By Matthew Willett
NPS Pharmaceuticals Inc. and Canadian subsidiary NPS Allelix Corp. turned over worldwide distribution rights for ALX-0646, a triptan-class serotonin agonist for migraine headache treatment, to Forest Laboratories Inc. in an agreement for the therapeutic's development and distribution.
David Clark, NPS vice president of operations, said the deal includes milestone payments and royalties in what he terms a standard licensing agreement.
The deal is the latest in a series of partnerships for NPS, headquartered in Salt Lake City, and NPS Allelix, based in Mississauga, Ontario.
The company's lineup of collaborators includes industry leaders like Amgen Inc., of Thousand Oaks, Calif.; SmithKline Beecham Corp., of Philadelphia; Abbott Laboratories, of Abbott Park, Ill.; and Eli Lilly and Co., of Indianapolis.
In licensing fees alone since 1993, NPS has garnered more than $21 million. Add in research support payments from licensing partners and equity investments from the same and the total rises to more than $47 million.
Clark said the deal with New York-based Forest is another in the tradition.
"It's a marvelous fit," he said. "Forest is very adept at marketing in the central nervous system market, and they've looked for a product like this, a second- or third- generation partnership."
ALX-0646 came to NPS as a part of the Allelix pipeline obtained in the pair's 1999 merger. (See BioWorld Today, Sept. 29, 1999, p. 1.) FDA-mandated toxicology studies are still pending before Forest can move the compound into the clinic, but a Phase I trial outside the U.S. indicated the compound is safe and well tolerated.
"The compound needs some additional preclinical work before we can continue with clinical trials," Clark said. "There were two challenges. First, how to finish the preclinical work, and, second, how to successfully market the compound with a lot of competition out there. We're not in the position to market with such competition, but Forest is well suited to that kind of program development, so it was important to get that deal done with them."
Clark added that the companies expect ALX-0646 to enter Phase I trials in mid-2001.
Triptans function, in part, through vasoconstriction of cerebral vessels. The drug bears promise, Clark said, for a selectivity that lowers the likelihood of causing cardiovascular side effects.
"It's a novel triptan compound," he said, "But it's selective, in contrast to other triptans on the market, for the 5ht-1d serotonin receptor. Other triptans are selective for both the 5ht-1d and 1b receptors, and this makes ALX-0646 less likely to produce cardiovascular side effects than others."
Migraine headaches affect more than 20 million Americans, and the market for migraine therapeutics is more than $1.4 billion annually.
Other therapeutics in the NPS and NPS Allelix pipeline include calcimimetic compounds for hyperparathyroidism; an osteoporosis therapeutic, ALX1-11, that uses recombinant human parathyroid hormone, and the glucogen-like peptide 2 (GLP-2) analogue ALX-600 for indications in gastrointestinal disorders.
Clark said NPS expects data from Phase II hyperparathyroidism trials later this year. ALX1-11 began a pivotal Phase III trial earlier this year and the company is expected to seek FDA approval upon successful completion. The company's drug for short bowel syndrome and intestinal atrophy due to chemotherapy treatment is in a pilot Phase II program that also began earlier this year.