April 4, 2012

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WHITEHOUSE STATION, N.J., April 4, 2012 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that several new data analyses from studies of VICTRELIS (boceprevir) capsules, the company's oral hepatitis C virus (HCV) NS3/4A protease inhibitor, will be presented at The International Liver Congress / 47th European Association for the Study of the Liver (EASL) annual meeting. The meeting will be held from April 18 – 22 in Barcelona. In total, more than a dozen abstracts highlighting Merck medicines and investigational therapies for chronic HCV infection will be presented.

Presented for the first time as part of a late-breaker poster session will be results from a randomized trial comparing ribavirin dose reduction and use of erythropoietin as methods of anemia management in previously untreated adult patients with chronic HCV genotype 1 receiving VICTRELIS plus peginterferon alfa and ribavirin (P/R).

Interim results also will be presented from the PROVIDE study, an ongoing, open-label, single-arm, multicenter rollover study for patients who participated in the P/R control arms of the Phase II and Phase III studies for VICTRELIS and failed to achieve SVR. These interim results will report sustained virologic response (SVR) rates in prior P/R treatment failures after retreatment with VICTRELIS and P/R, including those patients who met the traditional definition of null response (less than a 2 log10 HCV-RNA decline at treatment week 12).

"Merck remains committed to investigating therapies for the treatment of chronic hepatitis C, and we are excited to share new data on VICTRELIS at this year's EASL congress in Barcelona," said Eliav Barr, M.D., vice president, Infectious Diseases, Project Leadership and Management, Merck Research Laboratories.

The abstracts were published today and can be accessed on the EASL website. For program information, please visit http://www2.kenes.com/liver-congress/pages/home.aspx.

VICTRELIS (boceprevir) – Key Oral Presentation

Parallel Session - Hepatitis C Therapy
Thursday, April 19, 16:00 - 18:00 CEST, Hall A

Sustained Virologic Response (SVR) in Prior PegInterferon/Ribavirin (PR) Treatment Failures After Retreatment with Boceprevir (BOC) + PR: The PROVIDE Study Interim Results ; J.P. Bronowicki et al. 17:00-17:15 CET

VICTRELIS – Key Poster Presentations

A Randomized Trial Comparing Ribavirin Dose Reduction Versus Erythropoietin For Anemia Management In Previously Untreated Patients With Chronic Hepatitis C Receiving Boceprevir Plus Peginterferon/Ribavirin; F. Poordad et al. Abstract 1419. Thursday, April 19.

In Vitro Characterization of the Pan-Genotype Activity of the HCV NS3/4A Protease Inhibitors Boceprevir and Telaprevir; J. Howe et al. Abstract 844. Thursday, April 19.

HCV NS3/4A Protease Resistance-Associated Variants (RAVs) Identified in Genotype 1A Patients Exhibit Differences in Phenotypic Resistance to Boceprevir and Telaprevir in Genotype 1A Replicon Assays; S. Black et al. Abstract 1198. Thursday, April 19.

Indications and usage for VICTRELIS
VICTRELIS is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in combination with peginterferon alfa and ribavirin (P/R), in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

The following points should be considered when initiating VICTRELIS for treatment of chronic HCV infection:

  • VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
  • VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
  • VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log viral load decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
  • Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin

Important safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS and concomitant ribavirin.

VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced VICTRELIS plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio® (sildenafil) or Adcirca® (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and orally administered midazolam.

Anemia and/or Neutropenia -- The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations compared to peginterferon alfa and ribavirin alone and/or may result in worsening of neutropenia associated with peginterferon alfa and ribavirin therapy alone. Dose reduction or discontinuation of peginterferon alfa and/or ribavirin may be required. Dose reduction of VICTRELIS is not recommended. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.

Complete blood counts (with white blood cell differential counts) must be conducted in all patients prior to initiating combination therapy with VICTRELIS. Complete blood counts should be obtained at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate.

The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent) and dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previous treatment-failure patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent) and dysgeusia (44 vs. 11 percent), respectively.

VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.

Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf.

Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.

About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2011 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

# # #

VICTRELIS is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA

Revatio® and Adcirca® are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA.

Please see Prescribing Information for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf and Medication Guide for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf.

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Vertex's Abstracts at EASL 2012

Email received from Vertex April 4, 2012

Good afternoon,

Vertex will present data on INCIVEK® (telaprevir) tablets, approved for the treatment of hepatitis C, and one of its hepatitis C medicines in development, the non-nucleoside polymerase inhibitor VX-222, at the 47th Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 18 to 22, 2012.

The titles of the 14 accepted abstracts are included below, attached as a pdf and on our website at http://www.vrtx.com/2012-easl.html. The complete abstracts are now available through the EASL website at www.easl.eu.

Oral Presentation: April 20, 2012, 4:00 p.m. – 6:00 p.m. CET

· "Futility Rules in Telaprevir Combination Treatment"

Poster Presentations: April 21, 2012, 12:30 p.m. – 1:30 p.m. CET

· Poster # 1094:"100% SVR in IL28b CC Patients Treated with 12 Weeks of Telaprevir, Peginterferon and Ribavirin in the PROVE2 Trial"

· Poster # 1203: "All IL28b Genotypes Have High SVR Rates in Patients Treated with VX-222 in Combination with Telaprevir/Peginterferon/Ribavirin in the ZENITH Study"

· Poster # 1132: "High Concordance Between SVR12 and SVR24 in Patients Receiving Telaprevir Plus Peginterferon and Ribavirin in Three Phase 3 Clinical Trials: ADVANCE, ILLUMINATE and REALIZE"

· Poster # 1162: "Ribavirin Dose Modification in Treatment-Naïve and Previously Treated Patients Who Received Telaprevir Combination Treatment: No Impact on Sustained Virologic Response in Phase 3 Studies"

· Poster # 1167: "Pre-Treatment IP-10 Levels and IL28b Genotype in Prediction of SVR in Prior Treatment-Experienced Genotype 1 HCV Patients Treated with Telaprevir/ Peginterferon/ Ribavirin in REALIZE Study"

· Poster # 1150: "A Comprehensive Review of Patterns of Viral Load Decline in Patients Treated with Telaprevir Plus Peginterferon and Ribavirin"

· Poster # 1117: "Telaprevir French Cohort Authorisation for Temporary Use in Genotype 1 Hepatitis C Cirrhotic Patients with Prior Partial Response or Relapse"

· Poster # 1116: "Exposure-Response Relationships in Telaprevir Combination Therapy in Treatment-Naïve Genotype 1 Chronic HCV Patients"

· Poster # 1174: "Deep Sequencing Screening for Telaprevir-Resistant Viral Variants in Previous Null Responders Fails to Identify Those Patients at Risk of Failing Telaprevir Plus Peginterferon/Ribavirin Therapy”

· Poster # 1184: "Characterization of HCV Variants in Genotype 1 Treatment-Naïve Patients Administered the Combination of TVR and VX-222 in Dual Arms of ZENITH Study"

· Poster # 1102: "The Cost-Effectiveness of Telaprevir (TVR) in Combination with Pegylated Interferon-Alfa and Ribavirin (PR) for the Treatment of Genotype 1(G1) Chronic Hepatitis C Patients"

· Poster # 1169: "Health-Related Quality-of-Life Among Genotype 1 Treatment-Naïve Chronic Hepatitis C Patients Receiving Telaprevir Combination Treatment: Post-Hoc Analyses of Data from the ADVANCE Trial"

· Poster # 1170: "Predictors of Days Unable to Work Among Genotype 1 Treatment-Naïve Chronic Hepatitis C Patients: Post-Hoc Analyses of Data from Phase 3 ADVANCE and ILLUMINATE Studies"

Media Contacts:
Erin Emlock
Dawn Kalmar
Zachry Barber
617-444-6992

Investor Relations Contact:
Michael Partridge, 617-444-6108

Public release date: 4-Apr-2012

Contact: Mika Ono
mikaono@scripps.edu
858-784-2052
Scripps Research Institute

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Timothy Tellinghuisen, Ph.D., is an associate professor at the Scripps Research Institute, Florida campus.

