Oxygen Bio Reports Deal to Buy Levosimendan from Phyxius; Rockwell Announces Safety Results From Triferic Print E-mail
By Staff and Wire Reports   
Monday, 21 October 2013 19:33

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 21, 2013.

Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT) a developer of oxygen-carrying therapeutics, announced it has signed a Definitive Agreement (“Agreement”) to acquire certain assets of Phyxius Pharma, a privately-held biopharmaceutical company focused on the development and near-term commercialization of levosimendan to prevent and treat cardiac surgery patients at risk for developing low cardiac output syndrome (LCOS), a significant unmet medical need addressing an estimated $600 million market in the U.S.

According to the terms of the Agreement, Oxygen Biotherapeutics will acquire the exclusive rights to develop and commercialize levosimendan in North America, as well as integrating three key Phyxius Pharma executives into the Company's management team. The transaction is valued at approximately $4.8 million in stock as of October 18, 2013, based on Oxygen Biotherapeutics issuing an aggregate of approximately 3.4 million shares of its common stock and securities convertible into common stock to Phyxius Pharma's stockholders in a private placement. Upon closing of the transaction, Phyxius Pharma Co-Founder and CEO, John Kelley is to become CEO of Oxygen Biotherapeutics.

Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE MKT:LTS) acted as a financial advisor for the transaction.



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Rockwell Medical (NASDAQ: RMTI)
nnounced positive safety results of its large Phase 3 short-term safety study that was conducted in support of the New Drug Application for marketing approval of Triferic™. Triferic™ is the Company's late-stage investigational iron-replacement drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis.

"We are very pleased with the results of the short-term safety study," stated Mr. Rob Chioini, Founder, Chairman and CEO of Rockwell. "Triferic's™ clean safety profile together with its unique mode of action enabling efficient iron delivery and hemoglobin maintenance, while significantly reducing the need for ESA, highlight its potential to be the market-leading iron therapy treatment for CKD-HD patients."

"We continue to be impressed with Triferic™ and its safety profile," stated Dr. Ray Pratt, CMO of Rockwell. "Our clinical program is easily the largest and longest cohort of any parenteral iron drug and after 100,000 accumulated administrations we have not seen a single acute safety signal or anaphylactic reaction. This additional safety data, coupled with the successful Phase 3 CRUISE studies and ongoing open-label study, gives us great confidence that Triferic™ can provide dialysis patients safe, effective iron therapy."

This safety study was a prospective, randomized, double-blinded, placebo-controlled, crossover, multicenter, multinational, Phase 3 study with an enrollment of 718 CKD-HD patients in the US and Canada. It is followed by an ongoing optional open-label, uncontrolled extension study. Consistent with expectations, this study demonstrated that: Triferic™ reliably delivers iron via dialysate. There were no specific adverse events directly attributable to Triferic™. The adverse events during Triferic™ administration were those common in CKD-HD patients. No difference in type, frequency, severity or resolution of adverse events between Triferic™ and placebo. No anaphylaxis or hypersensitivity attributable to Triferic™. No evidence of changes in hepatic enzymes between Triferic™ and placebo. No evidence of first use events or an increase in hypotension.

In conclusion, the safety profile of Triferic™ is no different from placebo in this large, short-term safety study. Triferic™ shows no acute safety signals when administered via dialysate. The results of this study will be presented at the upcoming American Society of Nephrology meeting in Atlanta, GA November 6-10 2013.



Also Monday:



Altegra Health Inc., a leading provider of business, technology and consulting solutions that improve healthcare organization performance, today announced that Cigna Corporation (NYSE:CI) has selected Altegra Health to help optimize risk analytics and strategically enhance enrollee communications and engagement for the new commercial health insurance marketplace.

Anacor Pharmaceuticals (NASDAQ:ANAC) today announced it has entered into a research agreement with the United States Department of Defense, Defense Threat Reduction Agency (DTRA) to design and discover new classes of systemic antibiotics.

Aratana Therapeutics, Inc. (Nasdaq: PETX), a biopharmaceutical company focused on the licensing, development and commercialization of innovative medications for pets, today announced that it has elected Merck & Co, Inc.'s former Chief Marketing Officer Wendy Yarno to its Board of Directors.

ActiveCare, Inc. (OTCBB:ACAR), a leader in diabetes management wellness services, today announced the addition of Michael H. Sonnenberg to its Strategic Advisory Board. Sonnenberg, Founder and President of International Benefits Administration, is a recognized thought- leader in healthcare plan management aimed at delivering the highest quality of care while effectively managing the cost of that care for its partners and clients. 

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today announced the appointment of Ernest R. De Paolantonio, CPA MBA as Chief Financial Officer and Corporate Secretary.

Caliber Imaging & Diagnostics (OTCQB:LCDX)
formerly Lucid, Inc., was featured in an article in the Boston Globe on October 14.

