Magazin
2010-02-01
Osaka, Japan and London (ots/PRNewswire) - TakedaPharmaceutical Company Limited ("Takeda") and Takeda PharmaceuticalsEurope Limited ("TPEU"), its wholly owned subsidiary for oversight ofpan-European sales and marketing, jointly announced today thatMepact(R) (mifamurtide)(1), the first new treatment in 20 years toimprove survival in patients with osteosarcoma (malignant bonecancer)(2), is now commercially available in the European Union - viaa paid named-patient programme in countries where it is not initiallyreimbursed.*
To view the Multimedia News Release, please click:http://multivu.prnewswire.com/mnr/prne/takeda/40775
Osteosarcoma is a rare and often fatal disease, withapproximately 1,200 new cases diagnosed in Europe each year;primarily children and young adults(3).The standard treatment forosteosarcoma is surgical removal of the tumour (resection) withcombination chemotherapy before and after surgery. Mepact is used incombination with these other anti-cancer medicines after the cancerhas been removed by surgery(1).
Data from the largest independent clinical study ever completedin osteosarcoma (662 patients) conducted by the Children's OncologyGroup in the USA, showed that when combined with chemotherapy, Mepactreduced the risk of death by almost one third compared withchemotherapy alone. In addition, 78 percent of patients survivedafter six years of follow-up after treatment with Mepact andchemotherapy, compared with 70 percent receiving chemotherapyalone(4).
"There has been a significant lack of progress during the lasttwo decades in treating osteosarcoma," said Ian Lewis, Professor ofCancer Studies at St. James University Hospital in Leeds, England."The availability of mifamurtide brings hope to children and youngadults in need of a more positive treatment option for thisdevastating disease."
Dr Erich Brunn, Chief Executive Officer for TPEU said, "This isan important milestone for Takeda in Europe and for the treatment ofosteosarcoma. We are excited to bring this innovation to patients andphysicians."
Takeda anticipates that final reimbursement decisions in Europeancountries will be completed during the course of 2010.
About mifamurtide
Mifamurtide works by activating the body's immune system to killmicroscopic fragments of tumour cells (micro-metastases) which canbreak away from the main site of the osteosarcoma in the bone. Thesefragments 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 ofdeath in osteosarcoma(5).
Mifamurtide is indicated for the treatment of high-grade,resectable, non-metastatic osteosarcoma after complete surgicalremoval of the tumour (resection) in children, adolescents and youngadults between the ages of 2 and 30. "High grade" means that thecancer is a severe type. "Non-metastatic" means that there is nodetectable cancer beyond the primary tumour, but in many patientsthere are already micro-metastases in the lung. It is thesemicro-metastases that are the primary targets for Mepact, preventingthem from developing into metastases. Mepact is administered byintravenous infusion over the course of one hour, twice a week for 12weeks, and then once a week for 24 additional weeks, for a total of36 weeks of therapy or 48 doses(3).
Safety Information
Clinical experience with mifamurtide suggests that the mostcommon side effects are fever and chills, which can be prevented orreduced with simple pre-medication such as paracetemol(6). Detailedrecommendations for the use of mifamurtide are described in theSummary of Product Characteristics (SPC) which is published in theEuropean Public Assessment Report (EPAR) and is available in allofficial European Union languages.
Regulatory Progress
In June 2009 Takeda acquired IDM Pharma, Inc., which had alreadyobtained Market Authorization Approval for Mepact in the EuropeanUnion in March 2009(3), and now, TPEU is responsible for itscommercialization in Europe. Millennium: The Takeda Oncology Company(Cambridge, Mass.) is responsible for the global oncology strategy ofthe Takeda Group and for the development of Mepact.
*A named patient programme is a facility that enables thedistribution or supply of a medicine for the treatment of anindividual patient, at the specific request of his/her healthcareprovider, in cases where the medicine is currently not licensed orreimbursed. Each country has its own regulations that provide a legaland ethical way to allow access to patients who need these particularmedicines.
References:
1. Mifamurtide Summary of Product Characteristics 2009.
2. Grimer RJ, et al. Surgical Outcomes in Osteosarcoma. J BoneJoint 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 MuramylTripeptide to Chemotherapy Improves Overall Survival - A Report fromthe Children's Oncology Group. J Clin Oncol 2008; 26:633-638.
5. Meyers PA, Gorlick R: Osteosarcoma. Pediatr Clin North Am1997; 44:973-989.
6. Mori K, Ando K, Heymann D. Liposomal muramyl tripeptidephosphatidyl ethanolamine: a safe and effective agent againstosteosarcoma 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 globalcompany with its main focus on pharmaceuticals. As the largestpharmaceutical company in Japan and one of the global leaders of theindustry, Takeda is committed to striving toward better health forindividuals and progress in medicine by developing superiorpharmaceutical products. Additional information about Takeda isavailable through its corporate website http://www.takeda.com.
About Takeda Pharmaceuticals Europe Limited (TPEU)
Based in London, Takeda Pharmaceuticals Europe leads the overallbusiness activities of Takeda's European subsidiaries ("TES"),providing strategic direction and management support across theregion.
