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Process for preparation of Copolymer-1-used in the treatment of multiple sclerosis

Details

Project TitleProcess for preparation of Copolymer-1-used in the treatment of multiple sclerosis
Track Codencli-011
Websitehttp://nclinnovations.org/
Short Description


A novel process for the synthesis of Copolymer-1 and its pharmaceutically acceptable salts, which is used in the treatment of Multiple Sclerosis (MS). This process yields precisely tailored, non-toxic end products with readily available raw materials at a much reduced cost.

Abstract


BACKGROUND

Out of the many processes available today for synthesis of Copolymer- 1, no process provides control over the specific molecular weight (m. wt.) especially since the m.wt of 22KDa and above is considered toxic and without residual levels of acids


TECHNOLOGY DESCRIPTION

A novel process using readily available raw materials, for the synthesis of Copolymer-1 and its pharmaceutically acceptable salts is described here. The process uses a polymer bound catalyst as an initiator (which requires 10X less catalyst concentration than conventional systems). The resulting polymer has a narrow molecular weight distribution, with m.wt can be tailored to be in the range of 8-19KDa. Copolymer-1 could be injected subcutaneously, intra-peritoneally, intravenously, intramuscularly for the treatment MS.


MARKET POTENTIAL

• Over 2.5 million people suffer from MS worldwide*
• Even though there is no cure for MS, currently drugs are used to slow the progression or reduce the frequency of relapses
• The global market for MS therapeutics has been projected to exceed $12.5 billion by 2015**
• US has been termed as a growing market for MS therapeutics with the highest demand**

*http://www.wikinvest.com/concept/Multiple_Sclerosis_%28MS%29_Drug_Market **http://www.prweb.com/releases/multiple_sclerosis_market/autoimmune_disease/prweb3832894.htm


VALUE/ADVANTAGES

• A simple, cost-effective process using easily available raw materials
• Yields a product with high degree of purity (without requiring additional steps of separation, purification etc.)
• Molecular weight can be tailored to be in the range of 8-19KDa (hence overcoming toxicity issues; m. wt of over 20 KDa are known to be toxic)- with excellent control over the m. wt distribution
• High purity levels - almost no acid residues (less than 1% )


APPLICATIONS

• Copolymer-1 is used for treatment of MS
• Suggested application in the treatment of non-autoimmune neurodegenerative disorders such as glaucoma, acute CNS injuries, Alzheimer’s disease*

*Kipnis, J. and Schwartz, M., Dual action of glatiramer acetate (Cop-1) in the treatment of CNS autoimmune and neurodegenerative disorders, TRENDS in Molecular Medicine , Vol.8, 2002, Pg. 319-323


TECHNOLOGY STATUS

• Demonstrated at the lab scale
• On the lookout for potential partners for licensing
• Patent applications filed: PCT #- IN2009/000320, Indian #- 0599/DEL/2008


CONTACT

Case Manager: Magesh N
Phone: +91-20-25902982
Email: m.nandagopal@ncl.res.in

 
Tagsmultiple sclerosis, copolymer-1, specific molecular weight, polymer bound catalyst, initiator, highly pure
 
Posted DateJan 2, 2012 2:38 AM

Files

File Name Description
CopolymerA-Flyer None Download