Anonymous
04-09-2010, 05:47 PM
Q-Med AB and Oceana Therapeutics, Inc. Take Major Step Towards SOLESTA(TM) US Regulatory Filing
UPPSALA, Sweden and EDISON, N.J., Dec. 7 /PRNewswire/ -- Q-Med AB and Oceana Therapeutics, Inc. today announced that the SOLESTA(TM) pivotal study succeeded in meeting both primary endpoints for the treatment of fecal incontinence.
Q-Med AB and Oceana Therapeutics, Inc. intend to submit a PMA application to the FDA during the first quarter of 2010 based on the results of this study.
"This study is the ultimate result of years of hard work as we developed a product using our minimally invasive technology," said Bengt Agerup, Q-Med's President and CEO, and inventor of the NASHA(TM) technology. "It is with great pride that together with our partner, Oceana Therapeutics, we can move forward with the FDA approval process and work towards bringing SOLESTA(TM) into clinical practice."
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 percent 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 condition can have devastating effects on a patient's quality of life and psychological well being as many people resort to altering their social and physical activities, even their employment, to cope with the problem.
"We are extremely encouraged by the positive results from this pivotal trial. We believe SOLESTA has the potential to make a significant contribution in fulfilling an unmet medical need in the management of fecal incontinence and will therefore be a great addition to Oceana's product portfolio," said John Spitznagel, Chairman and CEO, Oceana Therapeutics, Inc. "These findings also mark an important milestone for the partnership between Q-Med AB and Oceana as the study outcomes will allow us to file for approval with the FDA in the first quarter of 2010."
Oceana's President and COO, David S. Tierney, M.D. added, "While SOLESTA is already available in Europe, we are confident that the publication of the study will enhance the adoption of this important treatment among the European professional community to help patients suffering from this condition."
About the Study
The Investigational Device Exemption Study was a randomized, subject and evaluator blinded, controlled, multi-center study designed to evaluate the efficacy and safety of SOLESTA for the treatment of fecal incontinence. More than 200 patients suffering from fecal incontinence were included in 13 study sites throughout the United States and Europe. Primary endpoints of the study looked at the efficacy of both groups at six months as well as evaluated the durability of response in the SOLESTA treatment group at 12 months.
About SOLESTA(TM)
SOLESTA is approved for use in Europe and Canada as an injectable treatment for fecal incontinence. SOLESTA is a biocompatible substance composed of stabilized hyaluronic acid, including dextranomer, manufactured according to Q-Med AB's patented technology, NASHA(TM). The treatment is a minimally invasive, in-office procedure. SOLESTA was developed in 2004 by Q-Med AB in Sweden. Oceana Therapeutics acquired the global rights to market and sell SOLESTA in June 2009.
About Q-Med AB
Q-Med is a medical device company that primarily develops, manufactures, markets and sells medical implants. Most of the products are based on the company's patented technology, NASHA(TM), for the production of stabilized non-animal hyaluronic acid. The company today has approximately 650 co-workers in 20 countries, with approximately 400 at the company's head office and production facility in Uppsala. Q-Med had sales of 1,272 MSEK during 2008. Q-Med AB is listed in the Mid Cap segment of the NASDAQ OMX Nordic.
About Oceana Therapeutics, Inc.
Oceana Therapeutics was founded in 2008 by a team of seasoned healthcare executives and is privately held. The Company is committed to acquiring and maximizing the potential of approved and late-stage development medical devices and specialty therapeutics, redefining the way illnesses are treated. Oceana's goal is to enable physicians to prescribe drugs and utilize devices that are tailored for the patient's disease - offering Optimal Outcomes - as well as the added economic benefit of limiting or eliminating hospitalization or reducing demand for surgery or emergency care. This approach balances both the patient's wellness needs and the physician's goal of providing outstanding patient care while efficiently balancing time and economic management constraints. For additional information about Oceana Therapeutics, visit the Company's website at www.oceanathera.com.
UPPSALA, Sweden and EDISON, N.J., Dec. 7 /PRNewswire/ -- Q-Med AB and Oceana Therapeutics, Inc. today announced that the SOLESTA(TM) pivotal study succeeded in meeting both primary endpoints for the treatment of fecal incontinence.
Q-Med AB and Oceana Therapeutics, Inc. intend to submit a PMA application to the FDA during the first quarter of 2010 based on the results of this study.
"This study is the ultimate result of years of hard work as we developed a product using our minimally invasive technology," said Bengt Agerup, Q-Med's President and CEO, and inventor of the NASHA(TM) technology. "It is with great pride that together with our partner, Oceana Therapeutics, we can move forward with the FDA approval process and work towards bringing SOLESTA(TM) into clinical practice."
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 percent 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 condition can have devastating effects on a patient's quality of life and psychological well being as many people resort to altering their social and physical activities, even their employment, to cope with the problem.
"We are extremely encouraged by the positive results from this pivotal trial. We believe SOLESTA has the potential to make a significant contribution in fulfilling an unmet medical need in the management of fecal incontinence and will therefore be a great addition to Oceana's product portfolio," said John Spitznagel, Chairman and CEO, Oceana Therapeutics, Inc. "These findings also mark an important milestone for the partnership between Q-Med AB and Oceana as the study outcomes will allow us to file for approval with the FDA in the first quarter of 2010."
Oceana's President and COO, David S. Tierney, M.D. added, "While SOLESTA is already available in Europe, we are confident that the publication of the study will enhance the adoption of this important treatment among the European professional community to help patients suffering from this condition."
About the Study
The Investigational Device Exemption Study was a randomized, subject and evaluator blinded, controlled, multi-center study designed to evaluate the efficacy and safety of SOLESTA for the treatment of fecal incontinence. More than 200 patients suffering from fecal incontinence were included in 13 study sites throughout the United States and Europe. Primary endpoints of the study looked at the efficacy of both groups at six months as well as evaluated the durability of response in the SOLESTA treatment group at 12 months.
About SOLESTA(TM)
SOLESTA is approved for use in Europe and Canada as an injectable treatment for fecal incontinence. SOLESTA is a biocompatible substance composed of stabilized hyaluronic acid, including dextranomer, manufactured according to Q-Med AB's patented technology, NASHA(TM). The treatment is a minimally invasive, in-office procedure. SOLESTA was developed in 2004 by Q-Med AB in Sweden. Oceana Therapeutics acquired the global rights to market and sell SOLESTA in June 2009.
About Q-Med AB
Q-Med is a medical device company that primarily develops, manufactures, markets and sells medical implants. Most of the products are based on the company's patented technology, NASHA(TM), for the production of stabilized non-animal hyaluronic acid. The company today has approximately 650 co-workers in 20 countries, with approximately 400 at the company's head office and production facility in Uppsala. Q-Med had sales of 1,272 MSEK during 2008. Q-Med AB is listed in the Mid Cap segment of the NASDAQ OMX Nordic.
About Oceana Therapeutics, Inc.
Oceana Therapeutics was founded in 2008 by a team of seasoned healthcare executives and is privately held. The Company is committed to acquiring and maximizing the potential of approved and late-stage development medical devices and specialty therapeutics, redefining the way illnesses are treated. Oceana's goal is to enable physicians to prescribe drugs and utilize devices that are tailored for the patient's disease - offering Optimal Outcomes - as well as the added economic benefit of limiting or eliminating hospitalization or reducing demand for surgery or emergency care. This approach balances both the patient's wellness needs and the physician's goal of providing outstanding patient care while efficiently balancing time and economic management constraints. For additional information about Oceana Therapeutics, visit the Company's website at www.oceanathera.com.