medac EULAR satellite symposium in London: International experts share experiences on MTX therapy, biosimilars, cardioprotective effects and patient adherence

London / Wedel (09 June 2016)

What are the current best-practice strategies using subcutaneous methotrexate in rheumatoid arthritis? Has the value of methotrexate as anchor drug changed in the age of biologicals and biosimilars? What is known about the effects and mechanisms conveyed by methotrexate (MTX) on the cardiovascular system? How can rheumatologists influence patient adherence?

These current topics in the field of rheumatology will be covered by this year’s EULAR satellite symposium held by medac, the world-wide leading provider of subcutaneous methotrexate.

“We are very much looking forward to the symposium,” states Heiner Will, Managing Director of medac. “Especially due to the participation of the former ACR president, Dr. Stanley Cohen, United States, who is going to share his expertise on subcutaneous methotrexate in daily practice. It has been published that MTX remains frequently under-dosed1; but nevertheless the potential of subcutaneous methotrexate improving RA therapy is increasingly recognized and applied in practice.”

The topic of methotrexate in the age of biosimilars and biologic drugs will be outlined by well-known Prof. Jürgen Braun, Germany. He had conducted the ground-breaking clinical trial showing that the parenteral MTX was more effective than the oral administration2. Usually, MTX increases the effectiveness of biologic agents in rheumatoid arthritis3, and also its advantageous cost-effectiveness persist in the presence of biosimilars4.

The important aspects of patient adherence or non-adherence to therapy and the role of the rheumatologists are going to be discussed by Prof. Johanna Hazes, the Netherlands. Her publications stress the value of open and trustworthy relationships between rheumatologists and patients5. Good relationships may enable discussing non-adherence issues and thus help the patient to focus on the treatment goal.

Another important highlight of the symposium will be the input provided by Prof. Evgeny Nasonov, Russian Federation, who is going to present recent insights in the cardioprotective mechanism of MTX6. The inflammatory events of RA are known to contribute to cardiovascular risk factors. Various hypothetical mechanisms will be discussed how methotrexate deploys its cardioprotective effects.

References

  1. O’Dell JR et al., Arthritis Rheumatol. 2015; 67 (suppl 10): ACR 2015 Abstract Number 1997

  2. Braun J et al., Arthritis Rheum 2008;58:73-81

  3. Nam JL et al., Ann Rheum Dis 2010;69:976-986

  4. Fitzpatrick R et al., Clin Rheumatol. 2013;32:1605-1612

  5. Pasma A et al., Arthritis Res Ther 2015;17:281

  6. Popkova TV et al., Curr Med Chem 2015; 22:1903-1910

About Medac Pharma: Practicing a patient-first philosophy

Medac Pharma, Inc. is a privately held specialty pharmaceutical company focused on the development, in-licensing and commercialization of late-stage molecules. The company strives to bring new life to products and solve everyday patient challenges in autoimmune disease and cancer.

Medac Pharma 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. For more information about medac GmbH, please visit www.medac.de.

For complete prescribing information, including Boxed Warning, and information on Medac Pharma’s CORE Connections program, please visit www.Rasuvo.com.

Top-class speakers address various issues on methotrexate (MTX) therapy during all stages of life at medac GmbH EULAR satellite symposium in Rome, Italy

Chicago, IL, June 9, 2015

Medac GmbH has invited internationally highly distinguished experts for a satellite symposium at the EULAR 2015 in Rome. The overall topic of the symposium reflects how methotrexate, the gold standard in therapy of rheumatoid arthritis, can accompany patients through stages of life.

“We feel honoured to have Prof James O’Dell chairing our symposium at this year’s EULAR. His work with MTX and other DMARDs in the well-known triple therapy is a milestone in the treatment of RA,” said Dr Ulrich Kosciessa, Managing Director of medac GmbH. As the world-wide leader for subcutaneous methotrexate therapy, Medac has a long tradition in supporting autoimmune research and application focussing on methotrexate. Kosciessa added: “Other highlights of our top-class symposium will be the discussion of MTX in early therapy presented by Dr Suzanne Verstappen, UK, Dr Ivan Foeldvari, Germany, talking about juvenile idiopathic arthritis, as well as Dr Gerolamo Bianchi, Italy, presenting data on MTX therapy improvement in middle-aged patients.”

Objectives of the symposium

Rheumatoid arthritis may affect patients at all stages in life. Methotrexate has been the disease-modifying anti-rheumatic drug (DMARD) of first choice for most age groups. The speakers of the symposium will discuss enhancement strategies of methotrexate and the management of tolerance issues such as dose adjustments, correct application of folic acid and switching to subcutaneous use. Also, patient-related topics as pregnancy and alcohol dependency are going to be considered. Finally, therapy adherence as another important aspect for all patient groups will be illustrated by current study results.

