
Napo Pharmaceuticals has terminated its Collaboration Agreement with Glenmark Pharmaceuticals, begun in July 2005, to develop and commercialise diarrhoea treatment crofelemer in more than 140 countries.
California, US-based Napo terminated the agreement on 8 December, citing breaches by Indian pharmaceutical firm Glenmark, including that it has yet to file a single application for regulatory approval with the Drugs Controller General India or any other regulatory agency.
Napo also alleges that Mumbai-based Glenmark has failed to develop, commercialise, file for or gain regulatory approval for crofelemer for use in HIV/AIDS patients – for which successful Phase III clinical trial results were announced in 2010 – or adult acute watery diarrhoea, for which there have been several successful clinical trial results, nor has it developed the drug for the treatment of paediatric diarrhoea.
‘Napo believes Glenmark has materially breached the Collaboration Agreement by failing to fulfill its basic responsibilities to develop and commercialise this important drug,’ said William Brewer, partner at law firm Bickel & Brewer and counsel for Napo.
‘Most notably, Glenmark has not filed a single application to register this drug in any country in the world, despite having had the licence for more than six years.’
Napo sent Glenmark a notice of default in September, which gave the firm 60 days to remedy the allegations. Napo has terminated the agreement based on Glenmark’s failure to cure these defaults.
Glenmark vehemently denies that Napo has any basis for terminating the Collaboration Agreement, and is seeking a declaration from an arbitration panel that Napo’s claims of a breach are unfounded.
The Glenmark termination follows Napo’s ending of a Collaboration Agreement with Salix Pharmaceuticals to commercially develop crofelemer in the US, Canada, Mexico, Europe and Japan.
The company says the ending of these paves the way for it to enter into new licensing agreements and press forward with registration and commercialisation of crofelemer worldwide, in countries such as India, Russia, Romania, Brazil, Australia, Switzerland, and South Africa.