JUPITER, FL, April 4, 2012 – Scientists from the Florida campus of The Scripps Research Institute have been awarded just over $1 million from the National Institutes of Health for a three-year study to develop new high-throughput screening tests to find compounds that disable a protein essential to hepatitis C virus (HCV) replication.

Timothy Tellinghuisen, a Scripps Florida associate professor, is the principal investigator for the study.

Hepatitis C is a slow-progressing disease that causes inflammation of the liver and affects some 170 million people worldwide, according to the Hepatitis Foundation International. Like the current approach to HIV/AIDS, a cocktail-based therapeutic approach, which uses multiple inhibitors targeting distinct aspects of the HCV life cycle, has emerged as one of the most promising.

In the search for new treatments against HCV, it has become critical to develop novel targets to attack.

Tellinghuisen's new research is focused on a potentially potent, but somewhat neglected, enzyme. This protease—an enzyme that breaks down proteins—is known as NS2, which is necessary for productive infections that produce new viruses and spread the infection among cells.

"The NS2 protein is needed for hepatitis C infections, but is poorly understood," Tellinghuisen said. "The new grant will help us develop potential chemical tools to look at the role of NS2 in HCV biology because we really don't know how the protein works."

Some recent studies suggest that the NS2 protease may be involved in altering gene expression in the host cell and in helping the virus defend against apoptosis or programmed cell death, in addition to the more direct roles for the protein in viral replication and particle assembly.

Tellinghuisen and his colleagues have already developed a small-scale screen to identify compounds that disrupt viral replication through NS2 protease activity.

"Our overall goal is to turn our small-scale NS2 assay into an assay appropriate for high-throughput small-molecule screening," he said, noting that would give the team access to the more expansive Molecular Libraries Probe Production Centers Network (MLPCN) screening center program at Scripps Florida.

MLPCN is a collaborative research network that uses use high-tech screening methods to identify small molecules to investigate the diverse functions of cells; Scripps Research is one of four large national centers.

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Abstract

Title: THE EFFICACY AND SAFETY OF THE INTERFERON-FREE COMBINATION OF BI201335 AND BI207127 IN GENOTYPE 1 HCV PATIENTS WITH CIRRHOSIS - INTERIM ANALYSIS FROM SOUND-C2

Speaker: Vicente Soriano

Author: V. Soriano1*, E. Gane2, P. Angus3, F. Stickel4, J.-P. Bronowicki5, S. Roberts6, M. Manns7, S. Zeuzem8, L. Dai9, W. Boecher10, J. Stern9, F. Mensa9

Affiliation: 1Department of Infectious Diseases, Hospital Carlos III, Madrid, Spain, 2Auckland Clinical Studies, Auckland, New Zealand, 3Austin Health, Liver Trasnplant Unit, Heidelberg, VIC, Australia, 4Universitätsklinik für Viszerale Chirurgie und Medizin, Bern, Switzerland, 5Hopital de Brabois, Vandoeuvre, France, 6Alfred Hospital, Department of Gastroenterology, Melbourne, VIC, Australia, 7Medizinische Hochschule Hannover, Hannover, 8Klinikum der J. W. Goethe-Universität, Frankfurt am Main, Germany, 9Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA, 10Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany. *vsoriano@dragonet.es

Background: SOUND-C2 is an open-label, randomized, phase IIb study with 5 treatment arms evaluating the efficacy and safety of interferon-free combination regimens of BI201335, an HCV protease inhibitor, and BI207127, a non-nucleoside RNA polymerase inhibitor, +/- ribavirin (R) for 16-40 weeks (W), in HCV GT1 infected treatment naïve (TN) patients. This is an interim sub-analysis of patients with compensated liver cirrhosis enrolled in SOUND-C2.
Methods: 37 patients with biopsy or Fibroscan confirmed cirrhosis were treated in 5 arms (described in Zeuzem et al, Hepatology, 2011, Supp1, LB15). All 37 patients had compensated liver disease, 25 were GT1b and 30 had IL-28b genotype CT/TT. Patients who received the same dose for 16, 28 or 40W (arms A, B and C) were pooled.

Results: Efficacy (ITT) and safety data in patients with cirrhosis (randomization not stratified by cirrhosis):

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[Table 1]

Mild skin and gastrointestinal disorders were the most commonly reported AEs.

Conclusions: Interferon-free combination therapy with BI201335, BI207127 and R achieved up to 60% SVR12 in GT-1a and up to 83% in GT1b patients with compensated liver cirrhosis. The safety and tolerability was more favorable in the BI207127BID arm than in the BI207127TID arms. Response rates in cirrhotic and non-cirrhotic patients were similar, but a statistical comparison is not possible due to the limited sample size and imbalances in host and viral factors. Thus, these SVR4/12 rates suggest that this IFN-free regimen may obtain similar SVR rates to those achieved with approved DAAs + PR regimens with shorter treatment duration. These are the first data of an interferon free-regimen in a population with compensated HCV cirrhosis and they support further evaluation of this regimen for chronic HCV GT1 infection, including patients with cirrhosis.

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Abstract

Title: High Sustained Virologic Response Rate in Treatment-Naïve HCV Genotype 1a and 1b Patients Treated for 12 Weeks with an Interferon-Free All-Oral Quad Regimen: Interim Results

Speaker: Mark Sulkowski

Author: M. Sulkowski1*, M. Rodriguez-Torres2, E. Lawitz3, M. Shiffman4, S. Pol5, R. Herring6, J. McHutchison7, P. Pang7, D. Brainard7, D. Wyles8, F. Habersetzer9

Affiliation: 1Johns Hopkins University School of Medicine, Lutherville, MD, USA, 2Fundacion de Investigacion de Diego, Santurce, Puerto Rico, 3Alamo Medical Research, San Antonio, TX, 4Liver Institute of Virginia, Richmond, VA, USA, 5Hôpital Necker, Paris, France, 6Nashville Gastrointestinal Specialists, Inc., Nashville, TN, 7Gilead Sciences, Inc., Foster City, 8University of California, San Diego, La Jolla, CA, USA, 9Hôpitaux Universitaires de Strasbourg, Strasbourg, France. *msulkowski@jhmi.edu

Background and aims: The efficacy and safety of an all-oral regimen of the NS5a inhibitor GS-5885, non-nucleoside NS5b inhibitor tegobuvir, NS3 protease inhibitor GS-9451, and ribavirin for 12 or 24 weeks were assessed in chronic HCV genotype (GT) 1-infected patients. We report interim results in patients who received a 12-week treatment regimen.

Methods: 141 treatment-naïve patients were randomized 1:2 to receive GS-5885 30mg/day (Arm 1; n=47) or GS-5885 90mg/day (Arm 2; n=94); patients in both arms received tegobuvir 30mg BID + GS-9451 200mg QD + ribavirin 1000-1200mg/day. Patients not achieving HCV RNA < 25 IU/mL at Week 2 (vRVR; Roche Cobas Taqman v2 with LLOQ=25 IU/mL) were switched to peginterferon-containing rescue therapy. Arm 2 patients who achieved vRVR and remained undetectable were re-randomized (1:1) at Week 12 to stop therapy immediately or continue for an additional 12 weeks (total duration, 24 weeks).

Results: 94 patients randomized to Arm 2 received treatment: 59% male, 12% black, 60% non-CC allele, 72% GT1a, 87% HCV RNA >600,000 IU/mL. 74 achieved vRVR and 64 were eligible for re-randomization at Week 12. 27/33 patients who stopped therapy at Week 12 have reached post-treatment Week 4. Of these, 26 (96%) achieved SVR4 (18/19 [95%] of the GT1a patients and all 8 GT1b patients). Viral breakthrough occurred only in GT1a patients (8/55). Two patients terminated early: 1 due to alcohol abuse and 1 withdrew consent. IL28B status did not appear to correlate with SVR4 or breakthrough. The most frequently reported AEs were headache (21%), fatigue (16%), diarrhea (14%), nausea (13%), and rash (11%). No WBC or platelet reductions were observed. Mean hemoglobin reduction was -2.3 g/dL. No patients were discontinued from all-oral therapy due to a drug-related adverse event.

