First Treatment to Improve Survival in 20 Years

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

ots Originaltext: Takeda Pharmaceutical Company
Im Internet recherchierbar: http://www.presseportal.de

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