European approval for hepatitis C drug, Telaprevir-Incivek "called Incivo in Europe."

Vertex, J&J hepatitis C drug gets EU nod
Tue Sep 20, 2011 10:46am EDT
(Reuters) - Vertex Pharmaceuticals Inc (VRTX.O) and partner Johnson & Johnson (JNJ.N) won European approval for their hepatitis C drug, Vertex said on Tuesday.The pill, which won U.S. approval in May, raked in strong sales of $75 million in the first five weeks it was sold in the country. Known as Incivek in the United States, it will be called Incivo in Europe.
J&J has European rights to the product, with Vertex receiving royalties. Vertex holds exclusive rights to the drug in the United States.

Also known as telaprevir, Incivek can nearly double the chances of curing hepatitis C, a serious liver disease, compared with prior standard treatments.
Approval for the drug in Europe was expected after the European Medicines Agency recommended it in July.
"The European approval and its timing were in line with our expectations," Wells Fargo Securities analyst Brian Abrahams wrote in a note to clients.

He expects Incivek sales to exceed market expectations in the second half of 2011.
Shares of Vertex were up 2.2 percent at $51.30 in morning trade on Tuesday on Nasdaq.
(Reporting by Anand Basu in New York, editing by Gerald E. McCormick)



Also See;
Health Canada Okays INCIVEK For People With Hepatitis C 
MSD launches hepatitis C drug Victrelis in UK
Health Canada Clears Victrelis-Boceprevir New Hepatitis C Drug


INCIVO® (Telaprevir) Approved in Europe Offering Higher Cure Rates for Genotype-1 Chronic Hepatitis C Compared to Standard Treatment


BEERSE, Belgium, September 20, 2011 /PRNewswire/ --




New Treatment Options Increase Chance of a Cure
Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical Companies, announced today that the European Commission has approved INCIVO® (telaprevir), a direct acting antiviral (DAA) protease inhibitor, for the treatment of genotype-1 chronic hepatitis C virus (HCV), in combination with peginterferon alfa and ribavirin, in adults. With this new class of medicines, of which telaprevir is the latest addition, more genotype-1 chronic HCV patients than ever before will have the chance of a cure.

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In clinical studies, telaprevir in combination with peginterferon alfa and ribavirin demonstrated significant improvements in cure rates, also known as sustained virologic response (SVR), for both previously untreated genotype-1 chronic HCV patients and those who have failed previous treatment compared to the standard treatment with peginterferon alfa and ribavirin alone.[1,2] The approval of telaprevir offers an improved and efficacious treatment regimen compared to the standard treatment for genotype-1 chronic HCV with the shortest course of treatment of any available treatment.[3,4]   Telaprevir  reduces the current total treatment duration by half in the majority of previously untreated patients and those who have relapsed.
"Today is an exciting day for adults with genotype-1 chronic HCV infection.  Before the introduction of protease inhibitors, treatment for HCV required a long duration and cured less than half of genotype-1 chronic HCV patients," said Professor Graham Foster, Queen Mary's University Hospital of London. "For many adults with genotype-1 chronic HCV, treatment with a telaprevir based regimen could provide a shorter treatment duration with improved cure rates compared to standard treatments.  Shortening treatment regimens, without compromising efficacy, is a valuable step to help patients adhere to their treatment."

The approval is based on the results of three Phase 3 studies in 2290 patients: ADVANCE, REALIZE and ILLUMINATE.[1,2,3] ADVANCE and REALIZE were randomized, double-blind, placebo-controlled studies that evaluated the efficacy and safety of telaprevir in combination with peginterferon alfa and ribavirin compared with the previous standard treatment (peginterferon alfa and ribavirin alone).[1,2]  The data showed that treatment with a telaprevir based regimen significantly increased cure rates for genotype-1 chronic HCV compared to the previous standard treatment in previously untreated patients (79% vs. 46%, p<0.0001) and patients who relapsed during previous treatment (84% vs. 22%, p<0.0001).[1,2] The data also showed a significant increase in cure rates for patients who either partially responded or did not respond to previous treatment, groups typically among the hardest to cure, compared to peginterferon alfa and ribavirin alone (61% vs. 15% and 31% vs. 5%, p<0.0001 respectively).[2]

Data from ILLUMINATE showed 24 weeks of treatment with a telaprevir based regimen was non-inferior to 48 weeks of a telaprevir based regimen for previously untreated genotype-1 chronic HCV patients who achieved and maintained an undetectable viral load early in their treatment at weeks 4 and 12 (also known as extended rapid viral response or eRVR).[3]

Chronic HCV is considered a 'viral timebomb' by the World Health Organization and can have severe consequences for both patients and public health systems.[5] More than 170 million people worldwide are infected with chronic HCV and many are unaware of their infection.[6]
"Hepatitis C can be a devastating disease; however, if treated successfully, patients can avoid life-threatening liver problems such as further liver damage, cirrhosis, liver failure and liver cancer. The arrival of Direct Acting Antivirals is the first treatment breakthrough in more than 10 years and a significant step forward for the hepatitis C community. It will offer more patients hope for a cure," said Charles Gore, World Hepatitis Alliance.

