Merck's MK-5172/MK-8742 Receives Breakthrough Therapy Designation from FDA; Cubist Announces Submission of NDA for Tedizolid Print E-mail
By Mary Davila   
Tuesday, 22 October 2013 18:52
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 22, 2013.

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


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.

Also Tuesday:

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.

Alphatec Holdings, Inc. (Nasdaq:ATEC)
, the parent company of Alphatec Spine, Inc., a medical device company that provides physician-inspired solutions for patients with spinal disorders, will release its third quarter 2013 financial results on Thursday, November 7th, 2013 after the close of the market.

Amarin Corporation plc (Nasdaq:AMRN)
, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today plans to reduce operating expenses by eliminating approximately fifty percent of its staff positions worldwide following the recent recommendation of the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee against the potential Vascepa® (icosapent ethyl) label expansion.

today announced results for the third quarter of 2013.

Anavex Life Sciences Corp. (OTCQB:AVXL)
today announced that the current issue of the peer-reviewed scientific journal PLOS ONE explains that sigma-1 receptor (Sig-1R) activity is involved in cellular survival by regulating and stabilizing a key cell stress sensor.

Applied Nanotech Holdings, Inc. (OTCQB: APNT)
announced that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant, in the amount of approximately $175,000 by the National Institute of Nursing Research, part of the National Institutes of Health (NIH).

Baroma, Inc. (OTCMarkets:BRMA)
today announced a strategic relationship with Walgreens (NYSE:WAG) (Nasdaq:WAG) that will bring pharmacists and hospital staff together to help reduce re-admissions and increase medication adherence for Baroma's accountable care organization (ACO).

BioLargo, Inc. (OTCQB: BLGO)
today announced that its Odor-No-More subsidiary has introduced a new line of odor and moisture control products to the US Government, and fulfilled its first order.

BioReference Laboratories, Inc. (Nasdaq:BRLI)
announces that Myriad Genetics has filed a lawsuit against it in the Federal District Court in Utah alleging that BioReference, through its genetic sequencing laboratory, GeneDx, Inc, is infringing on its intellectual property by offering OncoGeneDx, its comprehensive series of inherited cancers testing, including testing for BRCA1/2.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, a diagnostics company focused on developing genomic-based, oncology tests and services, today announced the pricing of its underwritten public offering of 2,858,000 shares of its common stock at a price to the public of $14.00 per share.

Can-Fite BioPharma (TASE: CFBI), (OTCQB: CANFY)
, a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today a series of clinical and corporate developments, with key events expected by the second week of December 2013.

Curis, Inc. (Nasdaq:CRIS)
, an oncology focused company developing novel, targeted drug candidates for the treatment of human cancers, and Debiopharm Group™ (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, including oncology as well as companion diagnostics, today announced the start of an open-label, multicenter Phase I dose-finding study of Debio 0932, a heat shock protein 90 (HSP90) inhibitor in combination with everolimus (Afinitor®), an inhibitor of mammalian target of rapamycin (mTOR) in patients with advanced or metastatic renal cell carcinoma (RCC), who have been previously treated with a VEGF-directed tyrosine kinase inhibitor.

CytoSorbents Corporation (OTCQB: CTSO)
, a critical care focused company commercializing its European Union approved CytoSorb® blood filter to treat life-threatening illnesses in the intensive care unit, will report Q3 2013 earnings after the market close on Wednesday, November 6, 2013.

DARA BioSciences, Inc. (NASDAQ: DARA)
, an oncology supportive care pharmaceutical company dedicated to providing health care professionals a synergistic portfolio of medicines to help cancer patients adhere to therapy and manage side effects arising from cancer treatment, today announced that on October 22, 2013, DARA BioSciences, Inc. (the "Company") entered into a Securities Purchase Agreement (the "Purchase Agreement") with certain institutional investors providing for the issuance and sale by the Company in a registered direct offering of 5,100,000 shares (the "Shares") of the Company's common stock, par value $0.01 per share, at an offering price of $0.50 per share (the "Share Offering") for gross proceeds of $2,550,000 before deducting for placement agent fees and expenses.

Easton Pharmaceuticals, Inc. (OTC: EAPH)
, a specialty pharmaceutical company that designs, develops, and markets a premium array of topically-delivered drugs and therapeutic healthcare products announced today it has signed a formal agreement with BMV Medica S.A. de C.V. (BMV) a Mexican Regulatory & Licensing consultancy to begin the process of submitting applications to obtain regulatory government approvals for its flagship product "VIORRA."

, 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).

