CHMP Recommendations for Approval Represent Industry Firsts Across Three Therapeutic Categories
PARSIPPANY, N.J. January 23--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 intravenous 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 haemostasis, respectively. We believe that these 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 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 & 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-centred 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. 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.
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.