Sanofi-Aventis and Japanese partner Taiho Pharmaceutical say that their new oral stomach cancer drug has shown that it significantly reduces the risk of death for patients with the disease compared to treatment by surgery only.
The companies presented data from a Phase III trial (ACTS-GC) at the Gastrointestinal Cancers Symposium in Orlando, USA, of the compound, called S-1, which showed that the drug reduced significantly the relative risk of death in early-stage gastric cancer patients by 32% compared with curative surgery alone.
The results of the study, which involved 1,059 Japanese patients, indicate that for all randomised patients overall survival at 3-years was 80.5% for patients receiving S-1 and 70.1% for patients undergoing surgery alone, which was the study’s main goal. Its secondary endpoints were also met, as three-year relapse-free survival was 72.2% in the S-1 arm and 60.1% for surgery alone and the firms noted that 6% or less of patients in the trial experienced adverse reactions such as nausea, diarrhoea, anorexia or haematological reactions.
Sanofi and Taiho said the study results represent “one of the most important advances in early-stage gastric cancer in 40 years” and added that the disease is the second most common cause of cancer death worldwide, claiming more than 700,000 lives per year.
S-1, which combines tegafur (a pro-drug of 5 fluoro-uracil), gimeracil (which inhibits dihydropyrimidine dehydrogenase enzyme activity) and oteracil, a gastrointestinal side effects corrector, is already marketed in Japan for the treatment of gastric, colorectal, head and neck, non-small cell lung, metastatic breast and pancreas cancers. Sales of the drug in 2005 were 31 billion yen, around $270 million.
Sanofi and Taiho teamed up in July last year and the agreement stated that the latter firm stands to benefit from upfront and milestone fees to the tune of $360 million, before royalties. The French drugmaker is responsible for development and commercialisation of S-1 in the USA, Europe and other countries in the world, except certain Asian nations.
Key Plavix trial starts today
Meantime, Sanofi and partner Bristol-Myers Squibb were also celebrating the news that rival Apotex had been denied a rehearing by a US appeals court over a ruling which stopped it selling a generic version of the two companies’ blockbuster blood-thinner Plavix (clopidogrel) until the eagerly-awaited patent trial on the drug, which starts later today, is resolved.
Sales of Plavix collapsed in the third quarter of 2006 after Apotex flooded the market with a six-month supply of generic clopidogrel in August. The case which begins today will deal with the validity of one of the compound's patents and most observers are now predicting that Sanofi and B-MS will win the day.
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