Forest Labs Announces Positive Phase III Study Results for Nebivolol and Valsartan Combination; Cepheid Receives FDA Clearance For Xpert BC) Test Print E-mail
By Staff and Wire Reports   
Thursday, 27 June 2013 18:20

Below is a look at some of the headlines for companies that made news in the healthcare sector on June 27, 2013.
Forest Laboratories (NYSE: FRX) announced positive topline results  from an 8-week pivotal Phase III clinical trial evaluating the efficacy and safety of investigational fixed dose combination (FDC) of nebivolol and valsartan for the treatment of hypertension.

The combination of nebivolol and valsartan demonstrated statistically significant reductions in diastolic blood pressure (DBP) vs. both nebivolol alone and valsartan alone at 8 weeks, which was the primary endpoint. The FDC also met the key secondary endpoint of change from baseline in systolic blood pressure (SBP) at 8 weeks.

The single pivotal nebivolol/valsartan FDC trial  was designed to meet the required regulatory “Combination Rule,” comparing a FDC against the highest approved dose of each component drug.

“These Phase III results in patients with Stage 1 or Stage 2 hypertension are exciting and demonstrate the potential benefits of this novel FDC -- a first-in-class beta blocker/ARB combination,” said Marco Taglietti, MD, Senior Vice President of Research and Development  and President, Forest Research Institute. “We are very pleased with these results which demonstrate the efficacy and safety profile of this combination and support the potential use of the nebivolol/valsartan FDC as a new treatment option for patients with hypertension who need dual therapy to reach their blood pressure goals.”

Based on these positive results, Forest plans to submit a regulatory filing with the Food and Drug Administration (FDA) in the first quarter of calendar year 2014.


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Cepheid (Nasdaq: CPHD) announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert® MRSA/SA Blood Culture (BC) test, which runs on the GeneXpert® System, for the detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically methicillin susceptible) in blood culture bottles showing gram-positive cocci in clusters in about one hour.

Cepheid's updated Xpert MRSA/SA BC test processes positive blood culture specimens to determine if a patient's blood is infected with MRSA or SA, which are frequent causes of sepsis in hospitalized patients. This will enable physicians to manage their patients more effectively, improving patient outcomes.

"In the case of sepsis, one of the ten leading causes of death in the United States, test results must be available on-demand in order to have maximum impact on patient management," said John Bishop, Cepheid's Chairman and CEO. "Our updated Xpert MRSA/SA BC test, along with the GeneXpert System, provides the ability to obtain specific accurate results twenty four hours a day, seven days a week."

Recent CDC data show that S. aureus (including MRSA) is the most common cause of central line-associated bloodstream infections and together with coagulase-negative staphylococci (CoNS) represent almost 24% of all central line infections1. Data on bloodstream infections from Mayo Clinic show that, taken together, S. aureus and CoNS represent almost 28% of significant positive blood cultures2.

Typically, physicians will order a set of blood culture bottles drawn from patients presenting with symptoms of systemic infections. Positive cultures can appear in as little as 16-24 hours, but then require further testing to identify the specific organism causing the infection. Although Gram stain results can be helpful for guiding empiric therapy, physicians have traditionally relied on slower culture methods, which often require an additional 24-48 hours.

"Having the capability to differentiate MRSA, S. aureus, and CoNS rapidly in blood culture specimens is a major responsibility of the clinical laboratory. The clear advantage of the three target detection algorithm in the Xpert MRSA/SA BC test is the direct identification of both MRSA and S. aureus in approximately 1 hour," said Fred C. Tenover, Ph.D., Cepheid's Vice President for Scientific Affairs. "This is what physicians, microbiologists, and pharmacists need for managing sepsis effectively."

"I've long been a champion of rapid detection of infections — tools like the Xpert MRSA/SA BC test give laboratories the opportunity to expand our roles in healthcare," said Dr. Donna Wolk, Ph.D., System Director, Clinical Microbiology at Geisinger Health Systems and Director of the Infectious Disease Research Laboratory at the Weis Research Center. "We can become diagnostics interventionists, able to catalyze improvements in patient care and healthcare delivery like never before. Plus, the expanded claim that allows the test to be performed from the top three providers of blood culture systems/bottles makes the test applicable to nearly all laboratories, large and small."



Also Thursday:



ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, announced that Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC, presented top-line results today from a phase IV clinical trial evaluating MuGard™ Mucoadhesive Oral Wound Rinse at the MASCC/ISOO International Symposium on Supportive Care in Cancer in Berlin, Germany.

Antares Pharma, Inc. (NASDAQ: ATRS) today announced that it has received a Notice of Issuance from the U. S. Patent Office for patent number 8,480,631 entitled “Hazardous Agent Injection System.”

