Cepheid Receives FDA Clearance For Xpert Flu/RSV XC; Supernus Receives Issuance of Fifth US Patent Protecting Trokendi XR(R) Print E-mail
By Marilyn Mullen   
Monday, 24 November 2014 19:47
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 24, 2014.
Cepheid (NASDAQ: CPHD) announced it has received clearance from the U.S. FDA to market its Xpert® Flu/RSV XC, an on-demand molecular test for accurate and reliable determination of Flu A, Flu B, and differentiation of RSV infection. Xpert Flu/RSV XC runs on Cepheid's GeneXpert® System, the world's leading molecular diagnostic platform with more than 7,500 systems installed worldwide.
Upper respiratory infections are one of the most common reasons for doctor and hospital visits and, in the United States, are the most common illness leading to school or work absences. Early symptoms for a wide variety of viral and bacterial respiratory infections are similar, yet treatment is different depending on the cause of infection. With Xpert Flu/RSV XC, hospitals and clinicians can be prepared to reliably diagnose and differentiate influenza strains and RSV in real-time.
"Influenza strains are notoriously unpredictable and the severity of flu outbreaks can vary widely from season to season," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Recent media coverage of serious viruses such as Enterovirus D68 and Ebola have raised public awareness, and created a greater need for healthcare workers to deliver timely and accurate test results for flu or RSV infection."
The flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and lungs. It can cause mild to severe illness, and at times can lead to death. Patients infected with the flu may be able to infect others beginning one day before symptoms develop and up to five to seven days after becoming sick. Some people, especially young children and people with weakened immune systems, might be able to infect others for a longer time.1
Respiratory syncytial virus (RSV) is a very common virus that leads to a wide range of respiratory symptoms in children and older adults. It can be more serious in young children, especially those in certain high-risk groups. Most infants have had an RSV infection by age two.2 RSV is the most common cause of bronchiolitis and pneumonia among infants and children under one year of age.3
Doctors Donna M. Wolk and Raquel M. Martinez, investigators at Geisinger Health System, were involved in investigational testing of Xpert Flu/RSV XC during Cepheid's product development phase. Their Microbiology Research team is planning a pilot testing program they call FluWorks©. This program aims to allow test results to be immediately delivered to physicians and patients or designated family members via electronic health records, web portal, or text messaging.
"We are anxious to understand the role that the Xpert Flu/RSV XC test can play in Geisinger's FluWorks program, designed to improve patient care, clinical operations, and laboratory stewardship. Rigorous investigational testing documented the assay's high accuracy and speed," said Dr. Wolk. "This winter, we plan to leverage the test's unique design to quickly test patients presenting with influenza-like illness at Emergency Departments, out-patient clinics, and in selected Urgent Care Clinics."
The severity of a flu outbreak can vary greatly from one season to the next depending on which flu viruses are spreading, how many people get vaccinated, and how well the flu vaccine is matched to the flu viruses that are currently causing illness.
"We employed a novel in silico approach to identify multiple complementary target segments to avoid the effects of seasonal genetic drift and to anticipate emerging novel influenza strains. Though simple to perform, Xpert Flu/RSV XC is a highly multiplexed, state-of-the-art test for fast and accurate detection and differentiation of Flu A, Flu B, and RSV infection," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "This test may also become a valuable asset in efforts toward pandemic preparedness, because it was designed from its inception to provide unprecedented coverage of both human and avian influenza strains."
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Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), announced the issuance of a fifth patent (number 8,889,191) by the United States Patent and Trademark Office (USPTO) covering Trokendi XR, its novel once-daily extended-release topiramate product. The patent provides protection for the product with expiration that is no earlier than 2027.
"We are very serious about securing intellectual property protection for our innovative products. This is now the second patent that issued this month on Trokendi XR. We will continue to build our patent estate to provide our products with the protection they are entitled to. We now have patent protection on Oxtellar XR® and Trokendi XR® through four and five issued U.S. patents, respectively," said Jack A. Khattar, President and CEO of Supernus.
Supernus has several additional patent applications for extended-release topiramate and extended-release oxcarbazepine pending in other geographic regions.
