In the girl I can apply for NDA
IDM Pharma's MEPACT (R) (Mifamurtide, L-MTP-PE) approved in Europe for the treatment of non-metastatic, operable osteosarcoma
IRVINE, Calif., March 23 / PRNewswire / - - First approval of a new active ingredient for the treatment of osteosarcoma in over 20 years
IDM Pharma, Inc. (Nasdaq: IDMI) announced today that the European Commission has officially approved MEPACT (R) (mifamurtide, L-MTP-PE) for the entire EU for the treatment of patients with non-metastatic, operable Osteosarcoma. Osteosarcoma is a rare bone tumor that typically occurs in children and young adults and is often fatal. Thanks to this central market approval, MEPACT can be put into circulation in the 27 member states of the European Union as well as in Iceland, Liechtenstein and Norway. MEPACT was granted orphan drug status in Europe in 2004. According to European pharmaceutical law, this is linked to the entitlement to be able to exclusively market the drug for the approval indication for a period of 10 years.
"Today's approval of MEPACT is an important milestone for physicians and patients in Europe. This means that for the first time in 20 years they have a new therapeutic option in connection with the treatment of osteosarcomas," said Timothy P. Walbert, President and Chief Executive Officer of IDM Pharma. "MEPACT is our most advanced drug candidate and the first to receive approval. Therefore, this is also an important milestone for IDM Pharma. We look forward to changes to the NDA application (application for approval of a new drug) in the United States. for mifamurtide and will continue to work to ensure that this important treatment option is available in the US market. "
Approval was based on the results of the MEPACT study (INT-0133), a phase 3 study funded by the National Cancer Institute (NCI) and conducted as a collaborative group study by the Children's Oncology Group (COG). With around 800 participants, it is the largest study to date on osteosarcoma patients. The study examined the treatment results that can be achieved in patients who receive MEPACT in addition to adjuvant chemotherapy with three or four drugs (cisplatin, doxorubicin and methotrexate with or without ifosfamide). The study results showed that adding MEPACT to chemotherapy reduced the risk of death by around 30 percent, with 78 percent of MEPACT-treated patients still alive after a six-year follow-up period.
"MEPACT is the first drug in more than 20 years that has shown a significant improvement in long-term survival in patients with osteosarcoma," said Dr. med. Ian Lewis, Professor of Cancer Research at St. James University Hospital in Leeds, England. "The result of 20 years of research and dedication to children and young adults with osteosarcoma, MEPACT's approval gives hope to a patient population in need of an innovative treatment option for their very serious disease."
"As an investigator who was involved in the development of MEPACT, I am delighted that the years of hard work and the intensive commitment of researchers all over the world have led to this positive result," said Dr. med. Eugenie Kleinerman, Professor of Pediatrics and Head of the Pediatric Department and Professor of Cancer Biology at The University of Texas M.D. Anderson Cancer Center. "Here a remarkable advance has been made in the treatment of osteosarcoma in young patients. This should give doctors and their patients hope for the treatment of this rare disease."
The company continues to explore strategic alternatives, which include finding strategic partners, merging and / or disposing of some or all of the company's operations and property, or raising additional capital for a functioning sales infrastructure for MEPACT.
Mifamurtide regulatory status in the United States
As previously announced, in the US, the company is continuing to work with the COG and outside experts and advisors to collect follow-up data from the phase 3 clinical trial of mifamurtide and to answer other questions the US may have. FDA notified the company in its rejection notice. The company plans to submit a revised version of the NDA application for approval of mifamurtide in mid-2009 and expects to provide updated information on the status of the application, including the timing, after a meeting with the FDA in March.
Mifamurtide received orphan drug status in the USA in 2001. The NDA was submitted to the FDA in October 2006 and accepted for review in December 2006.
