Regeneron Pharmaceuticals Inc. and Sumitomo Pharmaceuticals Co.Ltd. entered into an agreement worth up to $40 million to research,develop and commercialize brain-derived neurotrophic factor (BDNF)in Japan, the companies announced Wednesday.Regeneron, of Tarrytown, N.Y., gets an immediate research payment of$13 million, four annual payments of $3 million for research, one ofwhich cannot be canceled, and payments of $5 million for each of threemilestones met in Japan, Selena Chaisson, Regeneron's corporatefinance manager, told BioWorld. Also, Regeneron will be paid forproviding clinical supplies of BDNF, made at its protein manufacturingplant, to the Tokyo company for use in Japanese trials. Regeneron alsowill get royalties on BDNF sales in Japan.The deal stems from a 1989 agreement between the companies inwhich Sumitomo bought $4.4 million worth of Regeneron stock, andmade a $5.6 million research and development payment, entitlingSumitomo to a limited right of first refusal to license up to threeproduct candidates for commercialization in Japan. This is the firstcompound negotiated for by Sumitomo, a subsidiary of SumitomoChemical Co. Ltd., Chaisson said.Regeneron is developing BDNF in the U.S. and Europe incollaboration with Amgen Inc. of Thousand Oaks, Calif. They are in aPhase I/II trial of BDNF for amytrophic lateral sclerosis (ALS). Thepartnership is also in preclinical development of BDNF for potentialtreatment of neurodegenerative diseases, retinal diseases and peripheralneuropathies."With Amgen having the U.S. and Europe, the next large opportunityis Japan," Chaisson said. `We're very excited. [Sumitomo] has beenvery successful in that market. Having a strong partner in Japan isgoing to be extremely helpful to us."Leonard Schleifer, chairman, president and CEO of Regeneron, pointedout that "Sumitomo has demonstrated its substantial expertise indeveloping and marketing biotechnology-based products through itssuccessful commercialization of interferon and human growthhormone." The subsidiary had 1993 sales of 239.1 billion, or aboutU.S. $2.3 billion, Regeneron said.BDNF is a naturally occurring protein nerve growth factor that acts as asurvival-promoting factor for motor neurons. It was first described byresearchers at the Max Planck Institute in Germany, which grantedRegeneron an exclusive license to use technologies relating toneurotrophic factors. Regeneron holds U.S patents covering the geneencoding BDNF and BDNF protein compositions, and has other patentapplications, both in the U.S. and Japan, Chaisson said.Regeneron said research has shown application of BDNF to a site ofnerve injury prevents death of these cells, which otherwise can causeparalysis and lead to fatality in certain degenerative diseases, such asALS.The company also is developing two other neurotrophic factors:neurotrophin-3 (NT-3) and ciliary neurotrophic factor (CNTF), thecompany's lead compound.NT-3, also being developed with Amgen, is in toxicology testing inanimals. Chaisson said Regeneron hopes to file an investigational newdrug application later this year to test NT-3 in treating chemotherapy-induced neuropathy.In March, Regeneron announced that it had to modify and extend thePhase III trial of CNTF for ALS because many patients who receivedCNTF had reactions such as coughing, weight loss and suppressedappetites. That trial had originally been scheduled to be completed thismonth.Chaisson said, "There is an ongoing discussion with the FDA about theextension and modifications. We haven't reached a definitive plan."Regeneron (NASDAQ:REGN) stock closed at $7.50 Wednesday, down13 cents. n

-- Jim Shrine

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