Takeda Pharmaceutical Company Limited and IDM Pharma, Inc. announced that Takeda America Holdings, Inc., a wholly-owned subsidiary of Takeda (Takeda America), and IDM Pharma have entered into an agreement for Takeda America to acquire IDM Pharma. Takeda America has established Jade Subsidiary Corporation as a wholly-owned subsidiary to effect that transaction.
Under the agreement, Takeda America will purchase all of IDM Pharma's outstanding shares for US$2.64 per share in an all cash tender offer followed by a merger.
Millennium: The Takeda Oncology Company, Takeda's business unit responsible for global oncology strategy and development, will have global development responsibility for Mepact, IDM Pharma's primary asset, and Takeda Pharmaceuticals Europe Ltd. will be responsible for commercializing Mepact in Europe.
IDM Pharma received European marketing approval for Mepact (mifamurtide), a therapy indicated for the treatment of non-metastatic osteosarcoma (malignant bone cancer) following surgical removal of the tumor (resection) in children, adolescents and young adults. Osteosarcoma is a rare and often fatal disease, with approximately 1,200 new cases diagnosed in Europe each year. The disease affects primarily children and young adults. The European Commission formally granted a centralized marketing authorization for Mepact on March 6, 2009, allowing it to be marketed in the 27 EU member states, as well as in Iceland, Liechtenstein and Norway.
"Mepact delivers a demonstrated survival advantage for young patients with a specific type of bone cancer and provides Takeda with an approved therapy that contributes immediately to our top-line growth," said Erich Brunn, CEO of Takeda Pharmaceuticals Europe Limited, Takeda's wholly-owned UK-based subsidiary for overseeing pan-European sales and marketing. "We envisage that the product will become a key driver in enhancing our European oncology franchise."
"The European approval of Mepact was the result of decades of research and most importantly the dedication of patients and their families whose involvement in the phase 3 clinical trial was integral to providing access to the first new osteosarcoma treatment in more than 20 years," added Timothy P. Walbert, president and chief executive officer IDM Pharma. "Our goal has been to improve the lives of cancer patients by developing therapies that meet significant unmet treatment needs - Takeda shares this goal. We expect that the significant progress we've made with MEPACT during the last two years will continue to be met in osteosarcoma and other difficult to treat cancers."
The phase 3 Mepact trial was the largest study ever completed in osteosarcoma, enrolling approximately 800 patients. The study evaluated patient outcomes with the addition of Mepact to three- or four-drug adjuvant chemotherapy (cisplatin, doxorubicin, and methotrexate with or without ifosfamide). Results demonstrated that the addition of MEPACT to chemotherapy resulted in approximately a 30 per cent decrease in the risk of death with 78 per cent of patients surviving after six years of follow-up after treatment with Mepact. Mepact was well tolerated.
Mepact was granted orphan medicinal product status in Europe in 2004 and under European pharmaceutical legislation is entitled to a period of 10 years market exclusivity in respect of the approved indication.
IDM Pharma is focused on the development of innovative cancer products that either destroy cancer cells by activating the immune system or prevent tumor recurrence by triggering a specific adaptive immune response.
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.