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Medac Pharma, Inc. Secures FDA Approval of Rasuvo (methotrexate) injection for Rheumatoid Arthritis, Poly-Articular-Course Juvenile Idiopathic Arthritis and Psoriasis

July 14, 2014

U.S. District Court for the District of Delaware Concurrently Denies Motion For Preliminary Injunction Filed by Antares Pharma, Inc.

CHICAGO, July 14, 2014 /PRNewswire/ — Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced that the U.S. Food and Drug Administration (FDA) has approved Rasuvo(TM), a subcutaneous injectable methotrexate (MTX) therapy delivered in an auto-injector for rheumatoid arthritis (RA), polyarticular-course juvenile idiopathic arthritis (pJIA) and psoriasis. Rasuvo will be available in 10 dosage strengths, ranging from 7.5 mg to 30 mg in 2.5 mg increments and will be launched in the U.S.

The company concurrently announced that the U.S. District Court for the District of Delaware has denied a motion for a preliminary injunction filed by Antares Pharma, Inc.

“We’re delighted to have secured approval for our lead product, Rasuvo, and look forward to introducing this much-needed therapy to the market,” stated Ms. Terri Shoemaker, President and CEO of Medac Pharma, Inc. “Methotrexate has long been recognized as a mainstay in rheumatoid arthritis therapy. With its virtually painless administration, broad dose range, and significantly enhanced bioavailability, we believe Rasuvo may benefit those patients using methotrexate.” Regarding the U.S. District Court for the District of Delaware’s decision, Ms. Shoemaker stated, “We’re pleased with the Court’s decision and are moving forward with our commercialization efforts as planned.”

With more than 30 years of clinical usage, MTX remains the most commonly used drug for treating RA and is recommended by both the American College of Rheumatology and European League Against Rheumatism as a first-line therapy for RA patients. While many patients prescribed MTX take an oral form of this drug, this route of administration has been associated with highly variable absorption rates and inconsistent bioavailability among patients.

Medac Pharma, Inc. developed Rasuvo to optimize MTX therapy. The subcutaneous mode of delivery of Rasuvo, with its wide range of dosing options, has been designed to improve bioavailability.

Rheumatologist Eric Ruderman, MD, Professor of Medicine, Northwestern University Feinberg School of Medicine, stated, “As a rheumatologist, I believe Rasuvo will offer patients the opportunity to maximize the benefit they get from methotrexate. Rasuvo’s dosing flexibility, in particular, will be very helpful, as RA patients do not all respond equally to methotrexate, making it important to select a treatment regimen that is appropriate for the patient’s condition.”

For complete prescribing information, including Boxed Warning, please visit www.Rasuvo.com.

Indications and Important Safety Information Including Boxed Warning

INDICATIONS:

Rasuvo is a folate analog metabolic inhibitor indicated for the:

    --  Management of patients with severe, active rheumatoid arthritis (RA) and
        active polyarticular juvenile idiopathic arthritis (pJIA), who are
        intolerant of or had an inadequate response to first-line therapy.
    --  Symptomatic control of severe, recalcitrant, disabling psoriasis in
        adults who are not adequately responsive to other forms of therapy.

Limitations of Use

Rasuvo is not indicated for treatment of neoplastic diseases.

This product includes the following Black Box Warning:

WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY AND DEATH

Rasuvo should be used only by physicians whose knowledge and experience include the use of antimetabolite therapy. Because of the possibility of serious toxic reactions (which can be fatal), Rasuvo should be used only in patients with psoriasis or rheumatoid arthritis with severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy. Deaths have been reported with the use of methotrexate in the treatment of malignancy, psoriasis, and rheumatoid arthritis. Patients should be closely monitored for bone marrow, liver, lung, skin, and kidney toxicities. Patients should be informed by their physician of the risks involved and be under a physician’s care throughout therapy.

