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Biopharmaceuticals Regulatory

 News Release - January 23, 2015

The Medicines Company Receives CHMP Positive Opinions for Three Hospital Acute Care Products: KENGREXAL(TM) (cangrelor), ORBACTIV(TM) (oritavancin) and RAPLIXA(TM) (sealant powder)

CHMP Recommendations for Approval Represent Industry Firsts Across Three Therapeutic Categories

PARSIPPANY, N.J.--(Healthcare Sales & Marketing Network)--The Medicines Company today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued positive opinions recommending marketing authorization for three of its pipeline development candidates – KENGREXAL™ (cangrelor), ORBACTIV™ (oritavancin), and RAPLIXA™ (sealant powder). These positive opinion recommendations represent category firsts across three therapeutic areas:
  • KENGREXAL™ is the first intravenous antiplatelet agent that provides immediate, consistent, and rapidly reversible P2Y12 inhibition;
  • ORBACTIV™ is the first single-dose antibiotic for treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA); and
  • RAPLIXA™ is the first ready-to-use, biologically active, powdered fibrin sealant that provides hemostasis in a wide range of bleeding settings.
Phase III study results for these new products have been published in the New England Journal of Medicine (KENGREXAL™ and ORBACTIV™) and the Journal of the American College of Surgeons (RAPLIXA™).


“At a time of increasing interest in hospital-based innovation worldwide, products designed to address significant unmet needs in acute and intensive hospital care and which offer potential efficiencies of hospital performance do not come to market too often,” said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer,The Medicines Company. “To have three positive opinions on the same day for products which have the potential to improve hospital outcomes is remarkable.”

“We believe that KENGREXAL™, ORBACTIV™, and RAPLIXA™ will address significant medical needs and potentially offer improved hospital efficiency in patients with heart disease needing percutaneous coronary intervention, in patients with serious potentially resistant infections, and in patients undergoing surgery where standard surgical techniques are insufficient for improvement of hemostasis , respectively. We believe that these new products therefore represent significant market opportunities in Europe.”

Loretta Itri, MD, Executive Vice President, Global Health Science and Regulatory, The Medicines Company, added, “This achievement is a testament to the skills and commitment of our product development teams and to European regulatory agency assessment teams who work day in and day out to support innovation. We are grateful for the work and guidance of professionals at the European Medicines Agency and the Member States of the European Union during the process of evaluation. We are also grateful to the investigators and participants in R&D and manufacturing programs who created these new products.”

“With the ever challenging goal of improving speed and efficiency in the treatment of acute cardiac patients, it is critical for interventional cardiologists to have innovative tools that address existing treatment gaps and help to improve performance of PCI networks,” commented Stefan K. James, MD, PhD, Associate Professor of Cardiology, Uppsala Clinical Research Center (UCR), Uppsala University, Uppsala, Sweden. “Cangrelor would represent an important new agent for use in these life-saving procedures.”

Professor Dilip Nathwani, OBE, Consultant Physician and Honorary Professor of Infection at Ninewells Hospital and Medical School, University of Dundee, Dundee, UK, commented, “The development of new antibiotics remains one of the three key strategies to combat antimicrobial drug resistance. Although antibiotic pipelines for the treatment of serious Gram-positive infections including resistant pathogens such as MRSA have been growing, therapies that offer safe and effective, but alternative options to patient-centered treatment have been limited. New products, such as ORBACTIV™ with its single, once only dosing regimen for ABSSSI, may shift treatment paradigms for managing serious skin and soft tissue infection as they make their way into clinical practice by potentially simplifying the management of many patients, as well as impacting healthcare economics.”

“The recommendation for approval of RAPLIXA™ in the European Union potentially provides surgeons a new tool for the treatment of surgical bleeding across a wide range of surgical procedures,” said clinical investigator Professor Robert J. Porte, MD, PhD, Section of Hepatobiliary Surgery and Liver Transplantation, University Medical Center Groningen, The Netherlands. “RAPLIXA™ is a ready-to-use dry powder, fibrin sealant which may minimize the time required for preparation and potential wastage, and can be applied directly from the vial or with a spray device, providing much needed flexibility.”

