Proneuron Biotechnologies and Teva Pharmaceutical Industries Sign Agreement to Develop Glatiramer Acetate for Neurological Diseases Business Editors and Health/Medical Writers.
December 4, 2001

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LOS ANGELES and NESS-ZIONA, Israel (BW HealthWire), 2001

Proneuron Has Exclusive License from Weizmann Institute for Newly Discovered Uses of Neuroprotective Drug
Proneuron Biotechnologies Inc., a privately-held Delaware corporation with offices in Los Angeles and Ness-Ziona, Israel, today announced a collaborative licensing agreement with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) to develop the drug glatiramer acetate as a neuroprotective agent for the treatment of multiple acute and chronic neurological diseases, excluding multiple sclerosis. Glatiramer acetate is marketed by Teva under the trade name Copaxone(R) for multiple sclerosis.

Professor Michal Swartz and her colleagues at the Weizmann Institute of Science in Israel have discovered that glatiramer acetate may be an effective neuroprotective agent for other neurological disorders in addition to multiple sclerosis. The Weizmann Institute has provided Proneuron an exclusive license to intellectual property relating to this discovery.

Under the agreement with Teva, Proneuron will receive payments related to clinical and regulatory milestones for each clinical indication that Teva develops, and will receive royalties on Teva's worldwide net sales for all commercialized indications. In addition, Teva has made a first-time $10 million equity investment in Proneuron. Teva will fund all development and commercialization of the indications it pursues, and will pay for certain preclinical research activities conducted at Proneuron. Since the glatiramer acetate formulation and administration method for these new indications will be different than that of Copaxone, additional preclinical and early clinical studies will be conducted prior to performing Phase 2 and Phase 3 studies for the new indications.

Also, under the agreement, Proneuron will retain for its sole development three clinical indications: spinal cord injury, ALS and Huntington's Disease. Proneuron will be responsible for funding the development and commercialization of these indications.

According to Proneuron's chairman Dale S. Miller, the collaboration will develop new uses of glatiramer acetate aimed at Alzheimer's Disease, stroke, brain trauma, glaucoma, Parkinson's Disease, ALS, peripheral neuropathy, Huntington's Disease, spinal cord injury and other diseases that may be treatable with a neuroprotective agent.

"Given their success with the development and commercialization of Copaxone for multiple sclerosis, Teva is a natural partner for developing new uses for glatiramer acetate," said Miller. "The strength of our preclinical data, combined with its known safety profile in multiple sclerosis, make us enthusiastic about the potential for the compound in other neurological disorders. Moreover, the three clinical indications that Proneuron has retained will allow us to further our development as a clinical-stage biopharmaceutical company."

Glatiramer Acetate Found to Stimulate Neuroprotective Response
To induce a neuroprotective T-cell immune response, professor Schwartz has experimented with a variety of antigens that cross-react with myelin, a fatlike substance that surrounds nerves. Glatiramer acetate, a synthetic copolymer of amino acids that cross-reacts with myelin, was found to be an ideal antigen to stimulate this protective T-cell response. Multiple preclinical animal models of neurological disease, including models of spinal cord injury, glaucoma, brain trauma and ALS have demonstrated that glatiramer acetate can induce a beneficial T-cell mediated effect.

Clinical Trial for Spinal-Cord Injury Repair
Proneuron is performing Phase I clinical trials in Israel and Europe on another technology derived from professor Schwartz's laboratory at the Weizmann Institute--the use of autologous activated macrophages (a type of white blood cell) to treat acute, complete spinal cord injury. In addition, the company has preclinical programs in the field of protective neurological immunity.

Proneuron Biotechnologies Inc.
Proneuron Biotechnologies Inc., based in Ness-Ziona, Israel, is a privately-held biopharmaceutical company developing therapeutic products for the treatment of acute and chronic diseases of the central nervous system based on proprietary technology for modulating the interaction between the nervous and the immune systems. See http://www.proneuron.com for more information.

Editor's Note: Teva Pharmaceutical is making a separate announcement today regarding the collaboration.

CONTACT: Proneuron
U.S. Contact
Dale S. Miller
310/556-1063
info@proneuron.com

Israel Contact
Daniel Szobel
972-8-940-9550
daniel.szobel@proneuron.com

Versaggi Biocommunications®
Charles Versaggi, Ph.D.
415/397-3087
cv@versaggibio.com