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Telbivudine (LdT) Achieves Primary Endpoint in Phase III GLOBE Trial, Largest Ever Registration Trial in HBV
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This press release was issued by Idenix.
* Idenix and Novartis anticipate first regulatory filing by the end of 2005
* Complete GLOBE results to be submitted for presentation at American Association for the Study of Liver Diseases meeting in November 2005
CAMBRIDGE, Mass., July 28 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News) and Novartis Pharma AG announced today that the phase III GLOBE registration trial for telbivudine successfully reached its primary, composite efficacy endpoint of therapeutic response at one year in chronic hepatitis B patients. This endpoint, which was designed to assess if telbivudine was at least as effective as lamivudine, evaluated the combination of viral suppression (serum HBV DNA suppression below 100,000 copies/mL) coupled with either improved liver function (ALT normalization) or loss of detectable hepatitis B e-antigen (HBeAg).
The largest hepatitis B registration trial to date, GLOBE enrolled more than 1,350 patients in over 130 medical centers worldwide. The ongoing trial is evaluating the safety and efficacy of telbivudine compared to lamivudine in patients with HBeAg-positive and HBeAg-negative compensated chronic hepatitis B for two years of treatment in two daily treatment regimens: telbivudine 600 mg or lamivudine 100 mg.
The one-year analysis of this trial will be the primary data used for preparing the marketing registration applications. Idenix and Novartis plan to file with the U.S. Food and Drug Administration (FDA) by the end of 2005 for marketing approval of telbivudine for the treatment of chronic hepatitis B. Worldwide marketing filings, including the filing that will be submitted to the European Medicines Agency (EMEA), are expected in the first quarter of 2006. Idenix and Novartis are co-developing telbivudine.
The World Health Organization (WHO) has estimated that approximately 350 million people, or 5% of the world's population, are chronically infected with hepatitis B virus (HBV). Current treatment options are often associated with limited efficacy, poor tolerability or resistance concerns, and new therapeutic options are needed to respond to the significant unmet need in treating chronic hepatitis B.
"We are very pleased that telbivudine met the primary endpoint in the phase III GLOBE study and may provide an important new therapeutic option for patients with chronic hepatitis B," commented Nathaniel Brown, M.D., executive vice president of clinical development and chief medical officer of Idenix. "Bringing our first clinical candidate through this stage of development is a major milestone for Idenix, particularly given the large international scope of the GLOBE study."
The companies anticipate that complete data from the GLOBE study will be submitted for presentation to the American Association for the Study of Liver Diseases (AASLD) meeting in San Francisco, California, November 11-15, 2005.
More About Telbivudine
Telbivudine is a specific and selective, oral, once-daily nucleoside that is unique in its preferential inhibition of 2nd strand HBV DNA synthesis. This distinct mechanism of action may be responsible for the rapid and profound viral suppression associated with telbivudine treatment.
The GLOBE study results continue to support a favorable overall safety profile for telbivudine with no substantial safety issues being identified to date through the combined two years of treatment in the phase IIb clinical trial and in the phase III clinical program to date. The most frequently reported adverse events, regardless of attributability to study treatment, were upper respiratory infection and fatigue, which were equally common for telbivudine (14% and 12 %, respectively) and lamivudine (13% and 10% respectively).
An additional phase III trial is evaluating the safety and efficacy of telbivudine compared to lamivudine in HBeAg-positive and HBeAg-negative patients with decompensated chronic hepatitis B. This ongoing trial has enrolled 87 patients to date.
About Hepatitis B
Chronic Hepatitis B is caused by a virus that attacks the liver. The virus, which is called hepatitis B virus (HBV), can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. The WHO estimates that annually over 50 million people become infected with HBV and that more than one million individuals die from HBV-related chronic liver disease.
Idenix/Novartis Collaboration
Idenix is developing its hepatitis B clinical product candidates, telbivudine and valtorcitabine, in collaboration with Novartis Pharma AG under a development and commercialization arrangement established in May 2003. The collaboration arrangement further provides that Novartis and Idenix will co- promote in the United States, France, Germany, Italy, Spain and the UK those product candidates Novartis has licensed, including telbivudine and valtorcitabine, that are approved for marketing. Novartis holds the exclusive license to telbivudine and valtorcitabine in the rest of the world.
The collaboration also provides Novartis with an exclusive option to license and collaborate with Idenix in the development and commercialization of other product candidates in Idenix's portfolio, including valopicitabine (NM283), a direct antiviral hepatitis C product candidate.
