Taiho Pharmaceutical Co., Ltd. and its parent company, Otsuka Holdings Co., Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency (EMA), has issued an opinion recommending approval of Teysuno (S-1), a novel oral anti-cancer agent, for treatment in adults with advanced gastric cancer when given in combination with cisplatin. The Committee will now recommend that the European Commission (EC) grant marketing authorization for Teysuno, a decision that is normally issued within 67 days from adoption of a CHMP opinion.

“We are pleased with the CHMP’s positive opinion on Teysuno. It is an important step toward a new treatment option for European adults living with gastric cancer,” said Toru Usami, president, Taiho Pharmaceutical Co., Ltd. “The CHMP recommendation also represents the first regulatory milestone for Taiho outside of Japan and Asia. Teysuno is the first of what we hope will be many promising anti-cancer agents to be developed globally and made commercially available by Taiho.”

A member of the fluoropyrimidine class of chemotherapeutic agents, Teysuno is a combination of three pharmacological compounds: tegafur, an antimetabolite agent that, after absorption, is converted into the anti-cancer agent fluorouracil (5-FU); gimeracil (5-chloro-2, 4-dihydroxypyridine, or CDHP), which decreases the degradation of 5-FU by the body; and oteracil (Oxo), which decreases 5-FU activation in the gastrointestinal tract. The Committee’s recommendation was based in part on the results of the First-Line Advanced Gastric Cancer Study (FLAGS), the largest international phase III trial ever conducted in patients with advanced gastric cancer.

“In the FLAGS study, a Teysuno containing regimen was as effective as the comparator with a favourable safety profile,” commented Fabio M. Benedetti, MD, Chief Medical Officer of Taiho Pharma US, Inc. “Availability of Teysuno in Europe will provide physicians with another option in the management of this very difficult to treat disease.”

The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Teysuno and therefore recommends granting marketing authorization for the product. The CHMP recommendation requires formal approval by the EC for marketing of Teysuno in all European Union (EU) Member States, which is expected in early 2011.

Taiho is currently in discussions with potential marketing partners for Teysuno to ensure its timely and effective introduction to the European oncology community.

With an estimated 934,000 new cases per year (8.6% of all new cancer cases), gastric cancer is the fourth most common cancer worldwide, following lung, breast, and colorectal cancers. It is the second most common cause of cancer-related death, accounting for an estimated 700,000 to 800,000 deaths annually. Nearly 70% of new cases occur in developing countries; 42% of new cases occur in China alone.

In Europe, gastric cancer is the seventh most common cancer and the sixth most common cause of cancer death, with an estimated annual mortality rate of 118,200. In general gastric cancer incidence rates are about twice as high among men as in women. The disease is difficult to cure unless it is diagnosed in its early stages. Unfortunately, because early gastric cancer causes few symptoms, the disease is not usually diagnosed until it has reached an advanced stage.

In Europe, the five-year survival rate for gastric cancer is roughly 20% in men and 25% in women. Similarly, in the United States, the five-year survival rate for gastric cancer is 24%, though survival rates improve to 61% if the disease is detected early. However, less than one-quarter of gastric cancers are diagnosed at an early stage in the United States. In contrast, the five-year survival rate exceeds 50% in Japan, where early gastric cancer is diagnosed relatively frequently due to mass screening efforts, which have been practiced since the 1960s.

Teysuno was designated an orphan medicinal product by the EMA in 2007 in recognition of its development specifically to treat the rare condition of gastric cancer. Since its initial approval in Japan in 1999, Teysuno has become a standard of care there for the treatment of gastric cancer. Teysuno is also approved for patients with gastric cancer in South Korea, China, Singapore and Taiwan. Teysuno was subsequently approved in Japan for six additional indications: for the treatment of colorectal, head and neck, non-small cell lung, metastatic breast, pancreatic and biliary tract cancers.

Taiho Pharmaceutical Co., Ltd. (Taiho) is a company engaged in discovery, development, manufacturing and marketing of pharmaceutical products, with headquarters in Tokyo, Japan. Taiho is one of the leading companies focused on oncology.

The Otsuka Group is a global organization of 145 healthcare companies with nearly 39,000 employees. Otsuka Holdings Co., Ltd. is the Group's holding company. The main operating companies are Otsuka Pharmaceutical Co., Ltd.; Otsuka Pharmaceutical Factory, Inc.; Taiho Pharmaceutical Co., Ltd.; Otsuka Warehouse Co., Ltd.; and Otsuka Chemical Co., Ltd. The Group operates in 23 countries and regions, conducting diversified businesses in four segments all connected by a focus on health: pharmaceuticals, nutraceuticals, consumer products, and other product areas.