Healthcare Industry News: telbivudine
News Release - February 7, 2006
Idenix and Novartis Seek European Approval of Telbivudine for the Treatment of Patients with Chronic Hepatitis B* Application Features Positive Data from GLOBE Study
* GLOBE study results show treatment after one year with telbivudine provided significantly greater response on all evaluated virologic markers compared to lamivudine
* US and EU submissions now completed, submissions in key Asian markets planned to be completed in the first quarter 2006
CAMBRIDGE, Mass., Feb. 7 (HSMN NewsFeed) -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ) and Novartis (NYSE: NVS ) announced today the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) seeking marketing authorization for the 600 mg dose of telbivudine for the treatment of chronic hepatitis B. This MAA is the second in a series of submissions aimed at obtaining marketing approvals for telbivudine, an orally active, once-daily nucleoside analogue. A New Drug Application (NDA) was recently submitted with the United States Food and Drug Administration (FDA). Novartis expects to submit applications for marketing authorization in key Asian markets during the first quarter of 2006.
"This MAA submission with the EMEA is another significant step in the development of telbivudine, a drug with the potential to improve the management of chronic hepatitis B, a disease with potentially fatal consequences that affects millions of people around the globe," said Jean- Pierre Sommadossi, chairman and chief executive officer of Idenix. "The submission of the MAA in Europe and the NDA in the U.S. within a month of each other demonstrates the strength of our ongoing collaboration with Novartis."
The MAA submission is 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 from 112 clinical centers in 20 countries worldwide including (in Europe) 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 mainland China.
Chronic hepatitis B is the most common serious liver infection in the world. It can cause liver failure, cirrhosis (scarring), liver cancer and death.(1) It is caused by the hepatitis B virus (HBV), which infects the liver.(1) HBV is 50 to 100 times more infectious than HIV (the virus that causes AIDS).(2) Chronic hepatitis B is the tenth leading cause of death worldwide.(3) It affects approximately 350 million people worldwide and is responsible for up to 80 percent of the world's cases of primary liver cancer.(4) Each year approximately 1.2 million people die worldwide from hepatitis B-related chronic liver disease.(3) 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.(5)
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.
Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). Idenix's headquarters are located in Cambridge, Massachusetts, and it has drug discovery and development operations in Montpellier, France and drug discovery operations in Cagliari, Italy. For further information about Idenix, please refer to http://www.idenix.com.
Novartis AG (NYSE: NVS ) is a world leader in offering medicines to protect health, cure disease and improve well-being. Novartis' 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.
Novartis is strengthening its 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 press release contains "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward- looking statements can be identified by the use of forward looking terminology such as: "will", "option", "planned," "seeking," "expects," "with the potential to" or similar expressions or by express or implied discussions regarding regulatory submissions to the EMEA, FDA and other governmental authorities in Asia relating to registration of the product and potential therapeutic benefits and successful development and commercialization of telbivudine Such forward-looking statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. There can be no guarantee that telbivudine will be approved for sale in any market or that, if approved, revenues from sales of such product will reach any specific level. In particular, management's expectations regarding telbivudine could be affected by risks and uncertainties relating to the acceptance for filing and approval, if any, of regulatory filings seeking marketing authorization by the EMEA, FDA or other regulatory authorities in other jurisdictions; results of clinical trials, including additional data from the GLOBE study, and other studies with respect to telbivudine; the company's dependence on its collaboration with Novartis Pharma AG; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the ability of the company to attract and retain qualified personnel; competition in general and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for telbivudine. These and other risks which may impact management's expectations regarding telbivudine are described in greater detail under the caption "Factors That May Affect Future Results" in the company's quarterly report on Form 10-Q for the quarter ended September 30, 2005 and filed with the Securities and Exchange Commission and other filings that the company makes with the Securities and Exchange Commission.
All forward-looking statements reflect the company's expectations only as of the date of this release and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
(1) Centers for Disease Control and Prevention. Hepatitis B Frequently Asked Questions. Available at: http://www.cdc.gov/ncidod/diseases/hepatitis/b/faqb.htm Accessed 12/8/05
(2) World Health Organization. Hepatitis B Fact Sheet Number 204. Available at http://www.who.int/mediacentre/factsheets/fs204/en/print.html Accessed 12/8/05
(3) Lavanchy D. J Viral Hepat. 2004 Mar 11 (2): 97-107
(4) World Health Organization. Expanded programme on immunization hepatitis B vaccine - making global progress. Available at http://www.childrensvaccine.org/files/WHO_hep_B_update.pdf Accessed 12/8/05
(5) Robert Koch Institut. Epidemiologisches Bulletin. 18. November 2005 / Nr. 46
Source: Idenix Pharmaceuticals
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