|The Medicines Company Receives European Commission Approval for Three Products; Europe Deal Coming For Orexigen|
|By William Kent|
|Tuesday, 31 March 2015 00:00|
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 30, 2015.
The Medicines Company announced 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.
European approval of Orexigen Therapeutics Inc.'s (NASDAQ: OREX) anti-obesity drug sets the stage for an overseas partnership deal, an analyst said.
Orexigen, which announced marketing clearance for the product from European regulators late Thursday, closed up 4 percent Friday at $7.54. Shares were up more than 2 percent in Monday's premarket.
Leerink's Paul Matteis maintained an Outperform rating on the shares, noting that last month Orexigen said it was talking with multiple potential partners for the drug in Europe. The company had said it didn't expect to sign a deal until it had obtained marketing approval.
Orexigen has received $150 million in payments through a similar U.S. deal with Takeda Pharmaceutical Co. (OTC:TKPYY) dating from 2010, according to Matteis. Orexigen shares may also see gains next month when it submits outlines of an upcoming study to regulators. This will "help alleviate investor concerns" about Orexigen's standing with the Food and Drug Administration, Matteis said.
FDA officials were angered recently when Orexigen released what where intended as confidential interim results of a placebo-controlled study.
Achaogen, Inc. (Nasdaq:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant (MDR) gram-negative infections, is pleased to host a webcast and teleconference providing an update on its lead program, plazomicin.
Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, today announced it has reached an agreement with Sarissa Capital Management LP.
Analogic Corporation (Nasdaq:ALOG), enabling the world's medical imaging and aviation security technology, today announced the resignation of Michael Levitz, senior vice president, chief financial officer and treasurer, effective April 24, 2015.
Argos Therapeutics, Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer using its Arcelis® technology platform, today reported financial results for the fourth quarter and year ended December 31, 2014 and provided an update on the Company's clinical programs.
BioBlast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage, orphan disease-focused biotechnology company announced today positive in vivo proof-of-concept results for Cabaletta for Spinocerebellar Ataxia Type 3 (also known as SCA3 or Machado Joseph disease).
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced the results of a post-hoc sub-analysis of the PKU-016 or ASCEND study, the largest randomized controlled trial evaluating neurocognitive outcomes in patients with phenylketonuria (PKU) treated with the approved therapy Kuvan® (sapropterin dihydrochloride) at the 2015 American College of Medical Genetics and Genomics Annual Clinical Genetics Meeting.
Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology company with industry-leading expertise in the development of cardiovascular gene therapy, today announced financial results for the quarter and year ended December 31, 2014 and recent corporate highlights.
Coherus BioSciences, Inc. (Nasdaq:CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today announced it has commenced an underwritten public offering of $100,000,000 of shares of its common stock.
Innocoll AG (Nasdaq:INNL) today announced the securing of a credit facility for up to €25 million ($27.5 million) of debt financing to support the expansion of the Company's manufacturing and research and development facility in Saal Germany and clinical development of the Company's lead product candidates, XaraColl®, Cogenzia® and CollaGUARD®.
Lion Biotechnologies, Inc. (Nasdaq:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL), today announced that researchers from Moffitt Cancer Center reported positive results from a pilot trial of TIL and ipilimumab in patients with metastatic melanoma.
Matinas BioPharma Holdings, Inc. (OTCQB:MTNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of lipid-based prescription therapeutics for the treatment of infectious diseases and cardiovascular and metabolic conditions, today announced that upon a scheduled interim review, the study's Steering Committee recommended to stop enrollment early in its first-in-human study of investigational drug MAT9001 due to the study having enrolled a sufficient number of subjects (42 to date) necessary to demonstrate primary and secondary endpoints.
MELA Sciences, Inc. (Nasdaq:MELA), developer of the MelaFind® system, a non-invasive software-driven image analysis device intended to provide a dermatologist with objective data of clinically irregular pigmented moles when they choose to obtain additional info to help them decide whether or not to biopsy (at the most curable and cost-effective stage), today reported financial results and provided a business update.
Pacific Health Care Organization, Inc., (OTCQB: PFHO) today filed with the Securities and Exchange Commission its annual report on Form 10-K announcing financial results for the fiscal year ended December 31, 2014.
Signal Genetics, Inc. (Nasdaq:SGNL), a commercial stage, molecular genetics diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today reported recent achievements and financial results for the full-year ended December 31, 2014.
Stereotaxis, Inc. (Nasdaq:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, announced today that it has extended the maturity of its revolving credit facility with Silicon Valley Bank (SVB) by three years to March 31, 2018.
Trillium Therapeutics Inc. (Nasdaq:TRIL) (TSX:TR) an immuno-oncology company developing innovative therapies for the treatment of cancer, today announced that it is offering to sell US$50,000,000 of common shares and preferred shares in an underwritten public offering.
TOMI™ Environmental Solutions, Inc. (OTCQB:TOMZ), a global bacteria decontamination and infection prevention company, has accepted an invitation from The White House Office of Science and Technology Policy and the U.S. Agency for International Development ("USAID") to present at the "Innovation on the Edge: Accelerating Solutions in the Fight Against Ebola" discussion at the Eisenhower Executive Office Building in Washington, DC, on April 2, 2015.
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) and Intrexon Corporation (NYSE:XON) today announced their oncology programs will be strengthened through Intrexon's new global collaboration focused exclusively on novel chimeric antigen receptor T-cell (CAR-T) products with Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany.