Cangene To Be Acquired By Emergent BioSolutions For US$222 Million
Cangene Shareholders to Receive US$3.24 Per Share (C$3.44 Per Share) in Cash
Readers are referred to the cautionary notes regarding Forward-looking Information and non-IFRS Financial Measures at the end of this release. Unless noted otherwise, all dollar amounts are in U.S. dollars.
Cangene Corporation ("Cangene") (TSX:CNJ.TO - News) today announced the signing of a definitive agreement under which Emergent BioSolutions ("Emergent") (NYSE:EBS - News) of Rockville, Maryland will acquire Cangene in an all-cash transaction valued at US$222 million (approximately C$236 million1).
Under the terms of the agreement, which has been approved by the Boards of Directors of both companies, Cangene shareholders will receive US$3.24 per share (C$3.44 per share) in cash.
Echo Therapeutics Announces Strategic Partnership with Medical Technologies Innovation Asia (MTIA)
Echo to receive a $10 million cash investment from MTIA and Platinum Partners Company will withdraw the offering identified in recent Form S-1 filing Echo Therapeutics, Inc. (ECTE) ("Echo"), a medical device company developing its Symphony® CGM System as a non-invasive, wireless continuous glucose monitoring system, today announced that it entered into a strategic collaboration agreement with Medical Technologies Innovation Asia (MTIA), Ltd., Hong Kong, for a license arrangement and equity investment in Echo.
BG Medicine Welcomes Final Determination by CMS of 2014 Reimbursement for BGM Galectin-3(R) Test
BG Medicine, Inc. (BGMD) announced today that the Centers for Medicare and Medicaid Services (CMS) have published the final determination of the 2014 Medicare national limitation amount for the Company's galectin-3 blood test (analyte-specific CPT(R) Code 82777) at the amount of a crosswalked test (analyte-specific CPT(R) Code 84244) whose 2014 national limitation amount is $30.01. This national limitation amount will replace the galectin-3 blood test's national limitation amount of $17.80 that was effective in 2013.
"We are very pleased that CMS has finalized the previously announced preliminary determination of the Medicare reimbursement rate for our galectin-3 test," said Dr. Paul R. Sohmer, President and Chief Executive Officer of BG Medicine.
CytRx Reports Highly Statistically Significant Positive Results from its Global Phase 2b Clinical Trial
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced highly positive top-line efficacy results from a multicenter, randomized, open-label global Phase 2b clinical trial. The trial investigated the efficacy and safety of aldoxorubicin compared with doxorubicin in subjects with first-line metastatic, locally advanced or unresectable soft tissue sarcomas (STS). Aldoxorubicin combines the chemotherapeutic agent doxorubicin with a novel linker-molecule that binds specifically to albumin in the blood to allow for delivery of higher amounts of doxorubicin (3½ to 4 times) without the major dose-limiting toxicities seen with administration of doxorubicin alone.
FDA Grants Fast Track Designation to Navidea Biopharmaceuticals’ Lymphoseek® for Sentinel Lymph Node Detection in Patients with Head and Neck Cancer
– Fast-Track designation may expedite supplemental New Drug Application (sNDA) approval process –
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.
NeuroMetrix to Partner with Omron Medical Devices for Distribution of NC-stat DPNCheck in China
NeuroMetrix, Inc. (NURO), a medical device company focused on the treatment and management of the neurological complications of diabetes, announced that it had entered into an agreement with Omron Medical Devices, a subsidiary of Omron Healthcare China, to be the exclusive distributor for NC-stat® DPNCheck® in China. Earlier this year NeuroMetrix and Omron Healthcare Co. Ltd. announced a partnership for the exclusive distribution of NC-stat DPNCheck in Japan.
NC-stat DPNCheck is a rapid, accurate and quantitative point-of-care test for early detection of diabetic peripheral neuropathy (DPN), which affects over half of people with diabetes. DPN causes significant morbidity including pain, increased risk of falling in the elderly, and is the primary trigger for diabetic foot ulcers which may require lower extremity amputations.
Synthetic Biologics Enters into License with Cedars-Sinai Medical Center to Develop Novel Anti-infective Approaches for Irritable Bowel Syndrome (IBS), Obesity and Diabetes
Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of product candidates focused on the prevention and treatment of serious infectious diseases and other diseases, announced today that it entered into worldwide license and option agreements with Cedars-Sinai Medical Center ("Cedars-Sinai") for the development of new treatment approaches to target non-bacterial intestinal microorganism life forms known as archaea that are associated with intestinal methane production and chronic diseases such as irritable bowel syndrome (IBS), obesity and type 2 diabetes, through its newly formed subsidiary, Synthetic Biomics, Inc.
