First Treatment to Improve Survival in 20 Years

By Takeda Pharmaceutical Company, PRNE
Sunday, January 31, 2010

Now Available for Patients With Osteosarcoma (Bone Cancer)

OSAKA, Japan and LONDON, February 1 - 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 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

Video:
multivu.prnewswire.com/mnr/prne/takeda/40775

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

Discussion
June 9, 2010: 5:47 am

Interesting. Would need to read more studies to really appreciate.

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