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小木虫论坛-学术科研互动平台 » 生物医药区 » 新药研发 » 快捷药讯 » 【求助】发（（很多金币））求一个新药的信息
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wo668668

银虫 (小有名气)

[交流] 【求助】发（（很多金币））求一个新药的信息

商品名： Mepact
  通用名：米伐木肽(mifamurtide)
  分子式： C59H109N6O19P
  CAS登记号：83461-56-7
  2009年获欧盟批准上市

求：此化合物的
   1.理化性质
   2.制剂、处方、工艺及分析检测
   3.药理、毒性、药代

    有来源出处更好，能有多少就给多少信息，

已有的就可以了，结束，谢谢回复

[ Last edited by wo668668 on 2011-1-2 at 23:52 ]
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1楼 2010-12-30 22:39:49
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cuiyubin476

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小木虫(金币+0.5):给个红包，谢谢回帖交流
wo668668(金币+5): 2011-01-02 23:53:03
Information
Generic Name: mifamurtide   
Trade Name: Mepact (EU), Junovan (US)  
Synonym: MTP-PE, muramyl tripeptide phosphatidylethanol  
Entry Type: New chemical entity  

Category
BNF Category: Other antineoplastic drugs (08.01.05)
Pharmacology: Liposomal formulation of muramyl tripeptide phosphatidylethanolamine   
Epidemiology: Osteosarcoma is a rare disease, with about 1,200 new cases in Europe each year (12). 2-3% of all childhood cancers are osteosarcoma with survival at 60-65% (11)   
Indication: Osteosarcoma  
Additional Details: non-metastatic, resectable  

Developmental Status
UK: Launched  
EU: Launched  
US: Pre-registration (Filed)  
UK launch Plans: Available only to registered users
Actual UK launch date: 01/02/2010  

Method(s) of Administration   
Intravenous  

Comments
Feb 10: Launched in EU [13].
06/02/2010 16:58:41  
Jun 09: Takeda have taken over the originator company (May 09). EU launch delayed until 2010 (personal communication).
19/06/2009 12:15:04  
Mar 09: Company plan to submit an amended NDA to FDA mid-2009 after receiving a non-approvable letter, requesting more data, in Aug 08 (10)
09/03/2009 19:35:10  
Mar 09: Licensed in EU (10)
09/03/2009 19:21:55  
EU CHMP positive opinion for the treatment of patients with non-metastatic, resectable osteosarcoma, Nov 08. Recommendation to be adopted in Dec 08, with final approval 60-90days later. (9)
21/11/2008 09:35:23  
CHMP opinion expected Q3 08, final decision anticipated Q4 08 (8)
09/04/2008 12:45:47  
Confirmed plans to file in EU and expect to receive approval in 2007(1). Orphan drug status in EU and US (1). Plans to file in US in 06 (2). Filed in US Oct 06 (3). The FDA and the EMEA have designated Orphan Drug status to Junovan (3). Filed in EU Nov 06 (4). Negative opinion from FDA advisory committee May 07 (5). Non-approvable letter from FDA - more data required Aug 08 (6).
28/02/2008 09:51:04  
Confirmed plans to file in EU and expect to receive approval in 2007(1). Orphan drug status in EU and US (1). Plans to file in US in 06 (2). Filed in US Oct 06 (3). The FDA and the EMEA have designated Orphan Drug status to Junovan (3). Filed in EU Nov 06 (4). Negative opinion from FDA advisory committee May 07 (5). Non-approvable letter from FDA - more data required Aug 08 (6).


Company Information
Name: Takeda  
US Name: IDM Pharma  
  
NICE Information
In timetable: Yes   
When: Nov / 2010  
Note: 17th wave, STA  
   
   
Prescribing
Outlook: Available only to registered users

Trial or other data
Jul 10: in its draft guidance on mifamurtide, NICE has recommended against its use in combination with postoperative multi-agent chemotherapy in children, adolescents & young adults for treating high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection (14).
13/07/2010 09:49:30
Mar09: EU approval based on the Phase 3 MEPACT trial (INT-0133), a National Cancer Institute funded cooperative group study conducted by the Children′s Oncology Group and the largest study ever completed in osteosarcoma, enrolling approximately 800 patients. The study evaluated patient outcomes with the addition of mifamurtide to three- or four-drug adjuvant chemotherapy (cisplatin, doxorubicin, and methotrexate with or without ifosfamide). Results demonstrated that mifamurtide resulted in approximately a 30% decrease in the risk of death with 78% of patients surviving after six years of follow-up.(10)
09/03/2009 19:25:29
Filed in US for use in the treatment of newly diagnosed resectable high grade osteosarcoma following surgical resection in combination with multiple agent chemotherapy. IDM requested that the FDA consider granting priority review status, which could shorten review time from the standard ten months to six months if granted. The FDA customarily accepts or refuses to file NDAs and designates review status within 60 days of filing(3).  