Conclusions: High SVR rates were observed with this well-tolerated, 12-week, interferon-free, all-oral quad regimen in HCV GT1a and 1b patients who achieved vRVR and remained undetectable during 12 weeks of therapy. Viral breakthrough and relapse were limited to GT1a-infected patients.

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[Study Flow Chart]

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PRESS RELEASE

April 4, 2012, 12:33 p.m. EDT

Poster Presentations to Include Enanta's Nucleotide HCV Polymerase Inhibitor Program and Additional ABT-450 Data-

WATERTOWN, Mass., April. 4, 2012 /PRNewswire via COMTEX/ -- Enanta Pharmaceuticals, Inc., a research and development company dedicated to creating best-in-class small molecule drugs in the infectious disease field, announced today that key data from two of its hepatitis C (HCV) programs will be presented at the International Liver Congress(TM) 2012 (ILC2012), the annual meeting of the European Association for the Study of the Liver (EASL), April 18-22 in Barcelona, Spain. Oral presentations will discuss Phase 2 results from "Pilot" and "Co-Pilot", which investigated two different interferon-free combination regimens containing ABT-450, the lead candidate from Enanta's collaborative HCV protease inhibitor program with Abbott. ABT-450 will be included in two additional poster presentations and a third poster presentation will report in vitro data from Enanta's proprietary nucleotide HCV polymerase inhibitor program. Abstracts are available at www.easl.eu .

Phase 2 Data Highlights

In the study known as "Co-Pilot," different doses of ABT-450/r, plus ABT-333 and ribavirin administered for 12 weeks showed sustained virological response at 12 weeks post treatment (SVR12) in 93 percent and 95 percent of treatment-naive genotype 1 (GT1) patients. In these patients, response was independent of HCV subtype, host IL28B genotype or dose of ABT-450/r. In addition, SVR12 was achieved in 47 percent of patients who were previous non-responders to past HCV treatment.

In a separate study, known as "Pilot", 91 percent of genotype 1 infected, treatment-naive patients taking ABT-450/r and ABT-072 combined with ribavirin administered for 12 weeks, achieved sustained viral response at 24 weeks (SVR24).

"The results from Pilot and Co-Pilot showed very encouraging levels of sustained response and suggest that ABT-450 could be an important component in new interferon-free, all-oral regimens for previously treated and treatment-naive patients with HCV," said Jay Luly, Ph.D., President and CEO of Enanta. "Enanta's involvement in five distinct HCV drug classes provides multiple avenues to pursue our goal of bringing to patients innovative therapies that are safer and more effective than current treatments."

Oral Presentations

Oral Presentation, Eric Lawitz et al.; Thursday, April 19, 16:00-18:00 CET / 10:00 am - 12:00 pm EDT. A 12-week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naive HCV IL28B-CC Genotype-1-Infected Subjects

The objectives of the 12-week, phase 2 study were to assess the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450/r 150/100 mg QD and ABT-072 400 mg QD + ribavirin administered for 12 weeks.

The study was conducted in 11 treatment naive adults from multiple ethnic backgrounds with non-cirrhotic HCV GT1 (8 GT 1a, 3 GT 1b). Ribavirin 1000-1200 mg/day was weight-based and dosed twice daily.

The primary endpoint was percentage of patients with HCV RNA <25 IU/ml from week 4 through 12. Other trial endpoints include early virologic response, RVR and SVR through 24 weeks.

100 percent of patients maintained HCV RNA levels <25 IU/mL from weeks 4 through 12 of treatment, and all had undetectable HCV RNA from week 5 to the end of treatment.

91 percent of patients achieved SVR24,

In the trial, the most common adverse events reported were headache, fatigue, nausea and dry skin. There were no premature discontinuations.

Late-Breaking Oral Presentation, Fred Poordad, et al.; Saturday, April 21, 15:30-17:30 CET / 9:30-11:30 am EDT.12-Week Interferon-Free Regimen of ABT-450/r+ABT-333+Ribavirin Achieved SVR12 in More Than 90% of Treatment-Naive HCV Genotype-1-Infected Subjects and 47% of Previous Non-Responders

The objectives of this phase 2 study were to assess safety and tolerability 12-week interferon-free regimens in HCV GT1 patients who were either treatment naive or previous non-responders. The trial had three arms with three primary end points - rapid virological response (RVR) at week 4 and SVR at weeks 4 and 12.

Enrollment was open to GT1-infected patients regardless of IL28B host genotype and ribavirin dosing was weight-based.

95 percent (18 of 19) of treatment-naive patients infected with HCV GT1 (17 GT 1a, 2 GT 1b) achieved SVR12 with ABT 450/r 250/100 mg dosed once daily (QD) + ABT-333 400 mg dosed twice daily (BID) + ribavirin (Arm 1).

93 percent (13 of 14) of treatment- naive patients infected with HCV GT1(11 GT 1a, 3 GT1b) achieved SVR12 with ABT 450/r 150/100 mg QD + ABT-333 400 mg BID + ribavirin (Arm 2).

47 percent (8 of 17) of patients with HCV GT1 (16 GT1a, 1 GT1b) who had previously not responded to other HCV treatments achieved SVR12 with ABT 450/r 150/100 mg QD + ABT-333 400 mg BID + ribavirin (Arm 3).

One patient in Arm 1 discontinued due to asymptomatic isolated ALT/AST elevations at week 2. One patient in Arm 2 discontinued due to noncompliance in week 1. All remaining patients in Arms 1 and 2 completed treatment and achieved SVR12. In Arm 3, six patients experienced viral breakthrough while on treatment and three patients relapsed after treatment stopped.

In the trial the most common adverse events were fatigue (42 percent), nausea (22 percent) and headache (20 percent).

Abbott is developing ABT-450 with low dose ritonavir (ABT-450/r) which enhances the pharmacokinetic properties of ABT-450, allowing for once daily dosing. The use of ritonavir 100 mg with ABT-450 for the treatment of HCV is investigational.

Poster Presentations

Poster #867, Tami Pilot-Matias et al.; Friday, April 20 (11:00-11)(12:30-14)(15:30-16) "In vitro combinatory effect of HCV NS3/4A protease inhibitor ABT-450, NS5A inhibitor ABT-267, and non-nucleoside NS5B polymerase inhibitor ABT-333"

Poster #1187, Eric Lawitz et al; Saturday, April 21 (11:00-11)(12:30-13)(15:00-15)"ABT-450/ritonavir (ABT-450/r) combined with pegylated interferon alpha-2a/ribavirin after 3-day monotherapy in genotype 1 (GT1) HCV-infected treatment-naive subjects: 12-week sustained virologic response (SVR12) and safety results"

Poster #1200, Christopher M. Owens et al.; Saturday, April 21 (11:00 - 11)(12:30 - 13)(15:00 - 15)"Antiviral Activity of EP-NI266, a Potent Nucleotide HCV Polymerase Inhibitor"

About the Hepatitis C VirusHepatitis C is a liver disease affecting over 170 million people worldwide. The virus is spread through direct contact with the blood of an infected person. Hepatitis C increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer and death. Liver disease associated with HCV infection is growing rapidly, and there is an acute need for new therapies that are safer and more effective. Specifically targeted antiviral therapies for HCV, such as NS3/4a protease and NS5A inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.

