First Treatment to Improve Survival in 20 Years Now Available for Patients With Osteosarcoma (Bone Cancer)

Osaka, Japan and London (ots/PRNewswire) - Takeda Pharmaceutical Company Limited ("Takeda") and Takeda Pharmaceuticals Europe Limited ("TPEU"), its wholly owned subsidiary for oversight of pan-European sales and marketing, jointly announced today that Mepact(R) (mifamurtide)(1), the first new treatment in 20 years to improve survival in patients with osteosarcoma (malignant bone cancer)(2), is now commercially available in the European Union - via a paid named-patient programme in countries where it is not initially reimbursed.*

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Osteosarcoma is a rare and often fatal disease, with approximately 1,200 new cases diagnosed in Europe each year; primarily children and young adults(3).The standard treatment for osteosarcoma is surgical removal of the tumour (resection) with combination chemotherapy before and after surgery. Mepact is used in combination with these other anti-cancer medicines after the cancer has been removed by surgery(1).

Data from the largest independent clinical study ever completed in osteosarcoma (662 patients) conducted by the Children's Oncology Group in the USA, showed that when combined with chemotherapy, Mepact reduced the risk of death by almost one third compared with chemotherapy alone. In addition, 78 percent of patients survived after six years of follow-up after treatment with Mepact and chemotherapy, compared with 70 percent receiving chemotherapy alone(4).

"There has been a significant lack of progress during the last two decades in treating osteosarcoma," said Ian Lewis, Professor of Cancer Studies at St. James University Hospital in Leeds, England. "The availability of mifamurtide brings hope to children and young adults in need of a more positive treatment option for this devastating disease."

Dr Erich Brunn, Chief Executive Officer for TPEU said, "This is an important milestone for Takeda in Europe and for the treatment of osteosarcoma. We are excited to bring this innovation to patients and physicians."

Takeda anticipates that final reimbursement decisions in European countries will be completed during the course of 2010.

About mifamurtide

Mifamurtide works by activating the body's immune system to kill microscopic fragments of tumour cells (micro-metastases) which can break away from the main site of the osteosarcoma in the bone. These fragments can be carried in the blood to other parts of the body, particularly the lungs, allowing the disease to develop further. Disease progression in the lungs is in fact, the primary cause of death in osteosarcoma(5).

Mifamurtide is indicated for the treatment of high-grade, resectable, non-metastatic osteosarcoma after complete surgical removal of the tumour (resection) in children, adolescents and young adults between the ages of 2 and 30. "High grade" means that the cancer is a severe type. "Non-metastatic" means that there is no detectable cancer beyond the primary tumour, but in many patients there are already micro-metastases in the lung. It is these micro-metastases that are the primary targets for Mepact, preventing them from developing into metastases. Mepact is administered by intravenous infusion over the course of one hour, twice a week for 12 weeks, and then once a week for 24 additional weeks, for a total of 36 weeks of therapy or 48 doses(3).

Safety Information

Clinical experience with mifamurtide suggests that the most common side effects are fever and chills, which can be prevented or reduced with simple pre-medication such as paracetemol(6). Detailed recommendations for the use of mifamurtide are described in the Summary of Product Characteristics (SPC) which is published in the European Public Assessment Report (EPAR) and is available in all official European Union languages.

Regulatory Progress

In June 2009 Takeda acquired IDM Pharma, Inc., which had already obtained Market Authorization Approval for Mepact in the European Union in March 2009(3), and now, TPEU is responsible for its commercialization in Europe. Millennium: The Takeda Oncology Company (Cambridge, Mass.) is responsible for the global oncology strategy of the Takeda Group and for the development of Mepact.

*A named patient programme is a facility that enables the distribution or supply of a medicine for the treatment of an individual patient, at the specific request of his/her healthcare provider, in cases where the medicine is currently not licensed or reimbursed. Each country has its own regulations that provide a legal and ethical way to allow access to patients who need these particular medicines.

References:

1. Mifamurtide Summary of Product Characteristics 2009.

2. Grimer RJ, et al. Surgical Outcomes in Osteosarcoma. J Bone Joint Surg [Br] 2002;84-B:395-400.

3. European Medicines Agency. Assessment Report for MEPACT. Accessed 2 November 2009.

4. Meyers PA, et al. Osteosarcoma: The Addition of Muramyl Tripeptide to Chemotherapy Improves Overall Survival - A Report from the Children's Oncology Group. J Clin Oncol 2008; 26:633-638.

5. Meyers PA, Gorlick R: Osteosarcoma. Pediatr Clin North Am 1997; 44:973-989.

6. Mori K, Ando K, Heymann D. Liposomal muramyl tripeptide phosphatidyl ethanolamine: a safe and effective agent against osteosarcoma pulmonary metastases. Expert Rev. Anticancer Ther. 8(2), 151-159 (2008).

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website http://www.takeda.com.

About Takeda Pharmaceuticals Europe Limited (TPEU)

Based in London, Takeda Pharmaceuticals Europe leads the overall business activities of Takeda's European subsidiaries ("TES"), providing strategic direction and management support across the region.

Date of Preparation, November 2009. MEP 030

Contact:

CONTACT:  Contacts for the media, Takeda Pharmaceuticals Europe 
Limited,Nick Francis, Head of Communications,
+44(0)20-3116-8000,+44(0)7500-012866, nick.francis@tpeu.co.uk, Takeda
Pharmaceutical CompanyLimited. Seizo Masuda, Senior Manager,
Corporate Communications,+81-3-3278-2037, Masuda_Seizo@takeda.co.jp