Pharmasset Announces Initiation of Phase 3 Program for HCV; Vical Reports Financial Results Print E-mail
By Staff and Wire Reports   
Tuesday, 01 November 2011 19:04
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 1, 2011.

Pharmasset, Inc. (NASDAQ:VRUS) announced the initiation of a Phase 3 program with the hepatitis C virus (HCV) nucleotide analog, PSI-7977. This pivotal program will evaluate a 12-week, all-oral, interferon-free regimen of PSI-7977 and ribavirin in patients with HCV, independent of viral genotype or their ability to take interferon therapy.

The first trial, FISSION, will enroll approximately 500 treatment-naive patients with HCV genotype 2 or 3, and will evaluate the safety and efficacy of a 12-week interferon-free regimen of PSI-7977 and ribavirin compared to 24 weeks of pegylated interferon and ribavirin. The primary endpoint of the study is sustained virologic response 12 weeks after the completion of treatment (SVR12).

Pharmasset plans to initiate a second 12-week duration, interferon-free Phase 3 trial, POSITRON, in early 2012. This trial will enroll approximately 225 patients with HCV genotype 2 or 3 who cannot take interferon.

In mid-2012, Pharmasset intends to initiate a third 12-week duration, interferon-free Phase 3 trial, NEUTRINO. This trial will enroll patients who cannot take interferon, and will include patients with HCV regardless of viral genotype, including those with HCV genotype 1. The final study design will be based on emerging data from ELECTRON and from PSI-7977 plus RBV-containing arms in the ongoing QUANTUM study.

"Based on encouraging results to date, we have selected an IFN-free regimen of PSI-7977/RBV for our registrational program," said Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We continue to believe that interferon remains the greatest impediment to care for a majority of the millions of individuals living with HCV.  PSI-7977 has demonstrated high cure rates, without viral resistance, and across HCV genotypes; we hope to confirm these benefits in these registrational studies."

Pharmasset (VRUS +10.7%) jumps after announcing earlier it's initiated Phase 3 studies for its hepatitis C virus nucleotide analog, PSI-7977.

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Vical Incorporated (NASDAQ:VICL) reported financial results for the three months and nine months ended September 30, 2011. Revenues were $26.6 million for the third quarter of 2011 compared with $2.3 million for the third quarter of 2010, primarily as a result of the recognition of $25.1 million of license revenue for TransVax", Vical's therapeutic vaccine designed to control cytomegalovirus (CMV) reactivation in transplant recipients.

During the third quarter of 2011, Vical and Astellas Pharma Inc. entered into exclusive worldwide license agreements to develop and commercialize TransVax". The companies expect to begin a multinational Phase 3 registration trial of TransVax" in hematopoietic stem cell transplant (HSCT) recipients as well as a Phase 2 trial in solid organ transplant (SOT) recipients in the first half of 2012.

Under the agreements, Astellas will be responsible for further development and commercialization, including all costs. Vical has an option to co-promote TransVax" in the United States. Vical will provide assistance to Astellas with TransVax"-related manufacturing, regulatory and certain development activities, for which Astellas will reimburse all of Vical's future costs, including personnel and external expenses. Vical received $25 million upfront and will receive an additional $10 million upon finalization of the Phase 3 trial design, with potential total upfront and milestone payments through commercial launch of up to $130 million and double-digit royalties on net sales.

This development had a significant positive impact on Vical's third quarter financial results and is expected to continue to contribute to future financial results. Vical also reported progress during the third quarter in its Phase 3 Allovectin® immunotherapy program for metastatic melanoma and in its preclinical herpes simplex type 2 (HSV-2) vaccine program, as detailed below.

Shares of Vical (VICL +2.7%) buck the downtrend after its Q3 results blew out estimates. Revenue soared tenfold due to a surge in licensing revenue from its TransVax vaccine, which is designed to control cytomegalovirus reactivation in transplant recipients.



Also Tuesday:



Abbott (NYSE: ABT) today announced it has received U.S. Food and Drug Administration (FDA) approval for the next-generation XIENCE PRIME™ Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

Abiomed, Inc. (NASDAQ: ABMD)
, a leading provider of breakthrough heart support technologies, will host an investor and analyst day on Friday, December 9, 2011 from 2:00 to 4:30 p.m. at the New York Palace in New York City.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today it has formed a collaboration with GlaxoSmithKline (GSK) focused on Alnylam’s VaxiRNATM technology for certain GSK vaccine products, including influenza. VaxiRNA is a new RNAi technology for the enhanced production of viruses used in the manufacture of vaccine products.

Amarantus BioSciences, Inc. (OTCBB:AMBS), a biotechnology company developing MANF, a first-in-class disease–modifying therapeutic protein, today provided shareholders with an update on its corporate strategy.

AmerisourceBergen Corporation (NYSE: ABC) today announced that it has completed the previously announced acquisition of TheraCom, LLC, a subsidiary of CVS Caremark Corporation (NYSE: CVS).

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, announced today that it will host a conference call and live audio webcast at 8:30 a.m. EST on Tuesday, November 8, 2011 to report its third quarter 2011 financial results and provide a corporate update.

Cambrex Corporation (NYSE: CBM) announced that third quarter 2011 financial results will be released on Thursday, November 3, 2011 after the market closes.

Champions Oncology, Inc. (OTC Bulletin Board: CSBR), a company engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, has appointed Gary G. Gemignani to the Company's management team, as Executive Vice President and Chief Financial Officer.

Dyax Corp. (NASDAQ: DYAX)
, a developer of novel biotherapeutics for unmet medical needs, announced today the appointment of Ron Cohen, M.D. and Paolo Pucci to its Board of Directors.

Imaging3™, Inc. (OTCBB: IMGG)
, developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, today announced that the company's CEO, Mr. Dean Janes, summarized the meeting held with the FDA on October 17, 2011.

NanoLogix (Pink Sheets: NNLX), an innovator in the rapid detection, identification and antibiotic sensitivity determination of live bacteria announced today third-party results for detecting live Mycobacterium tuberculosis (TB) in a revolutionary time of 4 days with its BNP (BioNanoPore) technology.

Northwest Biotherapeutics (OTC.BB: NWBO) (Northwest Bio) today announced, as part of its program of public outreach and education, the availability online of an interview of Northwest Bio Chairman and CEO Linda Powers by CEO/CFO Publication.

Oncothyreon Inc. (Nasdaq: ONTY) today announced that it will conduct a conference call to discuss its third quarter 2011 financial results and provide a review of its pipeline of products in development on Tuesday, November 8, 2011 at 4:30 p.m. Eastern Standard Time.

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced that the Company will present at the 20th Annual Credit Suisse Healthcare Conference on Thursday, November 10 at 10:00 AM Eastern Time (7:00 AM Pacific Time).

Oncothyreon Inc. (Nasdaq: ONTY) today announced that it will conduct a conference call to discuss its third quarter 2011 financial results and provide a review of its pipeline of products in development on Tuesday, November 8, 2011 at 4:30 p.m. Eastern Standard Time.

TheDirectory.com, Inc. (PINKSHEETS: SEEK) today announced that it posted its seventh consecutive month of profitability during October.

VentriPoint Diagnostics (TSX VENTURE:VPT)(PINK SHEETS:VPTDF) announces the University of Chicago has secured a VentriPoint Medical System (VMS™) and has begun the clinical evaluation of the database for patients with Pulmonary Arterial Hypertension (PAH).

Vermillion, Inc. (NASDAQ: VRML), a leading molecular diagnostics company, has engaged Liolios Group to lead a new investor relations and financial communications program.



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