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Regeneron receives U.S. patent covering Axokine obesity drug candidate

TARRYTOWN, N.Y., Oct. 31, 2002 -- Regeneron Pharmaceuticals announced that the U.S. Patent and Trademark Office has granted it U.S. Patent No. 6,472,178 covering an isolated nucleic acid molecule that encodes Axokine, an expression vector containing this molecule, and methods of production of the molecule.

Axokine is currently being evaluated in a Phase III program for obesity. It is derived from the naturally occurring human protein, Ciliary Neurotrophic Factor (CNTF).

Regeneron has initiated a Phase III program for Axokine for the treatment of obesity which is expected to include a total of approximately 4,000 subjects.

Preclinical studies have shown that injected Axokine travels through the bloodstream to reach a critical area of the brain, known as the hypothalamus, which regulates body weight. Axokine is believed to bind to specific receptors and activate key signaling pathways in the hypothalamus that suppress appetite and subsequently lead to reduction in body weight.

Currently, the company is conducting four separate trials for Axokine, and plans to initiate other specialized studies in the near future. The initial pivotal trial, which enrolled approximately 2,000 subjects, includes a twelve-month treatment period, expected to be completed in January 2003. This will be followed by a 12-month, open-label safety extension phase.

Source: Regeneron Pharmaceuticals

Posted: October 2002