EWING, N.J., April 05, 2016 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) today disclosed that the “Pen 1” development project with Teva Pharmaceutical Industries, Ltd. (Teva) relates to a generic form of Forteo® (teriparatide [rDNA origin] injection) (Teriparatide), marketed by Eli Lilly and Company (Lilly). Forteo is an injectable treatment for osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid induced osteoporosis in men and postmenopausal women. On March 16, 2016 Lilly filed a lawsuit against Teva in response to Teva’s Paragraph IV notice and filing contained in their Abbreviated New Drug Application (ANDA) for Teriparatide filed with, and accepted by, the U.S. Food and Drug Administration (FDA). Based on available information, Antares believes that Teva may be the "first applicant" to file an ANDA for a generic equivalent of Forteo and, should Teva’s ANDA be approved, may be entitled to 180 days of generic market exclusivity.
“Today’s announcement represents an important step forward in the process of providing U.S. patients with a generic alternative to Forteo,” said Robert F. Apple, President and Chief Executive Officer of Antares Pharma. He continued, “The ANDA for Teriparatide represents the fourth ANDA for which Antares is the device developer and the third drug device combination product with first-to-file status using an Antares device. Teva is an extremely valuable partner and we look forward to working with them towards an approval of this important product.”
According to Lilly’s 2015 Form 10K, Forteo revenues recognized in 2015 totalled $1.3 billion, including U.S. revenues of $0.6 billion. Antares is responsible for developing and manufacturing the multi-dose pen that Teva will use for the Teriparatide product, if approved. The scope of the Teriparatide agreement with Teva is worldwide.
About Antares Pharma
Antares Pharma focuses on self-administered parenteral pharmaceutical products. The Company’s product, OTREXUP™ (methotrexate) injection for subcutaneous use, is approved in the U.S. for the treatment of adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. Antares Pharma is also developing QuickShot® Testosterone for testosterone replacement therapy, and has recently received a therapeutically equivalent approval for VIBEX® Sumatriptan USP for the acute treatment of migraines. The Company's technology platforms include VIBEX® disposable auto injectors, disposable multi-use pen injectors and reusable needle-free injectors. Antares Pharma has a multi-product deal with Teva Pharmaceutical Industries, Ltd. that includes VIBEX® epinephrine, exenatide multi-dose pen, and teriparatide multi-dose pen. Our reusable needle-free injector for use with human growth hormone (hGH) is sold worldwide by Ferring B.V. The Company is also working with AMAG Pharmaceuticals on a subcutaneous method of administering Makena, a progesterone product indicated for use in lowering the risk of pre-term birth.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the outcome of the pending patent litigation between Teva Pharmaceutical Industries, Ltd. (Teva) and Eli Lilly and Company regarding the Teriparatide multi-dose pen; the timing and approval, if any, by the U.S. Food and Drug Administration (FDA) of Teva’s Abbreviated New Drug Application (ANDA) for Teriparatide multi-dose pen and any future revenue resulting therefrom; Teva’s ability to adequately and timely respond to the Complete Response Letter received from the FDA for the VIBEX® epinephrine pen ANDA and approval by the FDA of the same, the timing and therapeutic equivalence rating thereof, and any revenue pre or post FDA approval; FDA action with respect to the ANDA filed for the exenatide pen; the timing of the launch of VIBEX® Sumatriptan Injection USP and the amount of revenue from the same, the timing and results of the phase 3 studies for QuickShot® Testosterone (QS T) and acceptance of the data by the FDA; the Company’s ability to successfully complete a New Drug Application for QS T and submit to the FDA and approval of the same by the FDA; continued growth of prescriptions and sales of OTREXUP™; the timing and results of research projects, clinical trials, and product candidates in development; actions by the FDA or other regulatory agencies with the respect to the Company’s products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. 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, 2014, 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.
Contact: Jack Howarth Vice President, Corporate Affairs 609-359-3016 firstname.lastname@example.org