|Anthera Announces Termination of Blisibimod Partnership in Japan by Zenyaku; OxySure to Host Special Stockholder Meeting|
|By Marilyn Mullen|
|Monday, 14 September 2015 19:03|
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 14, 2015.
Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) announced receipt of a termination notice from its development partner in Japan, Zenyaku, terminating the December 2014 Collaboration and License Agreement (the "License Agreement") effective January 7, 2016. The termination was "at will" and alleged no breach of the License Agreement by Anthera. At the time of the notification, no patients had been enrolled in any blisibimod clinical studies in the Zenyaku territory and Zenyaku had not purchased any blisibimod product from Anthera.
"Progress of blisibimod in Japan, particularly for IgA nephropathy, has been disappointing," said Paul F. Truex, Anthera's President and Chief Executive Officer. "Zenyaku's termination of the License Agreement will provide flexibility for us to pursue a potentially optimized development path for blisibimod in IgA nephropathy and facilitate discussions with alternative partners in Asia at the appropriate time. As a result of our financing efforts over the past twelve months, including Zenyaku's substantial equity investments and cost reimbursements, we remain well funded to advance the development of blisibimod and Sollpura."
As previously disclosed, Anthera entered into a collaboration and license agreement with Zenyaku in December 2014. The License Agreement required Zenyaku, subject to mutually agreed timelines, to develop and commercialize blisibimod in Japan. Prior to the notification of termination Zenyaku purchased $9.0 million of Anthera common stock at a thirty-percent premium to a trailing market price.
"Regaining full worldwide control of blisibimod development, and in particular the IgA nephropathy program, is exciting as we are now free to consider additional approaches including the potential examination of the clinical data from the BRIGHT-SC study at an earlier time point than originally planned," said Anthera's Chief Medical officer, Dr. Colin Hislop. "The BRIGHT-SC study remains fully blinded and will continue as planned with all currently enrolled patients continuing to follow the protocol."
About Blisibimod -- Blisibimod is a selective peptibody antagonist of the B-cell activating factor (BAFF) cytokine that is initially being developed as a treatment for lupus and IgA nephropathy. BAFF is a tumor necrosis family member and is critical to the development, maintenance and survival of B-cells. It is primarily expressed by macrophages, monocytes and dendritic cells and interacts with three different receptors on B-cells including BAFF receptor, or BAFF-R, B-cell maturation, or BCMA, and transmembrane activator and cyclophilin ligand interactor, or TACI. The BAFF-R receptor is expressed primarily on peripheral B-cells. Blisibimod consists of a novel BAFF binding domain fused to the N-terminus of the Fc region of human antibody. Blisibimod binds to BAFF and inhibits the interaction of BAFF with its receptors. The role of BAFF in lupus has recently been clinically validated in multiple late-stage clinical studies with anti-BAFF antibodies. We intend to advance the development of our BAFF antagonist, blisibimod, to exploit its broad potential clinical utility in autoimmune diseases, with initial focus on lupus. Blisibimod demonstrates anti-BAFF activity and has been shown to be safe and effective in selectively modulating and reducing B-cells in Phase 1 and Phase 2 clinical studies in lupus patients.
OxySure Systems, Inc. (OTCQB: OXYS), the medical device innovator of life-saving easy-to-use emergency oxygen solutions with its "oxygen from powder" technology and other medical solutions, today issued a reminder that the Company will conduct an Investor Day, from 10:00 a.m. to 11:30 p.m. CST on Tuesday, September 15, 2015. The event will be at the Company's headquarters, located at 10880 John W. Elliott Drive, Suite 600, Frisco, Texas 75033, and will be hosted by Board members Tom Cox, Jerry Jones, and Julian Ross.
