Nycomed has confirmed to NPS its commitment to license GATTEX for development and commercialization outside of North America. Under the terms of the agreement announced in September 2007, Nycomed will now pay NPS the $25 million balance of the $35 million up-front payment due NPS for the rights to develop and market GATTEX outside North America. In October 2007, NPS announced top-line results of the Phase 3 study of GATTEX in patients with short bowel syndrome (SBS). The company has requested a meeting to discuss the next steps in the drug's regulatory approval process with the FDA this year. NPS believes GATTEX could generate U.S. sales of between $150 and $250 million in this indication.
NPS is also running pre-clinical studies of GATTEX in support of a pediatric IND in necrotizing enterocolitis. NEC affects 12,000 neonates annually in the U.S. and mortality approaches 50% in infants weighing less than fifteen-hundred grams. Additional preclinical studies in chemotherapy-induced gastrointestinal mucositis will be initiated very soon. Chemotherapy-induced GI mucositis affects over 500,000 cancer patients in the U.S. annually.
NPS recently announced that Kirin Pharma has received approval to market cinacalcet HCl in Japan. This regulatory event triggered a $2 million milestone payment to NPS.
In September 2007, the FDA granted orphan drug status for PREOS as a treatment for hypoparathyroidism. The company is currently supporting a two-year study with PREOS in patients with hypoparathyroidism. The study was initiated by Dr. John Bilezikian at Columbia University and is now 96% enrolled.
The company believes that as a result of recent fundraising activities,
sales of non-core assets and the GATTEX partnership with Nycomed, it now
has the financial resources to fund the continued U.S. development of PREOS
in a variety of ind
|SOURCE NPS Pharmaceuticals, Inc.|
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