About EnantaEnanta Pharmaceuticals is a research and development company that uses its novel chemistry approach and drug discovery capabilities to create best in class small molecule drugs in the infectious disease field. Enanta is discovering and developing novel inhibitors and combinations of inhibitors targeted against the Hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes- protease (partnered with Abbott), NS5A (partnered with Novartis), nucleotide polymerase, and a host targeted antiviral (HTA) inhibitor class targeted against cyclophilin. Through its partnership with Abbott, collaboration protease inhibitor ABT-450 is being evaluated in combination with Abbott's non-nucleoside polymerase and NS5A inhibitors. Additionally, the Company has created a new class of antibiotics, called Bicyclolides, which overcomes bacterial resistance. Antibacterial focus areas include overcoming resistance to superbugs, treating respiratory tract infections, and developing intravenous and oral treatments for hospital and community MRSA infections. Enanta is a privately held company headquartered in Watertown, Mass. Enanta's news releases and other information are available on the company's web site at www.enanta.com .

For Enanta Investor Relations, please contact:Paul Mellett617-607-0761

For Enanta Public Relations, please contact MacDougall Biomedical Communications:Kari Watson781-235-3060 or kwatson@macbiocom.com 

SOURCE Enanta Pharmaceuticals, Inc.

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Also See:

  1. EASL 2012: Abbott to Present Positive Phase 2 Results from Multiple Interferon-Free Studies of Combination Regimens for the Treatment of Hepatitis C
  2. EASL 2012: Abbott hepatitis drug 93% effective in small study

EASL 2012: Abbott hepatitis drug 93% effective in small study

chi-abbott-hepatitis-drug-93-effective-in-smal-001

An Abbott hepatitis drug has proven effective in small trials. (Tribune file / April 4, 2012)

Reuters

9:24 a.m. CDT, April 4, 2012

A combination of experimental oral hepatitis C treatments being developed by Abbott Laboratories led to cure rates of more than 90 percent in previously untreated patients, according to data from a small mid-stage study.

The data, to be presented at a major European liver meeting this month, puts Abbott firmly in the crowded race to produce a short duration, interferon-free treatment regimen for the serious liver disease.

"This demonstrates unprecedented cure rates for the most common form of hepatitis C infection. And we were able to achieve those rates with only a 12-week duration of therapy," said Scott Brun, Abbott's divisional vice president for infectious disease development.

Abstracts, or brief summaries, of studies to be presented at the European Association for the Study of the Liver (EASL) meeting in Barcelona were made available on Wednesday.

"At EASL it's going to be very clear that we've reached a really transformational moment for patients with HCV (hepatitis C virus)," Brun said.

The Phase II trial of previously untreated patients, known as Co-Pilot, combined Abbot's protease inhibitor ABT-450 boosted by the antiviral drug ritonavir with its polymerase inhibitor ABT-333 and ribavirin, a drug that is part of all current hepatitis C regimens.

Patients received the combination therapy for 12 weeks and were checked 24 weeks later for signs of the virus in the blood to determine whether there was a sustained virologic response, or SVR. Any patients that achieved an SVR 24 weeks after completing treatment are deemed to be cured.

Eighteen of the 19 patients who received a 250 milligram dose of ABT-450 as part of their combination achieved SVR, or 95 percent, while 13 of 14 patients who got a 150 mg dose of ABT-450 were deemed to be cured, or 93 percent.

In a third arm of the study that involved patients who had failed to be helped by the former standard treatment of interferon and ribavirin, eight of 17 patients achieved SVR for a cure rate of 47 percent.

Abbott is also testing a drug from a promising class known as NS5A inhibitors in various all-oral combinations that it believes may improve cure rates for prior non-responders.

"For a first step it's very encouraging," Brun said of the new data in non-responders. "If you're able to add the potent NS5A inhibitor into the mix we think there's the potential to do even better and that's currently under study."

There were no serious side effects seen in the study, with the most common side effects fatigue, nausea and headache.

Source

Also See: EASL 2012: Abbott to Present Positive Phase 2 Results from Multiple Interferon-Free Studies of Combination Regimens for the Treatment of Hepatitis C

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PRESS RELEASE

April 4, 2012, 11:16 a.m. EDT

HUDDINGE, Sweden, April 4, 2012 /PRNewswire via COMTEX/ -- Including an Oral Presentation of final analysis of the TMC435 phase IIb ASPIRE (C206) study that have been selected to be highlighted during the official EASL Press Office activities

Medivir AB (omx:MVIR), a research-based specialty pharmaceutical company focused on infectious diseases, today announces that four abstracts related to its once daily (QD), oral investigational hepatitis C drug TMC435, development in collaboration with Janssen R&D Ireland, have been accepted for presentation at the 47th Annual meeting of the European Association for the Study of the Liver (EASL), taking place from April 18-22 in Barcelona, Spain.

The following abstracts will be presented orally:

  • TMC435 IN PATIENTS INFECTED WITH HCV GENOTYPE 1 WHO HAVE FAILED PREVIOUS PEGYLATED INTERFERON / RIBAVIRIN TREATMENT: VIROLOGIC ANALYSES OF THE ASPIRE TRIAL
  • TMC435 IN HCV GENOTYPE 1 PATIENTS WHO HAVE FAILED PREVIOUS PEGYLATED INTERFERON / RIBAVIRIN TREATMENT: FINAL SVR24 RESULTS OF THE ASPIRE TRIAL
  • COMPARISON OF TWO QUANTITATIVE HCV RNA ASSAYS IN SAMPLES FROM PATIENTS TREATED WITH A PROTEASE INHIBITOR-BASED THERAPY: IMPLICATIONS FOR RESPONSE GUIDED THERAPY

The following abstract will be presented as a poster:

  • Absence of PHOTOSENSITIVITY POTENTIAL OF tmc435 IN HEALTHY VOLUNTEERS

The abstracts will be available on the EASL website, http://www.easl.eu  as of today.

About Medivir

Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company's key pipeline asset is TMC435, a novel protease inhibitor in phase III clinical development for hepatitis C that is being developed in collaboration with Janssen Pharmaceuticals.

In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia to ensure timely commercialisation of TMC435 in the Nordic markets, once approved.

Medivir's first product, the unique cold sore product Xerese®/Xerclear®, was launched on the US market in 2011. Xerese®/Xerclear®, which has been approved in both the US and Europe, is being launched in collaboration with GlaxoSmithKline to be sold OTC in Europe, Japan and Russia. Rights in North America, Canada and Mexico were sold to Meda AB in June 2011. Medivir has retained the Rx rights for Xerclear® in Sweden and Finland.

For more information about Medivir, please visit the Company's website: http://www.medivir.com

For more information about Medivir, please contact: Medivir Rein Piir, EVP Corporate Affairs & IR Mobile: +46-708-537-292 M:Communications Europe: Mary-Jane Elliott, Amber Bielecka, Hollie Vile medivir@mcomgroup.com  +44(0)20-7920-2330

SOURCE Medivir

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ABBOTT PARK Ill., April 4, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) will present clinical trial results from two different interferon-free, Phase 2 studies for the treatment of hepatitis C (HCV) at the International Liver Congress™ 2012 (ILC 2012), the annual meeting of the European Association for the Study of the Liver (EASL), April 18-22 in Barcelona, Spain. Abstracts for the meeting were published online today.

In the study known as "Co-Pilot," different doses of ABT-450/r, plus ABT-333 and ribavirin administered for 12 weeks showed sustained virological response at 12 weeks post treatment (SVR12) in 95 percent and 93 percent of treatment-naive genotype 1 (GT1) patients. In these patients, response was independent of HCV subtype, host IL28B genotype or dose of ABT-450/r. In addition, SVR12 was achieved in 47 percent of patients who were previous non-responders to past HCV treatment.

In a separate study, known as "Pilot," 91 percent of genotype 1 infected, treatment-naive patients taking ABT-450/r and ABT-072 combined with ribavirin administered for 12 weeks, achieved sustained viral response at 24 weeks (SVR24).

Full results with longer-term follow-up data from both studies will be presented at the meeting. Abstracts are available at www.easl.eu.

"We are extremely encouraged to see this level of sustained response with only 12 weeks of therapy in patients who were new to treatment, and to see a response in patients who had failed past treatment because options to cure this population are limited," said Fred Poordad, M.D., chief of hepatology at Cedars-Sinai Medical Center in Los Angeles, and the lead investigator for Co-Pilot and an investigator for Pilot. "These data suggest that an interferon-free, all-oral regimen of direct-acting antiviral medications could be an important new treatment option for HCV, and we look forward to presenting additional data at the meeting."

