Investor Update
Basel, 22 October 2009
Phase III trial underway to investigate infusion-free administration of Herceptin for women with HER2-positive breast cancer
New subcutaneous delivery method may allow for less hospital time for patients and reduced strain on medical resources
Roche (SIX: RO, ROG; OTCQX: RHHBY) and Halozyme Therapeutics announced today that a new subcutaneous formulation of Herceptin using Halozyme’s Enhanze technology has entered phase III of its development. This innovative technology could allow patients with HER2-positive breast cancer to administer Herceptin for themselves with or without the support of a healthcare professional once every three weeks via a simple subcutaneous injection. Currently Herceptin, which prolongs lives of patients with this aggressive type of breast cancer, is given intravenously typically in a hospital setting at the same frequency.
Subcutaneous Herceptin administration means for example that patients with early breast cancer completing their one year of Herceptin therapy would have greater convenience of being able to receive treatment at their family doctor’s office or at home without having to go to a hospital, a significant and welcome benefit.
“Subcutaneous Herceptin could give women more time out of hospital while dramatically reducing the risk of their cancer coming back,” commented Jean-Jacques Garaud, Global Head of Pharma Development.
In addition, offering Herceptin treatment outside of the hospital setting could reduce costs and potentially help to maximize the efficient use of hospitals resources. Subcutaneous Herceptin would come in a ready-to-use administration device instead of an infusion-bag that needs to be prepared by a pharmacist. Physicians and nurses would conduct fewer infusions at the hospital freeing up infusion chair time for other procedures.
About breast cancer
Breast cancer is the most common cancer among women worldwide.1 Each year more than one million new cases of breast cancer are diagnosed worldwide, and nearly 400,000 people will die of the disease annually.2
In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as ‘HER2-positivity’ and affects approximately 20-25% of women with breast cancer.
About Herceptin
Herceptin is a humanised antibody designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. The mode of action of Herceptin is unique in that it activates the body’s immune system and suppresses HER2 to target and destroy the tumour. Herceptin has demonstrated unprecedented efficacy in treating both early and advanced (metastatic) HER2 positive breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2-positive breast cancer.
Herceptin received approval for use in the European Union for advanced (metastatic) HER2-positive breast cancer in 2000 and for early (adjuvant) HER2-positive breast cancer in 2006. In the advanced (metastatic) setting, Herceptin is approved for use as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, as first-line therapy in combination with docetaxel, and as a single agent in third-line therapy. It is also approved for use in combination with an aromatase inhibitor for the treatment of post-menopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer. In the early (adjuvant) setting, Herceptin is approved for use following standard (adjuvant) chemotherapy.
Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat more than 650,000 women with HER2-positive breast cancer worldwide.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
All trademarks used or mentioned in this release are legally protected.
References
1) World Health Organization, http://www.who.int/cancer/detection/breastcancer/en/
2) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. 2004