Idenix Pharma Will Cease IDX 184, IDX 19368; Gilead Announces Sustained Virologic Response Rates Studies of Sofosbuvir Print E-mail
By Staff and Wire Reports   
Monday, 04 February 2013 20:09

Below is a look at some of the headlines for companies that made news in the healthcare sector on February 4, 2013. Shares of Idenix Pharma (NASDAQ: IDIX) were halted during after-hours trading Monday. The company announced that it has "elected not to continue its clinical development program" for IDX184. In addition, it will not continue its development of IDX19368.

The company cites a decision by the FDA to keep the IDX184 and IDX19368 programs on clinical hold. Due to this decision, Idenix Pharma has elected to cease the development.


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Gilead Sciences (NASDAQ:GILD)
announced topline results from two Phase 3 studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide sofosbuvir in combination with ribavirin (FISSION) and in combination with ribavirin and pegylated interferon (NEUTRINO) among treatment-naïve patients with chronic hepatitis C virus (HCV) infection.

In the FISSION study, patients with genotype 2 or 3 HCV infection were randomized to receive either a 12-week course of sofosbuvir plus ribavirin (RBV) or standard of care with 24 weeks of pegylated interferon alfa-2a (peg-IFN) plus RBV. The study met its primary efficacy endpoint of non-inferiority of sofosbuvir plus RBV to peg-IFN plus RBV, with 67 percent (170/253) of patients achieving a sustained virologic response (SVR) in the sofosbuvir plus RBV treatment group versus 67 percent (162/243) in the peg-IFN plus RBV treatment group (95 percent CI for the difference: -7.5 to +8.0 percent for sofosbuvir plus RBV versus peg-IFN plus RBV; predefined criterion for non-inferiority was a lower bound of a two sided 95 percent CI of -15 percent). All common adverse events (e10 percent in any group) occurred more frequently in subjects receiving peg-IFN and RBV as compared to sofosbuvir and RBV. The most common adverse events in the sofosbuvir plus RBV arm occurring in e10 percent of the patients were fatigue, headache, nausea, insomnia and dizziness.

In the NEUTRINO study, patients with genotype 1, 4, 5 or 6 HCV infection were treated with a 12-week course of sofosbuvir, RBV and peg-IFN. This study met its primary efficacy endpoint of superiority compared to a predefined historic control SVR rate of 60 percent with 90 percent (295/327) of patients achieving SVR12 after completing therapy (P<0.001).

In the NEUTRINO study the most common adverse events that occurred in e20 percent of patients were fatigue, headache, nausea, insomnia and anemia.

These data support the favorable clinical profile of sofosbuvir as the backbone of a potent, safe and well-tolerated treatment regimen that is effective across a broad range of HCV patient genotypes, said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer, Gilead Sciences. The sofosbuvir regimens in these trials allowed us to shorten the duration of effective hepatitis C therapy to just 12 weeks for treatment-naïve patients with genotypes 1 through 6.


Also Monday:


ALR Technologies (OTCBB: ALRT)
, a medical device company providing remote monitoring and care facilitation for patients with chronic diseases, today delivered the following letter to its shareholders.

Amarantus BioScience, Inc. (OTCQB: AMBS)
, a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis centered around its patented therapeutic protein MANF, today reported that upon further analysis of the data reported on January 9th, 2013, the striatal reinnervation (densitometry) data produced in the 6 hydroxydopamine (6-OHDA) neurorestoration rat model of Parkinson's disease for MANF at 36ug achieved a statistically significant improvement over the data produced for GDNF, with a P value of 0.047.

AmpliPhi Biosciences Corporation [APHB.PK] (“Ampliphi”) (OTCBB:APHB)
, the anti-infective company focused on developing phage-based therapies to combat the growing threat of antibiotic-resistant infection, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 13/333,684 entitled “Bacteriophage-Containing Therapeutic Agents”.

Array BioPharma Inc. (NASDAQ: ARRY)
today reported results for the second quarter of its fiscal year ending June 30, 2013.

Bioanalytical Systems, Inc. (NASDAQ:BASI)
will release financial results for the first quarter ended December 31, 2012 at approximately 8:30 a.m. EST on Thursday, February 14, 2013.