"At this meeting, Abbott will present some of the first sustained viral response data for short course, interferon-free regimens for the treatment of HCV. The data suggest that with a 12-week regimen containing just two of our direct-acting antiviral medicines, and no peginterferon, we can achieve high cure rates in treatment-naive, genotype 1 patients," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. "Abbott's HCV pipeline includes several compounds in different drug classes and we have the flexibility to study a variety of multi-drug regimens for HCV, with a focus on interferon-free treatments. Abbott is committed to exploring a wide variety of options in our portfolio with the goal of developing optimized regimens to help patients."

Current treatments for HCV remain interferon-based and a significant number of HCV patients are unable or unwilling to take interferon due to contraindications and/or side effects. Specifically targeted antiviral therapies for HCV, such as protease inhibitors and non-nucleoside polymerase inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.

These two studies represent an important part of Abbott's broader HCV development program. Larger Phase 2 clinical trials are ongoing, and Abbott expects to present additional data later this year. In addition to its partnership with Enanta Pharmaceuticals on ABT-450 and protease inhibitors, Abbott has internal programs focused on additional viral targets. Abbott currently has investigational medicines with three different mechanisms of action in its ongoing clinical trials, including protease, polymerase and NS5A inhibitors. Abbott is well-positioned to explore combinations of these compounds, a strategy with the potential to markedly transform current treatment practices by shortening therapy duration, improving tolerability and increasing cure rates.

Study M12-746 (Co-Pilot)

Fred Poordad, et al.; Saturday, April 21, 15:30-17:30 CET / 8:30-10:30 a.m. CDT.

"12-Week Interferon-Free Regimen of ABT-450/r+ABT-333+Ribavirin Achieved SVR12 in More Than 90% of Treatment-Naive HCV Genotype-1-Infected Subjects and 47% of Previous Non-Responders"

  • The objectives of this Phase 2 study were to assess safety and tolerability of 12-week, interferon-free regimens in HCV GT1 patients who were either treatment-naive or previous non-responders. The trial had three arms with three primary endpoints – rapid virological response (RVR) at week 4 and SVR at weeks 4 and 12.
  • Enrollment was open to GT1-infected patients regardless of IL28B host genotype and ribavirin dosing was weight-based.
  • 95 percent (18 of 19) of treatment-naive patients infected with HCV GT1
  • (17 GT 1a, 2 GT 1b) achieved SVR12 with ABT-450/r 250/100 mg dosed once daily (QD) + ABT-333 400 mg dosed twice daily (BID) + ribavirin (Arm 1).
  • 93 percent (13 of 14) of treatment-naive patients infected with HCV GT1
  • (11 GT 1a, 3 GT 1b) achieved SVR12 with ABT-450/r 150/100 mg QD + ABT-333 400 mg BID + ribavirin (Arm 2).
  • 47 percent (8 of 17) of patients with HCV GT1 (16 GT 1a, 1 GT 1b) who had previously not responded to other HCV treatments achieved SVR12 with ABT-450/r 150/100 mg QD + ABT-333 400 mg BID + ribavirin (Arm 3).
  • One patient in Arm 1 discontinued due to asymptomatic isolated ALT/AST elevations at week 2. One patient in Arm 2 discontinued due to noncompliance in week 1. All remaining patients in Arms 1 and 2 completed treatment and achieved SVR12. In Arm 3, six patients experienced viral breakthrough while on treatment and three patients relapsed after treatment stopped.
  • In the trial the most common adverse events were fatigue (42 percent), nausea (22 percent) and headache (20 percent).

Study M12-267 (Pilot)

Eric Lawitz et al.; Thursday, April 19, 16:00-18:00 CET / 9:00-11:00 a.m. CDT.

"A 12-Week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naive HCV IL28B-CC Genotype-1-Infected Subjects"

  • The objectives of the 12-week, Phase 2 study were to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-450/r 150/100 mg QD and ABT-072 400 mg QD + ribavirin administered for 12 weeks.
  • The study was conducted in 11 treatment-naive adults with host IL28B "CC" genotype from multiple ethnic backgrounds with non-cirrhotic HCV GT1 (8 GT 1a, 3 GT 1b). Ribavirin 1,000-1,200 mg/day was weight-based and dosed twice daily.
  • The primary endpoint was percentage of patients with HCV RNA <25 IU/mL from week 4 through 12. Other trial endpoints include early virologic response, RVR and SVR through 24 weeks.
  • 100 percent of patients maintained HCV RNA levels <25 IU/mL from weeks
  • 4 through 12 of treatment, and all had undetectable HCV RNA from week 5 to the end of treatment.
  • 91 percent of patients (10 of 11) achieved SVR24.
  • In the trial, the most common adverse events reported were headache, fatigue, nausea and dry skin. There were no premature discontinuations.

ABT-450 is being developed with low dose ritonavir (ABT-450/r), which enhances the pharmacokinetic properties of ABT-450. The use of ritonavir 100 mg with ABT-450 for the treatment of HCV is investigational.

In addition to the oral presentations, Abbott has six poster presentations at ILC 2012:

  • Tami Pilot-Matias et al.; Friday, April 20 (11:00-11:30, 12:30-14:00, 15:30-16:00 CET)
    "In vitro combinatory effect of HCV NS3/4A protease inhibitor ABT-450, NS5A inhibitor ABT-267, and non-nucleoside NS5B polymerase inhibitor ABT-333"
  • Robert W. Baran et al.; Friday, April 20 (11:00-11:30, 12:30-14:00, 15:30-16:00 CET)
    "Hepatitis C Virus Patient Reported Outcomes (HCVPRO): Development and Validation of a Disease-Specific Patient Reported Outcomes Instrument for Health-Related Quality of Life Measurement"
  • Eric Lawitz et al.; Saturday, April 21 (11:00-11:30, 12:30-13:30, 15:00-15:30 CET)
    "Safety and antiviral activity of ABT-267, a novel NS5A inhibitor, during 3-day monotherapy: first study in HCV genotype-1 (GT1)-infected treatment-naive subjects"
  • J Greg Sullivan et al.; Saturday, April 21 (11:00-11:30, 12:30-13:30, 15:00-15:30 CET)
    "ABT-267 combined with pegylated interferon alpha-2a/ribavirin in genotype 1 (GT1) HCV-infected treatment-naive subjects: 12 week antiviral and safety analysis"
  • Eric Lawitz et al; Saturday, April 21 (11:00-11:30, 12:30-13:30, 15:00-15:30 CET)
    "ABT-450/ritonavir (ABT-450/r) combined with pegylated interferon alpha-2a/ribavirin after 3-day monotherapy in genotype 1 (GT1) HCV-infected treatment-naive subjects: 12-week sustained virologic response (SVR12) and safety results"
  • Fred Poordad et al.; Saturday, April 21 (11:00-11:30, 12:30-13:30, 15:00-15:30 CET)
    "ABT-072 or ABT-333 combined with pegylated interferon/ribavirin after 3-day monotherapy in HCV genotype 1 (GT1)-infected treatment-naive subjects:
    12-week sustained virologic response (SVR12) and safety results"

About the Hepatitis C Virus

Hepatitis C is a liver disease affecting as many as 170 million people worldwide. The virus is primarily spread through direct contact with the blood of an infected person. HCV increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer and death, and liver disease associated with HCV infection is growing rapidly.

Ritonavir Use in Treatment of HIV

Ritonavir is in a class of medicines called the HIV protease inhibitors. Ritonavir is used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. Ritonavir is for adults and for children greater than 1 month in age and older.

Ritonavir does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others. People taking ritonavir may still get opportunistic infections or other conditions that happen with HIV infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections.

