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FDA Approves Tyzeka (Telbivudine) for HBV

[Congrats to IDIX longs. The company has just graduated from a drug-discovery shop to a bona fide commercial operation.]

http://biz.yahoo.com/prnews/061025/new040.html?.v=40

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TYZEKA™ (telbivudine) Approved by U.S. Food and Drug Administration (FDA) as a New Treatment for Patients with Chronic Hepatitis B

Wednesday October 25, 3:36 pm ET

CAMBRIDGE, Mass., Oct. 25 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ) today announced the approval of TYZEKA(TM) (telbivudine) by the U.S. Food and Drug Administration (FDA) as a new once-a-day oral treatment, taken with or without food, for patients with chronic hepatitis B (CHB). TYZEKA rapidly and profoundly(1) suppresses the hepatitis B virus (HBV) in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

"The FDA approval of TYZEKA is a major milestone for Idenix as it is the first Idenix drug to receive U.S. approval," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer at Idenix Pharmaceuticals, Inc. "Receiving approval just six years after TYZEKA entered clinical development is a tremendous accomplishment and demonstrates Idenix's commitment to discovering and developing new treatment options for patients affected by devastating viral diseases."

"Profound suppression of the hepatitis B virus is associated with improved outcomes and is a primary treatment goal," said Adrian M. Di Bisceglie, MD, Professor of Medicine and Chief of Hepatology, Division of Gastroenterology and Hepatology, at Saint Louis University, and Co-Director, Saint Louis University Liver Center. "TYZEKA's ability to provide rapid viral suppression in the first 24 weeks of treatment, along with its safety and tolerability profile, make it a promising treatment option for appropriate patients."

Data from the pivotal phase III clinical trial, known as the GLOBE study, compared TYZEKA to lamivudine in 1,367 patients. The primary efficacy endpoint of the GLOBE study was therapeutic response at one year, a composite endpoint coupling viral suppression (serum HBV DNA suppression below 100,000 copies/mL) with either improved liver disease markers (ALT normalization) or loss of detectable hepatitis B e-antigen (HBeAg). In HBeAg-positive patients, therapeutic response was 75 percent among patients treated with TYZEKA and 67 percent for those patients treated with lamivudine, while the response for HBeAg-negative patients after one year was 75 percent vs. 77 percent, respectively. In the GLOBE study, patients who achieved non-detectable HBV DNA levels at 24 weeks were more likely to undergo e-antigen seroconversion, achieve undetectable levels of HBV DNA, normalize ALT, and minimize resistance at one year.

In clinical studies TYZEKA was generally well tolerated with most adverse experiences classified as mild or moderate in severity. Frequently occurring adverse events (> 5%) were upper respiratory tract infection (14%), fatigue and malaise (12%), abdominal pain (12%), nasopharyngitis (11%), headache (11%), blood CPK increased (9%), cough (7%), nausea and vomiting (7%), influenza and influenza-like symptoms (7%), post-procedural pain (7%), diarrhea and loose stools (7%), pharyngolaryngeal pain (5%). Please see Important Safety Information.

"The approval of TYZEKA is based primarily on the efficacy and safety data from the GLOBE study, the largest worldwide registration trial ever conducted to date in patients with chronic hepatitis B," said Nathaniel Brown, MD, chief medical officer of Idenix Pharmaceuticals, Inc. "We believe that TYZEKA will be an important new treatment option for patients with hepatitis B."

About TYZEKA

TYZEKA (telbivudine) is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

This indication is based on virologic, serologic, biochemical and histologic responses after one year of treatment in nucleoside-treatment-naïve adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease.

Already approved in Switzerland, telbivudine will be marketed as SEBIVO® outside the United States. Applications for approval were filed with the European Medicines Agency (EMEA) and the Chinese health authority in the first quarter of 2006.

About Hepatitis B

Approximately 1.25 million people in the United States are living with chronic hepatitis B(2) (CHB) caused by the hepatitis B virus, which infects the liver and is 50 to 100 times more infectious than HIV(3). CHB globally affects approximately 350 million people.(3)

Idenix/Novartis Collaboration

Idenix is co-promoting its hepatitis B product, TYZEKA, and developing its hepatitis B and hepatitis C clinical product candidates, (valtorcitabine and valopicitabine, respectively), in collaboration with Novartis Pharma AG under a development and commercialization agreement established in May 2003. Under this agreement, Novartis and Idenix will co-promote TYZEKA, and if successfully developed, valtorcitabine and valopicitabine, in the United States, France, Germany, Italy, Spain and the United Kingdom. Novartis has the exclusive right to commercialize licensed approved products in the rest of the world.

About Idenix

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, MA, 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). For further information about Idenix, please refer to http://www.idenix.com.
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