Healthcare Industry News: Novartis Pharma AG
News Release - March 2, 2007
SEBIVO(R) (Telbivudine) Approved in China as New Treatment Option for Patients with Chronic Hepatitis BChronic hepatitis B affects an estimated 100 million people in China(1)
SEBIVO(R) recently received positive opinion by the European Medicines Agency, and is already approved and available in the United States under the brand name TYZEKA(R)(telbivudine)
CAMBRIDGE, Mass., March 2 (HSMN NewsFeed) -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ) announced today that SEBIVO« (telbivudine) has received approval from the Chinese State Food and Drug Administration (SFDA) as a once-a-day treatment, taken orally with or without food, for the treatment of chronic hepatitis B (CHB). CHB remains a significant global health care concern, particularly in China where it affects more than 100 million people(1-3) - representing about one-third of those infected worldwide.(2) SEBIVO is expected to be available in China in April.
"The Chinese approval of telbivudine is positive news for the many CHB patients in China," said Dr. Calvin Q. Pan, MD, Director, Clinical Research/Hepatology, Mount Sinai Services at Elmhurst Hospital in New York City. "As a physician who treats many CHB patients in the U.S., it is good to know that the patients in China will also have access to this new treatment option. Now, Chinese patients may also benefit from telbivudine's ability to provide early viral suppression, a primary goal of treatment."
Telbivudine received regulatory approval in the United States from the Food and Drug Administration (FDA) in October 2006 for the treatment of CHB in adult patients with evidence of viral replication and active liver disease. Telbivudine is called TYZEKA in the United States and is called SEBIVO in all other countries. The approval of SEBIVO in China follows earlier approvals in Canada, Australia, Switzerland and several countries in Asia and Latin America. SEBIVO also recently received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommending approval by the European Commission.
Worldwide regulatory submissions have been based primarily on one-year data from the GLOBE study, the largest worldwide registration trial including hepatitis B e-antigen (HBeAg)-positive and HBeAg-negative patients with CHB, and the first to include patients from China. The study results demonstrated that telbivudine provided potent viral suppression and high rates of PCR- negativity after one year. An additional Chinese phase III trial, involving 332 adult Chinese patients with CHB, corroborated these findings and supplemented the filing in China.
About the GLOBE Study
Data from the worldwide phase III clinical trial, known as the GLOBE study, compared telbivudine to lamivudine, a commonly used antiviral therapy for the treatment of CHB, in 1,367 patients. In the GLOBE study, 60 and 40 percent of HBeAg-positive patients and 88 and 71 percent of HBeAg-negative patients achieved undetectable levels of HBV DNA (PCR-negativity) with telbivudine and lamivudine, respectively, at 52 weeks. Additionally, patients who achieved undetectable HBV DNA levels at 24 weeks were more likely to undergo e-antigen seroconversion, PCR-negativity, normalize ALT, and minimize resistance at one year.
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 HBeAg. In HBeAg-positive patients, therapeutic response was 75% (n=345/458) among patients treated with telbivudine and 67% (n=310/463) for those patients treated with lamivudine, while the response for HBeAg-negative patients was 75% (n=167/222) vs. 77% (n=173/224), respectively.
In the GLOBE study, telbivudine was generally well tolerated with most adverse experiences classified as mild or moderate in severity. Frequently occurring adverse events (> 5%) for telbivudine v. lamivudine, respectively, were upper respiratory tract infection (14% v. 13%), fatigue and malaise (12% v. 11%), abdominal pain (12% v. 13%), nasopharyngitis (11% v. 10%), headache (11% v. 14%), blood CPK increased (9% v. 7%), cough (7% v. 6%), nausea and vomiting (7% v. 6%), influenza and influenza-like symptoms (7% v. 8%), post- procedural pain (7% v. 6%), diarrhea and loose stools (7% v. 5%) and pharyngolaryngeal pain (5% v. 4%). Please see Important Safety Information.
Idenix and Novartis Pharma AG are co-promoting TYZEKA/SEBIVO, for the treatment of chronic hepatitis B, and co-developing valtorcitabine, a second hepatitis B compound, and valopicitabine, a hepatitis C compound, under a development and commercialization arrangement established in May 2003. Under this agreement, Novartis and Idenix will co-promote TYZEKA/SEBIVO and, if approved, valtorcitabine and valopicitabine in the United States, France, Germany, Italy, Spain and the UK. Novartis has the exclusive right to commercialize TYZEKA/SEBIVO, valtorcitabine and valopicitabine in the rest of the world.
Important Information about Telbivudine
The following information about telbivudine is adapted from the U.S. Food and Drug Administration's approved product label. It is anticipated that similar language related to the product's indication and important safety information will pertain to the product in global labeling.
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. Full prescribing information is available at www.tyzeka.com.
Important Safety Information about Telbivudine
-- 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 telbivudine. 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 telbivudine 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. Telbivudine therapy should be interrupted if myopathy is suspected, and discontinued if myopathy is diagnosed.
-- Because telbivudine is eliminated primarily by renal excretion, co- administration of telbivudine with drugs that affect renal function may alter plasma concentrations of telbivudine and/or the co-administered drug. Dose interval adjustment is recommended in patients with creatinine clearance < 50mL/min including those with ESRD on hemodialysis. For patients on hemodialyis, telbivudine should be administered after hemodialysis.
-- The safety and efficacy of telbivudine in liver transplant recipients are unknown. If telbivudine 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 telbivudine.
-- Patients should be advised that treatment with telbivudine has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination. -- Safety and effectiveness of telbivudine in pediatric patients under the age of 16 years have not been established.
-- 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 telbivudine has not been established. The relationship of initial treatment response to outcomes such as hepatocellular carcinoma and decompensated cirrhosis are unknown.
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 telbivudine in additional markets or potential future revenues from telbivudine. 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 telbivudine will be approved for sale in any additional markets or that revenues from the sale of telbivudine 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 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 are described in greater detail under the caption "Risk Factors" in the company's most recent quarterly report on Form 10-Q 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) Z Sun et. al. Prevention and control of hepatitis B in China. J Med Virol 2002, 67:447-450.
(2) Lesmana LA, Leung NW, Mahachai V, et al. Hepatitis B: overview of the burden of disease in the Asia-Pacific region. Liver Int 2006 Dec; 26 Suppl 2: 3-10.
(3) Guan Z, Dong Z, Wang Q, et al. Cost of chronic hepatitis B infection in China. J Clin Gastroenterol 2004 Nov; 38(10 Suppl): S175-S178.
Source: Idenix Pharmaceuticals
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