Hepatitis C related Press Releases

MIT: Stem cells could drive hepatitis research forward

Mark Hollmer — Wed, 01 Feb 2012 15:41:54 -0500

MIT: Stem cells could drive hepatitis research forward
By creating liver-like cells, scientists can study why people respond differently to the disease

CAMBRIDGE, Mass. -- Hepatitis C, an infectious disease that can cause inflammation and organ failure, has different effects on different people. But no one is sure why some people are very susceptible to the infection, while others are resistant.

Scientists believe that if they could study liver cells from different people in the lab, they could determine how genetic differences produce these varying responses. However, liver cells are difficult to obtain and notoriously difficult to grow in a lab dish because they tend to lose their normal structure and function when removed from the body.

Now, researchers from MIT, Rockefeller University and the Medical College of Wisconsin have come up with a way to produce liver-like cells from induced pluripotent stem cells, or iPSCs, which are made from body tissues rather than embryos; the liver-like cells can then be infected with hepatitis C. Such cells could enable scientists to study why people respond differently to the infection.

This is the first time that scientists have been able to establish an infection in cells derived from iPSCs - a feat many research teams have been trying to achieve. The new technique, described this week in the Proceedings of the National Academy of Sciences, could also eventually enable "personalized medicine": Doctors could test the effectiveness of different drugs on tissues derived from the patient being treated, and thereby customize therapy for that patient.

The new study is a collaboration between Sangeeta Bhatia, the John and Dorothy Wilson Professor of Health Sciences and Technology and Electrical Engineering and Computer Science at MIT; Charles Rice, a professor of virology at Rockefeller; and Stephen Duncan, a professor of human and molecular genetics at the Medical College of Wisconsin.

Stem cells to liver cells

Last year, Bhatia and Rice reported that they could induce liver cells to grow outside the body by growing them on special micropatterned plates that direct their organization. These liver cells can be infected with hepatitis C, but they cannot be used to proactively study the role of genetic variation in viral responses because they come from organs that have been donated for transplantation and represent only a small population.

To make cells with more genetic variation, Bhatia and Rice decided to team up with Duncan, who had shown that he could transform iPSCs into liver-like cells.

Such iPSCs are derived from normal body cells, often skin cells. By turning on certain genes in those cells, scientists can revert them to an immature state that is identical to embryonic stem cells, which can differentiate into any cell type. Once the cells become pluripotent, they can be directed to become liver-like cells by turning on genes that control liver development.

In the current paper, MIT postdoc Robert Schwartz and graduate student Kartik Trehan took those liver-like cells and infected them with hepatitis C. To confirm that infection had occurred, the researchers engineered the viruses to secrete a light-producing protein every time they went through their life cycle.

Genetic differences

The researchers' ultimate goal is to take cells from patients who had unusual reactions to hepatitis C infection, transform those cells into liver cells and study their genetics to see why they responded the way they did. "Hepatitis C virus causes an unusually robust infection in some people, while others are very good at clearing it. It's not yet known why those differences exist," Bhatia says.

One potential explanation is genetic differences in the expression of immune molecules such as interleukin-28, a protein that has been shown to play an important role in the response to hepatitis infection. Other possible factors include cells' expression of surface proteins that enable the virus to enter the cells, and cells' susceptibility to having viruses take over their replication machinery and other cellular structures.

The liver-like cells produced in this study are comparable to "late fetal" liver cells, Bhatia says; the researchers are now working on generating more mature liver cells.

As a long-term goal, the researchers are aiming for personalized treatments for hepatitis patients. Bhatia says one could imagine taking cells from a patient, making iPSCs, reprogramming them into liver cells and infecting them with the same strain of hepatitis that the patient has. Doctors could then test different drugs on the cells to see which ones are best able to clear the infection.
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BioLineRx Signs Exclusive License Agreement for BL-8020, an Oral Treatment for Hepatitis C

Tue, 24 Jan 2012 07:20:47 -0500

JERUSALEM--(BUSINESS WIRE)-- BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today it has signed a worldwide, exclusive license agreement with Genoscience, a French company focused on viral disease therapeutics, to develop and commercialize BL-8020, an orally available treatment for Hepatitis C.

BL-8020 has been developed for anti-viral therapy by Professor Philippe Halfon, Co-Founder and President of Genoscience. Prof. Halfon is a founder of several biotechnology companies and is world renowned for his work on HIV (AIDS virus), HPV (human papilloma virus causing cervical cancer) and Hepatitis.

BL-8020 acts via a unique mechanism of action, by inhibiting Hepatitis C virus (HCV)-induced autophagy, which differs from the mechanism of currently used anti-HCV agents. BL-8020's safety and efficacy were demonstrated in pre-clinical studies. These studies have shown that BL-8020, when combined with other anti-Hepatitis C virus (HCV) agents, has a synergistic effect. BL-8020's synergistic effect on other therapies is likely to increase their potency and reduce the numerous adverse effects often associated with these drugs, by enabling utilization of lower dosages. In addition BL-8020 may reduce therapy duration, which is currently up to 48 weeks. The use of two drugs acting by different mechanisms is also likely to be beneficial for patients who have developed resistance to current treatments and is an effective strategy used against other viruses such as HIV.

