Isis and Lilly Expand Collaboration to Include Affinitac Commercial-Scale Manufacturing

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Researched by Industrialinfo.com (Industrial Information Resources, Incorporated; Houston, Texas). Pharmaceutical giant Eli Lilly and Company (NYSE:LLY) (Indianapolis, Indiana) and a small biotech company called Isis Pharmaceuticals Incorporated (NASDAQ:ISIS) (Carlsbad, California) have reached a product launch manufacturing agreement for the antisense lung cancer drug Affinitac. The terms include a loan from Lilly to Isis in the amount of $21 million to construct a new manufacturing suite at their facility in Carlsbad. Currently under construction, Isis expects the new suite to begin delivering a supply of Affinitac to Lilly sometime in mid to late 2003. Isis currently manufactures Affinitac for clinical use and will now also produce product for commercial use for approximately a three-year period, after which Lilly plans to assume responsibility for manufacturing.

Affinitac is the first anti-cancer agent in a fundamentally new class of drugs, called antisense. The drug selectively inhibits the production of protein kinase C-alpha (PKC-alpha), a molecule implicated in both tumor development and maintenance. Antisense drugs are designed to have a high degree of target specificity that hopefully will provide them with a substantial advantage over traditional small molecule drugs in many difficult-to-treat diseases. Affinitac is currently undergoing two Phase II clinical trials and Lilly anticipates filing for FDA approval as early as next year.