    1. Methotrexate has been reported to cause fetal death and/or congenital
       anomalies. Therefore, Rasuvo is not recommended for females of
       childbearing potential unless there is clear medical evidence that the
       benefits can be expected to outweigh the considered risks. Rasuvo is
       contraindicated in pregnant women.
    2. Methotrexate elimination is reduced in patients with impaired renal
       functions, ascites, or pleural effusions. Such patients require
       especially careful monitoring for toxicity, and require dose reduction
       or, in some cases, discontinuation of Rasuvo administration.
    3. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic
       anemia, and gastrointestinal toxicity have been reported with concomitant
       administration of methotrexate (usually in high dosage) along with some
       nonsteroidal anti-inflammatory drugs (NSAIDs).
    4. Methotrexate causes hepatotoxicity, fibrosis and cirrhosis, but generally
       only after prolonged use. Acutely, liver enzyme elevations are frequently
       seen. These are usually transient and asymptomatic, and also do not
       appear predictive of subsequent hepatic disease. Liver biopsy after
       sustained use often shows histologic changes, and fibrosis and cirrhosis
       have been reported; these latter lesions may not be preceded by symptoms
       or abnormal liver function tests in the psoriasis population. For this
       reason, periodic liver biopsies are usually recommended for psoriatic
       patients who are under long-term treatment. Persistent abnormalities in
       liver function tests may precede appearance of fibrosis or cirrhosis in
       the rheumatoid arthritis population.
    5. Methotrexate-induced lung disease, including acute or chronic
       interstitial pneumonitis, is a potentially dangerous lesion, which may
       occur acutely at any time during therapy and has been reported at low
       doses. It is not always fully reversible and fatalities have been
       reported. Pulmonary symptoms (especially a dry, nonproductive cough) may
       require interruption of treatment and careful investigation.
    6. Diarrhea and ulcerative stomatitis require interruption of therapy:
       otherwise, hemorrhagic enteritis and death from intestinal perforation
       may occur.
    7. Malignant lymphomas, which may regress following withdrawal of
       methotrexate, may occur in patients receiving low-dose methotrexate and,
       thus, may not require cytotoxic treatment. Discontinue Rasuvo  first and,
       if the lymphoma does not regress, appropriate treatment should be
       instituted.
    8. Like other cytotoxic drugs, methotrexate may induce "tumor lysis
       syndrome" in patients with rapidly growing tumors.
    9. Severe, occasionally fatal, skin reactions have been reported following
       single or multiple doses of methotrexate. Reactions have occurred within
       days of oral, intramuscular, intravenous, or intrathecal methotrexate
       administration. Recovery has been reported with discontinuation of
       therapy.
    10. Potentially fatal opportunistic infections, especially Pneumocystis
        jiroveci pneumonia, may occur with methotrexate therapy.
    11. Methotrexate given concomitantly with radiotherapy may increase the risk
        of soft tissue necrosis and osteonecrosis.

CONTRAINDICATIONS

Rasuvo is contraindicated in the following:

    --  Pregnancy: Rasuvo can cause fetal death or teratogenic effects when
        administered to a pregnant woman. Rasuvo is contraindicated in pregnant
        women. If this drug is used during pregnancy, or if the patient becomes
        pregnant while taking this drug, the patient should be apprised of the
        potential hazard to the fetus.
    --  Nursing Mothers: Because of the potential for serious adverse reactions
        from methotrexate in breast fed infants, Rasuvo is contraindicated in
        nursing mothers.
    --  Alcoholism or Liver Disease: Patients with alcoholism, alcoholic liver
        disease or other chronic liver disease.
    --  Immunodeficiency Syndromes: Patients who have overt or laboratory
        evidence of immunodeficiency syndromes.
    --  Preexisting Blood Dyscrasias: Patients who have preexisting blood
        dyscrasias, such as bone marrow hypoplasia, leukopenia,
        thrombocytopenia, or significant anemia.
    --  Hypersensitivity: Patients with a known hypersensitivity to
        methotrexate. Severe hypersensitivity reactions have been observed with
        methotrexate use.

