March 24, 2014

Idenix

March 24, 2014

CAMBRIDGE, Mass., March 24, 2014 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced three poster presentations featuring clinical and preclinical data for the Company's nucleotide prodrug, IDX21437, and for samatasvir, Idenix's once-daily pan-genotypic NS5A inhibitor, at The International Liver Congress™ 2014, the 49th annual meeting of the European Association for the Study of the Liver (EASL), taking place in London, April 9-13, 2014. Full abstracts can now be viewed at the EASL Congress website.

The following abstracts will be presented in poster sessions during The International Liver Congress™ 2014 on Saturday, April 12, 2014, 9:00 am – 6:00 pm BST:

  • Poster No. 1244: Gupta et al. "Favorable Preclinical Profile of IDX21437, a Novel Uridine Nucleotide Prodrug, for Use in a Direct-Acting Antiviral (DAA) Regimen for HCV."
  • Poster No. 1221: Zhou et al. "Pharmacokinetic (PK) Drug-Drug Interaction between Samatasvir (IDX719), a Pan-Genotypic NS5A Inhibitor, and Simeprevir in Healthy Volunteers and HCV-Infected Subjects."
  • Poster No. 1222: Lawitz et al. "A Phase II Study of Samatasvir (IDX719) in Combination with Simeprevir and Ribavirin in Treatment-Naïve HCV-Infected Subjects with Genotypes 1b and 4 (HELIX-1 Study)."

ABOUT IDX21437

IDX21437, a next-generation uridine nucleotide prodrug inhibitor, has completed the single-dose portion of a phase I/II clinical trial and is currently being evaluated in the seven-day proof-of-concept portion of the trial, with results expected in the first half of 2014. Extensive preclinical testing for IDX21437 has demonstrated favorable antiviral activity across genotypes 1-6 and a safety profile which supported advancement into clinical trials. Based on this progress, the Company's goal is to initiate an Idenix-sponsored combination clinical trial of IDX21437 and samatasvir in mid-2014.

ABOUT SAMATASVIR

Samatasvir is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, samatasvir has been safe and well-tolerated after single and multiple doses of up to 150 mg in healthy volunteers up to 14 days duration, and in HCV-infected patients up to 12 weeks duration. There have been no treatment-related serious adverse events reported in the program. Samatasvir has demonstrated potent pan-genotypic antiviral activity in HCV-infected patients with mean maximal viral load reductions up to approximately 4.0 log10 IU/mL across HCV genotypes 1-4 in a proof-of-concept, three-day monotherapy study.

Under a non-exclusive collaboration with Janssen Pharmaceuticals, Inc., Idenix is evaluating all-oral, direct-acting antiviral HCV combination regimens including samatasvir, simeprevir (TMC435), a once-daily protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, and TMC647055/r, a once-daily non-nucleoside polymerase inhibitor boosted with low-dose ritonavir being developed by Janssen. In this program, Idenix is conducting two ongoing phase II 12-week clinical trials, HELIX-1 and HELIX-2.

ABOUT HEPATITIS C

Hepatitis C virus is a common blood-borne pathogen infecting three to four million people worldwide annually. The World Health Organization (WHO) estimates that more than 150 million people worldwide are chronically infected with HCV, representing a nearly 5-fold greater prevalence than human immunodeficiency virus.

ABOUT IDENIX

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.

FORWARD-LOOKING STATEMENTS

This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of IDX21437, samatasvir or any other drug candidate; the successful development of novel combinations of direct-acting antivirals for the treatment of HCV; and the likelihood and success of any future clinical trials involving samatasvir, IDX21437or our other drug candidates. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's annual report on Form 10-K for the year ended December 31, 2013 as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.

All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

Idenix Pharmaceuticals Contact:
Teri Dahlman (617) 995-9807

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Mar 24, 2014

NORTH CHICAGO, Ill., March 24, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) will present new data from its phase III hepatitis C development program at the 2014 International Liver Congress™ (ILC) in London, April 9-13. Detailed results from the SAPPHIRE-I, SAPPHIRE-II, PEARL-III, and TURQUOISE-II studies will be presented at the ILC on April 10-12. 

In presentations at the ILC, investigators will share detailed data results of four studies from AbbVie's phase III clinical trial program, the largest phase III program of an investigational, all-oral, interferon-free regimen for the treatment of chronic hepatitis C virus (HCV) infection in genotype 1 (GT1) adult patients.