Helmut Giersiefen, Ph.D., Senior Vice President, Head of European Commercial Operations, The Medicines Company, further noted “These new products will help us to extend and strengthen our relationships with leading European hospitals in the areas of acute and intensive care. We have a commercial leadership team in Zurich working with leading European firms who we anticipate will act as partners to educate, market, and distribute the medications, once approved for marketing authorization.”

Hospital care in Europe – including curative-rehabilitative care in inpatient and day care settings, is an area of significant unmet medical need, accounting for 31% of the overall healthcare spend in the region in 2012.. Progress in the treatment of life-threatening conditions such as heart attack, stroke and cancer has led to higher survival rates in most European countries. On average, mortality rates following hospital admissions for heart attack fell by 40% between 2000 and 2011 and for stroke by over 20%. Lower mortality rates reflect better acute care and greater access to dedicated stroke units in some countries.1 Antibiotic resistance is also a serious threat to public health in Europe, leading to increasing healthcare costs, prolonged hospital stays, treatment failures, and sometimes death.2

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. KENGREAL™ (cangrelor) and RAPLIXA™ new drug applications are under active review by the FDA.

For more information, visit www.themedicinescompany.com.

About KENGREXAL™ (cangrelor)

KENGREXAL™ (cangrelor) is an investigational agent not approved for commercial use in any market. KENGREXAL™, an 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.

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 proposed 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 in patients with active pathological bleeding; increased risk of bleeding because of impaired hemostasis and/or irreversible coagulation disorders; or any history of stroke or intracranial hemorrhage. KENGREXAL™ is also contraindicated in patients with known hypersensitivity to cangrelor or any component of the product. 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%).

About ORBACTIVTM (oritavancin)

ORBACTIVTM (oritavancin) for injection received FDA approval in the U.S. in August 2014. ORBACTIV™ is the first and only FDA-approved single-dose IV antibiotic for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin–resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).

The Marketing Authorization Application (MAA) submission for ORBACTIVTM 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 IV ORBACTIV™ dose infusion, versus 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg). ORBACTIV™approval in the US was also based on the results of the SOLO I and SOLO II clinical trials.

IMPORTANT SAFETY INFORMATION (UNITED STATES)

Contraindications

Use of intravenous unfractionated heparin sodium is contraindicated for 48 hours after ORBACTIV™ administration because the activated partial thromboplastin time (aPTT) test results are expected to remain falsely elevated for approximately 48 hours after ORBACTIV™ administration.

ORBACTIV™ is contraindicated in patients with known hypersensitivity to ORBACTIV™.

Warnings and Precautions

Concomitant warfarin use: Co-administration of ORBACTIV™ and warfarin may result in higher exposure of warfarin, which may increase the risk of bleeding. Use ORBACTIV™ in patients on chronic warfarin therapy only when the benefits can be expected to outweigh the risk of bleeding.

Coagulation test interference: ORBACTIV™ has been shown to artificially prolong aPTT for up to 48 hours, and may prolong PT and INR for up to 24 hours.

Hypersensitivity reactions have been reported with the use of antibacterial agents including ORBACTIV™. Discontinue infusion if signs of acute hypersensitivity occur. Monitor closely patients with known hypersensitivity to glycopeptides.

Infusion-related reactions have been reported. Slow the rate or interrupt infusion if infusion reaction develops.

Clostridium difficile-associated colitis: Evaluate patients if diarrhea occurs.

Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.

Prescribing ORBACTIV™ in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions (= 3%) in patients treated with ORBACTIV™ were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.

Please see www.orbactiv.com for the full US prescribing information.

About RAPLIXA™ (sealant powder)

RAPLIXA™ (sealant powder) is an investigational hemostatic agent, not approved for commercial use in any market. RAPLIXA™ is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, formulated as a unique dry powder topical product, which is an aid in hemostasis during surgery.

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.

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.

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 the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, 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 Quarterly Report on Form 10-Q filed with the SEC on November 7, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

1. Health at a Glance: Europe 2014, OECD Publishing. http://dx.doi.org/10.1787/health_glance_eur-2014-en

2. Summary of the latest data on antibiotic resistance in the European Union: European Centre for Disease Prevention and Control; November 2013.

http://ecdc.europa.eu/en/eaad/Documents/EARS-Net-summary.pdf.


Source: The Medicines Company

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Please address inquiries directly to the issuing company.



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