Nycomed has bought certain licensing rights to US group NPS Pharmaceuticals’ Gattex, a treatment for gastrointestinal disorders currently being assessed in late-stage development.
Gattex, a potential first-in-class drug, is a proprietary analog of a naturally-occurring peptide involved in the regeneration and repair of the intestinal lining, which has shown promise in mid-stage development. According to the group, a previous Phase II proof-of-concept study in patients with short bowel syndrome showed that daily subcutaneous injections of Gattex resulted in significant growth of the intestinal lining and boosted dietary absorption of nutrients and fluids.
NPS says it is planning to submit a New Drug Application for SBS in mid-2008, and is also evaluating the drug’s potential as a possible treatment for chemotherapy-induced gastrointestinal mucositis in cancer patients, and necrotising enterocolitis in preterm infants.
The deal provides Nycomed with worldwide rights to Gattex outside the USA, Canada and Mexico, and could see NPS net $185 million plus royalties.
Specifically, NPS stands to receive: an upfront payment of $35 million: a $10 million non-refundable commitment fee upon signing the agreement; and $25 million on the announcement of top-line results from the recently-completed Phase III SBS study, expected early in the fourth quarter of 2007. But the company could earn more than $150 million in payments related to meeting certain regulatory milestones for the SBS indication, the successful development of new indications and sales-based milestones, as well as double-digit royalties on future turnover.
Future development shared
Additionally, Nycomed has agreed to share in the cost of future development of the drug for different indications, although NPS will complete the current Gattex clinical program in SBS.
Explaining the strategy behind the deal, NPS president and chief executive Dr Tony Coles said: "This agreement expands our relationship with Nycomed and brings us an important strategic partner for Gattex outside North America. The collaboration provides us with a partner that will help us pursue a full development program for Gattex worldwide, not only in SBS, but potentially in other indications, as well.”
And Nycomed chief executive Hakan Bjorklund was equally positive about the move: "We believe Gattex has the potential to be an important new therapy for serious gastrointestinal conditions,” he said, and added that the company is “exited” to add the product to its pipeline, “as it perfectly matches our development and marketing capabilities in the gastroenterology field.”