By Kim Coghill

Washington Editor

Proneuron Biotechnologies Inc. and Teva Pharmaceuticals Industries Ltd. entered an agreement to expand development of Copaxone, a multiple sclerosis injection made from the molecule COP-1.

Proneuron, a privately held company with offices in Israel and Los Angeles, will retain rights to develop COP-1 for spinal cord injury, amyotrophic lateral sclerosis and Huntington¿s disease. Meanwhile, Teva, of Ness-Ziona, Israel, gains rights to other neurological diseases such as Alzheimer¿s, stroke, brain trauma, glaucoma and Parkinson¿s.

The deal is an outgrowth of a research and development contract Proneuron has with the Weizmann Institute of Science in Israel. Scientists at the institute discovered COP-1 (glatiramer acetate) and since it has entered the market as Copaxone, research has continued and yielded positive results.

¿Prof. Michal Swartz has discovered that if you apply COP-1 in a different methodology, the COP-1 will sensitize T cells and act as an antigen and the T cells will rescue and protect neurons in the body,¿ Dale Miller, chairman of Proneuron, told BioWorld Today. ¿This is a different mechanism of action than Teva uses for MS.¿

Teva is the only company in the world that manufactures COP-1. Therefore it was a logical partner for Proneuron, Miller said.

¿Because a small biotech company can¿t develop everything, we basically licensed to Teva some of the indications, but we got back something extremely important ¿ a manufacturing and supply agreement,¿ Miller said. ¿They¿ve got a commercial scale-up to manufacture this very complex molecule.¿

Under the agreement, 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.

Teva also has made a $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 at Proneuron.

¿This is very significant for Teva since COP-1 is their only proprietary drug and they now have a large number of indications,¿ Miller said. ¿We¿re also very optimistic of the promise of all of this, not only the indications we¿ve licensed to Teva, but the indications we¿ve retained show great promise.¿

The companies anticipate additional preclinical and early clinical studies since the glatiramer acetate formulation and administration will be different from what¿s on the market now.

Miller didn¿t specify a timeline nor did he indicate which diseases would be studied first by either Proneuron or Teva. He did, however, say that a glaucoma product could be extremely profitable since the disease is so common.

In other business, Miller said Proneuron, a five-year-old company, is involved in a ¿very promising¿ Phase I trial in Israel and Europe on nerve regeneration in the central nervous system (spinal cord injury). The company also is recruiting patients for a Phase Ib spinal cord injury study in Belgium.

No Comments