The corporate partnership formed between biotechnologyleader Amgen Inc. and neurotech hopeful RegeneronPharmaceuticals Inc. in the fall of 1990 has begun to bear fruit.

Amgen on Monday announced that it has filed aninvestigational new drug application (IND) on the partnership'sfirst drug ready for the clinic: brain-derived neurotrophicfactor (BDNF) for treating amyotrophic lateral sclerosis (ALS),commonly known as Lou Gehrig's disease.

Amgen-Regeneron Partners has conducted preclinical studiesdemonstrating the ability of BDNF to produce protective andsurvival-promoting effects on motor neurons. And preclinicalresults published in Nature last December by researchers fromAmgen, Washington University in St. Louis and the Max PlanckInstitute showed that damaged motor neurons are actuallyrescued from death because they are able to take up BDNF.

In fact, the Max Planck Institute received a U.S. patent coveringthe BDNF gene in January; Regeneron of Tarrytown, N.Y., is theexclusive licensee to the patent.

Under the terms of the Amgen-Regeneron partnership, Amgen(NASDAQ:AMGN) of Thousand Oaks, Calif., will now manage theBDNF clinical trials.

The joint venture is also responsible for bringing to the clinicneurotrophin-3 (NT-3), another neurotrophic factor in theproduct portfolio of Regeneron. From the start, Amgencontributed $16 million to this partnership, and since then hasprovided another $15 million in funding the development ofBDNF and NT-3, explained David Kaye, Amgen's manager ofproduct communications.

Given a successful clinical trial outcome for both products,Amgen has the commercial rights outside the U.S., Japan andcertain other Asian countries, and Regeneron gets royalties onthose sales. The companies will share the profits on sales in theU.S.

BDNF will be Regeneron's second neurotrophic factor to enterthe clinic for treating ALS. The first, ciliary neurotrophic factor(CNTF), has already advanced to Phase III trials, whichRegeneron began on its own in late March. Competitors for atreatment for ALS include neurotech company Cephalon Inc.(NASDAQ:CEPH), which is testing its recombinant insulin-likegrowth factor (IGF-1) in Phase II/III clinicals, and the SyntexUSA Inc./Synergen Inc. (NASDAQ:SYGN) joint venture, whichhas its own version of CNTF in Phase II/III trials.

"Active treatment (for those trials) should start this summer,"said Synergen spokesman Paul Laland.

Regeneron's stock (NASDAQ:RGEN) gained $1.75 a share onMonday, closing at $21.50. Amgen's, on the other hand, lost 13cents a share to close at $34.50.

-- Jennifer Van Brunt Senior Editor

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