Healthcare Industry News:  Antiplatelet Agent 

Biopharmaceuticals Regulatory

 News Release - March 30, 2015

The Medicines Company Receives European Commission Approval for Three Hospital Acute Care Products: KENGREXAL(TM) (cangrelor), ORBACTIV(R) (oritavancin) and RAPLIXA(TM) (sealant powder)

Marketing authorization valid in 31 countries of the European Economic Area

KENGREXAL™ is the first and only intravenous Antiplatelet Agent that provides immediate, consistent, and rapidly reversible P2Y12 inhibition

ORBACTIV® is the only single-dose intravenous antibiotic for treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria

RAPLIXA™ is the first ready-to-use, biologically active, powdered fibrin sealant that provides hemostasis in a wide range of bleeding settings

PARSIPPANY, N.J.--(Healthcare Sales & Marketing Network)--The Medicines Company today announced that the European Commission has granted marketing authorization for three of its hospital acute care products – KENGREXAL™ (cangrelor), ORBACTIV® (oritavancin), and RAPLIXA™ (sealant powder). These approvals follow the issuance of positive opinions in January by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The marketing authorization for each of these products is now valid in the 31 countries of the European Economic Area (EEA), which includes all 28 European Union (EU) Member States, plus Norway, Iceland and Liechtenstein.

“The EEA includes a population of more than 500 million people. Securing market authorization for these three acute care treatments opens the door for us and our partners to potentially improve patient care for many patients in European hospitals. We are grateful to the member state authorities, the European Medicines Agency and the European Commission for their timely review and approval of our applications,” said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer, The Medicines Company.

“For patients with heart disease needing percutaneous intervention, we believe KENGREXAL will play an important clinical role blocking platelets which are associated with potentially life-threatening thrombosis in patients undergoing heart angioplasty and stent procedures. ORBACTIV is a new drug to address acute bacterial skin and skin structure infections, including those caused by Methicillin-resistant Staphylococcus aureus or MRSA and others. In addition to the necessary bacterial killing qualities needed for these serious infections, ORBACTIV is given as a single dose which brings potential economic savings when compared to multiple days of intravenous infusions with the older product, vancomycin. Finally, RAPLIXA, a sealant presented as a ready-to-use powder, has demonstrated its applicability as a hemostatic agent in surgical bleeding encountered during spinal, vascular, liver and soft tissue surgery where conventional surgical techniques are ineffective or impractical. We believe this novel treatment option will be well received by the surgical community.”

Professor Philippe Gabriel Steg, MD, Director of the Coronary Care Unit, Hôpital Bichat-Claude Bernard, Paris, France, stated, “The availability of a potent, injectable, and reversible Antiplatelet Agent will be an important adjunct to our therapeutic armamentarium to reduce peri-procedural complications and help make PCI safer. It will be useful in a variety of settings from acute myocardial infarction to elective PCI, mostly in patients in whom Antiplatelet Agents have either not been administered or are known to be poorly effective.”

Professor Dilip Nathwani, OBE, Consultant Physician & Honorary Professor of Infection at Ninewells Hospital and Medical School, University of Dundee, Dundee, UK, said, “The approval of ORBACTIV is important news for patients with skin and skin structure infections, a welcomed addition for the infectious disease treating medical community and a potential cost savings for government healthcare systems in Europe. New long-acting antibiotics, such as ORBACTIV, with its single, once-only dosing regimen for ABSSSI, have the potential to be transformative in the treatment of patients with skin infections where MRSA is suspected, by simplifying the management of these infections.”

Professor Wolf O. Bechstein, MD, PhD, Professor of Surgery, Hospital of the Johann Wolfgang Goethe University, Frankfurt, Germany, noted, “I am pleased to see that RAPLIXA is approved throughout Europe. We were very fond of the product during the Phase 3B trial and look forward to using it in everyday practice. This will be an important new and innovative product for us to use in hemostasis treatment.”

The company used a centralized regulatory procedure which allows applicants to obtain authorization for marketing throughout the EU, subject to national pricing and reimbursement processes. “Some Member States such as England will allow marketing immediately,” said Stephanie Plent, MD, Executive Vice President and Chief Value Officer, The Medicines Company. “Other countries require pricing and reimbursement to be negotiated first, and that process is underway.”

Commercialization of each product will be directed by the company’s Global Innovation Groups, with European coordination via the company’s Zurich-based offices. The company will also begin finalizing logistics for product packaging and distribution channels for Europe. In addition, the company anticipates partnering with leading firms in Europe to provide the necessary field-based educational and promotional resources at a national and/or regional level.

“We are seeking potential partners to help us accelerate the commercialization of our assets during 2015 and beyond,” said Glenn Sblendorio, President and Chief Financial Officer, The Medicines Company. “These newly approved products are valuable assets to us, and as such, we are seeking the best partners possible. We know the patient populations, hospital markets and analytics, for each product. With the supply chain in place and the right partner on board, we will be ready to bring these important products to our customers, and most importantly, to patients.”

A new drug application for ORBACTIV® was approved by the United States Food and Drug Administration (FDA) in August 2014 after designation as a Qualified Infectious Disease Product (QIDP) under the U.S. Generating Antibiotic Incentives Now (GAIN) Act of 2012. A new drug application for KENGREAL™ (cangrelor) and a biologics license application for RAPLIXA™ are under active review by the FDA.

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About KENGREXAL™ (cangrelor)

KENGREXAL™ is the first and only immediately bioavailable and quickly reversible intravenous small molecule Antiplatelet Agent to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing PCI. Throughout Europe, there are approximately one million PCIs done per year in approximately 800 leading hospitals.

