Isis, Zeneca LifeScience Establish Manufacturing Collaboration

Isis Pharmaceuticals and Zeneca LifeScience Molecules have established an antisense oligonucleotide manufacturing collaboration through which Zeneca will produce compounds, using proprietary Isis manufacturing technologies, for upcoming clinical trials of Isis drugs. In addition, Isis hopes Zeneca will use the patented techniques for creating a new oligonucleotide contract manufacturing business, from which Isis would receive royalty payments.

Zeneca is constructing a dedicated manufacturing suite in its Manchester, England facilities to make room for the new work. Zeneca will produce kilogram quantities of first-generation (lead compound) oligos for Isis, but ultimately Isis plans to manufacture production quantities of its drugs.

By contracting for what amounts to a second manufacturing facility, Isis can now focus on producing first and second generation compounds and future commercial supplies of products, as they hit the market, at its Carlsbad, Calif. plant. Having a strong external partner to pick up manufacturing slack and support production also allows Isis to refine its process chemistry, which since 1992 has reduced the cost of producing large quantities of oligonucleotides by 97 percent.

According to Isis spokesman Christopher Keenan, the five-year collaboration will begin slowly and build up. The first target molecule is Isis 2302, which Isis is targeting to such autoimmune disorders as colitis, Crohn's disease, psoriasis, renal transplant rejection, and rheumatoid arthritis. Isis has an extensive preclinical pipeline of first and second generation antisense drugs, with six compounds in clinical development. The company plans to file its first New Drug Application within a few weeks.

For more information, contact: Christopher Keenan, Isis Pharmaceuticals, 2292 Faraday Ave. Carlsbad, CA 92008. Tel: 760-603-2641.

By Angelo DePalma