Novartis licenses rights to develop and commercialize new hepatitis treatment

Basel, June 2, 2005 - Novartis announced today that it has signed an exclusive global license agreement with Anadys Pharmaceuticals for ANA975 for the treatment of chronic hepatitis C virus (HCV).

 

Under the terms of the agreement, Novartis obtains the rights to develop, manufacture and commercialize ANA975 for HCV as well as to develop ANA975 in additional infectious disease indications, including hepatitis B virus infection (HBV). ANA975, an oral prodrug of Anadys' small molecule compound isatoribine, belongs to a new class of drugs being developed to regulate innate immunity by interacting with Toll-Like Receptor 7 (TLR7). ANA975 is currently in Phase I development for the treatment of HCV. Anadys successfully completed several proof of concept studies with isatoribine in patients with HCV.

 

HCV and HBV are progressive liver diseases that chronically affect approximately 170 million and 350 million people respectively, worldwide.  Chronic infections with hepatitis C and B viruses can eventually lead to cirrhosis, liver failure and hepatocellular carcinoma (liver cancer). Currently available treatments are often associated with limited efficacy, poor tolerability and/or resistance concerns.

 

"With this agreement, we are adding complementary compounds to the direct antivirals already in our hepatitis pipeline," said Thomas Ebeling, Chief Executive Officer of Novartis Pharma AG. "As the most advanced oral immunomodulator in development for hepatitis, ANA975 represents a potentially important advance in bringing more effective, tolerable therapy to hepatitis patients worldwide."

 

Novartis further obtained an exclusive option to license additional TLR7-based therapeutics developed by Anadys for HCV and HBV.  Additionally, Novartis has the option to in-license Anady's rights to ANA380, a nucleotide analog in Phase II development for treating chronic HBV.

 

Novartis, in collaboration with Idenix, is already developing two complementary drug candidates for the treatment of chronic HBV, LDT600 (telbivudine) and LDC300 (valtorcitabine).  Novartis has an exclusive option to license and collaborate with Idenix in the development and commercialization of other drug candidates in their portfolio, including direct antiviral hepatitis C compound NM283 (valopicitabine).

 

Each year three to four million people worldwide become newly infected with HCV. The current standard of care in HCV is combination therapy of subcutaneous interferon, an immunomodulator, and ribavirin, an antiviral.  This combination therapy is often associated with high incidence  of side effects and has limited efficacy in the most prevalent, genotype-1, of HCV genotypes. 

 

Despite immunization programs for hepatitis B, 5% of the world's population is chronically infected with HBV. Currently available therapies for chronic HBV include antivirals and subcutaneous interferon. More than one million individuals die worldwide from HBV-related chronic liver disease each year, demonstrating the urgent need for new treatment options.

 

The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "pipeline", "potentially", or similar expressions, or  by express or implied discussions regarding the potential development, regulatory approvals and commercialization of ANA975, ANA380, LDT600, LDC300 and NM283.  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 any of these products will be approved for sale in any market, or that any of them will achieve any particular level of sales.  Any such commercialization can be affected by, among other things, uncertainties relating to product development and clinical trials, including unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; as well as factors discussed in the Company's Form 20-F filed with the 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 described herein as anticipated, believed, estimated or expected.  Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

 

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81,400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

 

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