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Antares Pharma Announces the Publication of Three Abstracts at the 2014 European League Against Rheumatism Annual Congress

Companies mentioned in this article: Antares Pharma, Inc.

EWING, N.J. -- (BUSINESS WIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) today announced the publication of three abstracts at this year’s European League against Rheumatism (EULAR) Annual Congress being held in Paris, France on June 11 through June 14, 2014.

In partnership with clinical researchers in the United States and Europe, Antares Pharma, the maker of OTREXUP™ (methotrexate) for subcutaneous injection, supports original research intended to better understand the clinical role of subcutaneous methotrexate in the treatment of rheumatoid arthritis. Researchers from Switzerland, the United Kingdom, and the United States Veterans Administration will present original research at EULAR supported by unrestricted grants from Antares Pharma.

“Antares Pharma strongly believes in supporting the work of researchers who seek to better understand the role of subcutaneous methotrexate in the treatment of rheumatoid arthritis and we are committed to helping clinical researchers gain the knowledge they need to make the best possible choices for patients in their care,” said Antares Pharma President and Chief Executive Officer Paul K. Wotton, Ph.D.

EULAR has selected presentations by Rüdiger Müller, MD, et al, of the St. Gallen Hospital in Switzerland, and Bernard Ng, MD, of the U.S. Department of Veterans Affairs Hospital in Seattle, Washington be featured as part of its official, guided poster tour, during the congress.

“We are quite pleased for the researchers to be selected for this honor,” Dr. Wotton said.

EFFECTIVENESS, TOLERABILITY, AND SAFETY OF SUBCUTANEOUS METHOTREXATE IN EARLY RHEUMATOID ARTHRITIS: CLINICAL DATA FROM THE ST. GALLEN COHORT – EULAR14-SCIE-2013 (Rüdiger Müller, MD)

The objective of this study was to assess the clinical effectiveness and tolerability of subcutaneous (SC) methotrexate (MTX) among patients with rheumatoid arthritis (RA) who were naïve at baseline to both conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs). Seventy patients with RA and who were DMARD naïve were included in the analysis and administered SC MTX varying doses (10-25 mg/week, mean 18.2 mg) with 5 mg folic acid weekly. The primary endpoint was a change in Disease Activity Score (DAS28), and the secondary endpoints included time to employment of the first biologic agent and cumulative MTX doses. The study conclusion supports SC MTX as an effective and well-tolerated treatment option for patients with RA. Disease remission was achieved by a majority of patients following the initiation of SC MTX, and the addition of biologics was not needed throughout the study period for approximately half of the patients. SC MTX delayed the need for biologic therapy for approximately one year for almost half the patients identified.

FACTORS ASSOCIATED WITH METHOTREXATE TREATMENT DURATION, INCLUDING SUBCUTANEOUS USE, IN PATIENTS WITH RHEUMATOID ARTHRITIS: OBSERVATIONS FROM THE VETERANS AFFAIRS DATABASE – EULAR14-SCIE-3021 (Bernard Ng, MD)

The study objective was to determine whether patients identified in the Veterans Affairs (VA) database who were treated with injectable MTX after being unable to tolerate, or having an inadequate response to, oral MTX remained on MTX monotherapy longer than those treated only with oral MTX. An additional objective of the study was to compare the rates of liver enzyme abnormalities between patients using injectable MTX monotherapy and those using oral monotherapy. Of the 7,107 patients who were treated with MTX monotherapy for greater than 90 days, 3,910 required a therapeutic change (3,808 were treated with oral MTX and 102 with injectable MTX) defined as switching to or adding another DMARD or biologic agent. Patients treated with oral MTX remained on MTX monotherapy for an average of 627 days compared to 962 days for patients treated with injectable monotherapy. Therefore, among patients identified in the VA database, the use of injectable MTX was associated with significantly longer duration of MTX monotherapy compared with oral MTX. In addition, no significant differences in liver enzyme abnormalities were found between patients treated with injectable MTX and oral MTX.1

RA PATIENTS WITH INADEQUATE RESPONSE TO ORAL MTX MAINTAIN SATISFACTORY DISEASE CONTROL AND DURABLE LONG-TERM RESPONSE WHEN SWITCHED TO SC MTX MONOTHERAPY – EULAR14-SCIE-2353 (Anthony Hammond, MD)

In this analysis, RA patients switched from oral MTX to SC MTX monotherapy and were evaluated to understand durability of response and disease control. A retrospective analysis of RA patient data collected from 2003 to 2011 at a single site in the United Kingdom was performed. Per institutional practice, an incremental oral MTX dose increase was followed by a switch to SC MTX monotherapy. Folic acid (5-15 mg) was given one day after SC MTX treatment as a matter of routine practice. One hundred twelve RA patients were eligible for analysis, and in this single-center analysis, RA patients with an inadequate response to oral MTX for reasons of efficacy and/or tolerability maintained satisfactory disease control and durable long-term response when switched to SC MTX monotherapy.

“We believe these presentations affirm the clinical value of subcutaneous methotrexate in the treatment of rheumatoid arthritis and serve to help physicians better understand the role of subcutaneous methotrexate as an option before patients may need to initiate treatment with biologic therapy,” said LeRoux Jooste, General Manager Pharmaceuticals. “The data reported in these abstracts are derived from real-world experiences of rheumatologists, which we believe are meaningful and indicative of real-world patient response to treatment.”

Scientific posters which provide greater detail on the findings of this research will be presented by authors on Thursday, June 12, 2014. The official guided poster tour will take place Friday, June 13, 2014.

About Antares Pharma

Antares Pharma focuses on self-administered parenteral pharmaceutical products. The Company has received marketing approval from the U.S. Food and Drug Administration for OTREXUP™ (methotrexate) injection for the treatment of adults with severe active rheumatoid arthritis and children with active polyarticular juvenile idiopathic arthritis. LEO Pharma markets OTREXUP™ to dermatologists for adults with severe recalcitrant psoriasis. Antares Pharma is also developing VIBEX® QS T for testosterone replacement therapy. The Company's technology platforms include VIBEX® disposable Medi-Jet, disposable multi-use pen injectors and 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® [somatropin (rDNA origin) for injection] human growth hormone (hGH), VIBEX® epinephrine and several other products. In the U.S. Antares has received FDA approval for Gelnique 3%™ (oxybutynin) gel, 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.

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. These statements are indicated by the words “may,” “will,” “plans,” “intends,” “believes,” “expects,” “anticipates,” “potential,” “could,” “would,” “should,” and similar expressions, and includes statements regarding the data to be presented from research sponsored by the Company at the 2014 European League against Rheumatism (EULAR) Annual Congress. 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 with the commercial launch of OTREXUP™ for rheumatoid arthritis and psoriasis, market acceptance by physicians and patients of new products, delays in product development and changes or delays in the regulatory process for existing or new product candidates. 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, 2013, 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.

1 (Disclaimer: The views expressed in this abstract are those of the author and do not necessarily represent those of the Department of Veterans Affairs\University of Washington.)


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Contact:

Antares Pharma, Inc.
Jack Howarth
Vice President, Corporate Affairs
609-359-3016
jhowarth@antarespharma.com