|Bristol-Myers' Withdraws NDA on Asunaprevir In The US; BioCryst Reports on OPuS-1 Phase 2 Trial Results|
|By William Kent|
|Tuesday, 07 October 2014 23:16|
Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb (NYSE: BMY) has decided that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need.
Bristol-Myers Squibb's HCV strategy has always been to focus on the unique unmet medical need of each local market. For example, in Japan we were pleased to receive regulatory approval for the dual regimen of daclatasvir and asunaprevir in July, bringing Japanese patients with HCV the first all-oral, interferon- and ribavirin-free treatment regimen.
The dual regimen was developed to meet the distinct need of the Japanese patient population, and we believe this treatment has the potential to play a major role in curing HCV patients in Japan, as well as in other markets where the HCV patient population is similar to Japan. In the EU, daclatasvir was recently approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of HCV infection in adults. Similarly, we believe that daclatasvir-based regimens have the potential to fill continued unmet medical need in the U.S. and elsewhere in the world.
We plan to submit additional data for daclatasvir to the FDA from our ongoing clinical trial program focused on difficult-to-treat patients, including patients with HCV genotype 3, patients who are pre- and post-liver transplant, and patients co-infected with HIV. Next month at the annual meeting of The American Association for the Study of Liver Diseases (AASLD), we will present new data from several daclatasvir-based regimens. We look forward to bringing daclatasvir to patients in the U.S. and will continue to work closely with the FDA to advance our regulatory application, with the aim of bringing the investigational product to market as quickly as possible.
BioCryst Pharmaceuticals, Inc., (BCRX) announced results from its successful OPuS-1 (Oral ProphylaxiS-1) proof of concept Phase 2a clinical trial of orally-administered BCX4161 in patients with hereditary angioedema (HAE) will be presented as a late-breaker oral presentation at the 23rd EADV Congress taking place in Amsterdam October 8-12, 2014.
The presentation titled "BCX4161, an Oral Kallikrein Inhibitor, is effective and safe in the Prophylaxis of Acute Attacks in Patients with Hereditary Angioedema: Results of the Phase 2 Trial OPuS-1," will be presented by Marcus Maurer MD, Professor of Dermatology and Allergy, Charite-Universitasmedizin, Berlin and the principal investigator for OPuS-1. The presentation will take place during the "Late Breaking News in Dermatology" session on Saturday, October 11 at 1:00 PM Central European Time.
OPuS-1 evaluated 400 mg of BCX4161 administered three times a day for 28 days in HAE patients with a high attack frequency (>= 1 per week), in a randomized, double-blind, placebo-controlled, two-period cross-over design. The primary goals for the trial were to estimate the degree of efficacy of BCX4161 in reducing the frequency of angioedema attacks, and to evaluate the safety and tolerability of 28 days of BCX4161 treatment. The trial met the primary efficacy endpoint and all other objectives established for the trial.
BioCryst expects to initiate its OPuS-2 trial to evaluate the efficacy and safety of BCX4161 treatment for 12 weeks in patients with HAE before the end of 2014.
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing diagnostics and therapeutics for Alzheimer's disease, Parkinson's disease and ophthalmological disorders, announced that Roman Urfer, PhD, Chief Development Officer at NeuroAssets, presented animal data on mesencephalic-astrocyte-derived neurotrophic factor (MANF) in ocular conditions at the "Targeting Ocular Disorders" Conference in Boston, MA, yesterday (http://www.healthtech.com/Targeting-Ocular-Disorders).
Amedica Corporation (Nasdaq:AMDA), a biomaterial company focused on silicon nitride ceramics as a material platform to develop, manufacture and commercialize novel medical devices, is pleased to announce the appointment of Eric A. Stookey as a new independent member to the Company's Board of Directors, effective immediately.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services and mobile tools for medical groups and health systems, today announced its recognition as a leader in interoperability in the KLAS EMR Interoperability 2014 reporti.
Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of cell-free circulating tumor DNA and circulating tumor cells (CTCs), today announced the furthering of its collaboration with The University of Texas MD Anderson Cancer Center regarding studies focused on patients diagnosed with ovarian cancer.
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced that the Board of the Company has set Friday, November 07, 2014 as the date for the Company's annual meeting of stockholders, to be held at the Company's office at 530 University Ave, Suite 17, Palo Alto, CA 94301, at 9:00am PST, and any and all adjournments or postponements thereof, and authorizes and instructs the designated proxies to vote in the manner directed in the proxy cards received for each stockholder of record.
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today announced that it expects to report record volumes of prenatal testing in the third quarter and nine months ended September 30, 2014.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the first successful treatments performed at Germany's Mannheim University Hospital ("UMM"), using the Company's Focal One® HIFU device.
