ANTARES PHARMA® ANNOUNCES AVAILABILITY OF OTREXUP™ (METHOTREXATE)
`INJECTION FOR SUBCUTANEOUS USE TO TREAT RHEUMATOID ARTHRITIS (RA) AND
`PSORIASIS IN ADULTS, AND POLYARTICULAR IDIOPATHIC ARTHRITIS (pJIA) IN CHILDREN
`
`OTREXUP™ provides a new option that may benefit patients when the response to oral
`methotrexate is inadequate
`
`EWING, N.J., January 15, 2014 — Antares Pharma, Inc. (NASDAQ: ATRS) today announced the availability of
`OTREXUP™, the first U.S. Food and Drug Administration (FDA) approved subcutaneous (SC) methotrexate
`(MTX) product for once weekly self-administration with an easy-to-use, single dose, disposable auto injector.
`OTREXUP was approved by the FDA in October 2013. OTREXUP is available at distribution centers throughout
`the USA.
`
`Approximately 1.3 million Americans are diagnosed with RA and about 7.5 million with psoriasis. Initial treatment
`of these conditions with oral MTX usually provides a good response for many patients. However, some patients
`find it difficult to tolerate the oral formulation and/or receive limited benefit, especially when higher doses are
`required for a satisfactory response. Absorption following oral dosing showed a plateau effect at doses of 15 mg
`and greater.
`
`“OTREXUP provides an attractive new option that may benefit patients who have had an inadequate response to
`or are intolerant of oral MTX,” said Paul K. Wotton, Ph.D., President and Chief Executive Officer, Antares.
`“OTREXUP is an easy-to-use auto injector that delivers greater blood levels of medication than oral MTX.
`OTREXUP could extend the use and benefits of MTX and potentially delay or avoid the use of other more
`expensive treatment options in some patients.”
`
`OTREXUP is indicated for adults with severe active rheumatoid arthritis (RA) who have had an insufficient
`therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non-steroidal
`anti-inflammatory agents (NSAIDs), and children with active polyarticular juvenile idiopathic arthritis (pJIA).
`OTREXUP also is indicated for use in adults who need symptomatic control of severe recalcitrant, disabling
`psoriasis that is not adequately responsive to other forms of therapy.
`
`“CreakyJoints welcomes new treatment options for patients with RA,” said Seth Ginsberg, president and co-
`founder of CreakyJoints, one of the nation’s largest rheumatic disease patient advocacy groups. “Because so
`many RA patients have limited manual dexterity, conventional syringes for injection of methotrexate are often
`difficult to use. An easy delivery system that combines subcutaneous methotrexate with a pre-filled auto-injector
`is an important addition to treatment options available because it expands RA patients’ access to care.”
`
`The injectable use of MTX after an inadequate response to oral MTX is quite common in Europe and elsewhere
`in the world. In the United States, however, use of injectable MTX is often overlooked primarily due to the
`challenges of self-injection. The fear of needles, poor manual dexterity, especially in people living with RA, and a
`lack of confidence in accurately and safely self-injecting with a vial, needle and syringe may be some of the
`challenges people have to face.
`
`“OTREXUP is a useful new treatment option that physicians can consider for their patients who could continue to
`benefit from MTX when their tablets provide an inadequate response,” said Alvin F. Wells, MD, PhD, Director,
`Rheumatology & Immunotherapy Center, located in Franklin, Wisconsin. “An easy-to-use and almost pain-free
`injection can provide the higher blood levels of medication that may be necessary for these patients.”
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`Medac Exhibit 2059
`Frontier Therapeutics v. Medac
`IPR2016-00649
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`“Antares is committed to the consistent availability of OTREXUP and the support that patients and healthcare
`providers need,” said LeRoux Jooste, SVP and General Manager, Antares Pharmaceuticals. “We have shipped
`OTREXUP to distribution centers throughout the US and have ample inventory of OTREXUP available to supply
`the market. As a research and development company, we plan ahead to ensure that OTREXUP remains an
`available treatment option for the patients who need it.”
`
`For full prescribing information please visit WWW.OTREXUP.COM
`
`Important Safety Information
`Otrexup is a single-dose auto-injector containing a prescription medicine, methotrexate. Methotrexate is
`used to:
` Treat certain adults with severe active rheumatoid arthritis, and children with active polyarticular
`juvenile idiopathic arthritis (pJIA), after treatment with other medicines, including nonsteroidal anti-
`inflammatory drugs (NSAIDs) have been used and did not work well
` Control the symptoms of severe, resistant, disabling psoriasis in adults when other types of
`treatment have been used and did not work well
`Otrexup should not be used for the treatment of cancer. Otrexup should not be used for the treatment
`of children with psoriasis.
`
`Methotrexate includes the following boxed warning:
`Otrexup can cause serious side effects that can lead to death, including:
` Organ system toxicity. People who use methotrexate for the treatment of cancer, psoriasis, or
`rheumatoid arthritis have an increased risk of death from organ toxicity. Types of organ toxicity can
`include gastrointestinal, bone marrow, liver, immune system, nerve, lung, kidneys, and skin.