 
Also Monday:
 
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a diversified biotechnology company focused on the development of diagnostic and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine announced today that Gerald E. Commissiong, President and Chief Executive Officer, will present at the LD Micro Main Event VII micro-cap investor conference being held December 2 - 4, 2014 at the Luxe Sunset Hotel in Los Angeles, California.
Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced the closing of its previously announced public offering of common stock. 
Argos Therapeutics Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases based on the Arcelis® technology platform, today announced the company has been honored with a 2014 Red Herring North America Top 100 award.
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced that Chief Executive Officer Alex Zukiwski, M.D., is scheduled to present at the Annual LD Micro Conference, being held December 2-4, 2014 at the Luxe Hotel in Los Angeles, CA.
AV Therapeutics, Inc. (OTCQB:AVTH), a developer of cancer therapeutics and vaccines, is pleased to announce the completion of GMP synthesis of its lead prostate cancer drug, Capridine.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) and Prosensa Holding N.V. (Nasdaq:RNA) today announced that they have entered into a definitive agreement in which BioMarin will offer to purchase all of the outstanding ordinary shares of Prosensa for $17.75 per share, for a total up front consideration of approximately $680 million.
Bristol-Myers Squibb Company (NYSE:BMY) and Five Prime Therapeutics, Inc. (Nasdaq:FPRX) today announced that they have entered into an exclusive clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining Opdivo (nivolumab), Bristol-Myers Squibb's investigational PD-1 (programmed death-1) immune checkpoint inhibitor, with FPA008, Five Prime's monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R).
Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced that it has entered into a follow-on, milestone-based development agreement with a private contracting organization acting on behalf of the United States Centers for Disease Control and Prevention (CDC), for a multiplex POC influenza immunity test utilizing Chembio's patented Dual Path Platform (DPP®) technology.
CollabRx, Inc. (Nasdaq:CLRX), announced today that it received a letter from the NASDAQ OMX GROUP ("Nasdaq") stating that the bid price of the Company's common stock for the last 30 consecutive business days had closed below the minimum $1.00 per share required for continued listing under Listing Rule 5550(a)(2).
CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with human immunodeficiency virus (HIV), today announced that its company information is now available via S&P Capital IQ Corporation Records Listing Program. 
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, today announced that warrant holders have elected to exercise 22.8 million of their $2.00 warrants at a reduced exercise price of $1.00 per share, providing $22.8 million in gross proceeds to Ekso Bionics.
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the company will be webcasting its presentation at the 25th Annual Oppenheimer Healthcare Conference in New York on Wednesday, December 10, 2014 at 2:45 PM Eastern.
Forward Pharma A/S (Nasdaq:FWP) announced today that the Company received an issue notification from the United States Patent and Trademark Office (USPTO) regarding its patent application 13/143,498 covering its erosion matrix formulation of dimethyl fumarate (DMF).
FutureWorld Corp. (OTCQB; FWDG), a leading provider of advanced technologies and solutions to the global cannabis industry, announces today that it is depositing 10,000,000 shares of common stock of HempTech, Inc. with a trust formed for the benefit of holders of FutureWorld' common stock.  
iKang Healthcare Group, Inc. (Nasdaq:KANG), the largest provider in China's fast growing private preventive healthcare services market in terms of revenue in 2013, today announced its unaudited financial results for the fiscal second quarter ended September 30, 2014.
IPC The Hospitalist Company, Inc. (Nasdaq:IPCM), a leading national hospitalist physician group practice, today announced that R. Jeffrey Taylor, president and chief operating officer, is scheduled to present at the Piper Jaffray Healthcare Conference at the New York Palace Hotel in New York, NY.
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced the presentation of data describing its oncology product candidates at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain held November 18 to 21, 2014.
Matinas BioPharma Holdings, Inc. (OTCQB:MTNB), an emerging biopharmaceutical company focused on the development and commercialization of omega-3 fatty acid-based prescription therapeutics for the treatment of cardiovascular and metabolic conditions, announced today that it has appointed Kevin C. Maki, Ph.D. to its recently formed Scientific Advisory Board (SAB).
MedAssets (Nasdaq:MDAS) today announced that UNC Health Care, a not-for-profit health system based in Chapel Hill, NC, has renewed its agreement with the company to build upon its long-standing relationship with MedAssets in driving down costs and optimizing clinical, operational and financial performance.
