MSD launches hepatitis C drug Victrelis in UK

MSD launches hepatitis C drug Victrelis in UK

MSD (known as Merck in the US and Canada), today launched Victrelis (boceprevir) in the UK. The drug is a new treatment for chronic hepatitis C genotype 1 in adults with compensated liver disease who have yet to undergo treatment or have failed previous therapy.
Victrelis is the first licensed treatment for hepatitis C which is direct acting, targeting the virus itself. The launch follows an accelerated assessment by the European Medicines Agency (EMA), due to its "major public-health need."

In comparison to current therapies, Victrelis works through inhibiting a key viral enzyme, affecting the virus' ability to replicate.

Victrelis is to be used in combination with the current standard treatment to tackle genotype 1 of the virus, the most prominent strand in the UK, affecting 40-50 per cent of patients.
In clinical trials of those who had previously failed treatment, the addition of Victrelis to standard therapy almost tripled the number of patients clearing the virus.
Published: 02/08/2011

New treatment, 'Victrelis'®? (boceprevir), launched today for chronic hepatitis C genotype 1

First licensed drug to target the virus directly, helps clear the virus in almost 3 times as many patients who have failed previous treatment and nearly twice as many previously untreated patients compared to current therapy alone1 LONDON, [2nd August 2011] – 'Victrelis'® (boceprevir), the first licensed direct acting treatment for chronic hepatitis C (CHC) genotype 1 infection, is launched today in the UK, to be used in combination with current treatment (peginterferon alfa and ribavirin, known as standard therapy), in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.1 In clinical trials, the addition of boceprevir to standard therapy for those who had failed previous treatment, almost tripled (x2.8) the number of patients clearing the virus (achieving sustained virologic response, SVR) compared to standard therapy alone from 21% (17/80) to 59% (95/162).1 In previously untreated patients, the addition of boceprevir nearly doubled (x1.7) the number of patients clearing the virus compared to standard therapy alone from 38% (137/363) to 63% (233/368).1

The launch follows an accelerated assessment of boceprevir by the European Medicines Agency, due to its major public-health need.Dr Ashley Brown, Consultant Hepatologist of St Mary's & Hammersmith Hospitals, commented “Over the last 10 years there has been little development in the treatment of HCV and a significant proportion of patients fail to respond to current standard of care.

'Victrelis' is the first licensed drug to directly target the virus. It offers improved outcomes for genotype 1 patients and new hope for those in whom previous treatment has been unsuccessful."Around 250,000* people in the UK are chronically infected with hepatitis C.2,3,4,5

Many of those who are infected do not show symptoms for a long period and consequently diagnosis is often delayed.2,6 . As a result, hepatitis C is often described as the ‘silent epidemic’.2,6 A general practitioner with an average list of 1800 can expect to have eight to 20 patients with hepatitis C infection.7
"Hepatitis C, caused by a blood-borne virus, can result in inflammation of the liver and subsequent fibrosis (scarring) of the liver tissue. Ultimately, the hepatitis C virus can cause significant liver damage including cirrhosis and liver cancer.3 The virus exists in different strains called genotypes.

Genotype 1 is the most common in the UK, affecting 40-50% of patients,8 and is also the most difficult to clear with 40% SVR rates on current treatment versus around 80% for genotypes 2 and 3.9The addition of boceprevir to standard therapy was investigated in two pivotal Phase III studies, HCV RESPOND-2 and HCV SPRINT-2, involving 403 patients who had failed previous therapy1 and 1,097 untreated patients respectively.1

The design of both studies included a 'response guided therapy' arm which investigated shortened therapy duration. Treatment could be stopped after 28 weeks for some previously untreated patients, which is 5 months less than 48 weeks of standard therapy alone.1 Boceprevir is a direct acting antiviral agent which interferes with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme.1

This is in comparison to the current standard therapy which boosts the immune system to elicit a response. Treatment has a manageable side effect and tolerability profile with a low discontinuation rate due to adverse events.10,11 In clinical trials the most common adverse events were fatigue, headache, nausea, anaemia and dysgeusia (a metallic taste).1 Anaemia was observed in 49% of subjects treated with boceprevir and standard therapy, compared with 29% of subjects treated with standard therapy alone.1- end -* 200,000 (England)2 + 37,500 (Scotland)3 + 3,992 (NI)4+ 12,000 (Wales)5

Notes to Editor
More Information on boceprevir

Please refer to the Summary of Product Characteristics (SPC) included in this press kit.

Cost
The cost of boceprevir is £2,800 per pack of 336 tablets‘Victrelis’ is a Trademark of Merck and Co., Inc., Whitehouse Station, New Jersey, USA.MSD's global commitment to advancing hepatitis therapyMSD 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 boceprevir, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.

About MSD
Today's MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. 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 http://www.msd.com/ or http://www.msd-uk.co.uk/ .

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 MSD 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 MSD’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 the expected synergies from the merger of MSD 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; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; MSD’s ability to accurately predict future market conditions; dependence on the effectiveness of MSD’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.MSD 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 MSD’s 2010 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 (http://www.sec.gov/).
# #
#References1.
Summary of Product Characteristics for 'Victrelis
'2. Department of Health. Hepatitis C Action Plan for England. July 2004 3. HPS. Hepatitis C
http://www.hps.scot.nhs.uk/bbvsti/hepatitisc.aspx [accessed 26.05.11]4. Regional Advisory Committee on Communicable Disease Control. Strategic framework and action plan for the prevention and control of hepatitis C in northern Ireland 2004-20075. NHS Wales. http://www.wales.nhs.uk/sitesplus/888/page/43746 [accessed 26.05.11]6. Hepatitis C Trust.

About Hepatitis C.http://www.hepctrust.org.uk/Hepatitis_C_Info/About+Hepatitis+C/About+Hepatitis+C (accessed 07.06.11) 7. Nash K, Bentley I, Hirschfield G. Managing hepatitis C virus infection. BMJ. 2009;338:37-428. NICE. TA75 Hepatitis C - pegylated interferons, ribavirin and alfa interferon: guidance Sep 20109. Hepatitis C Trust. Overview of conventional treatment. http://www.hepctrust.org.uk/treatment/overview-of-conventional-treatment [accessed 07.06.11]10. Bacon, B.R. (2011). Boceprevir for Previously Treated Chronic HCV Genotype 1 Infection. N ENGL J Med Vol. 364;13, 1207-1217.11. Poordad, F.P. (2011). Boceprevir for Untreated Chronic HCV Genotype 1 Infection. N ENGL J Med Vol. 364;13, 1195-1206. Read more: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=44995#ixzz1Tt3OxVnf