|Merck's MK-5172/MK-8742 Receives Breakthrough Therapy Designation from FDA; Cubist Announces Submission of NDA for Tedizolid|
|By Mary Davila|
|Tuesday, 22 October 2013 18:52|
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has granted MK-5172/MK-8742 Breakthrough Therapy designation for treatment of chronic hepatitis C virus infection. MK-5172/MK-8742 is an all-oral combination regimen consisting of MK-5172, an investigational HCV NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor. Interim data from an ongoing Phase IIB clinical trial evaluating MK-5172/MK-8742 in genotype 1 infected patients (C-WORTHY Study) is scheduled to be presented at the 64^th American Association for the Study of Liver Disease Annual Meeting, Washington D.C., Nov. 1-5.
“The designation of MK-5172/MK-8742 as a Breakthrough Therapy for chronic hepatitis C is an important milestone for Merck,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “There remains significant unmet medical need in hepatitis C, and we are looking forward to working with the FDA to advance this program as quickly as we can to bring this investigational combination to HCV specialists and their patients.”
According to the FDA, the designation of an investigational drug as a Breakthrough Therapy is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Chronic hepatitis C is a priority focus of research and development at Merck. MK-5172 and MK-8742 are being investigated in a broad clinical program that includes studies in patients with multiple HCV genotypes who are treatment-naïve, treatment failures as well as other important HCV subpopulations such as patients with cirrhosis and those co-infected with HIV. For more information please see www.clinicaltrials.gov.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of its investigational antibiotic tedizolid phosphate (TR-701). Cubist is seeking approval of tedizolid phosphate for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Tedizolid phosphate is a once daily oxazolidinone being developed for both intravenous (I.V.) and oral administration for the treatment of serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).
Cubist added tedizolid phosphate to its pipeline through the recent acquisition of Trius Therapeutics. Earlier this year, tedizolid phosphate was granted Fast Track status, pursuant to the Generating Antibiotic Incentives Now (GAIN) Act, by the FDA for its Qualified Infectious Disease Product (QIDP) indications of ABSSSI, as well as Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP). The QIDP designation for tedizolid phosphate allows for certain incentives related to the development of new antibiotics, including eligibility for Fast Track status, Priority Review, and if tedizolid phosphate is ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity.
The NDA submission is based on data from two Phase 3 late-stage clinical studies, called ESTABLISH 1 and ESTABLISH 2, which enrolled 1,333 people in the U.S., Europe and other regions worldwide. As has been previously reported, tedizolid met the primary endpoint and all secondary endpoints defined by the FDA.
The Alkaline Water Company Inc. (OTCBB: WTER), developers of an innovative, state of the art, proprietary electrolysis beverage process, packaged and sold in 3 liter and 1 gallon sizes under the trade name Alkaline88, is pleased to announce the engagement of public relations agency Rogers & Cowan in order to capitalize on recent media activity in order to aid in the development of a comprehensive brand positioning strategy.
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EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that its high-intensity focused ultrasound (HIFU) for the treatment of localized prostate cancer, Ablatherm-HIFU, will be featured in multiple presentations addressing minimally invasive prostate cancer therapies and the successful evaluation of EDAP's device at the 31st World Congress of Endourology (WCE).
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Fresh Start Private Management Inc. (OTCQB: CEYY) announces that its revolutionary alcohol treatment program is now available to people in Arizona through Start Fresh Recovery Southwest, LLC, which operates under an exclusive distribution licensing arrangement with Kryptonite Investments, LLC, to administer the program. The company previously entered into a definitive agreement on April 8, 2013 with Kryptonite Investments, LLC, granting them rights to the entire state of Arizona and they will operate under the name, Start Fresh Recovery Southwest.
Gentium S.p.A. (Nasdaq:GENT) announced today that the European Commission has granted a Marketing Authorization for Defitelio® (defibrotide) for the treatment of severe hepatic veno-occlusive disease ("VOD") in adults and children undergoing hematopoietic stem cell transplantation therapy. Defitelio® is the first approved treatment in the European Union for this life-threatening condition.
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Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer and marketer of a broad range of tools to advance life science research and regenerative medicine, will announce results for its third quarter ended September 30, 2013 before market trading hours on Thursday, October 31, 2013.
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Novadaq® Technologies Inc. (NASDAQ:NVDQ) (TSX:NDQ), a developer of clinically-relevant imaging solutions for use in surgical and outpatient wound care procedures, today announced financial results for its third quarter ended September 30, 2013.
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Nuvilex, Inc. (OTCQB: NVLX) and its subsidiary, Medical Marijuana Sciences, Inc., received another validation of their efforts to bring research utilizing cannabidiol (CBD) as the basis for developing treatments for some of the deadliest forms of cancer to the industry.
OnPoint Medical Diagnostics (OTCQB:ONMD) announced today it has signed a contract with Children's Hospital of Philadelphia (CHOP) to provide OnPoint's MRI Quality Assurance (QA) software.
Pacific Biosciences of California, Inc. (Nasdaq:PACB) today announced financial results for the third quarter ended September 30, 2013.
Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported Pfizer Inc. (NYSE:PFE) has informed us that, having achieved technical milestones related to manufacturing, they will continue the development program for REMOXY® (oxycodone) Extended-Release Capsules CII.
Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of audio products and solutions, today announced it has filed a utility patent application with the United States Patent and Trademark Office (USPTO) to protect new innovations enabling its patented HyperSound™ directional audio speakers to be transparent.
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that the Mount Sinai Genetic Testing Laboratory and the Icahn Institute for Genomics and Multiscale Biology at Mount Sinai in New York City have adopted the Ingenuity® Variant Analysis™ solution for research and translational genomics applications related to characterizing and identifying rare diseases.
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TheDirectory.com, Inc. (PINKSHEETS: SEEK), an emerging leader in the Local search space, today announced that representatives from the Company will attend this year's ad tech digital media conference in New York City Nov. 6th and 7th.
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