About Idenix
Idenix Pharmaceuticals, Inc. 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 (HIV). Idenix's headquarters are located in Cambridge, Massachusetts. The company also has drug discovery and development operations in Montpellier, France and drug discovery operations in Cagliari, Italy. For further information about Idenix, please refer to http://www.idenix.com.
Idenix Pharmaceuticals Reports Second Quarter and Six Month Financial Results
CAMBRIDGE, Mass., July 28 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases, today reported unaudited financial results for the second quarter and six months ended June 30, 2005.
For the second quarter ended June 30, 2005, Idenix reported total revenues of $16.1 million, compared with total revenues of $42.8 million in the second quarter of 2004. Total revenues include reimbursement by Novartis of expenses incurred by Idenix in connection with the development of telbivudine and valtorcitabine, Idenix's drug candidates for the treatment of hepatitis B, and amortization of the up-front fees paid to Idenix in May 2003 when Novartis licensed Idenix's hepatitis B drug candidates. In the 2004 quarter, total revenues also included a $25 million milestone payment received from Novartis related to the successful completion by Idenix of a phase I clinical trial of valopicitabine, or NM283, Idenix's lead drug candidate for the treatment of hepatitis C. Idenix reported a net loss of $13.4 million or a loss of $0.28 per diluted share for the second quarter ended June 30, 2005, compared to net income of $21.0 million, or $0.53 per diluted share for the second quarter ended June 30, 2004.
For the six months ended June 30, 2005, Idenix reported total revenues of $31.0 million, compared with total revenues of $59.5 million for the six months ended June 30, 2004. The company reported a net loss of $22.7 million, or a loss of $0.47 per diluted share for the six months ended June 30, 2005, compared with net income of $15.1 million, or $0.39 per diluted share for the six months ended June 30, 2004.
The profitability experienced by the company for the quarter ended and six months ended June 30, 2004 was due to the recognition of the $25 million milestone payment received from Novartis during the second quarter of 2004. At June 30, 2005, Idenix's cash, cash equivalents and marketable securities totaled $129.1 million.
Business Highlights
"We have achieved significant milestones in our hepatitis B and hepatitis C development programs over the last three months," said Jean-Pierre Sommadossi, chairman and chief executive officer of Idenix. "Most significantly, as we reported in a separate press release today, the initial data indicate that telbivudine has met the primary efficacy endpoint in the 1,370 patient phase III GLOBE study. We anticipate finalizing the GLOBE data set shortly and plan to submit the complete data as a late-breaker abstract to the American Association for the Study of Liver Diseases for presentation at its annual meeting in November."
Additionally, the following accomplishments were realized by Idenix over the last three months:
* The company presented 2-year phase IIb telbivudine data at the 2005 Digestive Disease Week annual meeting that further demonstrated the correlation between early and profound viral suppression and markers of improved clinical outcomes. YOU CAN READ TELBIVUDINE STUDY RESULTS ON NATAP WEBSITE.
* The company completed enrollment (with 190 patients) of the phase IIb clinical trial of valopicitabine in treatment refractory patients. This clinical trial, which has been extended to 48 weeks, is a head-to-head trial comparing the combination of valopicitabine plus Pegasys¨ to ribavirin plus Pegasys¨ in hepatitis C genotype 1 patients who have previously failed at least 3 months of treatment with pegylated interferon plus ribavirin, the current standard therapy. Idenix expects to report preliminary clinical data from this phase IIb trial in the fall of 2005 and currently anticipates initiating a phase III clinical trial in this patient population in the first half of 2006.
* The company initiated the phase IIb trial of valopicitabine in treatment-naive hepatitis C genotype 1 patients at clinical sites in late July. This trial is designed to quantitatively assess the antiviral dose-response relationship for valopicitabine in treatment regimens comprising combinations of Pegasys¨ with various valopicitabine dosing regimens. The goal of this study is to identify the optimal combination regimen (valopicitabine plus pegylated interferon) for further study in phase III trials in treatment na•ve patients.
2005 Expectations
Based on the expected timing and cost of current and anticipated clinical trials and the planned growth of Idenix's commercial operations, the company currently expects its net use of cash to be between $70 million and $80 million in 2005, which would result in 2005 year-end cash, cash equivalents and marketable securities of between $77 million and $87 million.
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