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New HBV Drug Telbivudine: NDA submitted to FDA
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Press release distributed by Idenix.
IDENIX AND NOVARTIS ANNOUNCE NEW DRUG APPLICATION SUBMITTED TO THE U.S. FOOD AND DRUG ADMINISTRATION FOR TELBIVUDINE FOR THE TREATMENT OF CHRONIC HEPATITIS B
- Submission Based on Positive Data from GLOBE Study -
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Cambridge, MA; January 3, 2006 - Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX) and Novartis Pharmaceuticals Corporation (NYSE: NVS) announced today that a New Drug Application (NDA) was submitted to the United States Food and Drug Administration (FDA) seeking marketing approval for the 600 mg dose of telbivudine for the treatment of chronic hepatitis B. This NDA is the first marketing approval submission for telbivudine, an oral, once-daily nucleoside analog. Additional applications for marketing authorization in the European Union (EU) and key Asian markets are expected to be submitted by Novartis Pharma AG (an affiliate of Novartis Pharmaceuticals Corporation) in 1Q2006.
"Idenix is pleased to be submitting its first NDA for an agent that has the potential to provide a new treatment option for the millions of chronic hepatitis B patients around the world," said Jean-Pierre Sommadossi, chairman and chief executive officer of Idenix. "The submission of this application in just 7 years from discovery of the use of telbivudine for the treatment of hepatitis B highlights the expertise and execution capabilities of our team and the impact of our alliance with Novartis. This marks a significant step in our company's growth and in the pursuit of our goal of building a leading antiviral franchise."
The NDA submission is primarily based on one-year data from the GLOBE study, the largest registration trial for a chronic hepatitis B treatment and the first global trial to include clinical sites and patients in mainland China. The GLOBE study is an ongoing two-year phase III clinical trial comparing telbivudine with a standard therapy, lamivudine, in 1,367 adults with chronic hepatitis B from 112 clinical centers in 20 countries worldwide.
The FDA has up to 60 days to review an NDA submission prior to accepting it for filing.
The Centers for Disease Control and Prevention (CDC) estimates that 1.25 million Americans are chronically infected with hepatitis B1, the most common serious liver infection in the world that can cause liver failure, cirrhosis (scarring), liver cancer and death.2
Chronic hepatitis B is caused by the hepatitis B virus (HBV), which infects the liver.2 HBV is 50-to-100 times more infectious than HIV (the virus that causes AIDS).3 Chronic hepatitis B is the tenth leading cause of death worldwide.4 It affects approximately 350 million people worldwide and is responsible for up to 80 percent of the world's primary liver cancer.5 Each year approximately 1.2 million people die worldwide from hepatitis B-related chronic liver disease.4
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/Novartis Collaboration
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.
About Idenix
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.
About Novartis
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved net sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.1 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 91,700 people and operate in over 140 countries around the world.
Forward Looking Statements
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: "if," "expects," "has the potential to provide", "anticipate" or similar expressions or by express or implied discussions regarding the company's regulatory submissions to the FDA 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 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.
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References:
1 Centers for Disease Control and Prevention. Viral Hepatitis B Fact Sheet. Available at
www.cdc.gov/ncidod/diseases/hepatitis/b/fact.htm Accessed 12/8/05
2 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
3 World Health Organization. Hepatitis B Fact Sheet Number 204 Available at
www.who.int/mediacentre/factsheets/fs204/en/print.html Accessed 12/8/05
4 Lavanchy D. J Viral Hepat. 2004 Mar 11 (2): 97-107
5 World Health Organization. Expanded programme on immunization hepatitis B vaccine - making global progress. Available at
www.childrensvaccine.org/files/WHO_hep_B_update.pdf Accessed 12/8/05
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