Following is a list of AbbVie's phase III clinical trial program data being presented at the ILC:

  • SAPPHIRE-II: Phase III Placebo-Controlled Study of an Investigational Interferon-Free, 12-Week Regimen in 394 Treatment-Experienced Adults with HCV GT1
    Oral Presentation: General Session 1 and Opening
    April 10, 14:00-14:15 BST; ICC Auditorium
  • SAPPHIRE-I: Phase III Placebo-Controlled Study of an Investigational Interferon-Free, 12-Week Regimen in 631 Treatment-Naive Adults with HCV GT1
    Oral Presentation: General Session 2 and Awards 1
    April 11, 10:15-10:30 BST; ICC Auditorium
  • PEARL-III: Sustained Virologic Response 12 Weeks Post-treatment (SVR12) with an Investigational 12-Week Regimen in 419 Treatment-Naive HCV GT1b-Infected Adults
    Late Breaker Poster: Poster P1299
    April 12, 9:00-18:00 BST; Poster Exhibition
  • TURQUOISE-II: SVR12 Rates in 380 HCV GT1-Infected Adults with Compensated Cirrhosis Treated with an Investigational Regimen
    Oral Presentation: Late Breakers
    April 12, 15:30-15:45 BST; ICC Auditorium

AbbVie will present additional data in presentations throughout the Congress. The full ILC 2014 scientific program can be found at www.ilc-congress.eu/.

About AbbVie's Investigational HCV Regimen
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without ribavirin (RBV) (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing sustained virologic response (SVR) rates across different patient populations.

Additional information about AbbVie's phase III studies can be found on www.clinicaltrials.gov.

AbbVie's HCV Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without RBV with the goal of producing high SVR rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.

ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of HCV.

Safety Information for Ribavirin and Ritonavir
Ribavirin and ritonavir are not approved for the investigational use discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.

There are special safety considerations when prescribing these drugs in approved populations.

Ritonavir must not be used with certain medications due to significant drug-drug interactions and in patients with known hypersensitivity to ritonavir or any of its excipients.

Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score ³6.

See approved product labels for more information.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2013 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.

AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

SOURCE AbbVie

For further information: Media: Elizabeth Hoff, +1 (847) 935-4236, elizabeth.hoff@abbvie.com; Javier Boix, +1 (847) 937-6113, javier.boix@abbvie.com; Investor Relations: Elizabeth Shea, +1 (847) 935-2211, elizabeth.shea@abbvie.com

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Daclatasvir data demonstrates potential to address high unmet needs, including cirrhotic and treatment-experienced patients, and those with genotypes 1, 2, 3 and 4

Breadth of viral hepatitis data underscores Company’s commitment to advancing research of liver diseases

Monday, March 24, 2014 5:39 am EDT

"The wealth of data we are sharing at the International Liver Congress continue the positive momentum for daclatasvir after the Marketing Authorization Application was validated for Accelerated Regulatory Review by the European Medicines Agency, highlighting the important potential role for daclatasvir-based regimens in Europe."

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 12 abstracts have been accepted for presentation at The International Liver CongressTM, the 49th annual meeting of the European Association for the Study of the Liver (EASL), in London, April 9 – 13.

Key presentations include:

  • Two sets of pivotal results from a global, Phase III study (HALLMARK DUAL) investigating the efficacy and safety of an all-oral, interferon- and ribavirin-free regimen of daclatasvir and asunaprevir, including data in cirrhotic and non-cirrhotic patients with HCV genotype 1b infection, will be presented as late-breakers.
  • Virologic response results from analyses investigating daclatasvir in combination with sofosbuvir across genotypes 1, 2 and 3.
  • Virologic response and safety data for the investigational all-oral 3DAA regimen (daclatasvir/asunaprevir/BMS-791325) in genotype 4 patients, as well as bioequivalence data for the daclatasvir 3DAA regimen, which is being studied as a fixed-dose-combination treatment with twice daily dosing.

“These results are encouraging and show the potential of daclatasvir across multiple treatment regimens, with the goal of helping patients achieve cure regardless of genotype, stage of disease or response to previous therapies,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The wealth of data we are sharing at the International Liver Congress continue the positive momentum for daclatasvir after the Marketing Authorization Application was validated for Accelerated Regulatory Review by the European Medicines Agency, highlighting the important potential role for daclatasvir-based regimens in Europe.”

