The International Centre for Dispute Resolution Has Ruled in Favor of Glenmark Pharmaceuticals Ltd on the Arbitration Claim it Filed against Napo Pharmaceuticals, Inc.
MUMBAI, India, August 23, 2012 /PRNewswire/ –
This is to inform you that on August 22, 2012, the International Centre for Dispute
Resolution (“ICDR”) ruled in favor of Glenmark Pharmaceuticals Limited (“Glenmark”) on the
arbitration claim it filed on August 8, 2011 against Napo Pharmaceuticals, Inc. (“Napo”)
seeking, among other things, a ruling that Glenmark’s exclusive rights to develop,
commercialise and distribute Crofelemer in 140 countries for treatment of diarrheal
diseases 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
into the 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 the 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
(“Aptuit”) and enjoined Napo from disclosing such confidential information to third
parties and from purchasing or obtaining Crofelemer from Aptuit.
“We are delighted that the arbitrators have reaffirmed Glenmark’s rights to
commercialise Crofelemer through relief agencies. Diarrhea is a big concern around the
world, especially in emerging markets and globally millions of patients suffer from
diarrhea every year. This ruling will allow Glenmark to further its commitment to working
with relief agencies to distribute Crofelemer to affected populations. We also are pleased
that the arbitrators have prevented Napo from sharing confidential information concerning
the manufacture of Crofelemer with our competitors and other third parties,” said Mr.
Glenn Saldanha, Chairman & MD, Glenmark Pharmaceuticals Limited.
Napo also had filed a claim in the same proceeding seeking a ruling that Glenmark had
materially breached the Collaboration Agreement between the parties by failing to, among
other things, commercialise Crofelemer in all 140 countries in its territory and to
manufacture a pediatric formulation for Crofelemer. In its ruling today, the ICDR rejected
Napo’s material breach claim, finding that Glenmark has complied with all of its
obligations under the Collaboration Agreement.
The ruling today is an Interim Award addressing the issues presently before the ICDR.
Certain other issues between the parties have been deferred to a second phase.
Glenmark Pharmaceuticals has an exclusive license from Napo Pharmaceuticals, Inc. to
distribute and commercialise Crofelemer in 140 emerging countries (rest of world, or “ROW”
territories) including India for indications related to HIV, use in acute adult and
pediatric diarrhea. Crofelemer is a novel, first-in-class anti-diarrheal agent that has a
physiological and different mechanism of action from traditional anti-diarrheal agents.
Besides its potential efficacious role in multiple diarrheal indications, Crofelemer
controls diarrhea with no drug-drug interactions, minimal systemic adsorption and, unlike
current anti-diarrheals, no serious side effects.
For further information, please contact: Jason D'souza/ Rajdeep Barooah Tel:+91-22-40189919/40189984 email: email@example.com
SOURCE Glenmark Pharmaceuticals Ltd