Ritonavir Safety in Treatment of HIV

Patients should not take ritonavir with certain medicines, as these can cause serious or life-threatening problems such as irregular heartbeat, breathing difficulties, or excessive sleepiness. Patients should not take ritonavir if they have had a serious allergic reaction to any of its ingredients. Some patients taking ritonavir may develop liver and pancreas problems, which can cause death. Patients may develop large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, increased bleeding in people with hemophilia, allergic reactions, and/or changes in heart rhythm. Patients may develop signs and symptoms of infections that they already have after starting anti-HIV medicines.

For more information, please see the Important Safety Information and full Prescribing Information for ritonavir.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacturing and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's website at www.abbott.com.

SOURCE Abbott

RELATED LINKS
http://www.abbott.com

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BEERSE, Belgium, April 4, 2012 /PRNewswire/ --

Not Intended for US Journalists

- Analysis to be presented at European Association for the Study of the Liver (EASL) 2012 shows clinical and cost-effectiveness regardless of IL28B subtype -

Janssen Pharmaceutica NV (Janssen) will present a cost-effectiveness analysis for INCIVO(telaprevir) at the 47th annual meeting of the European Association for the Study of the Liver (EASL) in Barcelona. The analysis demonstrates that the addition of telaprevir to peginterferon alfa and ribavirin (PR) is cost-effective for both treatment-naïve and experienced patients with genotype-1 chronic hepatitis C virus (HCV), regardless of IL28B subtype.1 The analysis considers cost-effectiveness in terms of incremental cost per quality adjusted life year (QALY) gained from the perspective of the NHS in England and Wales.1

The analysis showed that the improved clinical outcomes from the addition of telaprevir to PR for the treatment of genotype-1 chronic HCV infection result in an Incremental Cost Effectiveness Ratio (ICER)1,2 of £13,553 for treatment-naïve patients and an average of £8,688 for treatment-experienced patients.1 The ICER is different depending on the characteristics of treatment-experienced patients, but for all groups, regardless of IL28B subtype, telaprevir was shown to be cost-effective according to the threshold of £20,000-£30,000 per quality adjusted life year (QALY).1,3,which is a measurement of the impact of a treatment on patient quality of life. Health authorities generally view a treatment to be cost-effective if it does not cost more than £20,000-£30,000 per QALY.1,3

Alessandra Baldini, EMEA Medical Affairs Director, Janssen said: "INCIVO has demonstrated a significant improvement in sustained virologic response (SVR) rates for genotype-1 chronic HCV compared to standard treatment with pegylated interferon and ribavirin, including for those patients who were considered difficult to treat. The analysis shows that the clinical benefits and improved outcomes provide a cost-effective long-term benefit for patients with genotype-1 chronic HCV infection."

Data from Phase 3 clinical trials showed that telaprevir in combination with PR demonstrated significant improvements in SVR, compared with PR alone, for both previously untreated genotype-1 chronic HCV patients and those who had failed previous treatment.4,5

"The cost-effectiveness of new direct-acting antivirals for HCV is an important consideration for national health authorities when assessing the benefit of making these treatments available for patients." said Charles Gore, President of the World Hepatitis Alliance. "The availability of direct acting antivirals like telaprevir has been a huge step forward in the fight against chronic HCV infection, giving more patients than ever the hope of clearing the virus from their bodies. We know that the long-term consequences of HCV can be devastating for both patients and health systems, so it is encouraging to see that these treatments are cost-effective in the long term."

An estimated 130-210 million people are infected with HCV worldwide6, and the virus has been described as a 'timebomb' by the World Health Organization due to low diagnosis and treatment rates and long-term consequences of HCV infection such as liver cirrhosis and liver cancer.6 Despite the availability of treatment options, as few as 3.5% of people with HCV are currently receiving treatment in Europe.7

  1. Additional telaprevir data to be presented at EASL will include:
  2. Retrospective sub-analyses from ADVANCE, ILLUMINATE and REALIZE studies in treatment naïve and previously untreated patients with genotype-1 chronic HCV showing that SVR rates for patients receiving telaprevir in combination with PR were not substantially affected by a ribavirin dose reduction8

About INCIVO®

INCIVO® (telaprevir), in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic HCV in adult patients with compensated liver disease (including cirrhosis) who are treatment naïve, and who have previously been treated with interferon alfa (pegylated or non pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.9 INCIVO is a small molecule, selective inhibitor of the HCV serine protease, and a member of the new class of medicine for the treatment of genotype-1 chronic HCV, direct acting antivirals (DAAs). Unlike previous treatments, DAAs act directly on viral enzymes and prevent the virus from replicating. INCIVO was approved by the European Commission on 19 September 2011.

Telaprevir was developed by Janssen-Virco BVBA, one of the Janssen Pharmaceutical Companies, in collaboration with Vertex and Mitsubishi Tanabe Pharma. Janssen has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Vertex has rights to commercialize telaprevir in North America where it is being marketed under the brand name INCIVEKTM. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries where it is being marketed as TELAVIC®.

Important Safety Information

Please see full Summary of Product Characteristics or visit http://www.emea.europa.eu for more details.

The overall safety profile of telaprevir is based on the Phase 2/3 clinical development programme. In clinical trials, the incidence of adverse events of at least moderate intensity was higher in the telaprevir group than in the placebo group (both groups receiving peginterferon alfa and ribavirin). The most frequently reported moderate adverse reactions (incidence ≥ 5.0%) were anaemia, rash, pruritus, nausea, and diarrhoea, and the most frequently reported severe adverse reactions (incidence ≥ 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea.9

Rash events were reported in 55% of patients with a telaprevir based regimen and more than 90% of rashes were of mild or moderate severity. Severe rashes were reported with telaprevir combination treatment in 4.8% of patients. Rash led to discontinuation in 5.8% of patients. Anaemia was reported in 32.1% of patients and led to discontinuation in 2.8%.9

About HCV

HCV is a blood-borne infectious disease that affects the liver.10,11With an estimated 130-210 million people infected worldwide,6 and three to four million people newly infected each year, HCV puts a significant burden on patients and society.12 Estimations indicate that HCV caused more than 86,000 deaths and 1.2 million disability-adjusted life-years (DALYs) in the WHO European region in 2002.13 Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases.14 About one-quarter of the liver transplants performed in 25 European countries in 2004 were attributable to HCV.13 The previously accepted standard treatment for HCV is peginterferon alfa combined with ribavirin,15 however this only clears the virus for 40-50 percent of genotype-1 chronic HCV patients.15,16

About Janssen

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world.

More information can be found at www.janssen-emea.com.

References:

  1. Curtis S, Cure S, Gavart S, et al. The cost-effectiveness of telaprevir (TVR) in combination with pegylated interferon-alfa and ribavirin (PR) for the treatment of genotype 1 chronic hepatitis c patients. Poster presented at the 47th Annual Meeting of the European Association of Study of the Liver (EASL); 2012
  2. Phillips C, What is Cost-effectiveness? Health Economics. Available via URL http://www.medicine.ox.ac.uk/bandolier/painres/download/whatis/Cost-effect.pdf
  3. NICE, Measuring effectiveness and cost effectiveness: the QALY. Available via URL: http://www.nice.org.uk/newsroom/features/measuringeffectivenessandcosteffectivenesstheqaly.jsp
  4. Zeuzem, S et al. Telaprevir for Retreatment of HCV Infection. N Engl J Med. 2011;364:2417-28.(REALIZE)
  5. Jacobson, I et al. Telaprevir for Previously Untreated Hepatitis C Virus Infection. N Engl J Med. 2011;364:2405-16. (ADVANCE)
  6. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. Journal of Hepatology. 2011; 55: 245-264
  7. Lettmeier B, Mühlberger N, Schwarzer R et al. Market uptake of new antiviral drugs for the treatment of hepatitis C. Journal of Hepatology 2008;49:528-536.
  8. Sulkowski, M S et al. Ribavirin dose modification in treatment-naïve and previously treated ppatients who received telaprevir combination treatment: no impact on sustained virologic response in phase 3 studies. Presented at EASL 2012
  9. Incivo® Summary of Product Characteristics, updated 2011
  10. Simin, M et al. Cochrane systematic review: pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C. Alimentary Pharmacology & Therapeutics. 2007; 25(10):1153-62.
  11. Centres for Disease Control and Prevention. Hepatitis C FAQs. [cited 2009 Dec 17] Available from: http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission.
  12. WHO. State of the art of vaccine research and development. Viral Cancers. Available from http://www.who.int/vaccine_research/documents/Viral_Cancers.pdf).
  13. Mühlberger, N et al. HCV-related burden of disease in Europe: a systematic assessment of incidence, prevalence, morbidity, and mortality. BMC Public Health. 2009; 9(34):1-14.
  14. Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Review of Vaccines 2008;7(7): 915-923.
  15. McHutchison, J et al. Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Treatment of Hepatitis C Infection. N Engl J Med. 2009; 361:580-93.
  16. The Hepatitis C Trust. Treatments: Potential New Drugs. [cited 2010 Feb 20] Available from: http://www.hepctrust.org.uk/treatment/potential-new-drugs/Drugs+that+target+the+virus .