Bristol-Myers Squibb is studying a broad portfolio of compounds in hopes of providing flexible treatment options to address the diverse unmet medical needs of a global HCV patient population. These investigational compounds include daclatasvir, an investigational NS5A replication complex inhibitor that has shown high antiviral potency and pan-genotypic activity across HCV genotypes in vitro; asunaprevir, an investigational NS3 protease inhibitor; BMS-791325, an investigational non-nucleoside inhibitor of the NS5B polymerase; and peginterferon lambda-1a (Lambda), an investigational type III interferon that has the potential to offer an alternative to alfa-interferon.

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

Title Date/Time Hepatitis C: Direct-Acting Antiviral Data

Oral Presentation (late-breaker): All-oral dual therapy with daclatasvir and asunaprevir in patients with HCV genotype 1b infection: Phase 3 study results -- April 12, 15:30 - 17:30

Poster (late-breaker): Efficacy and safety of daclatasvir in combination with asunaprevir (DCV+ASV) in cirrhotic and non-cirrhotic patients with HCV genotype 1b: Results of the HALLMARK DUAL study -- April 10, 09:00 - April 12, 18:00

Oral Presentation: Effect of baseline NS5A polymorphisms on virologic response to the all-oral combination of daclatasvir + sofosbuvir ± ribavirin in patients with chronic HCV infection -- April 11, 16:00 - 18:00

Poster: Effect of ribavirin on the safety profile of daclatasvir + sofosbuvir for patients with chronic HCV infection -- April 12, 09:00 - 18:00

Poster: All-oral therapy with daclatasvir in combination with asunaprevir and BMS-791325 for treatment-naive patients with chronic HCV genotype 4 infection -- April 12, 09:00 - 18:00

Poster: Daclatasvir, asunaprevir, and BMS-791325 in a fixed-dose combination: A phase 1 bioavailability study in healthy volunteers -- April 12, 09:00 - 18:00

Hepatitis B: Peginterferon Lambda-1a Data

Poster: Peginterferon Lambda-1a pharmacokinetics in subjects with impaired renal function -- April 12, 09:00 - 18:00

Oral: Peginterferon Lambda for the treatment of chronic hepatitis B (CHB): A phase 2b comparison with peginterferon alfa in patients with HBeAg-positive disease -- April 12, 15:30 - 17:30

Hepatitis C: Global Health Economics and Outcomes Research (GHEOR)

Oral Presentation: External validation of the risk-prediction model for hepatocellular carcinoma (HCC) from the REVEAL-HCV study using data from the U.S. Veterans Affairs (VA) health system -- April 10, 16:00 - 18:00

Poster: The impact of fibrosis on the risk of long-term morbidity and mortality in chronic hepatitis C patients treated in the veterans administration health care system -- April 11, 09:00 - 18:00

Poster: Early virologic responses and adverse events from the comparative assessment of effectiveness of antiviral therapies in hepatitis C study (CMPASS) -- April 12, 09:00 - 18:00

Poster: Determining the comparative effectiveness of emerging treatment regimens for hepatitis C virus (HCV) infection from single arm phase III trials -- April 12, 09:00 - 18:00 

About Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Up to 90 percent of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, up to 20 percent of people with chronic hepatitis C will develop cirrhosis; of those, up to 25 percent may progress to liver cancer. In the European Union (EU) an estimated 9 million people are living with hepatitis C, and an estimated 170 million people worldwide are infected with the virus.

About Bristol-Myers Squibb’s HCV Portfolio

Bristol-Myers Squibb’s research efforts are focused on advancing late-stage compounds to deliver the most value to patients with hepatitis C. At the core of our pipeline is daclatasvir (DCV), an investigational NS5A replication complex inhibitor that has been studied in more than 5,500 patients as part of multiple direct-acting antiviral (DAA) based combination therapies. DCV has shown a low drug-drug interaction profile, supporting its potential use in multiple treatment regimens and in people with co-morbidities.

In 2014, the U.S. Food and Drug Administration (FDA) granted Bristol-Myers Squibb’s investigational DCV Dual Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV infection.

