Novartis and Idenix seek European approval of telbivudine (LDT600) for the treatment of patients with chronic hepatitis B
* Telbivudine represents a potential new standard of care for hepatitis B treatment through rapid and sustained viral suppression
* US and European submissions now completed, submissions in key Asian markets planned to be completed in the first quarter 2006
* GLOBE study results show that after one year telbivudine provided superior response on all evaluated virologic markers compared to lamivudine
Basel, February 7, 2006 - Novartis and Idenix Pharmaceuticals, Inc. announced today the European submission of telbivudine (LTD600) for approval as a novel treatment for patients affected by chronic hepatitis B (CHB), a potentially fatal disease estimated to affect more than three million people in Europe and over 350 million people worldwide.
The European submission, done through the centralized procedure to the Committee for Medicinal Products for Human Use (CHMP), is the second in a series aimed at obtaining approvals for telbivudine (600 mg dose) as an orally active, once-daily nucleoside analogue. Telbivudine was recently filed with the US Food and Drug Administration for approval. Novartis expects to submit applications for approval in key Asian markets during the first quarter of 2006.
“Telbivudine has shown the potential to set a standard of care for the treatment of patients with hepatitis B through rapid and sustained viral suppression. The European filing is a significant step toward making this new treatment option available to more than three million patients estimated to be affected by the chronic hepatitis B virus in Europe,” said Dr. James Shannon, Global Head of Development, Novartis Pharma AG. “Novartis is committed to developing a range of novel therapies to help patients manage chronic hepatitis B as well as other serious infectious diseases.”
The European submission was based primarily on one-year data from the GLOBE study, the largest registration trial for a chronic hepatitis B treatment. The GLOBE study is an ongoing two-year Phase III clinical trial comparing telbivudine with a standard therapy, lamivudine, in the treatment of 1,367 adults with chronic hepatitis B. The study is being conducted at 112 clinical centers in 20 countries worldwide, including the Czech Republic, France, Germany, Greece, Italy, Poland, Spain, Turkey and the United Kingdom. GLOBE is the first international hepatitis B study to include clinical sites and patients in China.
Chronic hepatitis B is the most common serious liver infection in the world that can cause liver failure, cirrhosis (scarring), liver cancer and death. It is caused by the hepatitis B virus (HBV), which infects the liver. HBV is 50-to-100 times more infectious than HIV (the virus that causes AIDS). Chronic hepatitis B is the tenth leading cause of death worldwide. It affects approximately 350 million people worldwide and is responsible for up to 80 percent of the world’s cases of primary liver cancer. Each year approximately 1.2 million people die worldwide from hepatitis B-related chronic liver disease. In Europe there are considerable regional differences in the prevalence of chronic hepatitis B ranging from below 0.1% in Northwestern Europe to up to 8% in Eastern and Southern Europe.
Despite the availability of treatments for chronic hepatitis B, significant unmet needs still exist including the need for improved response rates, better-long-term efficacy, reduced rates of drug resistance, improved safety and tolerability, and more convenient dosing regimens.
Idenix is developing its hepatitis B clinical product candidates, telbivudine and valtorcitabine, in collaboration with Novartis Pharma AG under a development and commercialization arrangement established in May 2003. The collaboration arrangement further provides that Novartis Pharma AG and Idenix will co-promote telbivudine and valtorcitabine and other product candidates that Novartis Pharma AG has licensed, if successfully developed and approved for marketing, in the United States, France, Germany, Italy, Spain and the UK. Novartis Pharma AG holds the exclusive license to commercialize telbivudine and valtorcitabine in the rest of the world. The collaboration also provides Novartis Pharma AG with an exclusive option to license and collaborate with Idenix in the development and commercialization of other product candidates in Idenix’s portfolio, including valopicitabine (NM283), a direct antiviral for the treatment of chronic hepatitis C.
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, treat 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. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Group’s businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
This release contains certain “forward-looking statements”, relating to the Group’s business, which can be identified by the use of forward-looking terminology such as “potential”, “planned”, “expects”, “will”, “option,” or similar expressions, or by express or implied discussions regarding the potential approval of telbivudine by regulatory authorities, or regarding potential future sales of telbivudine. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with telbivudine to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that telbivudine will be approved for sale in any market, or that it will reach any particular level of revenue. Management’s expectations regarding telbivudine could be affected by, among other things, uncertainties relating to clinical trials, including new clinical data and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; Idenix’s dependence on its collaboration with Novartis Pharma AG; Idenix’s ability to obtain additional funding required to conduct its research, development and commercialization activities; competition in general; government, industry, and general public pricing pressures; as well as other risks and factors referred to in the Company’s current Form 20-F on file with the U.S. 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.
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 The European Liver Patients Association. European Liver Patients Association The Liver Report - Liver Disease in Europe and the Mediterranean Basin. April 2005.
 Centers for Disease Control and Prevention. Hepatitis B Frequently Asked Questions. Available at: www.cdc.gov/ncidod/diseases/hepatitis/b/faqb.htm Accessed 12/8/05
 World Health Organization. Hepatitis B Fact Sheet Number 204 Available at www.who.int/mediacentre/factsheets/fs204/en/print.html Accessed 12/8/05
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 Robert Koch Institut. Epidemiologisches Bulletin. 18. November 2005 / Nr. 46
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