SOURCE Janssen Pharmaceutica NV

Source

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April 04, 2012 10:44 AM Eastern Daylight Time

First Report of SVR4 Data from the study of daclatasvir (BMS-790052) plus GS-7977 +/-ribavirin in treatment-naïve patients with chronic hepatitis C genotype 1, 2, or 3, during a late breaker poster presentation

Oral presentations on hepatitis C investigational compounds daclatasvir (BMS-790052), asunaprevir (BMS-650032), and peginterferon lambda-1a (Lambda) demonstrate advancement of robust pipeline

Breadth of data highlights Company’s commitment to pursuing research that aims to improve the management of liver disease

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 20 abstracts on the Company’s research in liver disease have been accepted for presentation at The International Liver CongressTM 2012, the 47th annual meeting of the European Association for the Study of the Liver (EASL), in Barcelona, April 18 – 22. Bristol-Myers Squibb is studying a portfolio of compounds that has the potential to address unmet medical needs for patients with liver disease, including the investigational compounds daclatasvir, asunaprevir, Lambda, BMS-791325, and BMS-986094 (INX-189) for hepatitis C (HCV); brivanib for hepatocellular carcinoma (HCC); and BARACLUDE® (entecavir). BARACLUDE is currently indicated for the treatment of chronic hepatitis B (CHB) in adults with evidence of active viral replication and either evidence of persistent elevations in aminotransferases (ALT or AST), or histologically active disease.

Key presentations include one late breaker poster presentation and two oral presentations of Phase II data on the Company’s investigational HCV direct-acting antivirals (DAAs) and Lambda:

  • A late breaker presentation on the first report of SVR4 results from a Phase II study of the direct-acting antiviral daclatasvir (NS5A Inhibitor) and GS-7977 (formerly PSI-7977; an NS5B inhibitor), +/-ribavirin, in treatment-naïve patients with chronic HCV genotype 1, 2, or 3
  • An oral presentation on dual oral therapy with daclatasvir plus asunaprevir in HCV genotype 1b-infected null responders or ineligible/intolerant to alfa/ribavirin
  • The first report of SVR24 results from the EMERGE Phase IIb study peginterferon Lambda‐1a (Lambda) compared to peginterferon alfa‐2a (alfa) in treatment‐naïve patients with HCV genotypes 2 or 3

“Bristol-Myers Squibb is at the forefront of discovering, developing, and delivering potential treatments for diseases of the liver where there remains considerable unmet medical needs,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “For example, our goal in hepatitis C is to expand treatment options for patients by developing our portfolio of investigational compounds through multiple treatment approaches. The data we are presenting at the International Liver Congress help to expand our understanding of the potential efficacy and safety profiles of these investigational compounds and support our ongoing Phase III development program in HCV.”

The Company will also present a late-breaker oral presentation on data from the BRISK-PS study of investigational compound brivanib in patients with HCC who failed or were intolerant to sorafenib and six presentations of outcomes research/real-world data that add to the understanding of the prevalence of and current treatment patterns in HBV, HCV and HCC.

The complete list of Bristol-Myers Squibb data presentations is below. Abstracts can be accessed on the ILC/EASL website at http://www.easl.eu/_the-international-liver-congress/general-information.

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INDICATION and IMPORTANT SAFETY INFORMATION about BARACLUDE (entecavir) Tablets:

INDICATION

BARACLUDE is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The following points should be considered when initiating BARACLUDE:

  • This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease.
  • Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease.
  • Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY

  • Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
  • Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE (entecavir) is used to treat chronic HBV infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART).
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, alone or in combination with antiretrovirals.

Warnings and Precautions

  • Before initiating BARACLUDE therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use.
  • Lactic acidosis with BARACLUDE use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. BARACLUDE should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Adverse Reactions

  • In clinical trials in patients with compensated liver disease, the most common (≥3%) adverse reactions of any severity with at least a possible relation to study drug for BARACLUDE-treated subjects were headache, fatigue, dizziness, and nausea. In these trials, the most common adverse reactions of moderate to severe intensity (grades 2-4) were diarrhea, dyspepsia, nausea, vomiting, fatigue, headache, dizziness, somnolence, and insomnia.
  • In the decompensated liver disease trial, the most common adverse reactions of any severity among patients treated with BARACLUDE, regardless of causality, included: peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%). In this trial, 18% (18/102) of BARACLUDE (entecavir) patients and 20% (18/89) of adefovir patients died during the first 48 weeks of therapy. The majority of those deaths were due to liver related causes.

Drug Interactions

BARACLUDE is primarily eliminated by the kidneys, therefore coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Patients should be monitored closely when receiving BARACLUDE with other renally-eliminated drugs.

Pregnancy and Nursing Mothers

  • There are no adequate and well-controlled studies of BARACLUDE in pregnant women. BARACLUDE should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits.
  • There are no studies on the effect of BARACLUDE on transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.
  • It is not known whether BARACLUDE is excreted into human milk; however, many drugs are excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants from BARACLUDE, risks and benefits should be considered when deciding whether to discontinue breast-feeding or discontinue BARACLUDE in nursing women.

Pediatric Use

  • Safety and effectiveness of BARACLUDE in pediatric patients below the age of 16 years have not been established.

Renal Impairment

  • Dosage adjustment of BARACLUDE is recommended for patients with a creatinine clearance <50 mL/min, including those on hemodialysis or continuous ambulatory peritoneal dialysis.
  • The safety and efficacy of BARACLUDE (entecavir) in liver transplant recipients are unknown. Renal function must be carefully monitored both before and during treatment with BARACLUDE in a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus.

Dosage and Administration

BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal).

The recommended dose of BARACLUDE:

  • in nucleoside-naïve adults and adolescents (16+ yrs) with compensated liver disease is 0.5 mg once daily
  • in adults and adolescents (16+ yrs) with compensated liver disease, and refractory to lamivudine or with known lamivudine or telbivudine resistance mutations (rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L) is 1 mg once daily
  • in adults with decompensated liver disease is 1 mg once daily

The optimal duration of treatment with BARACLUDE for patients with chronic HBV infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.

Additional Information

BARACLUDE is not a cure for HBV. Patients should be advised that treatment with BARACLUDE has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.

Please see accompanying Full Prescribing Information, including Boxed WARNINGS, or click here.

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 product development. 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 compounds described in this release will receive regulatory approvals or, if approved, that they will become commercially successful. 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, 2011, 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.

BARACLUDE® (entecavir) is a registered trademark of Bristol-Myers Squibb.

Contacts

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

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PRESS RELEASE

April 4, 2012, 12:01 a.m. EDT

TARRYTOWN, N.Y., Apr 04, 2012 (BUSINESS WIRE) -- Regulatory News:

EpiCept Corporation (nasdaq omx stockholm exchange and otcqx:EPCT) announced today that new preclinical research for its apoptosis inhibitor drug candidate EP1013 (now renamed F573) has concluded that F573 is a new therapeutic drug candidate for the treatment of late-stage viral infection-induced hepatitis. The data were published in the Chinese Pharmacological Bulletin (2102 Volume 28 (1):136-139). F573 was discovered by EpiCept and licensed to GNI Group Ltd. in 2008 for clinical development in Asia, Australia and New Zealand.