Dr. Kinneret Savitsky, CEO of BioLineRx, said, “We are excited about entering the field of Hepatitis C therapeutics, which is a very important field in the pharmaceutical market today. The current global Hepatitis market is estimated at approximately $6.5 billion and is growing steadily. Current therapies are characterized by numerous severe side effects, long treatment duration and development of resistance. In these respects, BL-8020 has a demonstrated safety and efficacy profile, may shorten therapy duration and may combat resistance by acting as an add-on platform which can potentially be combined with other oral Hepatitis C therapies to increase their efficacy.”

"We were impressed by the drug development expertise of the BioLineRx team and are very pleased to collaborate with them for the further development of our product for the treatment of Hepatitis C," said Prof. Philippe Halfon, Co-Founder and President of Genoscience. "There is clearly a huge unmet medical need in finding a safe and effective treatment for the disease, and based on pre-clinical results, its unique mechanism of action and synergistic effect, we believe that our product, especially when combined with other available Hepatitis C drugs, has the potential to bring remedy to millions worldwide."

About Hepatitis C

Hepatitis C infection is a blood borne infection of the liver caused by the Hepatitis C virus (HCV) which becomes chronic in about 85% of cases. According to the World Health Organization (WHO), more than 170 million people worldwide are chronically infected with HCV. In addition, HCV infection is the leading cause of liver transplantation and is a risk factor for liver cancer. The global Hepatitis market was estimated at $6.5 billion in 2010 and is forecasted to grow to $11.5 billion in 2016.

About BioLineRx

BioLineRx Ltd. is a publicly-traded biopharmaceutical development company. It is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies. BioLineRx’s current portfolio consists of five clinical stage candidates: BL-1020 for schizophrenia has commenced a Phase II/III study; BL-1040, for prevention of pathological cardiac remodeling following a myocardial infarction, is currently undergoing a pivotal CE-Mark registration trial and has been out-licensed to Ikaria Inc. for a total deal value of $282.5 million, in addition to sales royalties; BL-5010 for non-surgical removal of skin lesions has completed a Phase I/II study; BL-1021 for neuropathic pain is in Phase I development and BL-7040 for treating Inflammatory Bowel Disease (IBD) has completed Phase I. In addition, BioLineRx has 12 products in various pre-clinical development stages for a variety of indications, including central nervous system diseases, oncology, infectious diseases, cardiovascular and autoimmune diseases.

BioLineRx’s business model is based on acquiring molecules mainly from biotechnological incubators and academic institutions. The Company performs feasibility assessment studies and development through pre-clinical and clinical stages, with partial funding from the Israeli Government’s Office of the Chief Scientist (OCS). The final stage includes partnering with medium and large pharmaceutical companies for advanced clinical development (Phase III) and commercialization. For more information on BioLineRx, please visit www.biolinerx.com.

The estimates and judgments with respect to BL-8020 included in this release are considered forward-looking statements, which involve certain risks and uncertainties, and are based on information available to the Company at the time of this release. Such estimates may not be realized or may be only partially realized, due to the significant uncertainty characterizing research and development activities in general, particularly those of drug development, including changes in regulation or uncertainty relating to the application of regulation, unexpected delays in obtaining regulatory approval, unexpected delays in patient recruitment for clinical trials, unexpected delays in other clinical trial preparatory activities, inefficiencies, inability to manufacture, toxicity, a high level of risk/reward in comparison. Any forward-looking statements represent the Company’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

CONTACT:

KCSA Strategic Communications
Garth Russell / Todd Fromer
1 212-896-1250 / 1 212-896-1250
grussell@kcsa.com / tfromer@kcsa.com
or
BioLineRx Ltd.
Tsipi Haitovsky, Public Relations
+972-3-6240871
tsipih@netvision.net.il

KEYWORDS: United States Europe North America France New York Middle East Israel

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Pharmaceutical

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First Hepatitis C Treatment Data Demonstrating Proof of Principle with Direct-Acting Antiviral-only Therapy Published

Jennifer Levin — Thu, 19 Jan 2012 10:36:36 -0500

First Hepatitis C Treatment Data Demonstrating Proof of Principle with Direct-Acting Antiviral-only Therapy Published
Study also Demonstrated 100% Sustained Virologic Response 12-Weeks Post Treatment with Quadruple Therapy

PRINCETON, N.J., Jan 18, 2012 (BUSINESS WIRE) -- --Phase II Investigational Data Published Today in the New England Journal of Medicine

Bristol-Myers Squibb Company today announced the full results, published in the New England Journal of Medicine, from a Phase II clinical trial in patients with hepatitis C virus (HCV) genotype 1 who had not responded to prior therapy with PEG-interferon alfa and ribavirin ('null responders'(1)). The study demonstrated that its primary endpoint of the achievement of sustained virologic response 12-weeks post-treatment (SVR12) is possible with a direct-acting antiviral (DAA)-only combination containing daclatasvir and asunaprevir (4/11 patients, including two of two patients infected with HCV genotype 1b). This study was the first study to demonstrate the possibility that hepatitis C can be cured (defined as sustained virologic response 48 weeks post-treatment or SVR48) without the use of interferon. The study also demonstrated that 100 percent (10/10) of these difficult-to-treat patients dosed with quadruple therapy containing daclatasvir and asunaprevir in combination with PEG-Interferon alfa and ribavirin achieved SVR12.

In this study there were no serious adverse events on treatment or discontinuations due to adverse events. Diarrhea was the most common adverse event in both groups (73% and 70%).

