Myriad, Pharmamar Announces Partnership with New HRD Test; Gilead Announces Update on Phase 3 Study for Genotype 1 Hepatitis C Patients Print E-mail
By Staff and Wire Reports   
Tuesday, 26 March 2013 21:25
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 26, 2013.

Myriad Genetics, Inc. (Nasdaq: MYGN)
announced that it has signed an agreement with PharmaMar, a leader in the development of marine-derived drugs. Under the terms of the agreement, Myriad will conduct homologous recombination deficiency (HRD) testing on patients enrolled in PharmaMar's Phase II clinical study of PM1183, a novel drug candidate which induces double-stranded DNA breaks to cause cell death. This partnership represents Myriad Genetics' first publicly announced commercial collaboration with its new HRD test.

"We are very pleased to collaborate with PharmaMar on their PM1183 development program with our new HRD test," said Peter Meldrum, President and Chief Executive Officer of Myriad Genetics, Inc. "We believe HRD status is the most effective mechanism for assessing patient response to DNA-damaging drugs and look forward to working closely with PharmaMar on this exciting new companion diagnostic program."

Myriad's HRD test is able to detect when a tumor has lost the ability to repair DNA damage and would therefore be more susceptible to the DNA-damaging classes of drugs. The test directly measures the end result of the loss of the DNA repair function regardless of the genomic causation. The HRD test is effective at detecting the loss of function irrespective of whether the defects in the genes involved in the DNA repair mechanism were caused by hereditary germ line mutations or somatic mutations accumulated during the patient's life.

Myriad's HRD test has been shown to accurately predict drug response in both ovarian cancer patients and triple negative breast cancer patients. It is estimated that 490,000 Americans are diagnosed with cancers each year that are eligible for treatment with DNA damaging classes of drugs. This represents a one to two billion dollar market opportunity for the HRD test in the United States alone.

Under the terms of the agreement, Myriad will assess HRD status in patients who have been treated with PM1183 in PharmaMar's Phase II clinical study. Utilizing this information, Myriad and PharmaMar will hope to garner more information surrounding the role of HRD status in PM1183 response.


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Gilead Sciences (Nasdaq: GILD)
provided an update on ION-1, a Phase 3 clinical trial evaluating a once-daily fixed-dose combination of the nucleotide sofosbuvir and the NS5A inhibitor ledipasvir with and without ribavirin (RBV) for 12 or 24 weeks among treatment-naïve genotype 1 patients with hepatitis C virus (HCV) infection (n=800). A planned review by the study's Data and Safety Monitoring Board (DSMB) of safety data from 200 patients in all four arms and of SVR4 rates (sustained virologic response four weeks after completion of therapy) from 100 patients in the two 12-week duration arms concluded that the trial should continue without modification. This recommendation is based upon the observed SVR4 rates exceeding the predefined threshold of 60 percent and the absence of significant safety issues. Enrollment of the remaining 600 patients in ION-1 is now underway.

Sofosbuvir/ledipasvir is also being evaluated in a second Phase 3 study, ION-2, initiated in January 2013, which is now fully enrolled. ION-2 is evaluating sofosbuvir/ledipasvir with RBV for 12 weeks, and with and without RBV for 24 weeks, among 400 treatment-experienced genotype 1 HCV patients. Participants in this study failed to respond to past therapy containing pegylated interferon (peg-IFN) or peg-IFN plus a protease inhibitor.

Sofosbuvir, ledipasvir and the sofosbuvir/ledipasvir fixed-dose combination are investigational products and their safety and efficacy have not yet been established.


Also Tuesday:


Ablynx (EURONEXT BRUSSELS: ABLX)
today announced that its 2013 Annual and Extraordinary General meeting (AGM) will be held on Thursday, 25 April 2013 at 11:00h CET at its headquarters at Technologiepark 21, 9052 Ghent.

Advaxis, Inc., (OTCBB: ADXS)
, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that an abstract has been accepted for oral presentation at The Society for Immunotherapy of Cancer (SITC) Cancer Immunotherapy Clinical Trials: Concepts and Challenges workshop being held April 4-5, 2013 at the National Institutes of Health Campus (Masur Auditorium) in Bethesda, MD.

Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH)
, today announced financial results and business highlights for the quarter and fiscal year ended December 31, 2012.

Aradigm Corporation (OTC BB: ARDM.OB)
(the “Company”) today announced financial results for the fourth quarter and full year ended December 31, 2012.

BioSpecifics Technologies Corp. (NASDAQ: BSTC)
, a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S., today announced positive, statistically significant top-line data from the Phase IIa study of XIAFLEX for the potential treatment of frozen shoulder (adhesive capsulitis).

Connectyx Technologies Holdings Group, Inc. (OTC Pink: CTYX)
, www.connectyx.com, a Healthcare Business Process Outsourcing (BPO) company with personal healthcare product offerings, announced today that Global Medical Direct, Midwest Medical Services and Complete Medical Homecare, (GMD) have signed a management agreement with Connectyx to provide management consulting which will include compliance services, new business development and strategic planning.

Gilead Sciences, Inc. (Nasdaq: GILD)
today provided an update on ION-1, a Phase 3 clinical trial evaluating a once-daily fixed-dose combination of the nucleotide sofosbuvir and the NS5A inhibitor ledipasvir with and without ribavirin (RBV) for 12 or 24 weeks among treatment-naïve genotype 1 patients with hepatitis C virus (HCV) infection (n=800).

INSCOR, Inc. (PINKSHEETS: IOGA)
announces the release of its new program based on the company's FIT OPEB plan.

InSite Vision Incorporated (OTCBB: INSV)
today announced that the U.S. Court of Appeals for the Federal Circuit affirmed by a split decision the ruling of the United States Patent and Trademark Office (USPTO) panel of judges which found in favor of the Company in its patent interference litigation with the University of California, San Francisco (UCSF), and confirmed the inventorship of InSite Vision’s U.S. Patents Nos. 6,239,113 and 6,569,443 protecting AzaSite® , AzaSite Xtra™ and AzaSite Plus™.

Neogen Corporation (Nasdaq: NEOG)
announced today that its net income for the third quarter of FY 2013, which ended Feb. 28, increased 27% to $6,652,000, or $0.27 per share, compared to the prior year's third quarter net income of $5,244,000, or $0.22 a share.

PharmaRoth Labs, Inc. (OTCPink: FROI)
the exclusive producer, marketer & distributor of Sucanon®, an oral Type-II Diabetes treatment, proudly announced that the United States Food and Drug Administration (FDA) has received the Company's completed New Dietary Ingredient (NDI) Notification.

PrimeraDx, Inc., a molecular diagnostics company, today announced it has formed a non-exclusive diagnostics co-development agreement with Quest Diagnostics (NYSE: DGX), the world's leading diagnostics information services company.

SK3 Group, Inc. (OTC Pink: SKTO)
today announces that it has appointed Jeffrey Benz, an experienced business attorney and former executive with various sports, entertainment, and technology companies, as General Counsel and Executive Vice President of Business, Legal, and Government Affairs.

Synageva BioPharma Corp. (Synageva) (NASDAQ:GEVA)
, a clinical stage biopharmaceutical company developing therapeutic products for rare diseases, announced the publication of an article by Bernstein et al entitled, “Cholesteryl Ester Storage Disease: Review of the Findings in 135 Reported Patients with an Under-Diagnosed Disease” in the online version and an upcoming print edition of the Journal of Hepatology.



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