Scios Nova Inc. and Kaken Pharmaceutical Co. Ltd. have expandeda 1988 agreement related to the former's recombinant basicfibroblast growth factor (bFGF).Kaken, of Tokyo, plans to begin Phase III trials of bFGF in Japanearly next month as a treatment for intractable dermal ulcers.Under the new agreement, Kaken will make payments to SciosNova for supply of material, for a manufacturing processdevelopment collaboration and for a license to Scios Nova's bFGFmanufacturing technology.The 1988 agreement granted Kaken exclusive rights to develop andmarket the protein for all indications in Japan, Korea, Taiwan,Hong Kong and the People's Republic of China. Under that deal,Scios Nova gets milestone payments and royalties on sales.Scios Nova, of Mountain View, Calif., is not disclosing financialdetails of the deal. But Kira Bacon, director of investor relations forScios Nova, said the first payment related to the amended deal willbe made in the quarter ending this month."There are a couple of significant aspects to this agreement,"Bacon told BioWorld. "The fact that they're going into Phase IIIstudies means the product is getting closer to commercialization,which would result in royalty payments to Scios Nova. We believestrongly in developing Scios Nova as a business, in increasing therevenues we generate to support research and development effortsand in helping move this company toward profitability. Thisagreement is another manifestation of that strategy."Fibroblast growth factor is a protein produced naturally in the bodythat the company said is a potent stimulator of blood-vesselformation and other tissue-repair processes. Scios Nova was thefirst to clone and produce recombinant human bFGF, and haspatents related to the protein.Yoshiharu Wakiyama, president of Kaken, said in a preparedstatement that "these new agreements with Scios Nova will ensurethat we have the manufacturing capabilities necessary for thecommercialization of bFGF. We look forward to a closercollaboration with Scios Nova scientists to expand our expertise inrecombinant production technologies."The company completed its own Phase II studies in wound-healingindications about a year ago, but had already decided to focus ondevelopment of acute-care products, Bacon said. The productcurrently is not being tested in the U.S. or Europe, where it isavailable for licensing in wound-healing areas, she added.Bacon said Scios Nova is supporting some academic researchrelated to acute-care uses of bFGF, such as coronary artery diseaseand stroke. She said the company intends to retain U.S. rights tothe protein in those areas.Toward its acute-care focus, Scios Nova's lead product, Auriculin(anaritide), is in Phase III trials for acute renal failure. Its secondproduct, Natrecor BNP, is in Phase I/II trials for acute congestiveheart failure.Scios Nova stock (NASDAQ:SCIO) gained 13 cents afterWednesday's announcement, and another 56 cents Thursday toclose at $6.69 per share. n

-- Jim Shrine

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