EXTON, Pa., Dec. 13 /PRNewswire-FirstCall/ -- Antares Pharma, Inc. announced important progress in the development of Anturol(TM), the Company's lead proprietary oxybutynin ATD(TM) gel product for the treatment of overactive bladder syndrome. Antares now projects completing Phase II Trials by the end of 2005. Phase III trials are expected to begin in early 2006.
Also announced today, was the execution of an agreement with Toronto based Patheon Inc. to provide manufacturing and scale-up support for the Phase III program. Patheon (http://www.patheon.com) is a leading global provider of drug development and manufacturing services to the international pharmaceutical industry, operating a network of 14 facilities in the United States, Canada and Europe.
Oxybutynin is used for adults with symptoms of overactive bladders that include sudden urges to urinate, urinary incontinence, and frequent urination. Annual sales of the leading products in this category were in excess of $500 million in 2004. The most common side effects of oxybutynin are dry mouth (3 out of every 5 or 60% of patients), constipation (1 out of every 6 patients), tiredness (1 out of every 8 patients), and headache (1 out of every 10 patients). Antares believes its gel formulation, if approved by the FDA, would mitigate many of these side effects.
James Hattersley, Vice President of Corporate Business Development at Antares Pharma, said, "Patheon has a successful track record with specialized manufacturing capabilities. We believe our relationship with Patheon will result in reliable, cost-effective, and high quality development services that we, and our partners, can depend on to support the commercialization of Anturol(TM).
Jack E. Stover, President and CEO of Antares Pharma, said, "Our progress with Anturol(TM), in anticipation of release of our Phase II results, continues as expected. We are particularly pleased with the growing commercial interest in Anturol(TM)."
About Antares Pharma
Antares Pharma is a specialized pharma product development company with patented drug delivery systems and injectable device engineering capabilities. Antares' current technology platforms include its ATD(TM) Advanced Transdermal Delivery system, Easy Tec(TM) oral fast-melt technology, and subcutaneous injection technology platforms including both Vibex(TM) disposable mini-needle injection device and Valeo(TM) / Vision(R) reusable needle-free injection devices. Antares Pharma is committed to leveraging its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. Overall, Antares' product pipeline will address unmet medical needs by reducing side effect profiles, improving safety, increasing effectiveness, and improving patient compliance and convenience.
Antares has active partnering programs with several pharmaceutical and distribution companies for a number of indications and applications, including diabetes, growth disorders, obesity, female sexual dysfunction and other hormone therapy. Its needle-free injector system is distributed in more than 30 countries for the administration of insulin and is marketed for use with human growth hormone through licensees in most major regions of the world. Licensees also market an ibuprofen gel in several major European countries. In addition, Antares Pharma is undertaking development or is conducting research on several product opportunities that it expects will form the basis of its specialized pharma program.
Antares Pharma has corporate headquarters in Exton, Pennsylvania, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The Company cautions readers that forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to differ materially and which are identified from time to time in the Company's reports filed with the U.S. Securities and Exchange Commission. Antares Pharma claims the protection of the Safe Harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Additional information is available online at http://www.antarespharma.com and http://www.mediject.com. Information included on the Company's websites is not incorporated herein by reference or otherwise.
Antares Pharma, Inc.CONTACT: Steve Chizzik or Ira Weingarten, both of Equity Communications,+1-973-912-0980; or Jack E. Stover, President and CEO, +1-610-458-6200, orLawrence M. Christian, CFO and Vice President, Finance, +1-610-458-6200,both of Antares Pharma, Inc.
