NPS Pharma posts overall positive Gattex data, but shares plunge due to two deaths

Shares in USA-based NPS Pharmaceuticals (Nasdaq: NPSP) plummeted as much as 38% to $4.92 in morning trading yesterday, closing down 33.1% at $5.19, after the specialty pharma company revealed new Phase III clinical data on its gastrointestinal drug Gattex (teduglutide) which, while positive overall in terms of efficacy, linked the product with three cases of cancer, including two resulting in death.

New data from STEPS 2, a long-term open-label study, showed that Gattex was associated with achieving and maintaining clinically meaningful reductions in parenteral nutrition (PN) and intravenous (IV) fluid volume in adult subjects with short bowel syndrome. Short bowel syndrome is a rare and debilitating condition in which the body is unable to absorb enough nutrients and/or fluids through the gastrointestinal tract and patients chronically rely on intravenous feeding to survive. NPS says it remains on track to submit its New Drug Application for Gattex in short bowel syndrome later this year.

Gattex has been licensed to Swiss drugmaker Nycomed (now part of Japan’s Takeda) for ex-USA, Canada and Mexico markets under a deal worth up to $185 million to NPS. Nycomed, which uses the trade name Revestive for teduglutide, filed for approval of the drug with the European Medicines Agency as a once-daily treatment of short bowel syndrome earlier this year (The Pharma Letter March 29).