- Sebivo provides more rapid and powerful viral suppression than lamivudine, the most widely prescribed treatment[1]
- Rapid and powerful viral suppression has been shown to lead to better treatment outcomes[2]
- Every year in Europe, 90,000 people will develop chronic hepatitis B and 24,000 will die from related complications such as cirrhosis or liver cancer[3]
Basel, April 30, 2007 - The European Commission has approved Sebivo® (telbivudine) as a new first-line treatment for chronic hepatitis B that has been shown to provide rapid and powerful viral suppression within six months of starting therapy[1].
Approval was based on one-year data from the GLOBE study demonstrating the benefits of Sebivo over lamivudine, the most widely prescribed therapy worldwide, in achieving rapid and powerful suppression of the hepatitis B virus (HBV)[1].
"Chronic hepatitis B is a serious condition that can lead to liver cirrhosis, liver cancer, liver failure, and ultimately death," said Thierry Poynard, MD, PhD, Professor of Medicine and Head of the Department of Hepato-Gastroenterology, Hôpital Pitié-Salpêtrière, France. "There is no cure for chronic hepatitis B, but high viral load increases the risk of serious complications. To reduce this risk, the goal of therapy is therefore to suppress the hepatitis B virus as much as possible, and to maintain that decrease over time. The GLOBE study shows that telbivudine does this more effectively than lamivudine."
Every year in Europe an estimated one million people are infected with HBV and 90,000 will become chronic carriers[3]. The incidence of chronic hepatitis B (CHB) ranges from 29 cases for every 100,000 people in Western Europe to 523 per 100,000 people in Eastern Europe[4]. Approximately 24,000 people in Europe die each year from complications of CHB, including cirrhosis or liver cancer[3].
GLOBE is the largest worldwide registration trial ever conducted in patients with CHB and included 1,367 adult patients at 112 clinical centers in 20 countries. In the European Union, participating countries included the Czech Republic, France, Germany, Greece, Italy, Poland, Spain and the UK.
Data from the study also indicated that Sebivo works very quickly, suppressing HBV to undetectable levels (i.e. PCR negativity) in more than half of patients at six months of treatment, and that 95% of patients who achieved PCR negativity within this time retained their undetectable virus levels at one year1,2. Preliminary two-year results from the GLOBE trial, completed after the EU submission, demonstrated that these benefits were maintained through two years of treatment[5],[6].
"The results of the GLOBE trial showed that the rapid viral suppression achieved with Sebivo at six months can predict outcomes through two years of study," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "This is encouraging news for patients and physicians due to the fact that powerful viral suppression, early in the course of treatment, has been shown to be predictive of long-term viral suppression and minimal resistance. We are excited that Sebivo has now been approved in the European Union and can be made available to patients there."
Sebivo delivers this rapid, powerful and sustained viral suppression with an overall clinical safety profile similar to that of lamivudine. It is given once-daily with or without food, helping to ensure better compliance and patient convenience.
The European Committee decision applies to all 27 countries in the European Union as well as Iceland and Norway. Launches will start in the second quarter of 2007 beginning in the UK and Germany. In addition to the EU, Sebivo is currently approved in 16 major markets including the United States (where it is marketed as Tyzeka®), Canada, Switzerland and China.
About Idenix/Novartis collaboration
Novartis Pharma AG and Idenix are co-promoting Sebivo, for the treatment of hepatitis B, and co-developing valtorcitabine, a second hepatitis B compound, and valopicitabine, a hepatitis C compound, under a development and commercialization arrangement established in May 2003. Under this agreement, Novartis and Idenix will co-promote Sebivo, valtorcitabine and valopicitabine in the US, France, Germany, Italy, Spain and the UK. Novartis has the exclusive right to commercialize Sebivo, valtorcitabine and valopicitabine in the rest of the world.
Disclaimer
The foregoing release contains forward-looking statements which can be identified by the use of terminology such as "tentative approval," "pending expiration," "expected," "will," "could," "promises to be", or similar expressions, or by express or implied discussions regarding the potential final marketing approvals of Sebivo, or potential future revenue from Sebivo. 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. There can be no guarantee that Sebivo will be approved for any other particular indications in the European Union or any other market, that Sebivo will be brought to market in the EU or in any other country, nor that Sebivo will reach any particular sales levels. In particular, management's expectations regarding the approval and commercialization of Sebivo could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general; increased government, industry, and general public pricing pressures; unexpected clinical trial results, including additional analysis of clinical data, or new clinical data; our ability to obtain or maintain patent or other proprietary intellectual property protection; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit
http://www.novartis.com.
References
[1] Lai, C. Hepatology. 2005 Oct (42.S1):78A.
[2] Zeuzem S, et al. Optimal virologic and clinical efficacy at one year is associated with maximal early HBV suppression in nucleoside-treated hepatitis B patients. J. Hepatol. 2006; 44 Suppl.2:S24.
[3] Van Damme P, et al. Hepatitis B prevention in Europe: a preliminary economic evaluation. Vaccine, Vol. 13, Supplement 1, pp. S54-S57, 1995 International Journal of Epidemiology; V.32; 2003; p118.
[4] Robert Koch Institute. Epidemiologisches Bulletin. 18. November 2005.
[5] Lai C-L, et al. Telbivudine vs lamivudine in HBeAg+ patients with CHB: two-year efficacy and predictors of response. Presented at APASL 2007.
[6] Liaw Y-F, et al. Telbivudine GLOBE Trial: 2 year efficacy and outcome predictors in HBeAg-negative patients with CHB. Presented at APASL 2007.
###
Media contacts
Attachments:
Media release (PDF)
