Collaboration on additional funding for treatment

News Release

Collaboration on additional funding for breast cancer treatment progressing

Auckland, 6th September 2005 – Roche Products (New Zealand) Ltd and Government drug funding agency PHARMAC are working collaboratively, to ensure rapid assessment for funding of breast cancer treatment Herceptin (trastuzumab) for women with early stage HER2 positive disease. If approved, expanded use of Herceptin is expected to require provision of an additional $25-30 million each year for use in early HER2 positive breast cancer where it has shown it reduces the chance of the cancer returning by 46%*1.

PHARMAC Chief Executive Wayne McNee says he is pleased that advice from Roche indicates that the treatment can be targeted to specific groups of patients, in order to more effectively manage the likely overall budgetary impact.

Roche Products Sales and Marketing Director Stuart Knight says the company is working closely with PHARMAC to ensure rapid assessment of the evidence in parallel with the registration processes that also require completion before funding can be achieved. “Herceptin is currently registered and funded for use in women where their cancer has spread. The new research in early breast cancer is very exciting and Roche is committed to ensuring it is available and funded for early breast cancer as soon as possible. Roche is aware of PHARMAC’s budget limitations and has raised the issue of funding early to enable PHARMAC to secure additional budget if required.”

“Roche will also work collaboratively with Medsafe to achieve an extension to Herceptin’s current product license. The company expects publication of the interim data from the recent Herceptin trial in October and will be in a position to submit the regulatory dossier to Medsafe by early 2006.”

Herceptin is currently prescribed and funded for women with advanced HER2 positive breast cancer, a particularly aggressive and frequently recurring breast cancer that is evident in around 20-30%2 of all breast cancer patients. Women diagnosed with breast cancer are tested to identify their HER2 status in advance of treatment to ensure Herceptin is used for women most likely to benefit.

ENDS

About Roche
Roche Products (New Zealand) Ltd is committed to providing innovative products for cancer care in New Zealand. Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-orientated health groups in the fields of pharmaceuticals and diagnostics. Roche’s products and services address prevention, diagnosis and treatment of disease, enhancing well-being and quality of life. Roche employs some 62 000 people in more than 150 countries around the world. The company has business alliances and R&D relationships with numerous partners, including majority ownership interests in Genentech and Chugai, which are both members of the Roche Group.

* p value <0.0001
The p value indicates the ‘statistical significance’ of these clinical studies.

References
1) Piccart-Gebhart, M. First results of the HERA trial, American Society of Clinical Oncology, Scientific Session, May 16, 2005
2) Harries M, Smith I. The development and clinical use of Trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002

What you should know about Herceptin
HERCEPTIN (trastuzumab) is a Prescription Medicine used to treat patients with metastatic (spreading) breast cancer who have tumours with a large amount of the HER2 protein.

Tell your doctor if you have coronary artery disease, hypertension, heart failure, lung disease or tumours, or if you are pregnant or breastfeeding.

Possible unwanted effects: Common: chills, shivering, fever, nausea, vomiting, pain, stiffness, shaking, headache, dizziness, cough, skin rashes, weakness, fatigue, abnormal heart beat, feeling faint, insomnia, anxiety, depression, runny or blocked nose, flu-like symptoms, chest infection, pain on urination, diarrhoea, hair loss, muscle or joint soreness. Serious: shortness of breath or breathing difficulty, severe coughing, severe feet or leg swelling, chest pain, abnormal heart beat, severe diarrhoea, feeling faint.

Ask your oncologist if HERCEPTIN is right for you. Use strictly as directed. If symptoms continue or you experience side effects or would like further information, please talk to your oncologist or visit www.medsafe.govt.nz for HERCEPTIN Consumer Medicine Information. HERCEPTIN (150mg and 440mg vials) is a funded medicine under Special Authority. A prescription charge and normal oncologist fees may apply.

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