TELBIVUDINE APPROVED IN SWITZERLAND FOR CHRONIC HEPATITIS B.Idenix Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :IDIX), Cambridge, Mass, has announced that the Swissmedic has approved telbivudine as a new treatment for chronic hepatitis Chronic hepatitis Long lasting inflammation of the liver due to viruses or other causes. Mentioned in: Tube Compression of the Esophagus and Stomach chronic hepatitis B (CHB) in compensated patients with evidence of viral replication and active liver inflammation. Telbivudine is a single pill taken orally, once-a-day, with or without food to suppress replication of hepatitis B Hepatitis B Definition Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic virus. "We are committed to improving the therapeutic options for patients with viral diseases with new drugs, such as telbivudine," said Jean-Pierre Sommadossi, chairman and chief executive officer of Idenix. "For Idenix, this is a major milestone as it is the first approval of Idenix's first drug candidate, telbivudine, in a European country, just 6 years after it entered clinical development. Having achieved this milestone is an inflection point Inflection Point An event that changes the way we think and act. -Andy Grove, Founder of Intel. Notes: For example, the fall of the Berlin Wall was an inflection point in global politics and the commercialization of the Internet was an inflection point in technology. in Idenix's evolution to a fully integrated pharmaceutical company." A new drug application was submitted by Idenix with the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in late 2005 and is currently under review. Regulatory applications were submitted by Novartis in 2006 in a number of regions including the European Union, Canada, Australia, Switzerland, Taiwan, South Korea and China seeking marketing approval of telbivudine for the treatment of CHB. Telbivudine will be called SEBIVO(R) in Switzerland. Safety Information About Telbivudine The diverse nature and rate of occurrence of adverse events were similar between telbivudine-treated patients and lamivudine-treated patients. The most common adverse events for telbivudine and lamivudine, regardless of attributability, were upper respiratory infection Noun 1. upper respiratory infection - infection of the upper respiratory tract respiratory infection, respiratory tract infection - any infection of the respiratory tract , headache, fatigue and nasopharyngitis. Grade 3-4 serum ALT elevations were more common in lamivudine-treated patients compared to telbivudine after week 24. Grade 3-4 creatine kinase (CK) elevations were more common with telbivudine compared to lamivudine by week 52. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least one year in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted. About Chronic Hepatitis B Approximately 350 million people worldwide are living with CHB, a virus which affects the liver, and is 50 to 100 times more infectious than the human immunodeficiency virus human immunodeficiency virus n. HIV. Human immunodeficiency virus (HIV) A transmissible retrovirus that causes AIDS in humans. (HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. ). Hepatitis B is the second most common cause of cancer after smoking, and each year an estimated 1.2 million people worldwide die from hepatitis B-related chronic liver disease Chronic liver disease is a liver disease of slow process and persisting over a long period of time, resulting in a progressive destruction of the liver. It includes amongst others:
Idenix/Novartis Collaboration Telbivudine is being developed in collaboration between Idenix and Novartis Pharma AG under a development and commercialization arrangement established in May 2003, along with another hepatitis B clinical product candidate, valtorcitabine. The collaboration arrangement further provides that Idenix and Novartis will co-promote telbivudine and valtorcitabine and other product candidates that Novartis has licensed, upon successful development and approval, in the US, France, Germany, Italy, Spain and the UK. Novartis holds the exclusive license to commercialize telbivudine and valtorcitabine in the rest of the world. In March 2006, Novartis expanded its collaboration with Idenix to include valopicitabine, an investigational agent for the treatment of chronic hepatitis C. About Idenix Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery, development and commercialization 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
For more information, call 617/995-9838 or visit http://www.idenix.com. |
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