Antares Pharma, Inc. (NYSE Amex: AIS), a leader in self-injection drug delivery technology and Uman Pharma, a manufacturer of top-quality injectable pharmaceutical products based in Quebec, Canada, today announced the formation of a strategic alliance covering Antares’ VIBEX™ MTX.
Under the terms of the agreement Antares and Uman will invest jointly to develop and commercialize VIBEX™ MTX, Antares’ novel pressure-assisted, injection device, containing methotrexate (MTX) for rheumatoid arthritis and related autoimmune conditions in the US and Canada. Antares will lead the clinical development program, FDA regulatory submissions, and retains rights to commercialize the VIBEX™ MTX product outside of Canada. Uman will perform formulation development and manufacturing activities to support the registration of VIBEX™ MTX and supply methotrexate in prefilled syringes to Antares for the US market. Uman received an exclusive license to commercialize the VIBEX™ MTX product in Canada. The companies intend to work together to commercialize the VIBEX™ MTX product in other territories.
“We are pleased to announce this partnership with such a strong partner as Uman Pharma to develop methotrexate for use in our VIBEX™ injection device,” stated Paul K. Wotton, Ph.D., President and Chief Executive Officer. “Our market research with physicians shows that most would use methotrexate by the parenteral route more frequently, thereby accelerating market growth, if provided with a simple-to-use and secure system that enabled patients to reliably and comfortably self-inject the drug. We believe that physicians and patients alike will welcome our VIBEX™ injection system for administering parenteral methotrexate.”
“We are very excited and proud to be associated with Antares Pharma for the development and manufacturing of methotrexate in pre-filled syringes and look forward to the anticipated launch of the VIBEX™ delivery technology for the US and Canadian markets,” stated Uman Pharma`s Chief Executive Officer, Mr. Sylvain Duvernay. “Entering this strategic alliance represents an important milestone for us and it is in line with our vision and our mission to bring top-quality products, adding a human touch to make a true difference in patients’ lives.”
About VIBEX™ MTX and Methotrexate
VIBEX™ MTX is Antares’ proprietary methotrexate injection system protected by several issued and pending patents. VIBEX™ is a trademark of Antares Pharma. Antares has conducted pre-clinical studies which demonstrated highly reproducible pharmacokinetics and excellent injection site tolerance when methotrexate was delivered using the VIBEX™ technology. Methotrexate is the most commonly prescribed disease-modifying anti-rheumatic drug (DMARD), used in an estimated 70% of rheumatoid arthritis patients. Methotrexate is started at a low dose, generally 7.5mg given orally, once-a-week, and titrated up for greater therapeutic effect, or until the patient incurs side effects. The maximum oral dose given is generally 20mg to 25mg per week. Studies have reported as many as 30% to 60% of patients experience gastrointestinal side effects with oral methotrexate, preventing further dose escalation or requiring discontinuation in some patients. Also, the extent of oral absorption of methotrexate varies considerably between patients and has been shown to decline with increasing doses, which may also contribute to insufficient therapeutic response even after dose escalation. Switching patients from oral to parenteral methotrexate improves absorption and has been associated with improved therapeutic response. Additionally, some studies have shown a lower incidence of gastrointestinal side effects in patients that were switched from oral to parenteral methotrexate.
About Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is a chronic autoimmune disorder characterized by painful inflammation of the synovial tissues lining the joints. RA generally starts between the ages of 25 and 55 years. Left untreated it often progresses to proliferation of tissues surrounding the joints and destruction of bones and cartilage, which restricts normal movement of the joint. RA affects about 2.1 million Americans, occurring in women at twice to three times the rate as that in men.
About Antares Pharma
Antares Pharma focuses on self-injection delivery technologies and topical gel-based pharmaceutical products. The Company’s subcutaneous and intramuscular injection technology platforms include VIBEXTM disposable pressure-assisted auto injectors, ValeoTM/Vision® reusable needle-free injectors, and disposable multi-use pen injectors. In the injector area, Antares Pharma has a multi-product deal with Teva Pharmaceutical Industries, Ltd that includes Tev-Tropin® human growth hormone and a partnership with Ferring Pharmaceuticals. In the gel-based area, the Company’s lead product candidate, Anturol® an oxybutynin ATD™ gel for the treatment of OAB (overactive bladder), is currently under evaluation in a pivotal Phase 3 trial. Antares also has a partnership with BioSante that includes LibiGel® (transdermal testosterone gel) in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin® (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the U.S. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development and product commercialization activities in Minneapolis, Minnesota and Muttenz, Switzerland.
About Uman Pharma
Uman Pharma is a fully-integrated Canadian pharmaceutical company that develops, manufactures and markets generic injectable and solid dosage products and is the only oncology plant in Canada featuring freeze dryer and pre-filled syringes capacity. Uman Pharma also offers a wide range of services, from developmental, to scale-up, to manufacturing clinical and commercial lots to clients and partners internationally. The Company brings together experienced people dedicated to high-quality health products to offer cytotoxic and high potent injectable drugs, as well as innovative solutions that will benefit hospital health professionals. Establishing strategic alliances worldwide, Uman Pharma is developing a comprehensive portfolio of generic anticancer drugs and specialty oncology products.
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. Such forward-looking statements include statements related to the Company’s future financial performance, and other statements which are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others difficulties or delays in the initiation, progress, or completion of its clinical trials, including the phase 3 trial of Anturol®, whether caused by competition, adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues, or other factors; that clinical trials may not demonstrate that Anturol® is both safe and effective for the treatment of patients with overactive bladder syndrome; that the safety and/or efficacy results of the phase 3 trial of Anturol® may not support an application for marketing approval in the United States or any other country; that an application for marketing approval may not be accepted for review or at all by the FDA or any other regulatory authority; and that the Company may lack the financial resources and access to capital to fund clinical trials. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2009, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.