"Even with the recent approval of two protease inhibitors, treatment of hepatitis C patients who have not responded to PEG-interferon alfa and ribavirin has limited success. Because of this high unmet medical need, there is a necessity for new combination regimens that can increase response rates in null responders," said lead investigator Anna Lok, MD, FRCP, director of clinical hepatology and professor in the department of internal medicine at the University of Michigan Medical School in Ann Arbor. "The data seen in this study with Bristol-Myers Squibb's investigational DAAs daclatasvir and asunaprevir, either as DAA-only therapy or as part of quadruple therapy, are encouraging as we work to advance hepatitis C therapy for this difficult-to-treat patient population. This study also shows for the very first time that sustained viral responses can be achieved without the use of interferon and ribavirin."

Daclatasvir is the first NS5A replication complex inhibitor to be investigated in HCV clinical trials and is currently in Phase III development. Asunaprevir is an investigational, oral, selective NS3 protease inhibitor.

Study Results

Viral Response: Dual DAA Therapy with daclatasvir and asunaprevir (Group A)

Eleven patients were randomized to receive dual DAA therapy for 24 weeks. Seven of the 11 patients (64%) in Group A achieved undetectable viral load by week four, and five patients remained undetectable at the end of treatment. Of these 11 patients, one patient relapsed at four (4) weeks post treatment while four patients (36%) had sustained virological response at 12 weeks post-treatment (SVR12). In follow-up to 48-weeks post treatment, no additional cases of viral relapses were observed.

Six patients, all with HCV genotype 1a, experienced viral breakthrough on dual DAA therapy, and analysis of HCV sequences following breakthrough confirmed resistance to both antivirals. With the addition of PEG-interferon alfa and ribavirin to their regimen (rescue therapy), four of the six patients achieved undetectable viral load. Two of these patients relapsed following the treatment period and two remained undetectable, one with 14 weeks and one with 42 weeks of post treatment follow-up. Two of the six patients did not achieve undetectable HCV RNA and treatment was discontinued.

Viral Response: Quadruple Therapy with daclatasvir, asunaprevir and PEG-Interferon alfa and ribavirin (Group B)

Ten patients were randomized to receive quadruple therapy for 24-weeks. Six of the 10 patients (60%) in Group B achieved undetectable HCV RNA by week four. Ten of the 10 patients (100%) were undetectable by the end of treatment, and all 10 achieved SVR12. No patients experienced viral relapse during 48 weeks of post-treatment observation.

Safety

In the study, there were no serious adverse events on treatment, no deaths, and no treatment discontinuations due to adverse events. Most adverse events were mild to moderate, and the most common AEs were diarrhea (group a:8/11)(group a:73%)(group b:7/10)(group b:70%), fatigue (group a:6/11)(group a:55%)(group b:7/10)(group b:70%), headache (group a:5/11)(group a:45%)(group b:5/10)(group b:50%), and nausea (group a:2/11)(group a:18%)(group b:5/10)(group b:50%).

Six patients (four from group A, including two receiving rescue therapy, and two from group B) experienced elevated liver enzymes [ALT >3x upper limit of normal (ULN)] which did not require treatment discontinuation or dose interruptions, and all patients stabilized or improved with continued therapy. Six patients, all of whom received PEG-interferon alfa and ribavirin, experienced Grade 3 or 4 neutropenia, a blood disorder characterized by an abnormally low number of white blood cells.

About the Study

This open-label, phase IIa study evaluated the antiviral activity and safety of the combination of daclatasvir and asunaprevir with and without PEG-Interferon alfa and ribavirin in 21 HCV genotype 1 null responders. Patients in the study were randomized to receive one of two treatment regimens for 24 weeks. The 11 patients in Group A received dual-DAA therapy with daclatasvir 60 mg once daily and asunaprevir 600 mg twice daily, both taken orally. The 10 patients in Group B received quadruple therapy with daclatasvir 60 mg once daily, asunaprevir 600 mg twice daily, PEG-interferon alfa 180 ug once weekly, and ribavirin 1000-1200 mg daily (according to body weight) in two divided doses. The primary study objective was to determine the proportion of patients achieving undetectable viral load (HCV RNA <10 IU/mL) 12 weeks post-treatment (SVR12). This dual-DAA combination is now in Phase III development.

About Bristol-Myers Squibb's Commitment to Liver Disease

Bristol-Myers Squibb is advancing a portfolio of compounds that aims to address unmet medical needs across the liver disease continuum, including hepatitis C, hepatitis B and liver cancer. The Company's hepatitis C pipeline includes a portfolio of compounds with different mechanisms of action, pursuing both biologics as well as small molecule antivirals. These compounds are being studied as part of multiple novel treatment regimens with the goal of increasing SVR rates across diverse patient types and geographies. Discovered by Bristol-Myers Squibb through a genomics approach, daclatasvir, also known as BMS-790052, is the first NS5A replication complex inhibitor to be investigated in hepatitis C clinical trials and is currently in Phase III development. Asunaprevir, also known as BMS-650032, is an NS3 protease inhibitor in Phase III development for hepatitis C.

About Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. An estimated 170 million people worldwide are infected with hepatitis C, with genotype 1 being the most prevalent genotype. Up to 90 percent of those infected with hepatitis C will not clear the virus and will become chronically infected. Twenty percent of people with chronic hepatitis C will develop cirrhosis and, of those, up to 25 percent may progress to liver cancer. Although there is no vaccine to prevent hepatitis C, it is a potentially curable disease.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews .

Bristol-Myers Squibb Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compound described in this release will move from exploratory development into full product development, that clinical trials of this compound will support a regulatory filing, or that the compound will receive regulatory approval or become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2010, in our Quarterly Reports on Form 10-Q, and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

(1) Null responders -- patients whose virus did not respond to prior treatment with PEG-interferon alfa and ribavirin (HCV RNA decrease <2 log10 at 12 weeks).

