Media Release
Basel, 15 December 2003
Roche
reports on two major achievements in Japan, the world's second largest pharmaceuticals market
Chugai
and Roche sign licensing agreement for anti-cancer drugs Avastin and Omnitarg in Japan - Pegasys reimbursement
achieved and launched in Japan
Roche and Chugai Pharmaceutical Co., Ltd., Tokyo, Japan, (“Chugai”) announced today two major achievements that will further strengthen the Roche Group’s position in the important Japanese market – a new licensing agreement for two innovative cancer drugs and the launch of Pegasys for hepatitis C.
Licencing
Agreement for Cancer Drugs
Roche and Chugai have signed a licensing agreement under
which Chugai will obtain exclusive rights in Japan to develop and market two innovative anti-cancer
drugs, Avastin (bevacizumab), and Omnitarg (pertuzumab), both discovered by Genentech, USA. Chugai will
pay license fees to Roche for the two drugs. Roche holds the exclusive rights outside the US and Genentech
in the US.
“There are approximately 1,3 million people in Japan who suffer from various cancers , hence the huge need for new and better medicines. We believe that Avastin and Omnitarg represent an important step forward in the fight to treat cancer” said William M Burns, Head of Roche’s Pharmaceutical Division. “The addition of these two drugs to Chugai’s portfolio will also further strengthen our position in Japan, the world’s second largest pharmaceuticals market.”
About
Avastin
Avastin – a recombinant humanized therapeutic antibody - inhibits Vascular
Endothelial Growth Factor (VEGF), a protein that is believed to play an important role in tumor angiogenesis.
By inhibiting VEGF, Avastin interferes with the blood supply to tumors, thereby inhibiting tumor growth
and potentially leading to tumor regression. It represents a promising, novel anti-cancer approach with
a broad potential in a number of solid tumors, and is likely to be complementary with current chemotherapy
approaches.
Chugai plans to start phase I clinical trials for Avastin next year with an initial target indication of metastatic colorectal cancer. Avastin has been filed by Roche in Europe and Genentech in the United States, both submissions for colon cancer. It is also being evaluated as a potential therapy in lung, renal, and other cancers. Genentech and Roche are either planning for, or currently conducting clinical trials for indications other than colon cancer, and depending on the outcome, Chugai will seek for additional indications in Japan.
About
Omnitarg
Omnitarg is a recombinant humanized monoclonal antibody which blocks the
ability of human epidermal growth factor type 2 (HER2) receptor to partner with other HER receptor group
members (HER1/EGFR, HER3, and HER4). As a result, cell signaling within cancer cells is blocked, which
ultimately leads to cancer cell growth inhibition regardless of the HER2 expression.
Chugai
plans to start phase I clinical trials for Omnitarg next year for the target indications of non-small
cell lung cancer, breast cancer, prostate cancer and ovarian cancer. Omnitarg is currently under joint
development by Genentech and Roche in the United States and Europe. In the United States, its safety
has been confirmed in the phase I clinical trials and its efficacy has been shown in the patients studied.
The phase II clinical trials have commenced for breast, non-small-cell lung, prostate, and ovarian cancers
with low HER2 expression.
Product Launch and
NHI Drug Price Listing of Pegasys in Japan
Chugai announced that it had launched
Pegasys for the treatment of chronic hepatitis C infection, following its listing on the National Health
Insurance (NHI) drug reimbursement price list. Pegasys was approved in Japan on October 16, 2003 under
the fast track review process and was launched on December 12th 2003 just after a year from its filing.
In Japan about 400,000 to 500,000 people with hepatitis C infection have been on therapy and there are between 30,000 and 40,000 patients each year who receive interferon treatments for chronic hepatitis C infection. In addition to these numbers it is estimated that there are 1.5 million carriers of the hepatitis C virus. Pegasys is Japan’s first approved pegylated interferon and patients now have the option to choose an efficacious hepatitis C treatment with a more convenient once-weekly dosage.
Pegasys was developed by Roche and was approved in Switzerland in July 2001. Since then, it has been approved as a treatment for chronic hepatitis C in 86 counties including the EU and United States. In these countries, Pegasys has already gained significant market share (over 50% of new prescriptions in the US) due to its higher cure rates compared to conventional interferon therapy.
About
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche
is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and
a leader in virology and transplantation. As a supplier of products and services for the prevention,
diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s
health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances
and R&D agreements with numerous partners, including majority ownership interests in Genentech and
Chugai.
About Chugai
Chugai
Pharmaceutical Co., Ltd. is one of Japan’s leading research-based pharmaceutical companies with strengths
in biotechnology products and in the therapeutic fields of oncology, renal diseases, cardiovascular
diseases, bone/joint diseases and transplantation/infection/immunity. With pharmaceutical sales of 237
billion yen in 2002, Chugai has invested in research and development capabilities in the US and Europe,
and has established sales and marketing operations in France, Germany and the UK. Chugai employs 5,774
employees world-wide.
Chugai has continued to contribute to the medical community by
drawing on its strengths in oncology, which is one of its strategic therapeutic field, through its long-standing
experience in the development and marketing of anti-cancer drugs such as Xeloda, Herceptin, Furtulon
and Rituxan in addition to supportive treatments such as the G-CSF, Neutrogin and anti-emetic drug,
Kytril. By adding the novel antibody drugs Avastin and Omnitarg to its anti-cancer product portfolio,
Chugai’s strengths in the oncology field are further enhanced, and will greatly contribute to the field
of cancer treatment.
These licensing events of the two drugs is the successful result of the collaboration between Chugai, Roche, and Genentech and Chugai will continue to contribute to the unmet needs of the medical community by creating innovative new drugs by uniting the research and development resources of the three companies.
About
Genentech
Genentech is a leading biotechnology company that discovers, develops,
manufactures and commercializes biotherapeutics for significant unmet medical needs. Sixteen of the
currently approved biotechnology products originated from or are based on Genentech science. Genentech
manufactures and commercializes 11 biotechnology products in the United States. The company has headquarters
in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA.
For additional information about the company, please visit the Internet.