Cellceutix Corporation (OTCQB: CTIX)
, a clinical stage biopharmaceutical company focused on discovering, developing and commercializing drugs to treat unmet medical conditions, is pleased to announce that it has expanded the infrastructure of the Company to accommodate the planned initiation of five Phase 2 clinical trials in 2014.

Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC)
today announced the presentation of findings from a preclinical study of PIXUVRI® (pixantrone) that suggest its mechanism of inducing tumor cell death is novel and distinct from that of anthracyclines such as doxorubicin.

CEL-SCI Corporation (NYSE MKT:CVM)
announced today it has held the Investigator Meeting for the European clinical investigators participating in the ongoing Phase III clinical trial of CEL-SCI’s investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Inj.).

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
announced today that data from two of its clinical programs, the Phase 1 dose-escalation CDX-1127 study and the Phase 2 recurrent rindopepimut study, will be presented at two upcoming medical meetings, the Society for Immunotherapy of Cancer (SITC) and the Society of Neuro-Oncology (SNO), respectively.

Celsius Holdings, Inc., (Other OTC:CELH)
the creator and marketer of Celsius®, the world's first and only negative calorie drink backed by clinical science, today reported its results of operations for the three and nine months ended September 30, 2013.

Cerus Corporation (NASDAQ: CERS)
announced today that Daniel Swisher, a Cerus director since June 2011, has been elected Chair of the Cerus Board of Directors, effective immediately.

Claritas Genomics, together with partners Life Technologies (NASDAQ: LIFE) and Lockheed Martin (NYSE: LMT), announced today that the Department of Veterans Affairs has awarded Claritas a $9 million contract for exome sequencing of Veteran samples, including those from the Million Veteran Program (MVP) over the next 12 months. 


CoroWare, Inc. (OTCQB: COWI)
announced today that the Depository Trust Company (DTC), has lifted the "Deposit Chill" on the Company's stock effective September 26, 2013, and has resumed accepting deposits of CoroWare's common stock for book entry transfer services. All deposit restrictions have been removed, and the Company is now once again fully "DTC Eligible", and has resumed electronic trading of the Company's common stock.

Dehaier Medical Systems Ltd. (Nasdaq:DHRM) ("Dehaier" or the "Company"), an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products, today announced that its management team will visit Israel to meet with high-tech medical companies and pursue further discussions with its long-term partner, WideMed Ltd., to broaden cooperation opportunities.

Depomed, Inc. (NASDAQ: DEPO) today announced that it has sold its interests in royalty and milestone payments under its license agreements in the Type 2 diabetes therapeutic area to PDL BioPharma, Inc. for $240.5 million.

DMH International, Inc. (OTCBB: DMHI) (OTCQB: DMHI)
, announced today that they had signed a definitive Letter of Intent to acquire 100% of Virtual Physician's Network (VPN), a medical software and applications provider.

Enzymotec Ltd. (Nasdaq:ENZY)
today announced that it will release financial results for the third quarter ended September 30, 2013 on Monday, November 11, 2013, before the market opens.

Given Imaging Ltd, (Nasdaq:GIVN)
, a world leader in GI medical devices and pioneer of capsule endoscopy, today announced results from two studies highlighting the clinical and economic benefits of PillCam ESO in the evaluation of patients with acute upper gastrointestinal (GI) bleeding in the emergency department setting.

Groupe Athena, Inc. (OTC Pink: GATA)
today posted their quarterly results for the three months ending September 30, 2013.

GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP)
, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced the successful closing of the European Mutual Recognition Procedure (MRP) in France for Sativex® oromucosal spray in the treatment of spasticity due to Multiple Sclerosis (MS) and a resulting recommendation for approval by the French authorities.

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, announced that it has hired Yoav Sibony, a veteran sales manager, as Harvard Bioscience's Vice President of Global Sales, a newly created position, effective October 21.

ICU Medical, Inc., (Nasdaq:ICUI)
, a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, announced today that due to health reasons Dr. George Lopez, ("Doc") will step down as President and Chief Executive Officer.

University of Cambridge, Genomics England Ltd., and Illumina, Inc. (NASDAQ:ILMN) today announced the start of a three-year project that will sequence 10,000 whole genomes of children and adults with rare genetic diseases.

IsoRay Inc. (NYSE MKT: ISR) (NYSE Amex: ISR)
, a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced it will host a booth October 21-24th at the Annual Meeting of the Congress of Neurological Surgeons.

La Jolla Pharmaceutical Company (OTCBB: LJPC)
, a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for patent application number 13/888,305 covering compositions of modified pectin.

Life Technologies Corporation (NASDAQ: LIFE)
and BGI, the world's largest genomics center and service provider, jointly announced that BGI has purchased 37 Ion Proton™ Sequencers and plans to add at least a dozen more by the end of the year, strengthening the organization's leadership position in the genomics industry.


Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) announced today that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014, for the Company's New Drug Application (NDA) for ZerenexTM (ferric citrate coordination complex), the Company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis.

 

MELA Sciences, Inc. (Nasdaq:MELA), a leader in the fight against melanoma with MelaFind®, the first and only FDA approved optical diagnostic device for melanoma detection used by dermatologists, today announced the results of four studies which were displayed in poster presentations at the Fall Clinical Dermatology Conference which took place from October 17 – 20, 2013 in Las Vegas, Nevada.

NanoViricides, Inc. (NYSE MKT:NNVC)
reports that its optimized injectable FluCide® drug candidate was found to be well tolerated in a non-GLP small animal safety/toxicology study. This study is an important step in the drug development pathway for FluCide. This study will provide guidance for the IND-enabling GLP safety and toxicology study.

NeuroGenesis, Inc. (PINKSHEETS: NEUN)
-- With numerous suicides monthly by returning veterans suffering from PTSD as reported in the Galveston Daily News and talked about on national talk shows like the Rush Limbaugh show, one company may have the answer.

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today reported data for four of its five clinical-stage programs at poster sessions at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 19-23, 2013, at the Hynes Convention Center in Boston, MA.

Opexa Therapeutics, Inc. (NASDAQ: OPXA)
, a biotechnology company developing Tcelna®, a novel T-cell immunotherapy for the treatment of multiple sclerosis (MS), today announced that the Company has been featured in Neurology Reviews.

Osiris Therapeutics, Inc. (NASDAQ:OSIR)
, announced today that it has reached agreement with the United States Food and Drug Administration (FDA) regarding the regulatory pathway for its Biosurgery products, Grafix® and Ovation®.

Pinacle Enterprise, Inc. (OTCBB: PINS) (OTCQB: PINS)
and its wholly owned subsidiary Alkame Water Inc. are pleased to announce that it has added two skateboarding legends, Ray "Bones" Rodriguez and Christian Hosoi to the Alkame Action Sports Team.

Press Ventures Inc.(OTCQB: PVEN)
, through its wholly-owned Polish subsidiary Biosafety Systems, Inc. Sp z o.o., is pleased to announce that it has engaged with the U.S. Environmental Protection Agency (EPA) office of pesticide programs, antimicrobial division in an effort to advance its application submissions to receive a "license to sell" designation for its patented Cedar Leaf Oil Diffusion ("CLO-D") biosafety system within the United States.

Puget Technologies (OTCBB: PUGE)
announced Cannabis Biotech, its subsidiary, is launching product research for a transmucosal delivery system whereby medical marijuana is delivered through the mucous membrane of the nasal cavity.

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA)
today announced a partnership with Clovis Oncology (NASDAQ: CLVS) to co-develop and co-commercialize a companion diagnostic test to guide the use of CO-1686, a novel Clovis Oncology product candidate currently in clinical development.

Seattle Genetics, Inc. (NASDAQ:SGEN)
today announced the initiation of a phase 1 clinical trial evaluating SGN-LIV1A for patients with LIV-1-positive metastatic breast cancer. SGN-LIV1A utilizes Seattle Genetics’ industry-leading antibody-drug conjugate (ADC) technology.


Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH)
, announced today presentation of positive results from a preclinical study of the Company's KLH-conjugate active immunotherapy vaccine demonstrating protection against Clostridium difficile ("C. diff") infection in mice.

StemCells, Inc. (Nasdaq:STEM) announced today the results of a four-year observation study in patients with neuronal ceroid lipofuscinosis (NCL), also referred to as Batten disease, who had been transplanted with the Company's proprietary HuCNS-SC® cells (purified human neural stem cells) in the initial Phase I study.

Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in the aesthetic medical device marketplace, announced that it has completed the multi-site clinical study for the UltraShape Contour I System for non-invasive abdominal circumferential reduction.

TherapeuticsMD, Inc. (NYSE MKT:TXMD)
announced today it will release its third quarter 2013 financial results on Monday, November 4, 2013 at approximately 4:00 pm EST and will host a conference call shortly thereafter at approximately 4:30 pm EST to review the results.

Transgene SA (Paris:TNG) (NYSE-Euronext: TNG)
today announced its financial results as of September 30, 2013 (third quarter and first nine months of 2013).

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)
, a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced it will release results for the third quarter of 2013 on Thursday, November 7, 2013, before the market opens.

Verastem, Inc. (NASDAQ:VSTM)
, focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, announced positive results from the Phase 1 portion of its Phase 1/1b study of defactinib (VS-6063) in combination with paclitaxel in patients with ovarian cancer that were presented at the 2013 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

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 preclinical data from three studies that highlight the versatility of the novel gene expression and control technology used to develop ZIOPHARM's synthetic biology pipeline in oncology.




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