SOURCE: Bristol-Myers Squibb Company

Bristol-Myers Squibb Company
Media:
Cristi Barnett, 609-252-6028
cristi.barnett@bms.com
or
Sonia Choi, 609-252-5132
sonia.choi@bms.com
or
Investors:
John Elicker, 609-252-4611
john.elicker@bms.com

Can-Fite BioPharma Announces Successful Results of its Phase I/II Liver Cancer Study with its CF102 Drug; the Study Achiev

Tue, 03 Jan 2012 11:20:22 -0500

PETAH-TIKVA, Israel--(BUSINESS WIRE)-- Can-Fite BioPharma Ltd (TASE:CFBI), a biotechnology company developing small molecule drugs for the treatment of inflammatory, and liver diseases, traded on the Tel Aviv Stock Exchange announced today the successful results of the Phase 1/2 study of its drug candidate CF102 in the treatment of hepatocellular carcinoma (HCC).

The company also announced today that a separate phase 1/2 study in patients with Hepatitis C (HCV) reached the study’s main objectives of safety and pharmacokinetic behavior.

The HCC study which was conducted under the supervision of Dr. Salomon M. Stemmer, Institute of Oncology, Davidoff Center, Rabin Medical Center, included 18 patients with HCC, most of them had failed prior treatment with Sorafenib (Nexavar), the only currently approved drug for this indication. The primary study objectives were to evaluate the safety profile of long-term administration of CF102 at 3 different dose levels in patients with HCC, and to determine the pharmacokinetic behavior of CF102 in this patient population. The secondary objective of the trial was to document evidence of clinical efficacy and to look at the correlation between A3 adenosine receptor expression levels at base line and patients’ response to CF102.

The study data demonstrate that the trial objectives were successfully achieved, showing a very favorable safety profile for CF102 in a patient population with hepatocellular carcinoma and Child-Pugh cirrhosis classes A and B. In addition, the median overall survival time was 7.8 months, which is very encouraging data given that most patients were treated in the second-line setting and some were Child-Pugh class B. Remarkably, the median overall survival time of the Child-Pugh B patients was 9.4 months, the longest overall survival time that has been reported in the literature for this patient population.

Out of the 18 patients, 9 were infected with Hepatitis C. In 7 patients treated with the high CF102 dosages, a reduction in HCV load was observed.

According to Dr. Keith Stuart, MD, Chairman, Department of Hematology and Oncology, Lahey Clinic Medical Center, Professor of Medicine, Tufts University School of Medicine: “The safety and efficacy data of the CF102 Liver Cancer study are impressive and encouraging in the context of other investigational drugs. Therefore, I would recommend further clinical development of this drug for the treatment of patients with hepatocellular carcinoma. I hope that the present data will be reproducible and that patients could benefit from this drug.”

In parallel, the company also announced today that a separate phase 1/2 study in patients with Hepatitis C (HCV) reached the study’s primary objectives of safety and pharmacokinetic behavior. However, a reduction in the HCV viral load was not observed. It should be noted that patients on this study were treated for several months only with the low dose of CF102.

According to Dr. Pnina Fishman, the company CEO, “We are very pleased that the study achieved all of its objectives in patients with HCC, most of whom had failed prior treatment with Nexavar. The impressive results in the HCC study encourage us to continue development of CF102 in patients with Liver Cancer. We will focus on this disease and will continue to observe the viral load of HCC patients who also suffer from HCV.”

CF102 is a small orally bioavailable drug which binds with high affinity and selectivity to the A3 adenosine receptor. The latter is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. The drug induces a robust anti-tumor effect via de-regulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells agonist at the A3 adenosine receptor.

About Can-Fite Biopharma Ltd.

Can-Fite Biopharma Ltd is a public company, trading on the Tel Aviv Stock Exchange. The company, which commenced business activity on 2000, was founded by Prof Pnina Fishman, researcher in the Rabin Medical Center, and Dr Ilan Cohen, patent attorney and senior partner at Reinhold Cohen Patent Attorneys. Prof Fishman serves as CEO of the company. The company was founded on the basis of Prof Fishman’s scientific findings, and is focused on the development of small molecule drugs, ligands to the A3 adenosine receptor. The latter mediates anti-inflammatory and anti-cancer effects and is suggested as a biological predictive marker. The company’s lead drug, CF101, is in advanced clinical development for the treatment of autoimmune inflammatory diseases. The CF102 drug candidate is being developed for the treatment of liver diseases. Can-Fite has a wealth of clinical experience: to date, more than 700 patients have participated in clinical trials conducted by the company. Can-Fite recently licensed its activity in the ophthalmic field to OphthaliX Inc.

About OphthaliX Inc (formerly Denali Concrete Management Inc).

OphthaliX Inc. (OTCBB:DCMG) is an advanced clinical-stage biopharmaceutical company focused on developing therapeutic products for the treatment of ophthalmic disorders. Denali's product candidate, CF101, is being developed to treat three ophthalmic indications: dry eye syndrome; glaucoma and uveitis. Can-Fite holds 82.3% in OphthaliX Inc.

