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Drugmaker Glenmark has filed a statement claim with the American Arbitration Association against the United States' Napo Pharmaceuticals – seeking to retain the terms of an earlier agreement between the two companies on Napo's proprietary anti-diarrhoeal compound Crofelemer.
Napo had earlier said that it terminated a July 2005 collaboration agreement between it and Glenmark, as it was “disappointed that Glenmark did not move forward to make this first-in-class drug available in any one of the 140 countries in which it was licenced to do so. We will bring this life-saving drug to the global market as quickly as possible,” Napo had said in its statement.
Effective December 8, 2011, the termination was based on Glenmark's alleged breaches of the collaboration agreement between the two parties, the company added. “Glenmark has yet to file a single application for regulatory approval with the Drugs Controller General India or any other regulatory agency,” Napo said.
Denying Napo's statements, Glenmark said that Napo has no basis to terminate the collaboration agreement on Crofelemer, and Glenmark was seeking a declaration from an arbitration panel that Napo's claims of breach were unfounded.
“On December 9, 2011, Glenmark formally requested that the arbitration panel issue an interim order directing Napo to comply with the Collaboration Agreement during the pendency of the arbitration,” Glenmark said.
Further, company officials familiar with the development told Business Line that the arbitration panel will also rule regarding clarification of marketing rights as requested by Glenmark in the previous appeal.
Glenmark continues to develop Crofelemer for all indications that the company has rights to, the official said. Filing timelines will depend on the availability of the complete regulatory data and Glenmark expects such filings to begin for the rest of the world markets in 2012 and hope to obtain approvals in the first six months of 2013, as planned, the official added.
Glenmark shares were down over four per cent on the BSE at Rs 294, on Tuesday.
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