Covidien Announces Definitive Agreement to Acquire Given Imaging
Advances Covidien strategy to more comprehensively address key specialties and procedures globally Adds Given Imaging’s broad suite of minimally invasive gastrointestinal diagnostic and monitoring solutions Accelerates development of world-class gastrointestinal portfolio focused on serving patient from diagnosis to treatment Accretive to earnings per share beginning in fiscal 2015
Covidien plc (COV) and Given Imaging Ltd. (GIVN) today announced a definitive agreement under which Covidien will acquire all of the outstanding shares of Given Imaging for $30.00 per share in cash, for a total of approximately $860 million, net of cash and investments acquired. This transaction provides Covidien additional scale and scope to serve the multibillion dollar global gastrointestinal (GI) market and supports the Company’s strategy to comprehensively address key global specialties and procedures.
Prana Completes PBT2 Dosing in IMAGINE Alzheimer's Disease Clinical Trial
95% Patient Retention Level Achieved in IMAGINE Trial
Prana Biotechnology (ASX: PBT) (NASDAQ: PRAN), a developer of best-in-class treatments for neurodegenerative disease, today announced the completion of the treatment phase of its IMAGINE Alzheimer's Disease (AD) clinical trial.
There were 42 patients with prodromal or mild AD enrolled in the Phase II double-blind placebo-controlled clinical trial of Prana's novel drug, PBT2. A total of 40 patients completed the planned 12 months of treatment with PBT2, or placebo, bringing the treatment phase of the trial to a close.
Medifocus Inc. Announces Record 294% Increase in Q2/FY 2014 Revenue
Revenue for the First Six Months in FY 2014 Reaches CN$2.55M, a 40% Increase Over Total Revenue in FY 2013
Medifocus, Inc. (OTCQX: MDFZF), (TSX VENTURE: MFS) (Medifocus or the Company), a leader in the use of focused microwave energy to treat cancer and other tumors, is pleased to announce its financial results for the three and six month periods of fiscal 2014 ending September 30, 2013.
Revenue for the second quarter of fiscal 2014 ending September 30, 2013 was CN$1.23M compared to revenue of CN$313,281 in the second quarter of fiscal 2013, representing a 294% increase. Revenue for the six months ending September 30, 2013 reached a record CN$2.55M, representing a 40% increase over total revenue in fiscal year 2013 of CN$1.81M. The revenue increase for both periods reflects the continued successful rollout and strong market acceptance of the Company's Prolieve® Thermodilatation System for treatment of Benign Prostatic Hyperplasia (BPH).
The Medicines Company Acquires Rempex Pharmaceuticals
Novel Portfolio of Gram-Negative Antibiotics in Development Added to The Medicines Company's Infectious Disease Hospital Care Franchise The Medicines Company (NASDAQ: MDCO) today announced that it has acquired Rempex Pharmaceuticals, Inc., a company with multiple potential new therapies focused on multi-drug resistant gram-negative bacteria.
Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company, said, "Acute and intensive care hospitals around the world face rapid and increasing antibacterial resistance, especially to gram-negative pathogens. The assets of Rempex, particularly Carbavance™, will allow us to intensify our efforts to save lives, alleviate suffering and contribute to the economics of healthcare by serving leading hospitals."
ARCA biopharma Announces US FDA Acceptance of Gencaro IND Application for the Treatment of Atrial Fibrillation
Phase 2B/3 GENETIC-AF Trial on Track to Begin Patient Enrollment in Q1 2014 Gencaro Potentially the First Genetically-Targeted Cardiovascular Treatment
ARCA biopharma, Inc. (ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that the Company’s GencaroTM Investigational New Drug (IND) application for atrial fibrillation (AF) has been accepted by the U.S. Food and Drug Administration (FDA) and is now active.
Oculus Innovative Sciences Receives FDA Clearance for Microcyn(R) Scar Management HydroGel
Oculus U.S Dermatology Partner, Quinnova Pharmaceuticals, Targeting U.S. Launch in Q2 2014
U.S. Double-Blind, Randomized Study for Scar Management Establishes Strong Foundation for International Approval
Oculus Innovative Sciences, Inc. (OCLS), a global healthcare company that designs, manufactures and markets prescription and non-prescription products in 27 countries, today announced that it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's new Microcyn(R) Scar Management HydroGel.
