Merck to Present New Data on VICTRELIS® (boceprevir) and Investigational Compounds MK-5172 and Vaniprevir for Chronic Hepatitis C Virus at The International Liver CongressTM / 2013 EASL Annual Meeting

Mon Apr 8, 2013 10:37am EDT

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http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20130408:nBw086182a

WHITEHOUSE STATION, N.J.--(Business Wire)--
Merck (NYSE: MRK), known as MSD outside of the United States and Canada,
announced today that two analyses of VICTRELIS (boceprevir) and data from Phase
II studies of two of Merck`s investigational medicines for chronic hepatitis C
virus (HCV) genotype 1, MK-5172 and vaniprevir (MK-7009), will be presented at
the 2013 International Liver Congress (EASL) Annual Meeting. The meeting will
take place in Amsterdam from April 24-28, 2013. 

Key Presentations About VICTRELIS 200 mg Capsules

* Safety And Efficacy Of Boceprevir/Peginterferon/Ribavirin (Boc/P/R)
Combination Therapy For Chronic HCV G1 Patients With Compensated Cirrhosis: A
Meta-Analysis Of Five Phase III Clinical Trials, J.M. Vierling et al. Late
Breaker. Thursday, April 25, 9:00- 18:00. RAI Convention Centre. 
* Virologic Response Rates Are Similar In Previously Untreated And Previously
Treated And Relapsed Patients Receiving Boceprevir Triple Therapy: A
Retrospective Analysis. Bacon, B. et al. Poster 791. Friday, April 26,
12:30-14:00. RAI Convention Centre.

Key Investigational Compound Presentations

* High Sustained Viral Response at 12- and 24-week follow-up of MK-5172 with
Pegylated Interferon alfa-2b and Ribavirin (PR) in HCV Genotype 1
Treatment-naïve Non-cirrhotic Patients. Manns, M. et al. Oral Presentation:
Friday, April 26, 16:00-18:00, RAI Convention Centre. 
* MK-5172 In Combination With Peg-Interferon And Ribavirin Elicits Limited
Resistance While Demonstrating Robust Efficacy In Treatment Naïve Genotype 1
Chronic HCV-Infected Patients. Howe, A. et al. Poster 1197. Saturday, April 27,
12:30-13:30. RAI Convention Centre. 
* Sustained Viral Response And Safety Of MK-7009 In Cirrhotic
Treatment-Experienced Patients With Genotype 1 HCV Infection Who Have Failed
Previous Pegylated Interferon And Ribavirin Treatment. Rodriguez-Torres, M. et
al. Oral Presentation. Saturday, April 27, 8:30-10:30. RAI Convention Centre.

"We are pleased to present new data on VICTRELIS that will help inform health
care professionals as they consider the use of VICTRELIS in appropriate
patients," said Eliav Barr, M.D., vice president, Infectious Diseases, Project
Leadership and Management, Merck Research Laboratories. "Merck is committed to
helping reduce the burden of this serious disease worldwide. We look forward to
sharing our new data about VICTRELIS and Merck's investigational medicines for
chronic hepatitis C with the global scientific community." 

MK-5172 is an investigational, once-daily, oral HCV NS3/4A protease inhibitor
currently in Phase II development. Vaniprevir is an oral, twice-daily HCV NS3/4A
protease inhibitor in Phase III development in Japan for the treatment of
genotype 1 patients. 

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. 

Indications and usage for VICTRELIS

VICTRELIS® (boceprevir) is indicated for the treatment of chronic hepatitis C
virus (HCV) genotype 1 (G1) infection, in combination with peginterferon alfa
and ribavirin (PR), 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, including prior null
responders, partial responders, and relapsers. 

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 PR. 
* The efficacy of VICTRELIS 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. 
* Poorly interferon responsive patients who were treated with VICTRELIS in
combination with PR 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 PR.

Important safety information about VICTRELIS

All contraindications to PR also apply since VICTRELIS must be administered with
PR. Because ribavirin may cause birth defects and fetal death, VICTRELIS in
combination with PR 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 2 or more forms of effective contraception
during treatment and for at least 6 months after treatment has concluded. One of
these forms of contraception can be a combined oral contraceptive product
containing at least 1 mg of norethindrone. Oral contraceptives containing lower
doses of norethindrone and other forms of hormonal contraception have not been
studied or are contraindicated. 

VICTRELIS is contraindicated in patients with a history of a hypersensitivity
reaction to VICTRELIS. 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 is also 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, drospirenone, 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 PR is associated with
an additional decrease in hemoglobin concentrations compared with PR alone
and/or may result in worsening of neutropenia associated with PR therapy alone.
Dose reduction or discontinuation of peginterferon alfa and/or ribavirin may be
required. If peginterferon alfa or ribavirin is permanently discontinued,
VICTRELIS must also be discontinued. Dose reduction of VICTRELIS is not
recommended. VICTRELIS must not be administered in the absence of PR. 

Complete blood count (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 2, 4, 8,
and 12, and should be monitored closely at other time points, as clinically
appropriate. Serious acute hypersensitivity reactions (eg, urticaria,
angioedema) have been observed during combination therapy with VICTRELIS and PR.
If such an acute reaction occurs, combination therapy should be discontinued and
appropriate medical therapy immediately instituted. 

The most commonly reported adverse reactions (>35%) in clinical trials in adult
patients receiving the combination of VICTRELIS with PR were: fatigue, anemia,
nausea, headache, and dysgeusia. Of these commonly reported adverse reactions,
fatigue, anemia, nausea, and dysgeusia occurred at rates ≥5% above the rates for
PR alone in either clinical study. The incidence of these adverse reactions in
previously untreated subjects that were treated with combination therapy with
VICTRELIS compared with PR alone were: fatigue (58% vs 59%), anemia (50% vs
30%), nausea (46% vs 42%), and dysgeusia (35% vs 16%), respectively. The
incidence of these adverse reactions in previous treatment failure patients that
were treated with combination therapy with VICTRELIS compared with PR alone
were: fatigue (55% vs 50%), anemia (45% vs 20%), nausea (43% vs 38%), and
dysgeusia (44% vs 11%), 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 for our marketed and
investigational medicines for the treatment of chronic HCV, 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. 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
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 2012 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). 

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.

Revatio® and Adcirca® are trademarks of their respective owners and are not
trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA.
VICTRELIS® is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc.,
Whitehouse Station, N.J., USA.

Merck
Media:
Caroline Lappetito, 267-305-7369
Sarra Herzog, 908-423-6154
or
Investors:
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088 



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