Despite recent medicinal developments, methotrexate has remained the gold standard in rheumatoid arthritis therapy, being a well-tolerated drug, making therapy affordable, and convincing with versatile applications. Medac GmbH aims to contribute to the success story of methotrexate by providing the drug world-wide under the brand names Metoject®, Metex® and Rasuvo™. The broad range of 10 dosages includes intermediate doses in ready-to-use syringes and autoinjectors.

Also, medac GmbH would like to recommend the new, innovative online help and support tool RA Coach for rheumatoid arthritis patients and their relatives. The RA Coach wants to enhance the disease self-management skills of RA patients and offers e.g. useful information and guided exercises (www.ra-coach.com).

About Medac Pharma: Practicing a patient-first philosophy

Medac Pharma, Inc. is a privately held specialty pharmaceutical company focused on the development, in-licensing and commercialization of late-stage molecules. The company strives to bring new life to products and solve everyday patient challenges in autoimmune disease and cancer.

Medac Pharma 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. For more information about medac GmbH, please visit www.medac.de.

For complete prescribing information, including Boxed Warning, and information on Medac Pharma’s CORE Connections program, please visit www.Rasuvo.com.

Media Contact:
Medac Pharma, Inc.
Zachary Adamerovich
zadamerovich@medacpharma.com
312-854-0511

Medac Pharma, Inc. announced today that it and its parent company, medac GmbH, have settled all litigation and patent office proceedings with Antares Pharma, Inc.

Chicago, IL, April 16, 2015

Medac Pharma, Inc., a privately-held pharmaceutical company, today announced that it and its parent company, medac GmbH, have settled all litigation and patent office proceedings with Antares Pharma, Inc. Pursuant to the settlement agreement, the parties will dismiss proceedings related to their respective patents pending before the United States District Court for the District of Delaware, the United States District Court for the District of New Jersey, the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office, and the Technical Board of Appeal of the European Patent Office. The settlement agreement also provides for a royalty-free cross-license under the patents-in-suit and their families allowing the manufacture and sale of Medac’s RASUVO™ and Antares’ OTREXUP™ in and for the U.S.

About Medac Pharma: Practicing a patient-first philosophy

Medac Pharma, Inc. is a privately held specialty pharmaceutical company focused on the development, in-licensing and commercialization of late-stage molecules. The company strives to bring new life to products and solve everyday patient challenges in autoimmune disease and cancer.

Medac Pharma 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. For more information about medac GmbH, please visit www.medac.de.

For complete prescribing information, including Boxed Warning, and information on Medac Pharma’s CORE Connections program, please visit www.Rasuvo.com.

For Media:
Tiberend Strategic Advisors, Inc.
Andrew Mielach
amielach@tiberend.com; (212) 375-2694

U.S. Court of Appeals for the Federal Circuit Concurrently Affirms Denial of Antares Pharma’s Motion to Prohibit the Marketing of Rasuvo

Chicago, IL, November 24, 2014

Medac Pharma, Inc., a privately held pharmaceutical company, today announced that it has filed a motion for a preliminary injunction against Antares Pharma, Inc. to prohibit sales of the 15, 20 and 25 mg doses of Otrexup™ (methotrexate) injection to new patients. The motion was filed in the United States District Court for the District of New Jersey in a suit for infringement of the U.S. patent 8,664,231 (the ‘231 patent). The patent, titled, “Concentrated Methotrexate Solutions,” is directed to a method for the treatment of inflammatory autoimmune diseases by subcutaneously administrating methotrexate at a concentration of more than 30 mg/mL. Medac Pharma’s Rasuvo™ (methotrexate injection) is available to fill the treatment needs of any patient affected by the requested injunction.

Concurrently, the U.S. Court of Appeals for the Federal Circuit has denied Antares Pharma’s motion to cease the marketing of Rasuvo, which was launched in early October 2014 in the U.S.

Earlier this year, on March 11, 2014, Medac Pharma announced that it had filed a lawsuit in the United States District Court of New Jersey against Antares Pharma, Inc., LEO Pharma A/S and LEO Pharma Inc. for infringement of the ‘231 patent, which includes the making and sale of concentrated methotrexate products for treating rheumatoid arthritis, polyarticular idiopathic arthritis and psoriasis. The preliminary injunction seeks an order to prohibit Antares from manufacturing and selling those products to new patients.