In 2013, Bristol-Myers Squibb’s investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation, which helped to expedite the start of the ongoing Phase III UNITY Program. Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. The daclatasvir 3DAA regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.

Daclatasvir is also being investigated in combination with sofosbuvir in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing Phase III ALLY Program.

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 clinical trials of these compounds will support regulatory filings, or that DCV or any other compounds mentioned in this release will receive regulatory approval or, if approved, that they will become commercially successful products. 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, 2013 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:
Jeff Smith,
Office: +33(0)1 58 83 83 21; Cell: +33(0) 6 03 99 40 18
jr.smith.paeurope@bms.com
or
Carrie Fernandez,
Office: +1-609-252-4831; Cell: +1-215-859-2605
carrie.fernandez@bms.com
or
Julie Ferguson,
Office: +1-609-252-5597; Cell: +1-312-385-0098
julie.ferguson@bms.com
or
Investors:
Ranya Dajani, 609-252-5330, ranya.dajani@bms.com
Ryan Asay, 609-252-5020, ryan.asay@bms.com

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Simeprevir has now been approved in Russia

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Stockholm, Sweden — Medivir AB (OMX: MVIR) announced today that that the Russian Ministry of Health has approved Sovriad® (simeprevir) for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults with compensated liver disease (including cirrhosis) who are treatment naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin. Russia will be the first country within EMEA to gain access to simeprevir, which represents a significant advance in hepatitis C treatment.

“The Russian approval is another important event for simeprevir and provides the hepatitis C patients in Russia with a new HCV treatment” said Maris Hartmanis CEO, Medivir.

Statistics provided by the World Health Organization in 2011 showed that Russia has the third-highest prevalence of HCV, with an estimated 3.7 million infected[1]). Though exact data for current rates is not available, in January 2014 alone, there were 4.858 new cases of HCV diagnosed in Russia. This reflects an increase of 3.5 percent in comparison to January 2013[2]).

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292.

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 08.30 CET on 24 March 2014.

About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 and 4 infected patients with compensated liver disease, including cirrhosis.

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. The treatment was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in November 2013 in Canada and the U.S.
The Committee for Medicinal Products for Human Use (CHMP) recently recommended Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. An approval is expected during Q2-2014.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on 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 simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

1) World Health Organization. Hepatitis C. http://www.who.int/csr/disease/hepatitis/Hepc.pdf

2)  Federal Service on Surveillance for Consumer Rights Protection and Human Wellfare

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Presentations Include late-breaking final results from the phase II COSMOS study

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that new data from the clinical development program for simeprevir in the treatment of genotype 1 or genotype 4 chronic hepatitis C virus (HCV) in adult patients with compensated liver disease will be presented at The International Liver Congress of the European Association for the study of the Liver (EASL). The International Liver Congress 2014 will take place from April 9-13 in London, United Kingdom.

Eight oral and poster presentations spanning over the phase II and phase III development program for simeprevir in treatment combinations with and without ribavirin and interferon are planned. New analyses of data from the phase III QUEST-1, QUEST-2 and PROMISE clinical trials of simeprevir in combination with pegylated interferon and ribavirin, as well as final data from the phase II COSMOS study will be presented during the Congress.

The data to be presented at the International Liver Congress 2014 include:

Late-Breaking Presentations

  • Simeprevir plus sofosbuvir with/without ribavirin in HCV genotype 1 prior null-responder/treatment-naïve patients (COSMOS Study): primary endpoint (SVR12) results in patients with METAVIR F3-4 (Cohort 2)
    - Lead Author: Eric Lawitz; The Texas Liver Institute, University of Texas Health Science Center, San Antonio, USA
  • Once-daily simeprevir (TMC435) with peginterferon/ribavirin in treatment-naïve or treatment-experienced chronic HCV genotype-4 infected patients: SVR12 results of a Phase 3 trial (RESTORE Study)
    - Lead Author: Christopher Moreno; ULB Hôpital Erasme, Brussels, Belgium

Oral Presentations

  • Once-daily simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 prior null responders with METAVIR F0-2: COSMOS Study Cohort 1 subgroup analysis
    - Lead Author: Mark Sulkowski; Johns Hopkins University School of Medicine, Baltimore, USA
  • Simeprevir with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in European patients who relapsed after previous interferon-based therapy: the PROMISE trial
    - Lead Author: Xavier Forns; Liver Unit, Hospital Clinic, Barcelona, Spain