In addition, the Company will be conducting a Special Meeting of its stockholders on the same day, commencing at 12:00 noon CST pursuant to proxy statements that were mailed to stockholders on August 19, 2015. At the Special Meeting, stockholders are expected to vote on matters related to an uplisting of the Company to a national exchange such as Nasdaq and an amendment of the Company's structure to facilitate significant future growth. Copies of the proxy statement can be found on the website of the Securities and Exchange Commission, located here:
A tour of the Company's production plant and operations will be provided. In addition, Cliff Meidl, Two-Time Olympian, USA Olympic Team Flag Bearer and OxySure Spokesman, will provide a motivational presentation, as well as other survivors who will be available to share their lifesaving and life changing stories.
Availability for interested parties is extremely limited. Those interested in attending should contact Kathryn Jayne at 972-294-6551 or at [email protected]
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, today announced participation in the following two investor conferences: James Noble, Chief Executive Officer of Adaptimmune, will present at the 2015 Morgan Stanley Global Healthcare Conference at 4:05 PM ET (9:05 PM BST) on Thursday, September 17, 2015.
Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development (OOPD) awarded a grant totaling $1.1 million over three years to Baylor College of Medicine in support of an ongoing Phase 2 trial of Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac (ADXS-HPV), in HPV-associated oropharynx (throat) cancer, a type of head and neck cancer.
Akers Biosciences, Inc. (NASDAQ:AKER) (AIM:AKR.L), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, announces that sales of the Company's consumer-focused METRON® Breath Ketone Test - the first and only disposable breath ketone test - have commenced through the Amazon Marketplace and via the Company's online sales portal www.metron.akersbio.com.
Amarantus BioScience Holdings, Inc. (OTCQX:AMBS), a biotechnology company developing therapeutic and diagnostic product candidates in orphan indications and neurology, announced that the U.S. Food and Drug Administration (FDA) has granted the company's investigational drug mesencephalic-astrocyte-derived neurotrophic factor (MANF) orphan drug designation for the treatment of retinal artery occlusion (RAO). RAO is a blockage of the blood supply to the retina which causes severe and sudden loss of vision.
Amgen (NASDAQ: AMGN) will participate in the Morgan Stanley Global Healthcare Conference on Wednesday, Sept. 16, 2015, at the Grand Hyatt New York in New York City, beginning at 9:55 a.m. ET.
Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced receipt of a termination notice from its development partner in Japan, Zenyaku, terminating the December 2014 Collaboration and License Agreement (the "License Agreement") effective January 7, 2016.
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for cancer and other life threatening diseases, today announced that four abstracts supporting the ongoing development of AR-12 as a broad-spectrum, antimicrobial drug have been accepted for presentation, one of which will be a podium presentation, at the upcoming Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) / International Congress of Chemotherapy and Infection (ICC) 2015, jointly hosted by the American Society for Microbiology (ASM) and International Society of Chemotherapy (ISC), and being held September 17-21, 2015 in San Diego, CA.
BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers, today announced that UK-based TC Biopharm Ltd, a developer of anti-cancer immunotherapies, has incorporated the Company's CryoStor clinical and commercial grade freeze media in its manufacturing and clinical delivery processes of ImmuniCell, a novel T cell based immunotherapy targeting various cancers.
CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant recipients, today announced that its proprietary donor-derived cell-free DNA (dd-cfDNA) technology has been selected to be studied in a major National Institutes of Health (NIH)-sponsored multicenter study of clinical outcomes in kidney transplantation.
Cellular Biomedicine Group Inc. (NASDAQ:CBMG), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, today announced a scheduled poster presentation during the 2015 European Cancer Congress (ECCO) annual meeting to be held in Vienna, Austria from September 25-29, 2015.
Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced an extension of its contract with the Biomedical Advanced Research and Development Authority (BARDA) for the development of the broad spectrum antiviral, brincidofovir, as a medical countermeasure to treat smallpox.
Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that data from the Company's Phase 2a portion of the Phase 1/2a clinical trial of GALE-301, or Folate Binding Protein, will be presented at the upcoming European Society for Medical Oncology (ESMO) European Cancer Congress 2015 in Vienna, Austria.
Gear International, Inc.(OTC PINK: GEAR) is pleased to announce that Cannaworx, a GEAR portfolio company, has partnered with Innovative Extractions to acquire cutting edge extraction systems in order to develop proprietary cannabis and hemp based products.
