Takeda to Acquire IDM Pharma, Adding MEPACT(R) (Mifamurtide), the First Treatment Approved for Osteosarcoma in More Than 20 Years, to Its Oncology Franchise
Millennium: The Takeda Oncology Company, Takeda’s business unit responsible for global oncology strategy and development, will have global development responsibility for MEPACT(R), IDM Pharma’s primary asset, and Takeda Pharmaceuticals Europe Ltd. will be responsible for commercializing MEPACT in
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
“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
“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
About MEPACT
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 percent decrease in the risk of death with 78 percent 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
MEPACT Important Safety Information
Safety of MEPACT has been assessed in studies of patients 2 to 30 years of age at initial diagnosis of osteosarcoma. The most common side effects were anemia, anorexia, headache, dizziness, tachycardia, hypertension, hypotension, dyspnea, tachypnea, cough, vomiting, diarrhea, constipation, abdominal pain, nausea, hyperhidrosis, myalgia, arthralgia, back pain, pain in extremity, fever, chills, fatigue, hypothermia, pain, malaise, asthenia, and chest pain.
A pharmacovigilance plan for MEPACT, as for all medicinal products, will be implemented as part of the marketing authorization.
Detailed recommendations for the use of MEPACT 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.
About IDM Pharma
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. IDM Pharma is dedicated to maximizing the full therapeutic and commercial potential of its innovative products to address the needs of patients and the physicians who treat these patients. For more information about the company and its products, visit www.idm-pharma.com.
About Takeda Pharmaceutical Company Limited
Located in
Transaction Information
This transaction is structured as an all cash tender offer for all of the outstanding shares of IDM Pharma common stock, followed by a merger in which remaining shares of IDM Pharma not tendered into the offer would be converted into the right to receive the same
Forward-Looking Statements
This press release includes forward-looking statements that are subject to risks, uncertainties and other factors, including the risks to both companies that the acquisition of IDM Pharma will not be consummated as the transaction is subject to certain closing conditions. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including statements regarding the anticipated timing of completion of the transaction; the ability to complete the transaction considering the various closing conditions; any projections of earnings, revenues or other financial items; any estimates or projections of the patient population for MEPACT; any statements regarding the future of MEPACT; any statements of the plans, strategies and objectives of management for future operations; any statements of expectation or belief; and any statements of assumptions underlying any of the foregoing. In addition, if and when the transaction is consummated, there will be risks and uncertainties related to Takeda’s ability to successfully incorporate IDM Pharma’s assets into its business operations, the ability to complete post-approval development commitments for MEPACT and the contribution of MEPACT to Takeda’s European oncology franchise. These and other risks and uncertainties are discussed in documents filed with the U.S. Securities and Exchange Commission by IDM Pharma, and will be discussed in the tender offer documents to be filed by Takeda or its affiliate and the Solicitation/Recommendation Statement to be filed by IDM Pharma. All forward-looking statements are based on information currently available to Takeda and IDM Pharma, and neither Takeda nor IDM Pharma assumes any obligation to update any such forward-looking statements or other statements included in this press release.
Important Additional Information Will Be Filed with the Securities Exchange Commission (SEC)
This press release is neither an offer to purchase nor a solicitation of an offer to sell shares of IDM Pharma, Inc.
At the time the tender offer is commenced,
SOURCE Takeda Pharmaceutical Company Limited; IDM Pharma, Inc.
