FDA Approves Solesta; Novel Specialty Therapeutic Addresses Treatment Void for Patients with Life-Altering Fecal Incontinence

FDA Approves Solesta®; Novel Specialty Therapeutic Addresses Large Treatment Void for Patients with Life-Altering Fecal (Bowel) Incontinence

Minimally Invasive, Outpatient Therapy

EDISON, N.J.--(BUSINESS WIRE)--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."

About Solesta

 Solesta® is a biocompatible tissue bulking agent, consisting of dextranomer microspheres and stabilized sodium hyaluronate. Solesta has been developed as a minimally invasive treatment for fecal incontinence. It is the only injectable gel to be administered in an outpatient setting without the need for anesthesia. Solesta is injected in the deep submucosal layer in the proximal part of the anal canal. While the exact mechanism of action has not been identified, it is hypothesized that the Solesta injections may narrow the anal canal and allowing for better sphincter control.

The Solesta PMA was submitted to the FDA in April 2010 for the treatment of fecal incontinence in adult patients who have failed conservative therapy (i.e., diet, fiber therapy, anti-motility medications). The PMA was reviewed by the FDA's Gastroenterology and Urology Devices Advisory Panel which met on December 2, 2010 and which voted that Solesta was safe and effective, and that its benefits outweighed its risks.

The main body of clinical evidence in the Solesta PMA submission involved a multi-center, prospective, randomized, Sham (placebo) controlled study of the product's effectiveness and safety. The study included 206 patients (136 Solesta, 70 Sham) and 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.

Results from this clinical trial of Solesta as a treatment for fecal incontinence were published in The Lancet (March 19, 2011; 377: 997-1003). In general, the authors of the article noted that the treatment not only met its safety and efficacy endpoints, but also was easily administered.

About Oceana Therapeutics

 Oceana Therapeutics is committed to commercializing best-in-class therapeutics to address unmet and under-satisfied medical needs with a focus on colorectal, gastroenterology and urological diseases. With executive offices in Edison, NJ and European operations headquartered in Dublin, Ireland, Oceana is exceptionally well positioned to pursue worldwide opportunities to acquire and maximize the potential of approved and late-stage specialty therapeutics, including devices, pharmaceuticals, and diagnostics. A privately held company, Oceana has investment support from the leading venture capital and private equity firms of Kelso & Company and Frazier Healthcare Ventures. For additional information visit www.OceanaThera.com. To learn more about Solesta visit www.SolestaInfo.com.

* Solesta® is a registered trademark of Q-Med AB of Uppsala, Sweden; Oceana Therapeutics acquired exclusive worldwide sales and distribution rights to Solesta in June 2009.

Suggested Articles

All 12 members of an FDA advisory committee voted to recommend the approval of teprotumumab for a rare, autoimmune eye disease.

Early data out of former Fierce 15 winner Gritstone Oncology have been heralded as a big win for the early-stage biotech by analysts.

Biogen will drop work on gosuranemab in progressive supranuclear palsy but continue on in Alzheimer's.