Conatus Pharmaceuticals Receives U.S. Orphan Drug Designation for Emricasan for Treatment of Liver Transplant Recipients With Reestablished Fibrosis
Conatus Pharmaceuticals Inc. (CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Conatus' drug candidate emricasan for the treatment of liver transplant recipients with reestablished fibrosis to delay the progression to cirrhosis and end-stage liver disease. The FDA's Orphan Drug Designation program is intended to encourage the development of drugs and biologics that may provide benefit to patients suffering from rare diseases or conditions.
OncoMed and Celgene Announce Strategic Collaboration Advancing Multiple Anti-Cancer Stem Cell Therapeutics to Offer Potential Benefits to Cancer Patients
Celgene Invests in OncoMed's Demcizumab and up to Five Additional Preclinical Biologics Programs; OncoMed Leads Early Clinical Trials and Retains Co-Development, Co-Commercialization and Profit-Sharing Rights
OncoMed to Receive $177.25 Million Upfront, Including a $22.25 Million Equity Investment
OncoMed Pharmaceuticals, Inc. (OMED) and Celgene Corporation (CELG) today announced an agreement to jointly develop and commercialize up to six anti-cancer stem cell (CSC) product candidates from OncoMed's biologics pipeline, including demcizumab (OMP-21M18, Anti-DLL4).
Ampio Receives FDA Confirmation that The Spring Study is Pivotal and Will Initiate the Final Pivotal Trial for Ampion™ Biological License Application (BLA)
Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced receipt of FDA correspondence confirming the acceptance of The Spring Study as pivotal and providing guidance for the design of the second and final pivotal trial of Ampion™ for the treatment of osteoarthritis of the knee (OAK).
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted the letter summarized the FDA's conclusions after reviewing the complete clinical data set provided by Ampio following their October 29th pre-BLA meeting. The FDA letter includes the following statements:
ICU Medical Receives Premier Inc. Contract for the New Diana™ Hazardous Drug Compounding System with Barcode Scanning
New Six-Year Agreement Marks the First GPO Contract for ICU Medical's Breakthrough Automated Sterile Compounding System for the Accurate, Safe, and Efficient Preparation of Hazardous Drugs, Set to Debut at ASHP Midyear in Orlando, December 8-12
ICU Medical Inc. (ICUI) today announced it has been awarded a six-year group purchasing contract from Premier Inc. for the DianaTM hazardous drug compounding system, the world's first user-controlled, automated sterile compounding system for the accurate, safe, and efficient preparation of hazardous drugs. Effective in 2014, this is the first time the Diana system, introduced in the United States in 2012, has been on contract with a group purchasing organization. A new version of the Diana system that incorporates a barcode scanning system will be debuted at the American Society of Hospital Pharmacists (ASHP) midyear clinical meeting in Orlando, FL, December 8-12, 2013.
ARIAD Announces Positive Opinion by the European Medicines Agency on the Continued Availability of Iclusig in Patients with Leukaemias
Recommendations made to minimize risk of occlusive vascular events
ARIAD Pharmaceuticals, Inc. (ARIA) today announced adoption of a positive opinion by the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) on the continued availability of Iclusig® (ponatinib) in the EU for use in patients in its authorized indications. Following its review of updated clinical-trial data on Iclusig, the CHMP made a series of recommendations on measures to help minimize the risk of occlusive vascular events in patients taking Iclusig. The authorized indications of Iclusig, as approved in July 2013, are as follows:
Cardiovascular Systems Prices Public Offering of Common Stock
Cardiovascular Systems, Inc. (CSI) (CSII), a medical device company focused on developing and commercializing innovative interventional treatment systems for vascular disease, today announced the pricing of an underwritten public offering of 2,608,696 shares of its common stock, at a price to the public of $30.00 per share. The net proceeds to CSI from the sale of the shares, after deducting underwriting discounts and commissions and estimated expenses, are expected to be approximately $73.4 million. All of the shares in the offering are to be sold by CSI. The offering is expected to close on or about November 26, 2013.
In connection with the offering, CSI has also granted the underwriters a 30-day option to purchase up to an additional 391,304 shares.
CombiMatrix Announces Contract With America's Choice Provider Network(R)
Provides Access to Company's Suite of Molecular Tests to Additional 14 Million Members Nationally
CombiMatrix Corporation (CBMX), a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that it has entered into a contractual agreement with America's Choice Provider Network(R) (ACPN(R)) for coverage of its diagnostic laboratory services.
The agreement with ACPN, a San Diego-based national healthcare savings provider network, provides access to CombiMatrix's suite of molecular diagnostic solutions and comprehensive clinical support—specializing in prenatal, miscarriage and pediatric healthcare—to more than 14 million members.