CONTACT:

Can-Fite BioPharma
Pnina Fishman, Ph.D., Chief Executive Officer
Tel: +972-3-9241114
Fax: +972-3-9249378
pnina@canfite.co.il
http://www.canfite.com

KEYWORDS: United States North America New York Middle East Israel

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Oncology Optical Pharmaceutical Other Health

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The Hepatitis C Virus Drug Market Will Experience Dramatic Near-Term Growth, Increasing from $1.7 Billion in 2010 to $16 B

Tue, 08 Nov 2011 09:21:36 -0500

After 2015, the Market Will Decrease to $11.3 Billion in 2020, Owing to a Decline in the Size of the Treatment-Eligible Population, According to Findings from Decision Resources

BURLINGTON, Mass.--(BUSINESS WIRE)-- Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the hepatitis C virus drug market will experience dramatic near-term growth, increasing from $1.7 billion in 2010 to $16 billion in 2015 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. This robust growth will be driven primarily by the launch of novel premium-priced agents that will increase the size of the drug-treated population, mainly as a result of the re-treatment of prior non-responder patients. After 2015, the market will decrease to $11.3 billion in 2020, owing to a decline in the size of the treatment-eligible population as disease prevalence declines and effective new regimens become available.

The findings from the Pharmacor topic entitled Hepatitis C Virus reveal that, following the 2011 market entry of the first two protease inhibitors to treat the disease—Vertex/Johnson & Johnson/Mitsubishi Tanabe’s Incivek/Incivo/Telavic (telaprevir) and Roche/Merck’s Victrelis (boceprevir)—both of these therapies are quickly being adopted, in combination with peg-interferon (IFN)-alpha and ribavirin, to treat genotype 1-infected hepatitis C virus. Telaprevir, which is available in the United States and Europe, has received marketing approval in Japan where it will launch by the end of 2011. However, boceprevir—which is also available in the United States and Europe—will not launch in Japan.

Owing to the large commercial potential that is well-recognized by pharmaceutical developers, the pipeline for hepatitis C virus remains dynamic and competitive. The recent launches of telaprevir and boceprevir as well as agents in late-stage development such as Johnson & Johnson/Medivir’s simeprevir and Boehringer Ingelheim’s BI-201335 (both protease inhibitors), Roche/Pharmasset’s mericitabine and Pharmasset’s PSI-7977 (both polymerase inhibitors) and Bristol-Myers Squibb’s NS5A inhibitor daclatasvir will drive market growth through 2020.

The findings also reveal that interviewed physicians report that a lack of IFN-free regimens is a significant unmet need in treating the disease. Complete elimination of peg-IFNs and ribavirin agents is highly desirable owing to their side effects, which prevent a significant number of individuals infected with hepatitis C virus from receiving antiviral therapy.

“Physicians we interviewed expect that IFN-free regimens will be much better tolerated and will enable treatment of patients who are contraindicated to IFN-alpha,” said Decision Resources Analyst Seamus Wilkinson-Levine, Ph.D. “We forecast that the first IFN-free regimens will be available in the United States and Europe by 2016 and in Japan by 2018.”

About Decision Resources

Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources Group company.

About Decision Resources Group

Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

CONTACT:

Decision Resources
Christopher Comfort, 781-993-2597
ccomfort@dresources.com

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Pharmaceutical Other Health Managed Care

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All-Oral Treatment Regimen of Bristol-Myers Squibb’s Investigational NS5A and NS3 Inhibitors Achieved 90% Sustained Virolo

Mon, 07 Nov 2011 19:20:49 -0500

Results add to data suggesting that SVR can be achieved with the combination of daclatasvir (BMS-790052) and asunaprevir (BMS-650032) in HCV genotype 1b patients
Study expanded to include alfa/RBV ineligible or intolerant patients

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a ten patient sentinel cohort of an ongoing Phase II study in which treatment with a dual, all-oral direct-acting antiviral (DAA) regimen of the investigational NS5A replication complex inhibitor daclatasvir (BMS-790052) and the investigational NS3 protease inhibitor asunaprevir (BMS-650032) achieved undetectable viral load at 12 weeks post-treatment (SVR12) in 90% (n=9/10) of genotype 1b hepatitis C (HCV) patients who had previously not responded to peginterferon alfa and ribavirin (alfa/RBV). Serious adverse events occurred in two patients in this study, of which one led to treatment discontinuation. The findings were presented at the 62^nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.

“Genotype 1 patients have a cure rate of about 45% when treated with interferon alfa and ribavirin. For the 55% of patients who do not achieve viral cure, further treatment has limited success, even with the addition of a protease inhibitor. There is a real unmet medical need for new treatment options that have the potential to increase response rates in null responders,” said Kazuaki Chayama, MD, PhD, Professor, Department of Medicine and Molecular Science, Graduate School of Biomedical Science, Hiroshima University, Hiroshima, Japan. “The results of this Phase II study of Bristol-Myers Squibb’s investigational, oral direct-acting antivirals are encouraging as we study potential hepatitis C therapies for this difficult-to-treat patient population.”

Based on the sentinel cohort results, the study has been expanded to include both genotype 1b patients who are null responders (n~20) and patients ineligible for alfa/RBV for medical reasons or who discontinued alfa/RBV after less than 12 weeks due to intolerance (n~20). HCV patients who are either ineligible for or intolerant to alfa/RBV represent a significant unmet medical need, as there are no effective treatments available to these patients.

