A Medical Device Daily Writer
Oceana Therapeutics (Edison, New Jersey) made definite progress with its newly acquired fetal incontinence treatment this week, after the company reported filing a PMA with the FDA for Solesta. If the application gains approval, then patients could have a minimally invasive treatment for fecal incontinence.
Fecal incontinence is a significant problem for many adults as it relates to the loss of voluntary control of stool, or bowel movements. It affects about 2% of the general population. Both men and women suffer from this problem, though it is more common in women because of injury during childbirth.
The company purchased all rights to Solesta, a gel that's inserted into the anal canal, and its patents from Q-Med (Uppsala, Sweden) in a transaction that was completed last June.
According to the company 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.
“It's for those patients who can't be treated with conservative procedures and who are up for surgery,“ a spokesman for Oceana told Medical Device Daily. “Solesta adds a whole new treatment option for patients.“
Solesta already has CE mark approval and approval in Canada. The U.S. is the next regulatory hurdle for the company to cross according to Oceana.
“Our hope is to be in a position to bring [Solesta] to the U.S. market in late 2010 or early 2011 – depending on FDA approval,“ according to a company spokesman.
Previously the companies collaborated on a multi-center prospective randomized, 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 placebo). 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 six 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.
David 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.“
The collaboration between Oceana and Q-Med led to Oceana Therapeutics acquiring Q-Med Scandinavia, which accounts for the majority of the business for Deflux and Solesta (Medical Device Daily, April 23, 2009).
Included in this transaction are the exclusive rights to market, sell and distribute Deflux and Solesta and other products intended for the management of urological and gastroenterological conditions worldwide.
Q-Med will continue to develop and manufacture all products under this agreement, while Oceana will focus on continued global commercialization of Deflux and Solesta.
Also under the agreement, Oceana made an initial payment of $60 million for the shares of Q-Med Scandinavia and an additional payment of $15 million upon the U.S. approval of Solesta.
If certain sales targets are achieved, Q-Med AB may receive additional milestone payments of up to $45 million. Oceana will pay a royalty for the licensing rights based on the net sales of the products.
Omar Ford, 404-262-5546;