AtheroNova Inc. (OTCBB: AHRO), a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced publication of the preclinical study that supported the clinical development of the Company's investigational AHRO-001 drug.

Baxter International Inc. (NYSE:BAX) today announced that the United States Food and Drug Administration (FDA) has approved RIXUBIS [Coagulation Factor IX (Recombinant)] for routine prophylactic treatment, control of bleeding episodes, and perioperative management in adults with hemophilia B.

Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) today announced that its President and Chief Executive Officer, Russell H. Plumb, will present an update on the company at the 8th Annual JMP Securities Healthcare Conference at 2:30 p.m. EDT, July 10, 2013, at The St. Regis Hotel in New York City.

Cepheid (Nasdaq: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert® MRSA/SA Blood Culture (BC) test, which runs on the GeneXpert® System, for the detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically methicillin susceptible) in blood culture bottles showing gram-positive cocci in clusters in about one hour.

Epizyme, Inc., (NASDAQ: EPZM) a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, today announced its participation in three upcoming conferences.

Islet Sciences, Inc., (OTC.BB: ISLT) a biotechnology company engaged in the research, development and commercialization of patented technologies for people with diabetes, announced today that Dr. Jonathan Lakey, Associate Professor of Surgery and Biomedical Engineering at the University of California Irvineand Chief Scientific Officer and Chairman of the Scientific Advisory Board of Islet Sciences, has received $1.27 million in grant funding from the JDRF to develop innovative methods to treat and possibly cure type 1 diabetes.

Immune Design, a leader in the field of therapeutic vaccines for cancer, infectious diseases and allergy, and Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that they have entered a license agreement providing Medicago the use and commercialization of Immune Design's proprietary synthetic Toll-like Receptor 4 agonist, Glucopyranosyl Lipid A (GLA).

MediSwipe Inc. (OTCQB: MWIP), a data management solutions company for the medicinal marijuana and health care industry, today announced that management has scheduled an investor conference call for Monday July 8th, 2013 at 4:00 pm Eastern time.

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced the first subject has been enrolled in its NAV4694 global, pivotal Phase 3 clinical trial.

NovaDel Pharma Inc. (OTC Pink: NVDL) announced today that the Special Meeting of the Company’s Stockholders scheduled for today for the purpose of obtaining stockholder approval of the sale of substantially all of the Company’s assets to Suda Ltd. and the liquidation and dissolution of the Company, was adjourned due to the lack of the requisite quorum.

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that The Better Way Back®, a NuVasive-supported patient education program, will hold two patient seminars in July.

Omthera Pharmaceuticals, Inc. (NASDAQ: OMTH)
today announced that, as of June 26, 2013, the Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, in connection with the previously announced merger agreement, entered into on May 27, 2013, among Omthera Pharmaceuticals, Inc., Zeneca, Inc. ("Parent") and KAFA Acquisition Corp., a wholly owned subsidiary of Parent.

Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT)
a developer of oxygen-carrying therapeutics, today announced results for the fiscal year (FY) ended April 30, 2013.

SurgiCount Medical, the wholly-owned operating subsidiary of Patient Safety Technologies, Inc. (the "Company", OTCBB:PSTX, OTCQB:PSTX) today announced it has signed an agreement with GNYHA Services, Inc. (New York, NY) to provide the SurgiCount Safety-Sponge® System to its health system members.

QLT Inc. (Nasdaq:QLTI) (TSX:QLT)
  is pleased to announce that the Company has completed today the previously announced special cash distribution (the "Cash Distribution") in the amount of US$200 million, by way of a reduction of the capital of the Company's common shares (the "Shares").

SK3 Group, Inc. (OTC Pink: SKTO)
announces that it has engaged the firm of L.L. Bradford Company, LLC to audit the financial statements of SKTO for the years ended 2010 through and 2012 and the current periods to date, and of its subsidiary, Medical Greens, Inc. through June 30, 2013.

Seattle Genetics, Inc. (NASDAQ:SGEN)
and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc. (Tokyo:4503), today announced that Seattle Genetics has exercised an option to co-develop an additional antibody-drug conjugate (ADC) under the companies’ existing ADC collaboration agreement.

SpectraScience, Inc. (OTCQB: SCIE)
, a San Diego-based medical device company, today announced it expects to recognize revenue of approximately $120,000 for its second quarter ending June 30, 2013.

ViroPharma Incorporated (Nasdaq: VPHM)
today announced updated data from the two ongoing, Phase 2 dose ranging studies investigating maribavir for both first line treatment of cytomegalovirus (CMV) viremia and treatment of resistant/refractory CMV.

Zogenix, Inc. (Nasdaq:ZGNX)
, a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced today an exclusive co-promotion agreement for Migranal® (dihydroergotamine mesylate, USP) Nasal Spray in the United States.




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