Sentinel Cohort Results

Of the 10 patients enrolled in the study, nine completed 24 weeks of treatment. Rapid and persistent viral suppression was observed in all nine patients, with undetectable viral load achieved by week 8 and sustained through the end of the 24 week post-treatment follow-up period. One patient discontinued the study at Week 2. This patient had a low viral load at the time of study discontinuation (1.8 log₁₀ IU/mL) and as reported by the investigator achieved and maintained an undetectable viral load through 24 weeks of follow-up post-discontinuation. Despite the evidence of baseline viral substitutions in some patients, there was no apparent association between those substitutions and response to treatment in this study.

Serious adverse events occurred in two patients. One patient experienced Grade 3 fever (pyrexia) and one patient developed Grade 4 elevated bilirubin levels (hyperbilirubinemia) that led to study discontinuation at week 2. As reported by the investigator, this patient achieved SVR with normalization of laboratory values upon discontinuation.

The most commonly reported on-treatment adverse events occurring in at least three patients were Grade 1 diarrhea (n=7), headache (n=4) and liver enzyme increases (n=3 ALT and AST). Of the liver enzyme increases, two patients experienced transient Grade 1 elevations and one patient had a Grade 2 elevation that began at week 16 of treatment and resolved within two weeks post-treatment.

About the Study

In this Phase II open-label clinical trial (AI447-017), a sentinel cohort of ten Japanese patients with chronic HCV genotype 1b infection with null response to prior alfa/RBV treatment (HCV RNA ≤ 2 log₁₀ IU/mL at 12 weeks of alfa/RBV therapy) were treated with daclatasvir 60 mg once daily and asunaprevir initially 600 mg twice daily and reduced to 200 mg twice daily, for 24 weeks. The primary efficacy endpoint was the proportion of patients with undetectable viral load (HCV RNA < 15 IU/mL) at 12 weeks post-treatment.

About Bristol-Myers Squibb’s Commitment to Liver Disease

Bristol-Myers Squibb is advancing a portfolio of compounds that aim to address unmet medical needs across the liver disease continuum, including hepatitis C, hepatitis B and liver cancer. The Company’s hepatitis C pipeline includes a portfolio of compounds with different mechanisms of action, pursuing both biologics as well as small molecule antivirals. These compounds are being studied as part of multiple novel treatment regimens with the goal of increasing SVR rates across diverse patient types and geographies. Discovered by Bristol-Myers Squibb through a genomics approach, daclatasvir, also known as BMS-790052, is the first NS5A replication complex inhibitor to be investigated in hepatitis C clinical trials and is currently in Phase III development. Asunaprevir, also known as BMS-650032, is an NS3 protease inhibitor in Phase II development for hepatitis C.

About Hepatitis C

About Bristol-Myers Squibb

Bristol-Myers Squibb Forward Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that clinical trials of this compound will support a regulatory filing, or that the compound will receive regulatory approval or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2010, in our Quarterly Reports on Form 10-Q, and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

CONTACT:

Bristol-Myers Squibb Company
Media:
Sonia Choi, 609-252-5132
sonia.choi@bms.com
or
Cristi Barnett, 609-252-6028
cristi.barnett@bms.com
or
Investors:
John Elicker, 609-252-4611
john.elicker@bms.com

KEYWORDS: United States Europe North America California New Jersey

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Pharmaceutical Research Science

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Vertex Announces Webcasts of Two Investor Presentations

Thu, 03 Nov 2011 18:21:05 -0400

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Vertex will webcast its company presentation at its investor event from San Francisco at the American Association for the Study of Liver Diseases (AASLD) on Monday, November 7, 2011 at 6:30 p.m. PST (9:30 p.m. EST).

Vertex will also webcast its presentation at the Credit Suisse Health Care Conference on Wednesday, November 9, 2011 at 8:30 a.m. MST (10:30 a.m. EST).

The presentations will be webcast live and may be accessed from ‘Events & Presentations’ on the home page of Vertex’s website at www.vrtx.com. A replay of the webcasts will also be available on the Company’s website for two weeks following the presentations. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.

About Vertex

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.

Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.

Vertex’s press releases are available at www.vrtx.com.

(VRTX-WEB)

CONTACT:

Vertex Pharmaceuticals Incorporated
Lora Pike, 617-444-6755
Director, Investor Relations

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical

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PURE Bioscience Reports Fourth Quarter and Fiscal Year 2011 Results

Mon, 31 Oct 2011 16:20:44 -0400

Conference Call begins Today at 4:30 p.m. Eastern time

SAN DIEGO--(BUSINESS WIRE)-- PURE Bioscience (NASDAQ: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today reported financial results for the fourth quarter and fiscal year ended July 31, 2011 (“fiscal 2011”).

Revenue for fiscal 2011 was $464,000, compared with revenue of $1,436,000 for the year ended July 31, 2010 (“fiscal 2010”). The net loss for fiscal 2011 was $8,349,000, or $0.22 per share, compared with a net loss of $6,760,000, or $0.20 per share, in fiscal 2010.

For the fourth quarter of fiscal 2011, revenue was $244,000, compared with revenue of $324,000 for the fourth quarter of fiscal 2010. The net loss for the fourth quarter of fiscal 2011 was $2,031,000, or $0.05 per share, compared with a net loss of $1,673,000, or $0.05 per share, for the fourth quarter of fiscal 2010.

As of July 31, 2011, the Company had cash and cash equivalents of approximately $1.8 million.