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.[4]

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 approximately 3%.[4]

"We are delighted by the European Commission approval of telaprevir and that we can now offer patients a significantly improved treatment option for HCV compared to the previous standard treatment," said Ramon Polo, Telaprevir Compound Development Team Leader. "Telaprevir is a cornerstone of the Janssen Companies' expanding infectious disease portfolio, which includes therapies in HIV/AIDS, tuberculosis, serious infections and now HCV that are helping to redefine and improve treatment outcomes. The Janssen Companies remain dedicated to improving the lives of patients and supporting healthcare professionals around the world."

About INCIVO®
INCIVO® will be made available by the Janssen Companies in countries throughout the European Union. Telaprevir was developed by Tibotec, one of the Janssen Pharmaceutical Companies, in collaboration with Vertex and Mitsubishi Tanabe Pharma. The Janssen Companies have the right to commercialize telaprevir in Europe, Latin America, the Middle East, Africa, India, Australia and New Zealand under the commercial name INCIVO®; Vertex has the right to commercialize telaprevir in North America under the name INCIVEK™ (approved by US FDA in May 2011 and by Health Canada in August 2011 for genotype-1 chronic hepatitis C with compensated liver disease); Mitsubishi Tanabe Pharma has the right to commercialize telaprevir in Japan and certain Far Eastern countries.

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

About HCV
HCV is a blood-borne infectious disease that affects the liver.[7,8] With an estimated 170 million people infected worldwide,[6,8] and three to four million people newly infected each year,[5] HCV puts a significant burden on patients and society. Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases. About one-quarter of the liver transplants performed in 25 European countries in 2004 were attributable to HCV.[9]   The previously accepted standard  treatment for HCV is peginterferon alfa combined with ribavirin,[8] however this only cures 40-50 percent of chronic genotype-1 HCV patients.[10]
HCV puts a significant burden on patients and society. 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.[9] Most of the DALYs (95%) were accumulated by patients in preventable disease stages.[9]

About Tibotec
Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global pharmaceutical and research development company. The Company's main research and development facilities are in Beerse, Belgium with offices in Titusville, NJ and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need.

About Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology , immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases.
Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.

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

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995.

These statements are based on current expectations of future events.
If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Tibotec Virco-Virology BVBA, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson.
Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies.
A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2011.
Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.govhttp://www.jnj.com or on request from Johnson & Johnson.
The Janssen Pharmaceutical Companies and Johnson & Johnson do not undertake to update any forward-looking statements as a result of new information or future events or developments.


References:
  1. John McHutchinson et al. Telaprevir in Combination with Peginterferon and Ribavirin in Genotype 1 HCV Treatment-Naïve Patients: Final Results of Phase 3 ADVANCE study. Paper presented at: The Liver Meeting of the American Association for the Study of Liver Diseases (AASLD); 2010.
  2. Zeuzem S, Andreone P, Pol S et al. REALIZE trial final results: telaprevir-based regimen for genotype 1 hepatitis C virus infection in patients with prior null response, partial response or relapse to peginterferon/ribavirin. Paper presented at: 46th annual meeting of the European Association for the Study of the Liver (EASL); 2011.
  3. Sherman, K et al. Telaprevir incombination with pegiterferon alfa2a and ribavirin for 24 or 48 weeks in treatment-naïve genotype-1 HCV patients who achieved an extended rapid viral response: Final results of phase 3 ILLUMINATE study. Paper presented at: The Liver Meeting of the American Association for the Study of Liver Diseases (AASLD); 2010.
  4. INCIVO® Summary of Product Characteristics 2011.
  5. WHO. State of the art of vaccine research and development. Viral Cancers. Available from http://www.who.int/vaccine_research/documents/Viral_Cancers.pdf).
  6. World Health Organization. Hepatitis C. Weekly Epidemiological Record. 1997;72:65-69.
  7. Centres for Disease Control and Prevention. Hepatitis C FAQs. [cited 2009 Dec 17] Available from: http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission.
  8. Simin M et al. Cochrane systematic review: peginterferon alfaplus ribavirin vs. interferon plus ribavirin for chronic hepatitis C. Alimentary Pharmacology & Therapeutics. 2007; 25(10):1153-62.
  9. Nikolai Mühlberger 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.
  10. 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
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