Terri Shoemaker, President and CEO of Medac Pharma, Inc., stated, “We are delighted that, as a result of the Federal Circuit’s decision, we can continue providing Rasuvo to patients for these chronic inflammatory autoimmune diseases. Given the successful development of our internal sales force and commercial teams, as well as our consistent and reliable supply chain of methotrexate, we are well positioned to provide all patients in need of subcutaneous methotrexate with Rasuvo.”

About Medac Pharma: Practicing a patient-first philosophy

Medac Pharma, Inc. is a privately held specialty pharmaceutical company focused on the development, in-licensing and commercialization of late-stage molecules. The company strives to bring new life to products and solve everyday patient challenges in autoimmune disease and cancer.

Medac Pharma 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.

For complete prescribing information, including Boxed Warning, and information on Medac Pharma’s CORE Connections program, please visit www.Rasuvo.com.

For Media:
Tiberend Strategic Advisors, Inc.
Andrew Mielach
amielach@tiberend.com; (212) 375-2694

Medac Pharma Brings Rasuvo From U.S. Concept to Launch in One Year

Chicago, IL, October 6, 2014

Medac Pharma, Inc., a privately held pharmaceutical company, has announced the launch of its lead product Rasuvo™ (methotrexate) injection for patients with rheumatoid arthritis (RA), poly-articular-course juvenile idiopathic arthritis (pJIA) and psoriasis in the U.S. 

Rasuvo is a single dose, subcutaneous methotrexate (MTX) auto injector offering the widest dose range in a subcutaneous MTX therapy. It is available in 10 dosage strengths, ranging from 7.5 mg to 30 mg in 2.5 mg increments. Rasuvo is available immediately through drug distribution centers throughout the U.S.  

“We are pleased to bring Rasuvo to the market and provide another treatment option for patients and healthcare providers to manage rheumatoid arthritis, poly-articular-course juvenile idiopathic arthritis and psoriasis,” said Ms. Terri Shoemaker, President and CEO of Medac Pharma. “The swift, successful execution of our commercial plan is a testament of our ability to leverage our internally-built sales, marketing and managed care account teams. Rasuvo is backed by our extensive resources and services, proving our commitment to patients.” Ms. Shoemaker also stated that the recently-founded commercialization efforts provide a strategic platform for the company’s growing portfolio.

Augmenting the launch, Medac Pharma has developed CORE Connections, a comprehensive program providing information, materials and assistance to help patients and healthcare providers obtain and use Rasuvo. Some of the components of CORE Connections include patient access and pharmacy support programs, reimbursement and copay assistance.

About Medac Pharma: Practicing a patient-first philosophy

Medac Pharma, Inc. is a privately held specialty pharmaceutical company focused on the development, in-licensing and commercialization of late-stage molecules. The company strives to bring new life to products and solve everyday patient challenges in autoimmune disease and cancer. For more information about Medac Pharma, please visit www.medacpharma.com.

Medac Pharma 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. For more information about medac GmbH, please visit www.medac.de.

For complete prescribing information, including Boxed Warning, and information on Medac Pharma’s CORE Connections program, 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

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

Chicago, IL, July 14, 2014

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™, 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

Medac Pharma, Inc. Announces Successful FDA Inspection Of Its Exclusive Methotrexate Manufacturer

Chicago, IL, May 14, 2014

Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced that ONCOTEC Pharma Produktion GmbH, a partially owned subsidiary of Medac Pharma’s parent company, medac GmbH, has completed a successful FDA inspection. ONCOTEC will serve as Medac Pharma’s exclusive methotrexate (MTX) manufacturer for its lead product currently under FDA review, Rasuvo™. Concurrently, Medac Pharma announced the PDUFA date for Rasuvo is July 10, 2014.

“The successful inspection of ONCOTEC’s facilities is yet another important inflection point as we look forward to a July 10 PDUFA date for Rasuvo,” said Ms. Terri Shoemaker, President and CEO of Medac Pharma. “ We believe our product has the potential to significantly enhance the therapeutic experience of patients with rheumatoid arthritis (RA), psoriasis and poly-articular-course juvenile RA. With potentially the widest range of dosing options available in an easy-to-inject autopen, we believe Rasuvo will become a preferred choice among healthcare providers and patients seeking a way to fully optimize methotrexate therapy.”

Medac Pharma is preparing to launch Rasuvo with its fully integrated commercial organization, including its own sales force and managed markets team.