Michael L. Krall, President and CEO, stated, “In the fiscal fourth quarter and recent weeks, we focused on initiatives in three important areas, namely 1) gaining regulatory approvals, 2) introducing PURE-branded products, and 3) developing business in key vertical markets. While much work remains to be done, I’m pleased with the progress in each of these areas. For example, Health Canada approved PURE™ Hard Surface for use in food premises and healthcare facilities; and we received an expanded EPA registration adding additional pathogens, including Hepatitis B, Hepatitis C and multiple drug-resistant bacteria, as well as reducing virus kill times to as quick as 30 seconds. We obtained NSF International registration for use of PURE Hard Surface as a no-rinse sanitizer in food processing areas, and we secured GRAS designation for SDC when used on food processing equipment. Each of these regulatory milestones expands and accelerates our market opportunities in the healthcare, institution and food markets.

“Following the introduction of PURE Hard Surface, during the fourth quarter we took direct control of SDC-based product sales through a restructuring of our sales, marketing and distribution strategy and operation. During the quarter we made valuable inroads for PURE Hard Surface in key new markets, including the food processing industry, which has been plagued with landmark safety issues this year. Because of its zero toxicity profile and impressive efficacy against so many dangerous pathogens, the application of SDC in this market is truly unique,” continued Krall.

“We’ve also bolstered our management team with the addition of key executives in finance and sales. In short, we are executing our strategy from a focused position of strength with new regulatory approvals, products, market awareness and experienced management that we believe will yield timely and significant results in the coming quarters,” added Krall.

Conference Call

The Company will host a conference call today beginning at 4:30 p.m. Eastern time to review and discuss the financial results and its business outlook, and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-407-8033 (domestic) or 201-689-8033 (international) a few minutes before the call start time. The call is being webcast and can be accessed at www.purebio.com. Investors can also access the webcast at www.InvestorCalendar.com. The webcast will be available for replay through October 31, 2012. A replay of the conference call will be accessible until midnight December 31, 2011 by dialing 877-660-6853 or (International) 201-612-7415, and entering the Account #: 286 and the Conference ID #: 381842.

About PURE Bioscience, Inc.

PURE Bioscience, Inc. develops and markets technology-based bioscience products that provide solutions to numerous global health challenges, including Staph (MRSA). PURE’s proprietary high efficacy/low toxicity bioscience technologies, including its silver dihydrogen citrate-based antimicrobials, represent innovative advances in diverse markets and lead today’s global trend toward industry and consumer use of “green” products while providing competitive advantages in efficacy and safety. Patented SDC is an electrolytically generated source of stabilized ionic silver, which formulates well with other compounds. As a platform technology, SDC is distinguished from competitors in the marketplace because of its superior efficacy, reduced toxicity and the inability of bacteria to form a resistance to it. PURE is headquartered in El Cajon, California (San Diego metropolitan area). Additional information on PURE is available at www.purebio.com.

This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate," "project,” "expect" or similar expressions. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s cash position and liquidity requirements, acceptance of the Company's current and future products and services in the marketplace, the ability of the Company to develop effective new products and receive regulatory approvals of such products, competitive factors, dependence upon third-party vendors, and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.

-Financial tables follow-

PURE Bioscience, Inc.
Consolidated Statements of Operations


		Year Ended
		July 31,
		2011			2010
Revenue
	Net product sales	$	454,180		$	1,416,137
	License fees		10,000			20,000
Total revenue			464,180			1,436,137

Operating costs and expenses
	Cost of goods sold		131,390			465,094
	Selling, general and administrative		6,520,160			5,861,976
	Research and development		2,179,508			1,927,183
	Impairment of capitalized assets		-			92,745
Total operating costs and expenses			8,831,058			8,346,998

Loss from operations			(8,366,878	)		(6,910,861	)

Other income (expense)
	Interest income		7,768			33,312
	Other income, net		10,000			117,265
Total other income (expense)			17,768			150,577

Net loss		$	(8,349,110	)	$	(6,760,284	)

Basic and diluted net loss per share		$	(0.22	)	$	(0.20	)

Shares used in computing basic
and diluted net loss per share			37,323,434			34,547,943

PURE Bioscience, Inc.
Consolidated Balance Sheets

			July 31,
			2011			2010
Assets
Current assets
	Cash and cash equivalents		$	1,793,629		$	2,192,543
	Accounts receivable, net			50,235			332,493
	Inventories, net			860,501			752,438
	Prepaid expenses			100,040			146,307
	Total current assets			2,804,405			3,423,781

Property, plant and equipment, net				426,382			696,974
Patents, net				1,917,110			1,872,882

Total assets			$	5,147,897		$	5,993,637

Liabilities and stockholders' equity
Current liabilities
	Accounts payable		$	676,491		$	329,281
	Accrued liabilities			257,683			243,898
	Deferred revenue			-			10,000
Total current liabilities				934,174			583,179

Deferred rent				5,608			16,045
Total liabilities				939,782			599,224

Commitments and contingencies

Stockholders' equity
	Preferred stock, $0.01 par value:
		5,000,000 shares authorized, no shares issued		-			-
	Common stock, $0.01 par value:
		100,000,000 shares authorized
		40,034,659 issued and outstanding at July 31, 2011, and
		35,488,317 issued and outstanding at July 31, 2010		400,347			354,883
	Additional paid-in capital			57,417,337			50,299,989
	Accumulated deficit			(53,609,569	)		(45,260,459	)
Total stockholders' equity				4,208,115			5,394,413

Total liabilities and stockholders' equity			$	5,147,897		$	5,993,637

CONTACT:

PURE Bioscience Investor Contact:
LHA
Don Markley, Senior Vice President
(310) 691-7100
dmarkley@lhai.com
or
PURE Bioscience Media Contact:
Gutenberg Communications
Michael Gallo
(212) 239-8594
mgallo@gutenbergpr.com

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Manufacturing Chemicals/Plastics

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Inhibitex to Host Conference Call to Report Third Quarter Financial Results on November 4, 2011

Wed, 26 Oct 2011 18:21:03 -0400

ATLANTA--(BUSINESS WIRE)-- Inhibitex, Inc. (NASDAQ: INHX) announced today that it will host a conference call on Friday, November 4, 2011 at 9:00 a.m. EDT to review the Company’s third quarter financial results and provide an update on recent corporate developments. The Company will issue a press release regarding its financial results on the same day, prior to the conference call.