Information on osteosarcoma
2 to 3% of all childhood tumors are osteosarcomas. Since osteosarcomas usually arise from osteoblasts, children and adolescents are most often affected in the growth phase. Boys and girls are affected almost equally often up to later adolescence, afterwards boys more often. While most tumors occur in larger bones such as the thigh, tibia, and humerus, and that area of the bone with the fastest growth rate, osteosarcomas can manifest in any bone. The most common symptom is pain. As the tumor grows, swelling and restricted mobility can occur.
Osteosarcoma is a rare disease that is diagnosed in approximately 1,200 new cases annually in the United States. The situation is similar in Europe. According to Children's Oncology Group (COG), the survival rate for children with osteosarcoma has remained unchanged at 60-65% since the mid-1980s. The standard treatment for osteosarcoma is tumor resection in combination with chemotherapy before and after surgery.
Important safety information about MEPACT (R)
The safety of MEPACT has been assessed in studies in patients 2 to 30 years of age at the time of initial diagnosis of osteosarcoma. The most commonly observed side effects were anemia, anorexia, headache, dizziness, tachycardia, high blood pressure, low blood pressure, shortness of breath, accelerated breathing, cough, vomiting, diarrhea, constipation, abdominal pain, nausea, increased sweating, myalgia, arthralgia, back pain, pain in the extremities, fever, chills, fatigue, hypothermia, pain, malaise, weakness and chest pain.
As with all drugs, MEPACT will also use a pharmacovigilance plan, which is part of the approval.
Precise recommendations on the use of MEPACT can be found in the information for healthcare professionals (SPC) for the drug, which was published in the relevant European public assessment report (EPAR) and is available in all official EU languages.
Information on IDM Pharma
IDM Pharma is dedicated to the development of innovative cancer drugs that either destroy cancer cells by activating the immune system or prevent tumor recurrence by triggering a specific adaptive immune response. IDM Pharma strives to maximize the therapeutic and market potential of each of its innovative products in order to meet the needs of patients and their doctors.
Based on its current development and operations plans, the company believes it will have adequate funds to run its business by mid-2009. The company does not currently have any operational sales infrastructure for MEPACT and has no plans or sufficient resources to maintain it.
Further information about the company and its products can be found at http://www.idm-pharma.com.
This press release contains forward-looking statements that reflect management's current views with regard to future events, including statements regarding the commercialization of MEPACT in the EU, the company's liquidity timeframe for its proposed operations, the company's belief that the data is out of phase -3 study on mifamurtide justifies the approval of mifamurtide in the USA based on the clinical benefit-risk profile, as well as plans of the company to collect additional phase 3 data in an amended NDA application for approval of mifamurtide in the USA, Analyze and submit, including the expected time for this amended NDA application, to respond to other questions raised by the FDA, and the company's plans to evaluate strategic alternatives and / or raise additional capital. Actual results could differ materially from the forward-looking statements due to a number of critical factors including whether the company elects to establish a sales infrastructure for MEPACT in the EU, the date of submitting an amended NDA application to the FDA, the possibility that additional Data from the phase 3 clinical trial of mifamurtide and other information contained in supplements to the company's filing for mifamurtide does not provide an adequate basis for mifamurtide to be approved within the company's anticipated timeframe in the U.S. whether the company will be able to do so Conduct strategic transactions on terms acceptable to the company's shareholders, such as the volatile economic environment affecting the company's efforts to conduct strategic transactions or to raise additional capital and whether the company's funds are sufficient for the planned business activities. These and other risks that affect the company and its drug development programs, intellectual property rights, employees, and operations are detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended December 30, filed with the SEC filed with the SEC. September 2008 and other periodic reports filed with the SEC. The company expressly disclaims any intention or obligation to update any forward-looking statements unless required by law.
Inquiries & contact:
Bob De Vaere, Chief Financial Officer of IDM Pharma, Inc.,
+ 1-949-470-6447, or Geoff Curtis from WeissComm Partners,
+ 44- (0) -7827-860-299, [email protected]
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