Healthcare Industry News: Novartis Pharma AG
News Release - September 21, 2006
Telbivudine Approved in Switzerland for Chronic Hepatitis BCAMBRIDGE, Mass., Sept. 21 (HSMN NewsFeed) -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ), announced today that the Swissmedic has approved telbivudine as a new treatment for 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 virus.(1)
"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 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 (FDA) 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 SEBIVOŽ 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, 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,(2) a virus which affects the liver, and is 50 to 100 times more infectious than the human immunodeficiency virus (HIV).(2) Hepatitis B is the second most common cause of cancer after smoking,(2) and each year an estimated 1.2 million people worldwide die from hepatitis B-related chronic liver disease.(3)
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.
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 and human immunodeficiency virus. 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 "promising," "are committed to," "improving," "will be" or similar expressions or by express or implied discussions regarding improved therapeutic options, potential market approval of telbivudine in other jurisdictions and potential sales of 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 other market or that revenues from the sale of telbivudine will reach any specific level in Switzerland or other countries, if any, in which regulatory approval to market telbivudine may be obtained. In particular, management's expectations could be affected by the unexpected regulatory actions or delays with respect to the regulatory review of pending telbivudine marketing applications or government regulation generally; uncertainties relating to results of clinical trials, including additional data relating to the ongoing phase III and IIIb clinical trial evaluating telbivudine; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the company's dependence on the collaboration it has with Novartis Pharma AG; the ability of the company to attract and retain qualified personnel; competition in general; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for telbivudine and 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 quarterly report on Form 10-Q for the quarter ended June 30, 2006 and 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. Lavanchy D. J Viral Hepatology. 2004 Mar 11 (2): 97-107
3. World Health Organization. Hepatitis B. Available at: http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index1.html .
Source: Idenix Pharmaceuticals
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