WARNINGS AND PRECAUTIONS

    --  Organ System Toxicity: Rasuvo has the potential for serious toxicity.
        Rasuvo should be used only by physicians whose knowledge and experience
        include antimetabolite therapy. Because of the possibility of severe
        toxic reactions (which can be fatal), Rasuvo should be used only in
        patients with psoriasis or rheumatoid arthritis with severe,
        recalcitrant, disabling disease, which is not adequately responsive to
        other forms of therapy.
    --  Embryo-Fetal Toxicity: Methotrexate has been reported to cause fetal
        death and/or congenital anomalies. Rasuvo is not recommended for females
        of childbearing potential unless there is clear medical evidence that
        the benefits can be expected to outweigh the considered risks.  Rasuvo
        is contraindicated in pregnant women with psoriasis or rheumatoid
        arthritis. Exclude pregnancy before treatment. Females should be
        counseled on the serious risks to the fetus should they become pregnant
        while undergoing treatment.  Avoid pregnancy if either partner is
        receiving Rasuvo. Advise males to avoid pregnancy for a minimum of three
        months after therapy and females to avoid pregnancy for at least one
        ovulatory cycle after therapy.
    --  Effects on Reproduction: Methotrexate has been reported to cause
        impairment of fertility, oligospermia and menstrual dysfunction in
        humans, during and for a short period after cessation of therapy.
    --  Laboratory Tests: Patients undergoing Rasuvo therapy should be closely
        monitored so that toxic effects are detected promptly.  Baseline
        assessment should include a complete blood count with differential and
        platelet counts, hepatic enzymes, renal function tests and a chest
        X-ray.
    --  Risks from Improper Dosing: The physician and/or pharmacist should
        emphasize to the patient that Rasuvo is administered once weekly and
        mistaken daily use has led to fatal toxicity.
    --  Patients with Impaired Renal Function, Ascites, or Pleural Effusions:
        Elimination is reduced. Such patients require especially careful
        monitoring for toxicity and require dose reduction or, in some cases,
        discontinuation of Rasuvo administration.
    --  Dizziness and Fatigue: May impair ability to drive or operate machinery.
    --  Malignant Lymphomas: Non-Hodgkin's lymphoma and other tumors have been
        reported in patients receiving low-dose oral methotrexate.  However,
        there have been instances of malignant lymphoma arising during treatment
        with low-dose methotrexate, which have regressed completely following
        withdrawal of methotrexate, without requiring active anti-lymphoma
        treatment.  Discontinue Rasuvo first and, if the lymphoma does not
        regress, appropriate treatment should be instituted.
    --  Tumor Lysis Syndrome: Like other cytotoxic drugs, methotrexate may
        induce "tumor lysis syndrome" in patients with rapidly growing tumors.
    --  Concomitant Radiation Therapy: Methotrexate given concomitantly with
        radiotherapy may increase the risk of soft tissue necrosis and
        osteonecrosis.

ADVERSE REACTIONS

The most frequently reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequently reported adverse reactions are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection.

DRUG INTERACTIONS

    --  Aspirin, NSAIDs, and Steroids: Concomitant use may elevate and prolong
        serum methotrexate levels, resulting in deaths from severe hematologic
        and gastrointestinal toxicity.
    --  Proton Pump Inhibitors (PPIs): Concomitant use of some PPIs may elevate
        and prolong serum levels of methotrexate and cause increased toxicity.
    --  Oral Antibiotics: Certain oral antibiotics may decrease intestinal
        absorption of methotrexate or interfere with enterohepatic circulation
        by inhibiting bowel flora and suppressing metabolism of the drug by
        bacteria. Use of Rasuvo with penicillins should be carefully monitored.
    --  Hepatotoxins: Patients receiving concomitant therapy with Rasuvo and
        other potential hepatotoxins should be closely monitored for possible
        increased risk of hepatotoxicity.
    --  Theophylline: Methotrexate may decrease the clearance of theophylline,
        therefore theophylline levels should be monitored.
    --  Folic Acid and Antifolates: Vitamin preparations containing folic acid
        or its derivatives may decrease responses to systemically administered
        methotrexate.  Folate deficiency states may increase methotrexate
        toxicity.
    --  Mercaptopurine: Methotrexate increases the plasma levels of
        mercaptopurine, therefore dose adjustment may be required.
    --  Other Drugs: Toxicity may be increased because of displacement of
        certain drugs. Use of Rasuvo with probenecid should be carefully
        monitored.

USE IN SPECIFIC POPULATIONS

    --  Pediatric Use: Safety and efficacy of Rasuvo have not been established
        in pediatric patients with psoriasis, neoplastic disease, and pJIA.
    --  Geriatric Use: Use caution in dose selection.  Elderly patients should
        be closely monitored for early signs of hepatic, bone marrow and renal
        toxicity.
    --  Renal Impairment: Elimination is reduced.  Patients require careful
        monitoring for toxicity and require dose reduction or discontinuation of
        Rasuvo.
    --  Hepatic Impairment: Contraindicated in patients with alcoholic liver
        disease or other chronic liver disease.

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.

About Medac Pharma, Inc.

Medac Pharma, Inc. is the wholly-owned subsidiary of medac GmbH, a well-known and respected global pharmaceutical company that has been making scientific and therapeutic discoveries for more than 40 years.

Medac Pharma, Inc. is focused on developing therapies with the potential to make meaningful differences in patients’ lives. The company’s approach is to improve existing agents by enhancing the mode of delivery, addressing safety profiles and inventing ways to maximize efficacy.

For more information, please visit www.medacpharma.com.

For Media:

Tiberend Strategic Advisors, Inc.

Andrew Mielach

amielach@tiberend.com; (212) 375-2694

SOURCE Medac Pharma, Inc.


Source: PR Newswire



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