FDA approvals for Gattex, Adasuve, Varizig and Tamiflu

Ahead of the Christmas holiday period, the US Food and Drug Administration announced a number of regulatory decisions, including the approval of US biopharma company NPS Pharmaceuticals’ (Nasdaq: NPSP) Gattex (teduglutide [rDNA origin]) for injection, for subcutaneous use for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support. Gattex will be made available in the USA in the first quarter of 2013.

“Gattex is a ground-breaking therapy that has been evaluated in the largest clinical program to date in short bowel syndrome,” said Francois Nader, president and chief executive of NPS Pharmaceuticals. “We are very excited about the opportunity to help SBS patients by offering this first-in-class therapy. The approval of Gattex is a crowning achievement for our company and the catalyst for our transformation into a premier orphan drug business. We are prepared for a successful launch based on productive interactions with payers, methodical patient identification, and the strategic development of our field-based commercial infrastructure. We have also launched NPS Advantage, our free support program that includes, care coordinators who will work closely with patients to help them understand the clinical characteristics of Gattex and navigate the reimbursement landscape.”

Gattex is the first major long-term treatment advance for SBS in nearly 40 years, the company noted. The unique mechanism of action of Gattex enhances gastrointestinal absorption. In Phase III studies, significant reductions in PN/IV volume and infusion days per week were achieved from pre-treatment baseline. In addition, some patients achieved independence from PN/IV support. NPS, which reported about $101 million in 2011 revenue last year, may see peak annual sales from Gattex reach $350 million, Mr Nader, said in an October interview quoted by Bloomberg.