Poster Presentations

  • Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naïve European patients in the QUEST-1 and QUEST-2 Phase 3 trials
    - Lead Author: Graham R. Foster; Queen Mary’s, University of London, London, UK
  • Simeprevir reduces time with peginterferon/ribavirin-induced symptoms and quality-of-life impairments: 72-week results from three Phase 3 studies
    - Lead Author: Jane Scott; Janssen
  • Virology analyses of simeprevir in Phase 2b and 3 studies
    - Lead Author: Oliver Lenz; Janssen
  • Deep sequencing analyses of minority baseline polymorphisms and persistence of emerging mutations in HCV genotype 1-infected patients treated with simeprevir
    - Lead Author: Bart Fevery; Janssen

Full session details and data presentation listings for The International Liver Congress 2014 can be found at

http://www.ilc-congress.eu.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 10.15 CET on 24 March 2014.

About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 and 4 infected patients with compensated liver disease, including cirrhosis.

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. The treatment was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in November 2013 in Canada and the U.S. and in March 2014 in Russia. The Committee for Medicinal Products for Human Use (CHMP) recently recommended Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. An approval is expected during Q2-2014.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on 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 simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

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Company to Initiate Phase 3 Clinical Development Program in Q2 2014

March 24, 2014 07:30 AM Eastern Daylight Time

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that new Phase 2 data for its two investigational hepatitis C virus (HCV) treatments - MK-5172, an investigational HCV NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor – are scheduled to be presented at the 49th Annual Meeting of the European Association for the Study of the Liver (EASL), also known as The International Liver Congress™ 2014. The data are from Merck’s overall Phase 2 clinical program. The meeting will take place in London, United Kingdom, April 9 - 13, 2014.

“These additional clinical data for MK-5172 and MK-8742 build upon the clinical evidence collected to date across a broad spectrum of patients with chronic HCV”

Based on the results of the Phase 2 program, Merck is initiating a Phase 3 clinical trial program, to be named C-EDGE. The C-EDGE program is designed to evaluate these investigational treatments across genotypes and in different HCV subpopulations, including patients with chronic kidney disease, HIV/HCV co-infection, and cirrhosis.

“These additional clinical data for MK-5172 and MK-8742 build upon the clinical evidence collected to date across a broad spectrum of patients with chronic HCV,” said Dr. Eliav Barr, vice president, Infectious Disease, Merck Research Laboratories. “Based on these data, we are pursuing a Phase 3 clinical program for these potentially important investigational medicines.”

In October 2013, Merck announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to the investigational combination MK-5172/MK-8742 for treatment of chronic HCV infection.

Selected Presentations for MK-5172/MK-8742:

  • Efficacy and Safety of MK-5172 and MK-8742 ± Ribavirin in Hepatitis C Genotype 1 Infected Patients with Cirrhosis or Previous Null-Response: The C-WORTHY Study. Lawitz, E. et al. Oral presentation #O61: April 11, 2014, 4:00-4:15 p.m. BST.
  • Efficacy and Safety of the All-Oral Regimen, MK-5172/MK-8742 ± RBV for 12 Weeks in GT1 HCV/HIV Co-infected Patients: The C-WORTHY Study. Sulkowski, M. et al. Oral presentation #O63: April 11, 2014, 4:30-4:45 p.m. BST.
  • Safety and Efficacy of the All-Oral Regimen of MK-5172/MK-8742 ± Ribavirin in Treatment-naïve, Non-cirrhotic Patients with Hepatitis C Virus Genotype 1 Infection: The C-WORTHY Study. Hezode, C et al. Oral Presentation #O10: April 10, 2014, 4:45-5:00 p.m. BST.

Merck’s Commitment to HCV

For more than 25 years, Merck has been at the forefront of the response to the HCV epidemic, and has helped to make a difference through our proud legacy of commitment to innovation, collaborating with the community, and expanding global access to medicines. Merck is dedicated to applying our scientific expertise, resources and global reach to deliver healthcare solutions that support people living with HCV worldwide.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of 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.

Merck 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. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent 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 2013 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).

Contacts

Merck
Media Contacts:
Caroline Lappetito, 267-305-7639
Sarra Herzog, 908-423-6154
or
Investor Contacts:
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088

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