Eastman Gains Marketing Rights To Protein Used By Immune System

Posted: October 12, 1987

Eastman Pharmaceuticals, a subsidiary of Eastman Kodak Co., has paid Immunex Corp. of Seattle slightly more than $3 million for rights to market a genetically engineered protein, interleukin-4 (IL-4).

Interleukins are members of a class of naturally occurring proteins, the lymphokines, which play a vital role in the regulation of the body's immune system. Immunologists consider lymphokines to be chemical messengers that signal various components of the immune system to spring into action when foreign matter invades the body.

IL-4, which occurs naturally in the body in immeasurably small quantities, was identified by researchers in 1984. Under certain conditions, the substance is secreted by the T-lymphocytes, or T-cells, that regulate the immune system. T-cells produce the material as part of the body's immune reaction.

IL-4 then acts on certain white blood cells known as B-lymphocytes, causing them to proliferate and begin to make antibodies. The substance also is known as B-cell growth factor.

Using the techniques of genetic engineering, scientists for Immunex isolated the gene responsible for production of IL-4 and inserted it into cells that could be grown in the laboratory to produce larger quantities of the scarce material. Immunex did most of the scientific work on IL-4 as part of a joint venture with Eastman Kodak.

Researchers hope that they eventually will be able to use IL-4 and other synthetically produced lymphokines to stimulate the immune system. Christopher S. Henney, scientific director of Immunex, said IL-4 might be useful for treating certain types of cancer and diseases characterized by a deficiency of antibodies. The substance will not enable the immune system to fend off the AIDS retrovirus, but it might help patients with acquired immune deficiency syndrome withstand infections that often turn out to be fatal.

Eastman Pharmaceuticals, which is based in Malvern, has entered into numerous joint ventures as part of its strategy to become a major drug company by the early 1990s.

Under terms of the purchase, Eastman Pharmaceuticals will conduct human testing of IL-4 beginning early next year. If federal regulators approve the substance for use, Eastman will be responsible for marketing and selling it. Immunex retained manufacturing rights and will get royalties on sales.

CENTOCOR AND N.J. FIRM

RESOLVE PATENT DISPUTE

Centocor Inc., the biotechnology company based in Malvern, has resolved a potentially troubling patent dispute with Immunomedics Inc. of Newark, N.J.

Centocor obtained rights last month to three patents owned by Immunomedics covering use of monoclonal antibodies for diagnostic imaging or treatment of cancer.

Antibodies are proteins produced by the body's immune system in response to the presence of foreign materials. Researchers for Centocor and other biotechnology companies have been seeking to grow large quantities of identical antibodies in the laboratory and put them to use for detection or treatment of disease.

So far, Centocor has developed two medical-imaging products that utilize monoclonal antibodies tagged with radioactive substances.

When injected into heart-attack patients, Centocor's Myoscint imaging agent attaches to dead heart tissue and allows cardiologists to assess the extent of the damage. Fibriscint, another antibody tagged with radioactive substances, binds to blood clots so that physicians can determine their location and extent. Centocor sells both products in parts of Europe and has applied to the Food and Drug Administration for permission to market them in the United States.

Centocor has been developing three similar imaging agents for detection of breast, ovarian and prostate cancer - products that potentially infringed on the Immunomedics patents. The company is about to begin clinical testing of the imaging agents, which are being called Centoscan M, O and P.

The Immunomedics patents are reasonably broad and appear to cover all applications of monoclonal antibodies for diagnostic imaging. The patents have not yet been legally tested, however. Courts commonly reduce the scope of broad patents when competitors get the chance to present additional information.

"There has been considerable debate within the industry over the strength of those patents," said Charles C. Cabot, a spokesman for Centocor.

Cabot said his company had faced a difficult decision on whether to license the patents from Immunomedics or to put together an expensive effort to have them overturned. Centocor was offered a license on reasonable terms, he said, and made "a defensive business decision" not to challenge the patents. Specific terms were not disclosed, but Centocor said it paid an initial fee and royalties on the sale of products.

A spokesman for Immunomedics estimated the value of the deal at $7 million to $10 million.

RORER GROUP ACQUIRES

THE RIGHTS TO CELIPROLOL

Rorer Group Inc. of Fort Washington has acquired all rights to celiprolol, a compound used in the treatment of hypertension, angina and other cardiovascular conditions. The substance belongs to a class of drugs, the beta blockers, that calm the sympathetic nervous system and reduce the workload on the heart.

Rorer purchased rights to the product from its Austrian developer, Chemie Linz. Terms of the transaction were not disclosed.

Rorer already had marketing rights to the substance for the United States and several European countries because of its acquisition last year of USV Pharmaceutical Inc., which had obtained limited rights to celiprolol from Chemie Linz in 1981.

Rorer has been selling the drug under the name Selectol in Europe and has sought permission from the Food and Drug Administration to sell the product in the United States, where it will be known as Celectol.

By buying all rights to the substance, Rorer eliminates royalty payments to Chemie Linz on future sales of the drug. Rorer also gains control over worldwide marketing of the drug, related formulations and certain derivative products.

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