Oceana Therapeutics Announces U.S. Launch of Solesta®, The Only Nonsurgical FDA Approved Treatment for Patients Who Fail Conservative Therapy for Fecal (Bowel) Incontinence

Outpatient Procedure Performed in Minutes Without Need for Anesthesia

EDISON, N.J.--(BUSINESS WIRE)--Oceana Therapeutics, a global company focused on acquiring, developing and commercializing best-in-class specialty therapeutics, today announced the U.S. launch of Solesta®*, a significant new treatment option offering patients with fecal (bowel) incontinence an opportunity for restored confidence to pursue a more normalized lifestyle.

“The administration of Solesta does not involve surgery and can be performed without anesthesia”

The Food and Drug Administration (FDA) approved Solesta for the treatment of fecal incontinence in adult patients who fail conservative therapy (e.g., diet, fiber therapy). In a press release of May 27, 2011, the Director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health noted the difficulty in treating fecal incontinence and that the approval of Solesta provides a minimally invasive treatment option.

Solesta is an injectable gel delivered into the anal canal in an outpatient procedure taking approximately 10 minutes. “The administration of Solesta does not involve surgery and can be performed without anesthesia” noted, John T. Spitznagel, Oceana’s Chairman & CEO. “This is a major treatment innovation for the many underserved patients faced with social embarrassment and the potential need for invasive, surgical therapies.”

David S. Tierney, MD, Oceana’s President & COO, added, “Solesta represents a powerful nonsurgical addition to the treatment arsenal of colorectal surgeons. These specialists are engaged in both noninvasive and surgical treatments of bowel incontinence, and enthusiastically welcome an entirely new treatment regime to fill the wide gap that previously existed between conservative and invasive therapies.”

The Solesta launch is being spearheaded by Oceana’s own team of field representatives in combination with specialty wholesalers and specialty pharmacies. The product is now fully available in the U.S. and Oceana’s field team has actively begun meeting with colorectal surgeons as part of an overall focus on supporting Solesta with a strong medical education program.

About Solesta

Solesta® is a biocompatible tissue bulking agent, consisting of dextranomer microspheres and stabilized sodium hyaluronate. Solesta has been developed for the treatment of fecal incontinence. It is the only injectable gel to be administered in an outpatient setting without the need for surgery or 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 allow for better sphincter control.

The Solesta Premarket Approval Application (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 FDA’s Gastroenterology and Urology Devices Advisory Panel reviewed the PMA on December 2, 2010 and voted for approval. The FDA granted marketing approval in May 2011.

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. Additionally, patients have been followed for over 2 years and the corresponding data showed no decline in effectiveness.

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. The Company’s growing portfolio of specialty therapeutics includes Deflux®*, available internationally for the pediatric urinary condition vesicoureteral reflux, and Solesta®*, a new nonsurgical treatment option for patients afflicted with fecal (bowel) incontinence. Oceana is a privately held company with 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. Additional information about Deflux and Solesta, including prescribing and safety information, is available, respectively, at www.Deflux.com and www.SolestaInfo.com.

* Deflux® and Solesta® are registered trademarks of Q-Med AB of Uppsala Sweden; Oceana Therapeutics acquired worldwide sales and distribution rights to both products in June 2009.