The Marketing Authorization Application (MAA) submission for KENGREXAL to the EMA was based on the results from the CHAMPION PHOENIX trial, which provided the primary evidence of efficacy for the PCI indication for KENGREXAL. The results of CHAMPION PHOENIX, an 11,145 patient Phase 3 randomized, double-blind clinical trial comparing KENGREXAL to oral clopidogrel in patients undergoing PCI were reported in March 2013. Data from the CHAMPION-pooled population of over 25,000 PCI patients provide additional clinical support for safety.

KENGREXAL is contraindicated when there is active bleeding or increased risk of bleeding because of impaired hemostasis and/or irreversible coagulation disorders, or due to recent major surgery/trauma or uncontrolled severe hypertension. KENGREXAL is also contraindicated in patients with any history of stroke or transient ischemic attack (TIA) and in patients with hypersensitivity to the active substance or to any of the excipients. In addition, KENGREXAL can increase the risk of bleeding. In clinical trials, the most common adverse reaction in patients treated with KENGREXAL was bleeding (17.5%) and dyspnoea (1.3%).

Cangrelor is not approved for commercial use in the United States and a new drug application for KENGREAL™ (cangrelor) is under active review by the FDA.

About ORBACTIV® (oritavancin)

ORBACTIV® is the first and only single-dose intravenous antibiotic for treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible isolates of Gram-positive microorganisms, including Methicillin-resistant Staphylococcus aureus (MRSA).

The Marketing Authorization Application (MAA) submission for ORBACTIV to the EMA was based on the results of the SOLO I and SOLO II clinical trials which were randomized, double-blind, multi-center trials that evaluated a single 1200 mg IV dose of ORBACTIV for the treatment of ABSSSI in 1,987 patients, and assessed a large subset of patients with documented MRSA infection (405 patients). These trials demonstrated non-inferiority for the primary and secondary endpoints evaluating 1200 mg once-only ORBACTIV IV dose, versus 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg). ORBACTIV approval in the US in August 2014 was also based on the results of the SOLO I and SOLO II clinical trials.

It is estimated that the incidence of complicated skin and skin structure infections in the top EU countries (Germany, France, UK, Italy and Spain) is approximately 400,000 patients, of which 65,000 have confirmed MRSA infections. Nearly two-thirds of hospitalized patients in Europe with an ABSSSI infection due to MRSA are admitted via the emergency room, and nearly one in every five of these patients are admitted from a nursing home. ABSSSI infections due to MRSA are typically linked to longer hospitalizations which contribute to high treatment costs. ORBACTIV may offer reduced hospital resources for treatment administration and potentially reduce the length of stay within the hospital.

ORBACTIV is contraindicated in patients with hypersensitivity to the active substance or to the excipients. Additionally, use of intravenous unfractionated heparin sodium is contraindicated for 48 hours after oritavancin administration because the activated partial thromboplastin time (aPTT) test results are expected to remain falsely elevated for approximately 48 hours after oritavancin administration. The most commonly reported adverse reactions (=5%) in patients treated with ORBACTIV® were: nausea, hypersensitivity reactions, infusion site reactions, and headache.

In the United States, please see, for additional information regarding ORBACTIV, including related warnings and precautions.

About RAPLIXA™ (sealant powder)

RAPLIXA™ is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, formulated as a unique dry powder topical hemostatic product.

The Marketing Authorization Application (MAA) submission for RAPLIXA™ (formerly known as Fibrocaps) to the EMA was based on a pivotal Phase III clinical trial, FINISH-3. FINISH-3 is an international, randomized, single-blind, controlled trial that compared the efficacy and safety of RAPLIXA, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen with gelatin sponge, vs. gelatin sponge alone for use as a hemostat for surgical bleeding in four indications (spinal, hepatic, vascular, soft tissue dissection). The Phase III trial, which studied a total of 719 patients, met all primary and secondary hemostasis efficacy endpoints in four distinct surgical indications of spinal surgery, hepatic resection, vascular surgery and soft tissue dissection.

It is estimated that there are 110 million surgical procedures per year worldwide which result in bleeding that requires a hemostatic product, of which approximately 400 thousand occur in the EU market. RAPLIXA’s novel, dry powder formulation offers surgeons an efficacious product that can be stored at room temperature, applied using multiple methods in a variety of bleeding situations.

RAPLIXA is contraindicated in patients with known hypersensitivity to RAPLIXA or any known components of the products. RAPLIXA should not be applied directly into the circulatory system. Intravascular application of RAPLIXA may result in life-threatening thromboembolic events. Do not use RAPLIXA for treatment of severe arterial bleeding. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma are employed for RAPLIXA, despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. RAPLIXA must not be used as a glue for the fixation of patches. RAPLIXA must not be used as a glue for intestines (gastrointestinal anastomoses). Life threatening air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealant/hemostatic products. Spray application of RAPLIXA must not be used in endoscopic or laparoscopic procedures. The most commonly reported adverse events (>5%) in patients treated with RAPLIXA were nausea, constipation, post-operative pain, hypokalemia, pyrexia, and low blood pressure, with the majority considered mild in intensity.

RAPLIXA is not approved for commercial use in the United States and a biologics license application is under review by the FDA.

About The Medicines Company

The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.

Forward-Looking Statements

Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," “hopes” and “potential” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether we are able to successfully develop our business infrastructure and our global operations, whether our global operations are adversely affected by international risks and uncertainties, whether reimbursement by government payers or other third-party payers is available or limited for our products, whether pricing is delayed or set at unfavorable levels or access to our products is reduced or terminated by governmental and other third-party, whether physicians, patients and other key decision makers will accept clinical trial results and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Annual Report on Form 10-K filed with the SEC on March 2, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

Source: The Medicines Company

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