Dr. Jan-Arne Gewert, Managing Director of ONCOTEC, remarked, “We’re pleased to expand our long-term relationship of 15 years with medac GmbH by serving as the exclusive supplier of methotrexate for its wholly-owned subsidiary, Medac Pharma, in the U.S. Given our company’s extensive history of quality manufacturing, we’re confident we’ll meet the needs of Medac Pharma as it prepares to launch Rasuvo.”

Currently under FDA review, Rasuvo is designed to improve bioavailability and overcome tolerability issues associated with today’s oral MTX therapies. Medac Pharma plans to offer Rasuvo in 10 dosage strengths, ranging from 7.5 mg to 30 mg in 2.5 mg increments.

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

Medac Pharma, Inc. Secures FDA Approval of Trade Name Rasuvo™ for Lead Methotrexate Subcutaneous Injectable Product

Chicago, IL, April 15, 2014

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 granted approval for the name Rasuvo™ for the company’s lead compound, MPI-2505, a subcutaneous injectable methotrexate (MTX) delivered in a ready-to-use autopen.

Currently under FDA review, Rasuvo is being developed for multiple indications, including rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis, and is designed to improve bioavailability and overcome tolerability issues associated with today’s oral MTX therapies. Medac Pharma plans to offer Rasuvo in 10 dosage strengths, ranging from 7.5 mg to 30 mg in 2.5 mg increments.

“Securing name approval for our lead compound is another important milestone as we prepare for a potential U.S. launch of Rasuvo later this year,” said Ms. Terri Shoemaker, President and CEO of Medac Pharma, Inc. “With its planned 10 dosage strengths and ease of administration, Rasuvo is well-positioned to offer patients an optimal therapeutic option for managing rheumatoid arthritis and other related diseases as our product will offer the widest range of dosing options compared to other subcutaneous methotrexate therapies.”

About Medac Pharma, Inc.

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

Medac Files Lawsuit Against Antares Pharma, Inc., LEO Pharma A/S and LEO Pharma Inc. for Patent Infringement

Chicago, IL, March 11, 2014

Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announce the issuance, via its parent company, medac GmbH, of U.S. patent 8,664,231 (the ‘231 patent) from the United States Patent and Trademark Office (USPTO). The patent, entitled “Concentrated Methotrexate Solutions,” is directed to a method for the treatment of inflammatory autoimmune diseases by subcutaneously administering methotrexate (MTX) at a concentration of more than 30 mg/ml.

Medac Pharma and medac GmbH also announce the filing of a lawsuit in the United States District Court in New Jersey against Antares Pharma, Inc. (NASDAQ: ATRS), LEO Pharm A/S and LEO Pharma Inc. for infringement of the ’231 patent by their making, selling and offering for sale of Otrexup™ (methotrexate) injection products for treating forms of rheumatoid arthritis, polyarticular idiopathic arthritis and psoriasis.

“The grant of the ‘231 patent in the U.S. is an important step in our ongoing development of MPI-2505, which we believe has the potential to be a best-in-class treatment option for rheumatoid arthritis and psoriasis,” said Ms. Terri Shoemaker, President and CEO of Medac Pharma, Inc. “A key advantage to MPI-2505 is its wide range of methotrexate dosing options, which are designed to improve bioavailability and overcome tolerability issues associated with today’s oral methotrexate therapies. Providing patients with a ready-to-use autopen for the administration of MPI-2505 in reduced drug volumes also addresses the stigmas associated with injectable medicines. As such, the grant of the ‘231 patent is a significant event for Medac Pharma, and we and our parent company, medac GmbH, plan to vigorously defend and enforce it.”

About Medac Pharma, Inc.

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

Lessons from the Top Women in Pharma and Healthcare

January 16th, 2014

Do women in the healthcare industry really hit a glass ceiling? The recent announcement of Mary Barra as CEO of GM kicked off a plethora of articles asking that question. Certainly the statistics seemed to support this notion. Overall, women currently hold 8% of the Fortune 100 CEO positions, and slightly over 4% of Fortune 500 and 1000 positions.

GM’s announcement reminded me of the study we conducted 10 years ago, for Women in High Places: Leading the Global Challenge of Medicine (WHIP). At that time, out of over 1,500 organizations, fewer than 9% of healthcare companies and 5% of academic/research medical institutions in the USA had women in the top three levels of the company (starting with corporate VP levels or full professorships), with nary a female CEO in sight.

Glass ceiling? No. Taking a closer look, we found that there was not so much a glass ceiling, as a fog bank at the bottom. To make matters worse, the WHIP study found that one-third of women qualified for that first critical position as a first-line manager in industry or as a research fellow or assistant professor. There was, indeed, de facto discrimination.

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