Ista gets marketing rights, U.S. exclusivity for Vitrase

IRVINE, Calif. — Ista Pharmaceuticals reacquired from Allergan all U.S. marketing rights for its formulation of hyaluronidase, shortly after receiving U.S. market exclusivity for the drug from federal regulators. Ista announced the changes in two press releases.

Vitrase (ovine lyophilized hyaluronidase for injection, Ista) was approved for use as a spreading agent for anesthesia injections in May 2004. Last week, Ista was granted 3 years of U.S. marketing exclusivity for Vitrase for this indication by the Food and Drug Administration. The FDA cannot approve any other hyaluronidase in the United States until May 2007, according to Ista.

Today, Ista announced that it will pay $10 million to Allergan to regain the U.S. marketing rights for Vitrase, of which $6.5 million is due in 15 days, Ista said in a second press release. The company also renegotiated its rights to market the drug in countries outside the United States. Allergan retained an option to commercialize the drug for posterior segment applications in Europe.

In March 2000, Allergan acquired the right to market, sell and distribute Vitrase for uses in the posterior segment of the eye in the United States and all international markets excluding Japan. In December 2001, Ista granted Otsuka Pharmaceutical exclusive marketing rights to the drug in Japan.

In the changes announced today, Allergan will receive royalty payments from Ista on Ista’s U.S. sales of Vitrase for use in the posterior segment, according to the press release. Ista will be responsible for securing regulatory approval in Europe for Vitrase for the treatment of vitreous hemorrhage, and Allergan will have the option of commercializing the drug for that use in Europe, the press release noted.

Vitrase is in clinical trials for posterior segment indications, including the clearing of vitreous hemorrhages and uses in diabetic retinopathy.