Antares Pharma Announces First Shipment of Commercial VIBEX™ Auto-Injector Devices to Teva
EWING, N.J.--(BUSINESS WIRE)-- Antares Pharma, Inc. (NAS: ATRS) today announced the first shipment of commercial-ready VIBEX™ auto-injector devices to Teva at the end of the first quarter 2013. This initial order for pre-launch quantities of the generic epinephrine auto-injector represents the first of many shipments that will take place during 2013.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, "Today's announcement marks yet another milestone for Antares and the successful commercial production of VIBEX™ devices is an important achievement." Dr. Wotton continued, "Our growing and maturing development pipeline that includes OTREXUP™ for Rheumatoid Arthritis and QST for testosterone replacement therapy, is constructed around the proprietary VIBEX™ platform and this demonstrated ability to manufacture devices at a commercial scale is both a significant accomplishment for the Company and a major step forward for our own internal development programs."
Antares entered into an exclusive license development and supply agreement under which Teva is obligated to purchase all of its epinephrine auto-injector device requirements from us. We receive a negotiated purchase price for each device sold and will receive royalties on sales of their epinephrine product. On April 26, 2012, Antares announced a settlement agreement with Meridian Medical Technologies, a Pfizer subsidiary under which Teva may launch a generic epinephrine auto-injector on June 22, 2015 or earlier under certain circumstances, subject to approval from the U. S. Food and Drug Administration.
About Antares Pharma
Antares Pharma focuses on self-administered parenteral pharmaceutical products and topical gel-based medicines. The Company is developing OTREXUP™, a combination product for the delivery of methotrexate using Medi-Jet™ technology for the treatment of rheumatoid arthritis, poly-articular-course juvenile rheumatoid arthritis and psoriasis, as well as VIBEX™ QS T for testosterone replacement therapy. The Company's technology platforms include VIBEX™ disposable Medi-Jet™, disposable multi-use pen injectors and Vision™ reusable needle-free injectors marketed as Tjet® and Zomajet® by Teva Pharmaceutical Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring), respectively. Antares Pharma has a multi-product deal with Teva that includes Tev-Tropin® human growth hormone (hGH), VIBEX™ epinephrine and several other products. Antares Pharma's partnership with Ferring includes Zomacton® hGH. In the U.S. Antares has received FDA approval for Gelnique 3%™, a treatment for overactive bladder that is marketed by Actavis. Elestrin® (estradiol gel) is FDA approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and is marketed in the U.S. by Meda Pharma. Antares Pharma has two facilities in the U.S. The Parenteral Products Group located in Minneapolis, Minnesota directs the manufacturing and marketing of the Company's reusable needle-free injection devices and related disposables, and develops its disposable pressure-assisted Medi-Jet and pen injector systems. The Company's corporate office and Product Development and Commercial Groups are located in Ewing, New Jersey.
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are indicated by the words "may," "will," "plans," "intends," "believes," "expects," "anticipates," "potential," "could," "would," "should," and similar expressions. 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, changes in revenue growth and difficulties or delays in the initiation, progress, or completion of product development. In addition, the epinephrine auto-injector product referred to in this press release has not yet been approved by the FDA, and the amount of auto-injector device sales and future royalties received by the Company are dependent on Teva receiving FDA approval of this product. 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, 2012, 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.
Antares Pharma, Inc.
Jack Howarth, 609-359-3016
Vice President, Corporate Affairs
KEYWORDS: United States North America New Jersey Pennsylvania
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