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, announced today that it will be showcasing their robotic exoskeleton technology at the American Congress of Rehabilitation Medicine's (ACRM) 91st Annual Conference, taking place from October 7-11, 2014 at the Metro Toronto Convention Center, Toronto, ON, Canada.
Dr. William Mitchell, Ph.D., a Professor of Pathology, Microbiology and Immunology at Vanderbilt University who also serves as a Director with Hemispherx Biopharma (NYSE:HEB), will chair three sessions on Neurological Infections Associated with Virus, Agriculture and Plant Virology, and Recent Advances in Drug Discovery during the 4th World Congress on Virology in San Antonio, Texas on October 8.
LifeLearn Inc., a company devoted to mobilizing knowledge in the animal health industry, and IBM (NYSE:IBM) today announced that beta clients including Animal Medical Center (AMC) in New York are tapping the power of Watson to transform how veterinarians access and interpret unlimited amounts of structured and unstructured information.
Medgenics, Inc. (NYSE MKT:MDGN), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that initial data from its ongoing Phase 1/2 clinical trial of MDGN-201 (TARGTEPOTM) formerly known as EPODURETM, will be presented at the 22nd Annual Congress of the European Society of Gene and Cell Therapy (ESGCT) being held in The Hague, Netherlands from October 23rd-26th, 2014.
MediWound Ltd. (Nasdaq:MDWD), a fully-integrated, biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the Company's NexoBrid® will be featured in multiple oral and poster presentations at the 17th Congress of the International Society for Burn Injuries (ISBI) taking place October 12-16, 2014 in Sydney, Australia.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced the launch of electronic referrals and online order management for iConnect® Network.
Naturally Splendid Enterprises (FRANKFURT:50N) (TSX.V:NSP) (OTCQB:NSPDF) is pleased to announce that the company's 100% owned American subsidiary, Naturally Splendid Enterprises USA Limited headquartered in the state of Colorado, has signed a letter of intent with Full Spectrum Laboratories Limited (FSL) headquartered in Dublin, Ireland, to license FSL's cannabinoid extraction and patented formulation technologies.
Nature's Sunshine Products, Inc. (Nasdaq:NATR), a leading natural health and wellness company engaged in the manufacture and direct sale of premium-quality nutritional and personal care products, today announced that Ingrum Bankston, M.D., of Tuscaloosa, Alabama, has joined Nature's Sunshine Products' ("NSP") Medical and Scientific Advisory Board.
Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, announced today that additional positive anatomic and visual acuity data from the IMPACT study, a phase II clinical trial evaluating Squalamine eye drops (OHR-102) for the treatment of the wet form of age-related macular degeneration (wet AMD), will be presented in two separate podium sessions at the 2014 American Academy of Ophthalmology (AAO) Annual Scientific Meeting, being held in Chicago, Illinois, from October 17-21, 2014.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, announced that Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed, will speak today at the 13th Annual BIO Investor Forum being held in San Francisco, CA.
OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing novel cancer therapeutics, today announced that the first patient has been enrolled in a Phase 1b/2 clinical study that will evaluate fosbretabulin in combination with Votrient™ (pazopanib) in patients with recurrent ovarian cancer.
Premier, Inc. (Nasdaq:PINC) has added real-time predictive analytics from Predixion Software to its integrated technology platform PremierConnect®.
Premier, Inc. (Nasdaq:PINC) today announced that it plans to proceed with an underwritten company-directed offering on behalf of selling member-owner stockholders who have elected to participate in Premier's upcoming October 31, 2014 share exchange process, as contemplated by a registration rights agreement executed in connection with Premier's initial public offering.
Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases, including hormone responsive cancers, today announced the closing of its previously announced public offering of 3,128,524 shares of common stock at a public offering price of $18.25 per share, including 378,524 shares sold pursuant to the partial exercise of the underwriters' option to purchase additional shares of common stock.
Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that it received $8,003,578.05 in cash on 838,071 warrants exercised at $9.55 per warrant.
StemCells, Inc. (Nasdaq:STEM), a world leader in the research and development of cell based therapies for the treatment of disorders of the central nervous system, announced today that it has initiated its Pathway® Study, a Phase II proof of concept clinical trial using its proprietary HuCNS-SC® platform of human neural stem cells for the treatment of cervical spinal cord injury (SCI).
T2 Biosystems (Nasdaq:TTOO), a company developing innovative diagnostic products to improve patient health, today announced that the T2Candida® Panel and the T2Dx® Instrument will be included in four oral and poster presentations during IDWeek 2014™.
Therapix Bio (TASE:TRPX) (OTC:THXBY) today announced that its American Depository Receipts (ADRs) have been registered and approved for trading on OTCQB®. The ADRs, each representing 20 ordinary shares, began trading on October 6, 2014 under the symbol THXBY.