Oceana Therapeutics, Q-Med submit Solesta PMA application for treatment of fecal incontinence

Oceana Therapeutics and Q-Med AB today announced the filing of a Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for Solesta^® for the treatment of Fecal (or Bowel) Incontinence, a largely unsatisfied medical need afflicting millions of Americans.

“Having now brought Solesta through the development pipeline, Oceana has clearly demonstrated its commitment to being the first-in-class specialty company with the ability to effectively execute the Buy & Build, Search & Develop strategy of identifying, acquiring and commercializing approved and late-stage specialty therapeutics”

John T. Spitznagel, Oceana's Chairman & CEO, said "This represents a major milestone in the growth of our Company. It is a testimony to the dedication, experience and excellence of the Oceana team and reflects the strength of our close working relationship with Q-Med."

Q-Med's President & CEO, Bengt Ågerup, commented, "We are very pleased to partner with Oceana in achieving this important step towards bringing Solesta into the U.S. market. Solesta, which utilizes our NASHA™ technology, is a potentially significant product and we share in Oceana's enthusiasm regarding the product's growth prospects."

Solesta, which has been under development as a minimally invasive treatment for patients who have failed conservative therapy, is an injectable gel administered in an outpatient setting without the need for anesthesia. Through a transaction finalized on June 9, 2009, Oceana Therapeutics obtained the exclusive worldwide marketing rights to Solesta from Q-Med AB and has since collaborated on a multi-center, prospective, randomized, Sham (placebo) controlled study of the product's effectiveness and safety.

The pivotal study, representing the main body of clinical evidence in the PMA submission, involved 206 patients (136 Solesta, 70 Sham). The study consisted of a 6-month double-blinded phase followed by an open label phase in which patients originally randomized to Sham treatment were offered Solesta. The primary efficacy objective of the study required: 1) demonstrating a statistically significant Solesta effect after 6 months of treatment; 2) meeting a pre-defined threshold for clinical significance; and 3) showing durability of the Solesta benefit up to 12 months after treatment. All three of these endpoints were met.

Tracy Hull, MD, Professor of Surgery, Digestive Disease Institute, Colon and Rectal Surgery at the Cleveland Clinic in Cleveland OH, and a Solesta principle investigator, commented, "This is a significant medical problem that can greatly diminish a patient's quality of life. Moreover, there is a large treatment gap between conservative therapies for fecal incontinence such as dietary control - with or without medical therapy - and more involved treatments such as surgery. Our clinical experience with this novel injectable material suggests that it may be a useful option for patients who fail conservative therapy."

Spitznagel noted, "This is truly a milestone event in Oceana's rapid growth given the fact that our Company is less than two years young and that we acquired Solesta along with Deflux® less than a year ago." Deflux, a treatment for children with an anatomical bladder defect, was also acquired from Q-Med in June 2009 and is now sold by Oceana worldwide.

"Having now brought Solesta through the development pipeline, Oceana has clearly demonstrated its commitment to being the first-in-class specialty company with the ability to effectively execute the Buy & Build, Search & Develop strategy of identifying, acquiring and commercializing approved and late-stage specialty therapeutics," said Spitznagel.

David S. Tierney, MD, Oceana's President & COO, added, "While the outcome and timing of any regulatory filing can never be assured, we are highly encouraged by the breadth and quality of this PMA filing and look forward to potentially launching Solesta in the U.S. in late 2010 or early 2011."

"We are well prepared to support the launch of Solesta by leveraging the commercial strengths we have put in place to fuel the market growth of Deflux," said Tierney. "As commercial assets, Solesta and Deflux provide a solid foundation for a well managed build out of our marketing and sales infrastructure."