`
`
`
`Your doctor will do blood tests and other types of tests before you take and while you are taking
`Otrexup to check for signs and symptoms of organ toxicity. Call your doctor right away if you have
`any of the following symptoms of organ toxicity: vomiting, diarrhea, mouth sores, fever, confusion,
`weakness, temporary blindness, seizures, headache, back pain, neck stiffness, paralysis, irritability,
`sleepiness, problems with coordination, dry cough, trouble breathing, and severe skin rash.
`
` 
`
` Women who are pregnant are at increased risk for death of the baby and for birth defects in
`the baby. Women who are pregnant or who plan to become pregnant must not take Otrexup. A
`pregnancy test should be performed before starting Otrexup.
`
`
`
`Contraception should be used by both females and males while taking Otrexup. Pregnancy should
`be avoided if either partner is receiving Otrexup:
`• For a minimum of 3 months after treatment with Otrexup for males.
`• During and for at least 1 menstrual cycle after treatment with Otrexup for females.
`
`What are the possible side effects of Otrexup?
`Otrexup may cause serious side effects, including:
`• Fertility problems. Methotrexate, the active ingredient in Otrexup, may affect your ability to have a
`baby. Males may have a decreased sperm count, and females may have changes to their menstrual
`cycle. This can happen while taking Otrexup and for a short period of time after you stop.
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`• Certain cancers. Some people who have taken methotrexate have had a certain type of cancer
`called Non-Hodgkin’s lymphoma and other tumors. Your doctor may tell you to stop taking Otrexup if
`this happens.
`• Tissue and bone problems. Taking methotrexate while having radiation therapy may increase the
`risk of your tissue or bone not receiving enough blood. This may lead to death of the tissue or bone.
`Common side effects of Otrexup include: nausea, stomach pain, indigestion (dyspepsia), mouth sores,
`and rash.
`
`Who should not take Otrexup?
`Do not take Otrexup if you:
`• Are pregnant or planning to become pregnant
`• Are breastfeeding; Otrexup can pass into your breast milk and may harm your baby
`• Have alcohol problems (alcoholism)
`• Have liver problems
`• Have problems fighting infection (immunodeficiency syndrome)
`• Have been told you have (or think you have) a blood disorder such as low levels of white blood cells,
`red blood cells (anemia), or platelets
`• Have had an allergy to methotrexate or any of the ingredients in Otrexup
`
`What should I tell my doctor before taking Otrexup?
`Before you take Otrexup, tell your doctor if you have any other medical conditions. Tell your doctor
`about all of the medicines you take, including prescription medicines, over-the-counter medicines,
`vitamins, and herbal supplements.
`
`Otrexup may affect how other medicines work, and other medicines may affect how Otrexup works,
`causing side effects. Ask your doctor or pharmacist for a list of medicines if you are not sure.
`
`Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all
`the possible side effects of Otrexup. For more information, ask your doctor or pharmacist.
`
`You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
`www.fda.gov/medwatch, or call 1-800-FDA-1088.
`
`For more information, go to www.Otrexup.com or call 1-855-OTREXUP (1-855-687-3987).
`
`About Antares Pharma
`Antares Pharma focuses on self-administered parenteral pharmaceutical products and topical gel-based
`medicines. The Company is developing VIBEX QS T for testosterone replacement therapy. The Company's
`technology platforms include VIBEX® disposable Medi-Jet® , disposable multi-use pen injectors and VisionTM
`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. Antares Pharma's partnership with Ferring includes Zomacton® hGH
`(somatropin) injection. In the U.S. Antares has received FDA approval for Gelnique 3%TM (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
`
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`injection devices and related disposables, and develops its disposable pressure-assisted MediJet and pen
`injector systems. The Company's corporate office and Product Development and Commercial Groups are
`located in Ewing, New Jersey.
`
`About Creaky Joints
`CreakyJoints (http://www.CreakyJoints.org) is the world's leading arthritis support, education, advocacy and
`research community for people with arthritis (RA, PsA, OA, and other rheumatic diseases) as well as their
`caregivers. It is a part of the non-profit Global Healthy Living Foundation (http://www.GHLF.org).CreakyJoints
`was co-founded by arthritis patient Seth Ginsberg in 1999, and today, has a reach of more than 25 million
`people per week, according to Facebook (http://www.Facebook.com/CreakyJoints), making it the most popular.
`GHLF and CreakyJoints work to create an environment where strength, experience, and information can be
`exchanged to improve quality-of-life through educational programs, supportive social media, innovative
`research initiatives and nurtured collaborative advocacy among other organizations. Membership within
`CreakyJoints is free and encouraged for anyone who is impacted by arthritis.
`
`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, including statements regarding the potential benefits of
`OTREXUP and its consistent availability. 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,
`market acceptance by physicians and patients of new products, difficulties or delays in the commercial launch
`of OTREXUP, difficulties or delays in the manufacture, supply or distribution of OTREXUP 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, 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.
`
`Contact:
`Jack Howarth
`Vice President, Corporate Affairs
`609-359-3016
`jhowarth@antarespharma.com
`
`Media Contact:
`Elaine Andrecovich
`Makovsky
`212-508-9675
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