BioClinica, Inc. (NASDAQ: BIOC)
, a leading global provider of clinical trial management solutions, will release its financial results for the fourth quarter and year ended December 31, 2012 on Wednesday, February 6, 2013.

BioLife Solutions, Inc. (OTCBB: BLFS)
, a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract media manufacturer, today announced that Rick Stewart, Chief Executive Officer of Kirkland, Washington-based Cardiac Dimensions, has joined its board of directors and has been appointed to its Audit Commitee. Stewart replaces Howard Breslow, who submitted his resignation from the board.

BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX)
, a biopharmaceutical development company, notes that, as previously disclosed, results from the interim analysis of the Phase II/III CLARITY clinical trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, are expected to be reported during the week of March 18, 2013.

BioSpecifics Technologies Corp. (NASDAQ: BSTC)
, a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX® in Europe and Eurasia, today announced that The Journal of Urology has electronically published the uncorrected proof of the pivotal IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials on its website at www.jurology.com.

Celgene Corporation (NASDAQ: CELG)
plans to present at three upcoming investor conferences.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, today reported net income for the quarter ended December 31, 2012, of $91.1 million, or $0.77 per diluted share, compared to net income of $63.1 million, or $0.53 per diluted share, for the same period in 2011.

EasyMed Services, Inc. (CNSX:EZM) (PINKSHEETS:EMYSF) (MUN:EY6)
is pleased to announce that it has entered into a commercial agreement with Geneva-based GKAN Holdings SA ("GKAN") to target new customers.

GelStat Corporation (PINKSHEETS: GSAC)
, a consumer healthcare company primarily focused on the development and marketing of over-the-counter (OTC) products for the safe and effective treatment of pain, inflammation and sleep disorders, announces that it has retained List Services Corp. ("LSC") to manage all branding and marketing efforts for GelStat Corporation and its products.

Gilead Sciences (Nasdaq:GILD)
today announced topline results from two Phase 3 studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide sofosbuvir in combination with ribavirin (FISSION) and in combination with ribavirin and pegylated interferon (NEUTRINO) among treatment-naïve patients with chronic hepatitis C virus (HCV) infection.

Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY)
, a publicly traded portfolio of biotech companies, based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, today announced that its portfolio company, KAHR Medical Ltd. ("KAHR"), was granted a U.S. patent approval (U.S. Patent No. 8329657).

Hanover Portfolio Acquisitions (OTCQB: HVPA)
, an intellectual property investment and monetization firm, announced today that Robert Fidler, an equestrian industry expert and former owner of hundreds of racehorses, has joined the Company as a Strategic Advisor.

ICON plc, (NASDAQ:ICLR) (ISIN:IE0005711209)
, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has agreed, subject to certain closing conditions, to acquire the Clinical Trial Services Division of Cross Country Healthcare, Inc. (NASDAQ:CCRN), for a cash consideration of $52 million, plus an earn-out of up to $3.75 million related to certain performance-based milestones.

IGI Laboratories, Inc. (NYSE MKT: IG)
, a New Jersey based generic topical pharmaceutical company, today announced it has entered into an agreement to purchase the topical pharmaceutical product Econazole Nitrate Cream 1% from Prasco, LLC., a privately-held pharmaceutical company located in Ohio.

InspireMD, Inc. (OTC: NSPRD)
announced financial results for the period ended Dec. 31, 2012, the second quarter of its 2013 fiscal year.

Life Technologies Corporation (NASDAQ: LIFE)
today announced results for its fourth quarter for the year ended Dec. 31, 2012.

Luminex Corporation (NASDAQ: LMNX)
today announced financial results for the fourth quarter and year ended December 31, 2012.

Medbox, Inc. (OTC Markets: MDBX)
(www.medboxinc.com), announced that they have initiated a program through their public education division that will engage in an informational campaign featuring printed literature to be distributed to future retail marijuana establishments as well as online support services through a website.

The Medicines Company (Nasdaq: MDCO)
and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that they have formed an exclusive global alliance for the development and commercialization of Alnylam’s ALN-PCS RNAi therapeutic program for the treatment of hypercholesterolemia.