Epizyme, Inc. (NASDAQ: EPZM)
, a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, today provided a corporate update and reported financial results for the quarter ended September 30, 2013.

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.

Given Imaging (Nasdaq:GIVN)
today announced that the company will host a conference call on Wednesday, November 6, 2013 at 9:00am ET, 4:00pm Israel time to discuss third quarter 2013 financial results.

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.

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that its newest antibody-drug conjugate (ADC), IMMU-132, has produced durable partial responses in three different cancer types in early phase of clinical evaluation.

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced the issuance of U.S. patent no. 8,562,988 to its majority-owned subsidiary, IBC Pharmaceuticals, Inc. (IBC), for "Novel Strategies for Improved Cancer Vaccines."

IntelliCell BioSciences, Inc. (OTCQB: SVFC)
, a regenerative medicine company utilizing adult autologous vascular cells (SVFCs) derived from the blood vessels found in adipose tissue, announced today that it has received notice that its patent application has been filed in Thailand.

Life Technologies Corporation (NASDAQ: LIFE)
today announced the inaugural Ion Torrent™ Breakthrough Award 2013 winner.

LipoScience, Inc. (Nasdaq:LPDX)
today announced that it will release its third quarter of fiscal year 2013 financial results after the market close on Tuesday, November 5, 2013.

Medical Marijuana, Inc. (OTC Pink:MJNA) is pleased to inform shareholders and the general public that HempMedsPX – a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc. – is actively addressing the public's interest in cannabidiol (CBD)-rich hemp oil-based products by unveiling three new product lines at CHAMPS in Denver, Colorado October 22-24, 2013

MediSwipe Inc. (OTCQB: MWIP)
, the leader in Compassionate Care Technology Solutions for the medicinal marijuana industry, reported today that its Board of Directors has made a decision to consolidate its current authorized and outstanding common shares and reverse split the Company's shares on the basis of ten old shares for one new share subject to approval by FINRA as outlined in the amended Pre 14C information statement planned to be filed today.

is pleased to announce that it has signed an agreement with Groupon to launch its LED Botanical Light Therapy in the Boca Medical Spa, our new Boca Raton, Florida office located directly across from Boca Raton Regional Hospital.

Merge Healthcare Incorporated (Nasdaq:MRGE)
, a leading provider of clinical systems and innovations that seek to transform healthcare, today announced that Confluence Health-Central Washington Hospital & Clinics, has implemented Merge Hemo to automate their cath lab processes.

Nature's Sunshine Products, Inc. (Nasdaq:NATR)
, a leading natural health and wellness company engaged in the manufacture and direct selling of nutritional and personal care products, today announced that it will report third quarter financial results for the period ended September 30, 2013 on Wednesday, November 6th, after the close of market.

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.

Nutra Pharma Corporation (OTCQB: NPHC)
, a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, announced today that their Chief Executive Officer, Rik J Deitsch, was interviewed by Chris Castaldo of Wall Street Buy Sell Hold.

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.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for the ERADICATE Hp study - a Phase III clinical study with RHB-105 for the treatment of Helicobacter pylori (H. pylori) bacterial infection.

StemCells, Inc. (Nasdaq:STEM)
, the leading stem cell company developing novel cell-based therapeutics for disorders of the central nervous system, announced today that Ann Tsukamoto, Ph.D., Executive Vice President, Scientific and Strategic Alliances at StemCells, will speak at the B-Debate International Center for Scientific Debate Barcelona,to be held October 23-24 in Barcelona, Spain., 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.

Vascular Solutions, Inc. (Nasdaq:VASC)
today reported financial results for the third quarter ended September 30, 2013.

Vision-Sciences, Inc. (Nasdaq:VSCI)
announced today that the detailed findings of a twelve-month evaluation of its EndoSheath® technology in the critical care setting were presented by Dr. Flavia Petrini, Professor of Anaesthesia and Intensive Care, Università Gabriele d'Annunzio Chieti-Pescara (Italy), in a scientific poster at the 67th National Congress of the Società Italiana di Anestesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI).

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
, a biopharmaceutical company focused on the discovery and development of new cancer therapies, and Intrexon Corporation (NYSE:XON), a leader in synthetic biology, today announced the presentation of a preclinical study demonstrating the potential for using Intrexon's regulated gene expression system, the RheoSwitch Therapeutic System® (RTS®), in human mesenchymal stem cells (hMSCs).

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
today announced financial results for the third quarter ended September 30, 2013, and provided an update on the Company's key development activities.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
today announced that it intends to commence an underwritten public offering of $50,000,000 of shares of its common stock. All of the shares in the proposed offering are to be sold by ZIOPHARM.

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