Antares Pharma, Inc. (AMEX:AIS) announced that its partner, Jazz Pharmaceuticals, Inc. (NASDAQ:JAZZ) plans to initiate a Phase III clinical trial for a Central Nervous System (CNS) product candidate they call JZP-7 which utilizes Antares’ ATD™ (Advanced Transdermal Delivery) system to deliver ropinirole. The product candidate is designed to provide an effective, once-daily treatment for moderate to severe restless legs syndrome (RLS). One pharmacokinetic (PK) study has been completed and data from a second PK study is being analyzed. In the first study, doses were well tolerated locally and systemically for five days. In the second study, subjects were successfully escalated to higher doses and there were no serious adverse events. Final analysis of the safety data is still ongoing. The Phase III trial is currently planned to begin in the fourth quarter of this year.
“We are pleased with the progress that our partner, Jazz Pharmaceuticals, has made with JZP-7. Advancing to Phase III with JZP-7 clearly demonstrates the versatility of our ATD™ system and its application in this important therapeutic area of CNS. In addition, we anticipate receiving milestone payments as the product progresses, as well as milestones upon launch and royalties,” said Jack Stover, President and CEO of Antares.
Ropinirole was the first treatment approved by the FDA for the treatment of moderate to severe RLS. RLS is a sensorimotor neurological disorder characterized by uncomfortable sensations in the legs when patients are inactive, that leads to an urge to move. RLS is a common disorder with prevalence estimates of 5%-10% of the US population. RLS severely disrupts sleep and patient quality of life, with some patients experiencing symptoms at rest during the day as well as at night. Ropinirole and other dopamine agonists are currently first-line treatment for daily RLS symptoms. The worldwide market for ropinirole and other dopamine agonist products is reported to be approximately $2.2 billion. By providing continuous, once-daily, delivery of ropinirole in our sustained release ATD gel system it is anticipated that symptoms will be effectively controlled night and day resulting in a positive impact on patients’ quality of life. In addition to RLS, ropinirole is also approved by the FDA for early and late stage Parkinson’s Disease both as initial therapy and as adjunctive treatment with levodopa.
About Antares Pharma
Antares Pharma is a specialized pharma product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has three validated systems: the ATDTM Advanced Transdermal Gel Delivery system, subcutaneous injection technology platforms including both VibexTM disposable pressure assisted auto injectors and ValeoTM/Vision® reusable needle-free injectors; and Easy TecTM oral disintegrating tablets (ODT). Two of the systems have generated FDA approved products. Antares Pharma leverages its multiple drug delivery systems to add value to existing drugs and to create new products. The Company’s products are engineered to improve safety and efficacy profiles by minimizing dosing and reducing side effects while enabling improved patient compliance. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.
Safe Harbor Statement
This press release contains forward-looking statements, within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, that involve significant risks and uncertainties, including those discussed in this release and others that can be found in the “Risk Factors” section of Antares’ Annual Report on Form 10-K for the year ended December 31, 2007 and in Antares’ periodic reports on Form 10-Q and other filings made with the Securities and Exchange Commission. Antares is providing this information as of the date of this release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. No forward-looking statement can be guaranteed and actual events and results may differ materially from those projected. Forward-looking statements, including statements regarding the timing of product sales, market estimates and market potential provide Antares' current expectation or forecasts of future events. Antares' results could differ materially from those reflected in these forward-looking statements due to decisions of regulatory authorities, Antares' ability to execute on its development plans and general financial, economic, regulatory and political conditions affecting the pharmaceutical industry generally.