Once SEBIVO is approved for China, how will NVS/IDIX make a fair profit on selling this drug into a region where that average wage is $55-$85/month for the average worker? Will the Chinese Government pick up the bill for this drug, or will the common Chinese worker be expected to pay for the drug?
Perhaps I should have researched this aspect before I became a IDIX shareholder.
[This action was fully expected once the CHMP endorsed Sebivo two months ago. Rollout begins in the current quarter in the UK and Germany, and IDIX receives a $10M milestone payment from NVS.]
>> Sebivo® (Telbivudine) Approved in European Union as a New Treatment for Chronic Hepatitis B Patients
Monday April 30, 2:00 am ET
Every year in Europe an estimated one million people are infected with the hepatitis B virus and 90,000 will become chronic carriers and 24,000 will die
CAMBRIDGE, Mass., April 30 /PRNewswire-FirstCall/ -- The European Commission today approved SEBIVO® (telbivudine), a new once-a-day oral treatment for adult patients with chronic hepatitis B (CHB) and evidence of viral replication and active liver disease. The European Commission decision applies to all 27 countries in the European Union as well as Iceland and Norway. Launches are expected to start in the second quarter of 2007 beginning with the United Kingdom and Germany. The approval of SEBIVO in Europe triggers a milestone payment from Novartis Pharma AG to Idenix[$10M]. In addition to the European Union, SEBIVO is currently approved in more than 15 major markets, including the United States [where it is marketed as TYZEKA® (telbivudine)], Canada, Switzerland and China.
"The approval of SEBIVO now offers Europeans infected with chronic hepatitis B a new treatment option," said Professor Thierry Poynard of Hopital Pitie-Salpetriere, University of Paris VI, France and an investigator in the phase III GLOBE study. "There is no cure for chronic hepatitis B. High hepatitis B viral load increases the risk of serious complications. To reduce this risk, the goal of therapy is to suppress the hepatitis B virus as much as possible, and to maintain that decrease over time."
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. The worldwide phase III GLOBE study compared telbivudine to lamivudine, a commonly used antiviral therapy for the treatment of CHB, in 1,367 patients. In the European Union, participating countries included the Czech Republic, France, Germany, Greece, Italy, Poland, Spain and the UK.
"The European approval of SEBIVO is another significant achievement for Idenix," said Jean-Pierre Sommadossi, chief executive officer and chairman of Idenix. "Working with our alliance partner, Novartis, we have gained approval of SEBIVO in more than 40 countries in less than 18 months. The speed with which we have gained these approvals is a testament to our strength and focus on developing new antiviral agents."
About Idenix
Idenix Pharmaceuticals, Inc., (Nasdaq: IDIX ) 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. <<
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