F573 delivered intravenously demonstrated a therapeutic effect in a study involving 60 mice with acute liver injury, including a reduction in TNF-a and cell apoptosis. GNI Group Ltd. also noted that F573 reduced mice mortality caused by acute liver injury and that these animal studies provide important proof and direction for future human studies.

EpiCept President and CEO Jack Talley commented, “This is the first published evidence of F573’s activity in viral hepatitis, an inflammation of the liver caused mainly by three specific viruses (hepatitis A, B and C). According to the C. Everett Koop Institute, 3-5 million Americans are infected with hepatitis C alone, with at least 170 million people infected globally. GNI’s continued progress against this disease may enable us to advance the development of the compound in other territories, particularly North America and Europe.”

As part of its license agreement with GNI Group Ltd., EpiCept is eligible to receive milestone payments of more than $12 million based on the clinical advancement of F573 in Asia, Australia and New Zealand, as well as royalties on commercial sales. EpiCept retains the commercial rights to F573/EP1013 in all other markets. The next potential milestone payment would occur in conjunction with initiation of a Phase I trial in any of the territories outlined in the agreement. In July 2011, Shanghai Genomics, a wholly owned subsidiary of GNI Group Ltd., filed an Investigational New Drug (IND) application for F573 in China.

About EP1013/F573

F573 is a di-peptide small-molecule compound with a potent inhibitory effect on caspases, a class of enzymes involved in cell death and inflammation. Drug efficacy has been shown in animal models relating to liver failure, brain ischemia and myocardial infarction. GNI Group Ltd. has secured a series of patent rights for F573 in China, Japan other key territories from EpiCept Corporation to develop this drug for liver diseases.

About EpiCept Corporation

EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of pain and cancer. The Company's pain portfolio includes AmiKet™, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies. The Company's lead oncology product is Ceplene®, which has been granted full marketing authorization by the European Commission for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. The Company has other oncology drug candidates currently in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors.

In January 2012, EpiCept engaged SunTrust Robinson Humphrey to assist the Company in exploring strategic alternatives to maximize the commercial opportunity of AmiKet™ for the treatment of CIPN following taxane-based therapy. The engagement is focused on the identification and implementation of a strategy designed to optimize AmiKet’s value for the Company’s stockholders, which includes the evaluation of potential transactions involving the sale of the Company.

Forward-Looking Statements

This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements which express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risk that the development of our EP1013 product candidate will not be successful, the risk that we will not be able to find a partner to help conduct the Phase III trials for AmiKet™ on attractive terms, a timely basis or at all, the risk that Ceplene® will not receive regulatory approval or marketing authorization in the United States or Canada, the risk that Ceplene® will not achieve significant commercial success, the risk that any required post-approval clinical study for Ceplene® will not be successful, the risk that we will not be able to maintain our final regulatory approval or marketing authorization for Ceplene®, the risk that Azixa™ will not receive regulatory approval or achieve significant commercial success, the risk that we will not receive any significant payments under our agreement with Myrexis, , the risk that clinical trials for AmiKet™ or crolibulin(TM) will not be successful, the risk that AmiKet™ or crolibulin(TM) will not receive regulatory approval or achieve significant commercial success, the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later-stage clinical trials, the risk that we will not obtain approval to market any of our product candidates, the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern, the risks associated with our ability to continue to meet our obligations under our existing debt agreements, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings which are available at www.sec.gov or at www.epicept.com . You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.

*Azixa is a registered trademark of Myrexis, Inc.

EPCT-GEN

SOURCE: EpiCept Corporation

Source

April 4, 2012, 2:00 a.m. EDT

Loos, France, Apr 04, 2012 (Thomson Reuters ONE via COMTEX) -- GFT505: GENFIT VERY SATISFIED WITH THE SCIENTIFIC ADVICE OF THE EUROPEAN MEDICINES AGENCY (EMA)

- The EMA gives a favorable response to questions concerning GFT505 and the phase IIb study in NAFLD/NASH. EMA experts give their recommendations for the phase III development plan.

Lille (France), Cambridge (Massachusetts, United States), April 4th, 2012 - GENFIT (alternext:ALGFT)(isin:FR0004163111), a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, today announces that it has received the official scientific opinion of the European Medicines Agency (EMA) on the efficacy/safety ratio of GFT505, the design of the upcoming phase IIb study, and the clinical development plan for GFT505 in non-alcoholic steatohepatitis (NASH*).

The EMA gave a favorable response to all the questions related to GFT505 and its efficacy/safety ratio at the proposed therapeutic doses. The opinion of the EMA experts concerning the pivotal phase IIb study that aims to demonstrate the therapeutic activity of GFT505 on the histological regression of NASH is in agreement with the study protocol submitted by GENFIT. Finally, the EMA has given its recommendations for the phase III development plan of GFT505 in this new therapeutic indication.

The positive opinion of the EMA opens the door to the initiation of the pivotal phase IIb study, pending regulatory authorization by national health agencies. At least 270 patients with NASH will be recruited for this international (Europe, US) multi-center study, one of the largest ever conducted for NASH. The objective is to provide the first proof of therapeutic efficacy for a product dedicated to the treatment of NASH (there is currently no existing treatment for NASH).

The EMA judged satisfactory GENFIT's comments on the questions raised, and opted for the 'accelerated' procedure to give its opinion. "The delivery of the EMA's scientific advice and the concordance between our proposals and their recommendations validate the foundations and the rationale of the clinical development plan that we have implemented for GFT505 in NASH. We are currently entering similar discussions with the Food and Drug Administration to enable the opening of US clinical centers for our phase IIb study." commented Dr. Remy Hanf, EVP, Product Development.

*About NASH:

NAFLD (non-alcoholic fatty liver disease) and in particular NASH (non-alcoholic steatohepatitis) are serious liver diseases that can lead to cirrhosis and liver cancer. The development of NAFLD/NASH is associated with the diabetic pathophysiological process. NAFLD is believed to affect between 80 and 100% of diabetic patients, and progresses to chronic liver disease (NASH) in 20-50% of cases. Mortality due to liver disease is thus 2-3-fold higher in the diabetic population than in the overall population. The NASH market was estimated at 615 $M in 2010 and should reach 2,008 $M in 2018.

About GENFIT:

GENFIT is a biopharmaceutical company focused on the Discovery and Development of drug candidates in therapeutic fields linked to cardiometabolic disorders (prediabetes/diabetes, atherosclerosis, dyslipidemia, inflammatory diseases.). GENFIT uses a multi-pronged approach based on early diagnosis, preventive solutions, and therapeutic treatments, and advances therapeutic research programs, either independently or in partnership with leading pharmaceutical companies including Sanofi, to address these major public health concerns and their unmet medical needs. GENFIT's research programs have resulted in the creation of a rich and diversified pipeline of drug candidates at different stages of development, including GENFIT's lead proprietary compound, GFT505, that is currently in Phase II.

With facilities in Lille, France, and Cambridge, MA (USA), the Company has approximately 100 employees. GENFIT is a public company listed on the Alternext trading market by Euronext(TM) Paris (alternext:ALGFT)(isin:FR0004163111).

www.genfit.com

Contacts:

GENFIT

Jean-Francois Mouney - CEO & Chairman of the Management Board

Ph. +333 2016 4000

Milestones - Press Relations

Bruno Arabian

Ph. +33 1 7544 8740 / +336 8788 4726 - barabian@milestones.fr

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients.

The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the

information contained therein.

Source: GENFIT via Thomson Reuters ONE

HUG#1599931

2012.04.04 PR GENFIT EMA advice - http://hugin.info/143426/R/1599931/504922.pdf

Source