Medivation, Inc. (NASDAQ: MDVN)
today announced that Kathryn E. Falberg has been elected to the Company's Board of Directors.

MMRGlobal, Inc. (OTCQB: MMRF)
, through its wholly owned subsidiary MyMedicalRecords, Inc. (MMR), and Interbit Data (Interbit), strategic partner and Licensee, today announced that Sturgis Hospital in Michigan, a 5-Star Acute-Care hospital, has gone live with MyMedicalRecords Personal Health Record (PHR) and patient portal (www.mmrpatientvideos.com).

Novadaq®Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ)
, a developer of clinically-relevant fluorescence imaging solutions for use in surgical procedures, today announced that Dr. Arun Menawat, the company's President and Chief Executive Officer, will present Novadaq's corporate overview at two investor healthcare events in February.

Rafarma Pharmaceuticals, Inc. (OTC:RAFA)
announced that it has received the general license for pharmaceutical products and has started the manufacturing of 3 new products.

Regulus Therapeutics Inc. (NASDAQ: RGLS)
, a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus, will present a company overview at the 15th Annual BIO CEO & Investor Conference on Tuesday, February 12, 2013 at 1:00 pm EST.

RepliCel Life Sciences Inc. (CNSX:RP) (OTCBB:REPCF)
(the "Company" or "RepliCel") is pleased to report that it will be meeting with the German Competent Authority responsible for cellular therapies (the Paul Ehrlich Institute (PEI)) to discuss plans for its upcoming Phase II clinical trial for its autologous hair cell product, RCH-01, on February 5, 2013.

Rockwell Medical (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 deficiency, secondary hyperparathyroidism and hemodialysis, announced successful topline results from the PRIME clinical study of Soluble Ferric Pyrophosphate (SFP), its investigational iron-delivery drug currently in Phase 3 clinical studies for the treatment of iron deficiency in hemodialysis patients.

RXi Pharmaceuticals Corporation (OTC: RXII)
, a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced that the Company’s President and Chief Executive Officer, Dr. Geert Cauwenbergh, will present at the 15th Annual BIO CEO & Investor Conference on Monday, February 11th at 4:00pm ET.

Soligenix, Inc. (OTCQB: SNGX)
(Soligenix or the Company), a development-stage biopharmaceutical company, announced today the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it advances the development of SGX942 for the treatment of oral mucositis, a common complication of cancer treatments.

SpectraScience, Inc. (OTCQB: SCIE)
CEO Michael P. Oliver, was recently interviewed on the popular broadcasting website CorporateProfile.com, an online financial news company providing retail and institutional investors with insight into the companies that are making headlines through its unique and entertaining platform.

St. Jude Medical, Inc. (NYSE:STJ)
, a global medical device company, today announced the first patient implant of its 25 mm Portico™ Transcatheter Aortic Heart Valve using the Transfemoral Delivery System in its ongoing European trial.

Targacept, Inc. (NASDAQ: TRGT)
, a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), today announced that Dr. Stephen A. Hill, President and Chief Executive Officer, is scheduled to present at the 15th Annual BIO CEO & Investor Conference at The Waldorf Astoria New York in New York City on Monday, February 11, 2013 at 1:00 p.m. Eastern Time.

United Therapeutics Corporation (NASDAQ: UTHR)
today announced that its Board of Directors authorized the repurchase of up to an additional $420 million of the company's common stock.  

Verenium Corporation (Nasdaq: VRNM)
, a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today announced the commercial launch of Pyrolase® HT cellulase, a next-generation cellulase enzyme for use as a biocatalyst to break down the guar-based gel used in hydraulic fracturing.
VIASPACE, Inc. (OTCQB: VSPC)
today announced that Chairman, Dr. Kevin Schewe and CEO, Dr. Carl Kukkonen, together attended the 16th Annual Energy, Utility and Environment Conference (EUEC) held in Phoenix, Arizona from Monday, January 28 through Wednesday, January 30, 2013.

Z Trim Holdings, Inc. (OTC: ZTHO)
, a bio-technology company providing value-added ingredients to a variety of industries, today announced that it recorded, in the month of January 2013, sales growth of 22% over sales in January 2012.




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