Evidence Based Evaluations
SMC  http://www.scottishmedicines.org/smc/7718.html
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7楼2011-01-01 22:49:10
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yalefield

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warlen(金币+1):谢谢参与 2010-12-31 09:40:37
wo668668(金币+10): 2010-12-31 12:52:08
Systematic (IUPAC) name
2-[(N-{(2R)-[(2-acetamido-2,3-dideoxy-D-glucopyranos-3-yl)oxy]-propanoyl}-L-alanyl-D-isoglutaminyl-L-alanyl)amino]ethyl (2R)-2,3-bis(hexadecanoyloxy)propyl hydrogen phosphate

Identifiers

CAS number        
（1）83461-56-7
（2）838853-48-8 (mifamurtide sodium · xH2O)

Chemical data

Formula         C59H109N6O19P
Mol. mass         1237.499 g/mol
SMILES         eMolecules & PubChem

Pharmacokinetic data

Bioavailability         N/A
Half-life         minutes (in plasma)
18 hrs (terminal)

Therapeutic considerations

Licence data         EMA:Link
Pregnancy cat.         not investigated
Legal status         ℞ Prescription only
Routes         intravenous liposomal infusion over one hour

muramylNAc-Ala-isoGln-Lys-tripeptide-PE

Pharmacological Action

Adjuvants, Immunologic [Link to MeSH] - Substances that augment, stimulate, activate, potentiate, or modulate the immune response at either the cellular or humoral level. The ... [show more]

Adjuvants, Immunologic [Link to MeSH] - Substances that augment, stimulate, activate, potentiate, or modulate the immune response at either the cellular or humoral level. The classical agents (Freund's adjuvant, BCG, Corynebacterium parvum, et al.) contain bacterial antigens. Some are endogenous (e.g., histamine, interferon, transfer factor, tuftsin, interleukin-1). Their mode of action is either non-specific, resulting in increased immune responsiveness to a wide variety of antigens, or antigen-specific, i.e., affecting a restricted type of immune response to a narrow group of antigens. The therapeutic efficacy of many biological response modifiers is related to their antigen-specific immunoadjuvanticity. [show less]

Immunologic Factors [Link to MeSH] - Biologically active substances whose activities affect or play a role in the functioning of the immune system.

  Pharmacological Classification
Chemical Actions and Uses [Link to MeSH]
      Pharmacologic Actions [Link to MeSH]
            Physiological Effects of Drugs [Link to MeSH]
                  Immunologic Factors [Link to MeSH]
                        Adjuvants, Immunologic [Link to MeSH]
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2楼2010-12-31 03:22:36
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ultrafrost

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warlen(金币+1):谢谢参与 2010-12-31 09:40:42
wo668668(金币+10): 2010-12-31 12:49:24
可以参考一下wiki百科
http://en.wikipedia.org/wiki/Mifamurtide
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3楼2010-12-31 08:54:24
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zsl2131182

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warlen(金币+1):谢谢参与 2010-12-31 09:40:49
wo668668(金币+5): 2010-12-31 12:48:10
欧洲批准米伐木肽(mifamurtide)注射剂上市

欧洲批准IDM Pharma公司的米伐木肽注射剂（mifamurtide，L-MTP-PE，:Mepact）上市，用于治疗非转移性可切除的骨肉瘤（少见但主要造成儿童和青年死亡的骨瘤）。本品是20余年来首个获准上市治疗骨肉瘤的新药。本品可在欧盟27个成员国以及冰岛、列支敦士登和挪威销售。

     米伐木肽是20余年来首个改善骨肉瘤患者长期存活的药品。患者术前化疗，随后手术切除骨瘤，而后再化疗。当患者接受术后化疗的同时也静脉注射注射本品免疫治疗（一周2次，3个月，随后一周1次，6个月）。化疗如同炸弹摧毁肿瘤，而米伐木肽如同魔铲可彻底清除疾病显微战壕内的残留物。

     米伐木肽通过刺激诸如巨噬细胞等某些白细胞来杀灭肿瘤细胞。本品制成球形脂质体，囊泡内是胞壁酰三肽（MTP）。此脂质触发巨噬细胞去消耗米伐木肽。一旦消耗完，MTP刺激尤其是在肝、脾和肺内的巨噬细胞去寻找肿瘤并杀灭之。

     米伐木肽注射剂获准上市基于Ⅲ期临床研究结果。国立癌症研究所（NCI）建立的协作组，由儿童肿瘤组（COG）进行研究，完成本品治疗骨肉瘤最大研究课题在册的患者约800例。研究评价了米伐木肽与3～4种辅助化疗药（顺铂、多柔比星、甲氨蝶呤、有或无异环磷酰胺）联合用药的结果。研究显示，米伐木肽与化学药物联合使用可使死亡率降低约30%，78&经治疗的患者存活长达6年以上。
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4楼2010-12-31 08:57:54
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