Date of Preparation, November 2009. MEP 030
ots Originaltext: Takeda Pharmaceutical CompanyIm 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, TakedaPharmaceutical CompanyLimited. Seizo Masuda, Senior Manager, Corporate Communications,+81-3-3278-2037, Masuda_Seizo@takeda.co.jp
First Treatment to Improve Survival in 20 Years
Osaka, Japan and London (ots/PRNewswire) - TakedaPharmaceutical Company Limited ("Takeda") and Takeda PharmaceuticalsEurope Limited ("TPEU"), its wholly owned subsidiary for oversight ofpan-European sales and marketing, jointly announced today thatMepact(R) (mifamurtide)(1), the first new treatment in 20 years toimprove survival in patients with osteosarcoma (malignant bonecancer)(2), is now commercially available in the European Union - viaa paid named-patient programme in countries where it is not initiallyreimbursed.*
To view the Multimedia News Release, please click:http://multivu.prnewswire.com/mnr/prne/takeda/40775
Osteosarcoma is a rare and often fatal disease, withapproximately 1,200 new cases diagnosed in Europe each year;primarily children and young adults(3).The standard treatment forosteosarcoma is surgical removal of the tumour (resection) withcombination chemotherapy before and after surgery. Mepact is used incombination with these other anti-cancer medicines after the cancerhas been removed by surgery(1).
Data from the largest independent clinical study ever completedin osteosarcoma (662 patients) conducted by the Children's OncologyGroup in the USA, showed that when combined with chemotherapy, Mepactreduced the risk of death by almost one third compared withchemotherapy alone. In addition, 78 percent of patients survivedafter six years of follow-up after treatment with Mepact andchemotherapy, compared with 70 percent receiving chemotherapyalone(4).
"There has been a significant lack of progress during the lasttwo decades in treating osteosarcoma," said Ian Lewis, Professor ofCancer Studies at St. James University Hospital in Leeds, England."The availability of mifamurtide brings hope to children and youngadults in need of a more positive treatment option for thisdevastating disease."
Dr Erich Brunn, Chief Executive Officer for TPEU said, "This isan important milestone for Takeda in Europe and for the treatment ofosteosarcoma. We are excited to bring this innovation to patients andphysicians."
Takeda anticipates that final reimbursement decisions in Europeancountries will be completed during the course of 2010.
About mifamurtide
Mifamurtide works by activating the body's immune system to killmicroscopic fragments of tumour cells (micro-metastases) which canbreak away from the main site of the osteosarcoma in the bone. Thesefragments 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 ofdeath in osteosarcoma(5).
Mifamurtide is indicated for the treatment of high-grade,resectable, non-metastatic osteosarcoma after complete surgicalremoval of the tumour (resection) in children, adolescents and youngadults between the ages of 2 and 30. "High grade" means that thecancer is a severe type. "Non-metastatic" means that there is nodetectable cancer beyond the primary tumour, but in many patientsthere are already micro-metastases in the lung. It is thesemicro-metastases that are the primary targets for Mepact, preventingthem from developing into metastases. Mepact is administered byintravenous infusion over the course of one hour, twice a week for 12weeks, and then once a week for 24 additional weeks, for a total of36 weeks of therapy or 48 doses(3).
Safety Information
Clinical experience with mifamurtide suggests that the mostcommon side effects are fever and chills, which can be prevented orreduced with simple pre-medication such as paracetemol(6). Detailedrecommendations for the use of mifamurtide are described in theSummary of Product Characteristics (SPC) which is published in theEuropean Public Assessment Report (EPAR) and is available in allofficial European Union languages.
Regulatory Progress
In June 2009 Takeda acquired IDM Pharma, Inc., which had alreadyobtained Market Authorization Approval for Mepact in the EuropeanUnion in March 2009(3), and now, TPEU is responsible for itscommercialization in Europe. Millennium: The Takeda Oncology Company(Cambridge, Mass.) is responsible for the global oncology strategy ofthe Takeda Group and for the development of Mepact.
*A named patient programme is a facility that enables thedistribution or supply of a medicine for the treatment of anindividual patient, at the specific request of his/her healthcareprovider, in cases where the medicine is currently not licensed orreimbursed. Each country has its own regulations that provide a legaland ethical way to allow access to patients who need these particularmedicines.
References:
1. Mifamurtide Summary of Product Characteristics 2009.
2. Grimer RJ, et al. Surgical Outcomes in Osteosarcoma. J BoneJoint 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 MuramylTripeptide to Chemotherapy Improves Overall Survival - A Report fromthe Children's Oncology Group. J Clin Oncol 2008; 26:633-638.
5. Meyers PA, Gorlick R: Osteosarcoma. Pediatr Clin North Am1997; 44:973-989.
6. Mori K, Ando K, Heymann D. Liposomal muramyl tripeptidephosphatidyl ethanolamine: a safe and effective agent againstosteosarcoma 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 globalcompany with its main focus on pharmaceuticals. As the largestpharmaceutical company in Japan and one of the global leaders of theindustry, Takeda is committed to striving toward better health forindividuals and progress in medicine by developing superiorpharmaceutical products. Additional information about Takeda isavailable through its corporate website http://www.takeda.com.
About Takeda Pharmaceuticals Europe Limited (TPEU)
Based in London, Takeda Pharmaceuticals Europe leads the overallbusiness activities of Takeda's European subsidiaries ("TES"),providing strategic direction and management support across theregion.
Date of Preparation, November 2009. MEP 030
ots Originaltext: Takeda Pharmaceutical CompanyIm 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, TakedaPharmaceutical CompanyLimited. Seizo Masuda, Senior Manager, Corporate Communications,+81-3-3278-2037, Masuda_Seizo@takeda.co.jp
Takeda Pharmaceutical Company ,Story,Pressemappe