Medgenics, Inc. (NYSE MKT:MDGN) today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. 
Medical Marijuana, Inc. (OTC Pink:MJNA) is pleased to inform shareholders and the general public that its portfolio companies were featured in news media reports from the 3rd annual Marijuana Business Conference held Nov. 12-14th in Las Vegas.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will participate at the 26th Annual Piper Jaffray Healthcare Conference being held December 2-3 in New York City.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that its presentation at the 2014 Deutsche Bank BioFEST conference will be webcast on Monday, December 1 at 1:40 p.m. ET.
Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced today that it has formed a "Diabetes Consortium" that will be tasked with the development of Nuvilex's treatment for insulin-dependent diabetes.
ProQR Therapeutics N.V. (Nasdaq:PRQR), an innovative biopharmaceutical company engaged in the discovery and development of RNA-based therapeutics for the treatment of severe genetic disorders, today announced results for the third quarter of 2014.
Proteon Therapeutics Inc. (Nasdaq:PRTO), a company developing novel, first-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular diseases, today announced the previous closing of its initial public offering of 6,110,000 shares of its common stock at an initial public offering price of $10.00 per share, which closed on October 27, 2014.
Radius Health, Inc. (Nasdaq:RDUS) announced today that results from a multi-center, multi-national, double-blind placebo controlled Phase 2 trial evaluating the effects of the investigational drug abaloparatide on bone mineral density (BMD) were published online for early release on November 13, 2014, ahead of print by the Journal of Clinical Endocrinology & Metabolism (JCEM) [doi:10.1210/jc.2014-3718].
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, announced today the completion of the previously announced underwritten public offering of an aggregate of 4,140,000 shares of its common stock at a price to the public of $100.00 per share, which included 540,000 shares of its common stock sold pursuant to the full exercise of the option to purchase additional shares previously granted to the underwriters.
Second Sight Medical Products, Inc. (Nasdaq:EYES), a developer, manufacturer and marketer of implantable visual prosthetics to restore some functional vision to blind patients, today announced that the underwriter for its initial public offering exercised its entire over-allotment option to purchase an additional 525,000 shares of the Company's common stock.
Sharps Compliance Corp. (Nasdaq:SMED), has announced the promotion of Dennis Halligan to Vice President of Marketing.
Stericycle, Inc. (Nasdaq:SRCL) today announced that its board of directors has unanimously selected Brent Arnold, currently Executive Vice President and President, Stericycle USA/Canada, to succeed Richard Kogler as Chief Operating Officer effective January 1, 2015. 
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the publication of results from the Company's REVEAL-1 (Response Evaluation of Vosaroxin in Elderly AmL) trial, a Phase 2 trial of single agent vosaroxin in previously untreated, poor-risk elderly acute myeloid leukemia (AML) patients who are unlikely to benefit from standard induction chemotherapy, in the November 17, 2014 Online Version of Record of the British Journal of Haematology.
Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced the issuance of a fifth patent (number 8,889,191) by the United States Patent and Trademark Office (USPTO) covering Trokendi XR, its novel once-daily extended-release topiramate product.
VBI Vaccines (Nasdaq:VBIV) will present at the LD Micro Conference on Wednesday, December 3rd at 9:00 AM PT. The event is being held in Los Angeles, CA at the Luxe Sunset Boulevard Hotel.
VeriTeQ Corporation (OTC Markets:VTEQ) a provider of implantable medical device identification and radiation dose measurement technologies, announced today that, in conjunction with its customer Establishment Labs, S.A. ("EL"), it will initiate development of a pressure-sensing microtransponder to be used in tissue expanders for breast reconstruction and tissue expansion.
Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced that Jeffrey L. Cleland, PhD, Chief Executive Officer, is scheduled to present at the 26th Annual Piper Jaffray Health Care Conference on Tuesday, December 2, 2014 at the New York Palace Hotel in New York City.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today John Varian, the Company's Chief Executive Officer, is scheduled to present at the 26th Annual Piper Jaffray Healthcare Conference on Wednesday, December 3, 2014, at 9:30 a.m. ET.



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