Healthcare Industry News: Novartis Pharma AG
News Release - October 25, 2006
TYZEKA(TM) (telbivudine) Approved by U.S. Food and Drug Administration (FDA) as a New Treatment for Patients with Chronic Hepatitis BCAMBRIDGE, Mass., Oct. 25 (HSMN NewsFeed) -- 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."
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-na´ve 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.
Important Safety Information About TYZEKA * Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.
* Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including TYZEKA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
* Cases of myopathy have been reported with TYZEKA use several weeks to months after starting therapy. Myopathy has also been reported with some other drugs in this class. Physicians considering concomitant treatment with these or other agents associated with myopathy should weigh carefully the potential benefits and risks and should monitor and advise patients to report any signs or symptoms of unexplained muscle pain, tenderness or weakness, particularly during periods of upward dosage titration. TYZEKA therapy should be interrupted if myopathy is suspected, and discontinued if myopathy is diagnosed.
* Because TYZEKA is eliminated primarily by renal excretion, co-administration of TYZEKA with drugs that affect renal function may alter plasma concentrations of TYZEKA and/or the co-administered drug. Dose interval adjustment is recommended in patients with creatinine clearance < 50mL/min.
* The safety and efficacy of TYZEKA in liver transplant recipients are unknown. If TYZEKA treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function should be monitored both before and during treatment with TYZEKA.
* Patients should be advised that treatment with TYZEKA has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
* Safety and effectiveness of TYZEKA in pediatric patients under the age of 16 years have not been established.
* Selected treatment-emergent clinical adverse events of moderate to severe intensity (Grade 2-4) reported in the GLOBE study with Tyzeka were: muscle-related symptoms 2%; fatigue/malaise 1%; headache 1%; pyrexia 1%; abdominal pain <1%; arthralgia <1%; cough <1%; diarrhea <1%; gastritis <1%.
* Creatine kinase (CK) elevations were more frequent among subjects on telbivudine treatment. Grade 3/4 CK elevations occurred in 9% of telbivudine-treated patients and 3% of lamivudine-treated patients.
* The optimal duration of treatment with TYZEKA has not been established. The relationship of initial treatment response to outcomes such as hepatocellular carcinoma and decompensated cirrhosis are unknown.
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 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.
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.
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 "commitment," "may," "promising," "will," or similar expressions, or by express or implied discussions regarding potential approvals of TYZEKA in additional markets, the potential future development of other products, or potential future revenues from TYZEKA or any other products. 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 guarantees that TYZEKA will be approved for sale in any additional markets, that any other products will be approved for sale in any market, or that revenues from the sale of TYZEKA or any other products will reach any particular level. In particular, management's expectations could be affected by unexpected regulatory actions or delays, or government regulation generally; unexpected clinical trial results, including additional analysis of existing clinical data and new clinical data; the ability to advance valopicitabine into phase III clinical trials, 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; government, industry, and general public pricing pressures; competition in general; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for telbivudine, valopicitabine, its other product candidates and its discoveries. These and other risks which may impact management's expectations regarding telbivudine and Idenix's other product candidates are described in greater detail under the caption "Risk Factors" in the company's annual report on Form 10-K for the year ended December 31, 2005 as 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 Lai, C. Hepatology. 2005 Oct (42.S1):78A
2 Center for Disease Control Hepatitis B Fact Sheet
3 World Health Organization Hepatitis B Fact Sheet
4 Lavanchy, D. Journal of Viral Hepatitis, March 2004
Source: Idenix Pharmaceuticals
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