FDA approves Oceana's Solesta for treatment of fecal incontinence

May 31 2011

Oceana Therapeutics, a global company focused on acquiring, developing and commercializing best-in-class specialty therapeutics, announced that the U.S. Food and Drug Administration (FDA) has approved Solesta® as a treatment for fecal (bowel) incontinence in adult patients who have failed conservative therapy such as dietary control.

"This is a pivotal development, one that advances Oceana Therapeutics to an exciting new growth stage," said John T. Spitznagel, Oceana's Chairman & CEO. "Moreover, Solesta epitomizes our corporate mission to commercialize specialty therapeutics for unmet medical needs and to achieve optimal outcomes and enhanced patient quality of life."

David S. Tierney, Oceana's President & COO, said, "Solesta was developed in collaboration with Q-Med AB as a minimally invasive injectable gel that can be administered, relatively quickly, in an outpatient setting without the need for anesthesia. This is a significant new treatment option for the many underserved patients who fail conservative therapy and face a life of potential social humiliation and the possibility of severe invasive treatment such as surgery."

"I also want to commend everyone involved in the speedy responses to the items raised about a month ago in the FDA's approvable letter for Solesta," said Tierney. "The turnaround time between the FDA's approvable letter and today's announced marketing approval of Solesta has been, in our view, remarkably fast."

Oceana intends to focus Solesta marketing and medical educational support on colorectal surgeons, specialists in treating bowel incontinence. The Company is also moving expeditiously to put in place marketing materials, build product inventory, and be prepared to ship and launch Solesta during the second half of 2011. "The sooner we get Solesta into the hands of the physicians, the sooner it will be available to patients who can benefit from the product," said Tierney. "So, we intend to push hard for a 3rd quarter U.S. launch, although we realize that is an aggressive target."