Webcast Information

To access the conference call, please dial (877) 407-9210 (domestic) or (201) 689-8049 (international). A replay of the call will be available from 11:00 a.m. Eastern Time on November 4^th until December 4, 2011 at midnight. To access the replay, please dial (877) 660-6853 (domestic) or (201) 612-7415 (international) and reference the account # 286 and the conference id # 382037. A live audio webcast of the call and the archived webcast will be available in the News and Events section of the Inhibitex website at http://www.inhibitex.com.

About Inhibitex

Inhibitex, Inc. is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company’s clinical-stage pipeline currently includes two Phase 2 development programs; INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C infections and FV-100, a nucleoside analogue in development for the treatment of shingles-associated pain. The Company also has other HCV nucleotide polymerase inhibitors in preclinical development and has licensed the use of its proprietary MSCRAMM^® protein platform to Pfizer for the development of a staphylococcal vaccine, which is currently being evaluated in a Phase 1/2 clinical trial.

For additional information about the Company, please visit www.inhibitex.com.

CONTACT:

Inhibitex, Inc.
Russell H. Plumb, 678-746-1136
Chief Executive Officer
rplumb@inhibitex.com

KEYWORDS: United States North America Georgia

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Pharmaceutical

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Gilead and GlobeImmune Announce License and Collaboration Agreement to Develop Therapeutic Vaccine Products for Treatment

Mon, 24 Oct 2011 17:20:51 -0400

FOSTER CITY, Calif. & LOUISVILLE, Colo.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq:GILD) and GlobeImmune, Inc. today announced that the companies have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of therapeutic vaccine products for use in conjunction with Viread^® (tenofovir disoproxil fumarate) and other oral therapies for the treatment of chronic hepatitis B virus (HBV) infection.

Under the terms of the agreement, Gilead will pay GlobeImmune an upfront payment and provide support for GlobeImmune’s continued development of its HBV therapeutic vaccine program through Phase 1a clinical trials. Gilead can assume full responsibility for clinical development following Phase 1a. GlobeImmune also could receive additional payments based upon achievement of certain development milestones, as well as royalties on future potential net sales.

The goal of the research collaboration is to create and develop therapeutic vaccine products that have specific HBV DNA antigens cloned into S. cerevisiae (a species of yeast). The companies anticipate that the combination of a therapeutic vaccine with oral suppressive antiviral therapy could help increase surface antigen (HBsAg) loss with seroconversion – a marker of the resolution of chronic HBV infection.

“This collaboration is a significant milestone in GlobeImmune’s efforts to advance therapies for major unmet medical needs,” said David Apelian, MD, PhD, Senior Vice President Research & Development and Chief Medical Officer at GlobeImmune. “Based on the proof-of-concept studies in hepatitis C infection, we believe that the combination of GlobeImmune’s Tarmogen immunotherapy products with oral suppressive antiviral therapy will help eliminate the cells harboring the hepatitis B virus, thus increasing seroconversion within a finite period.”

“Finite therapy remains a significant unmet need for patients with chronic hepatitis B,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We are hopeful that this approach will allow us to explore whether adaptive immunomodulatory approaches to HBV will help us improve HBsAg seroconversion, thereby eliminating the need for life-long daily therapy.”

About GlobeImmune

GlobeImmune, Inc. is a private company developing therapeutic vaccines called Tarmogen^® products for the treatment of cancer and infectious diseases. Tarmogens stimulate the natural production of T cells that are capable of locating and eliminating cancer cells and virally-infected cells. GlobeImmune has raised over $160 million to date in support of its programs. For additional information, please visit the company’s website at www.globeimmune.com.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific. For more information on Gilead, please visit www.gilead.com.

Gilead Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks related to the development and commercialization of therapeutic vaccines for the treatment of chronic HBV infection. Further, there are risks related to clinical trials of therapeutic vaccines under the collaboration, including the ability to enroll sufficient patients, the possibility of unfavorable results, the need to modify or delay the studies or to perform additional trials and the risk of failing to obtain approvals from the regulatory authorities. As a result, therapeutic vaccines under the collaboration may never be successfully commercialized. In addition, Gilead and GlobeImmune may make a strategic decision to terminate the collaboration or discontinue development of certain therapeutic vaccines under the collaboration. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Viread is a registered trademark of Gilead Sciences, Inc.

Tarmogen is a registered trademark of GlobeImmune, Inc.

CONTACT:

Gilead Contacts:
Susan Hubbard, 650-522-5715 (Investors)
Cara Miller, 650-522-1616 (Media)
or
GlobeImmune Contacts:
David Apelian, MD, PhD, MBA, 303-625-2820
Chief Medical Officer
or
Russo Partners
Matt Middleman, 917-734-0324 (Media)

KEYWORDS: United States Europe North America California Colorado

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Pharmaceutical

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