The Hawai'i Medical Service Association (HMSA) and Healthways, Inc. (NASDAQ:HWAY) are announcing a new extended agreement to better support their efforts to improve the health and well-being of Hawaii as an evolution of their partnership, which currently spans 15 years.
iCAD, Inc. (Nasdaq:ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that the Company will present at the 6th Annual Craig-Hallum Alpha Select Conference in New York City.
Innocoll AG (NASDAQ:INNL) announced that James P. Tursi, M.D., will depart Innocoll to pursue another opportunity.
Kite Pharma, Inc. (Nasdaq:KITE) today announced that it has expanded its collaboration with the Netherlands Cancer Institute (NKI).
Lion Biotechnologies, Inc. (Nasdaq:LBIO) a biotechnology company that is developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TIL), today announced that it has opened enrollment in a Phase 2 clinical trial of its lead product candidate, LN-144, for the treatment of refractory metastatic melanoma.
Marrone Bio Innovations, Inc. (NASDAQ:MBII), a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets, announced today that its GRANDEVO bioinsecticide has received a completeness determination from the European Commission and is now cleared to begin the evaluation for Annex 1 listing and commercialization in the European Union.
MediWound Ltd. (Nasdaq:MDWD), a fully integrated biopharmaceutical company specializing in innovative therapies to address unmet needs in severe burn and wound management, announces that a "Meet the Expert" panel chaired by BMO Capital Markets and comprised of leading burn specialists from across Europe will be convened at the upcoming 16th European Burns Association (EBA) Congress on September 17th at 1:00 p.m. Eastern time.
Merge Healthcare Incorporated (NASDAQ:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, entered into an agreement to provide its Merge Hemo™ solution to Baptist Health System of Birmingham, Alabama.
Myriad Genetics, Inc. (NASDAQ:MYGN) announced today that Mark C. Capone, president and CEO, Myriad Genetics, is scheduled to present at the Morgan Stanley Healthcare Conference at 9:20 a.m. EDT on September 18, 2015, at the Grand Hyatt in New York City, New York.
Northwest Biotherapeutics (NASDAQ: NWBO), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that CEO Linda Powers will present at the SMi 4th Annual Cancer Vaccines Conference in London on Wednesday, September 16, 2015 at the Marriott Hotel, Regents Park.
Nuo Therapeutics, Inc. (OTCQX:NUOT), a pioneer in biodynamic therapies, today announced it has launched a series of educational tools designed to aid wound care centers in making the transition from ICD-9 to ICD-10 in advance of the October 1st 2015 implementation date, as mandated by the Centers for Medicare & Medicaid Services (CMS).
OncoSec Medical Incorporated (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced the appointment of David P. Meininger, PhD, MBA, to the newly created position of Senior Vice President of Business Development, effective today.
ProQR Therapeutics N.V. (NASDAQ:PRQR) today announced that PQ-010-002 is open for enrollment. The primary objective of PQ-010-002 is to estimate the effect of topical administration of QR-010 on the nasal mucosa in the restoration of CFTR function, as measured by Nasal Potential Difference (NPD). PQ-010-002 is an open-label, exploratory study evaluating the effect of QR-010 in ∆F508 homozygous (carry two allelic copies) and compound heterozygous (carry one copy of the ∆F508 mutation and one other disease causing mutation) cystic fibrosis (CF) patients. QR-010 is a novel investigational RNA therapeutic designed to repair the genetic mutation in the mRNA of CF patients due to the ∆F508 mutation.
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today announced that Dr. Paul Ashton, President and CEO, will present at the Ladenburg Thalmann 2015 Healthcare Conference on September 29, 2015 at 10:30 a.m. ET at the Sofitel Hotel in New York City.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today announced topline results from the Phase 2b CyNCh study, which did not meet its primary endpoint of improving nonalcoholic steatohepatitis (NASH) in children.
VBI Vaccines Inc. (Nasdaq:VBIV) is pleased to announce the promotion of Dr. David E. Anderson, Ph.D., to Chief Scientific Officer.