קופקסון: פריצת דרך מסחרית וקלינית
המפתחים: מכון ויצמן למדע וחברת טבע החברה: טבע
שנת רישום הפטנט: 1971
Developers: Weizmann Institute of Science and TEVA Company: TEVA
Year of Patent: 1971
Modern medicine is advancing rapidly. One of the most prominent and lucrative developments has been in the field of nervous system-related debilitating diseases: a treatment for Multiple Sclerosis developed already 50 years ago at the Weizmann Institute of Science - Coplymer 1, later given the brand name recognized worldwide today as Copaxone.
Although not a cure, Copaxone represented a significant breakthrough in treatment and mitigation of MS symptoms. Its main function is to reduce the frequency of MS relapses and even reduce its progression.
Following patent registration in 1971, and Phase 1 clinical trials that showed significant reduction in relapses and good tolerance of injections, Copaxone’s commercial rights were acquired by TEVA which then initiated intensive worldwide Phase III trials.
The product’s first commercial milestone was recorded in November 1996 when a 20 milliliters dosage was authorized by Israeli health authorities. The following month, TEVA received approval from the FDA to sell Copaxone for RRMS (Relapsing-Remitting Multiple Sclerosis), becoming a truly global product with subsequent approvals for marketing in Russia, Canada, the E.U. and others.
The introduction of Copaxone caused a dramatic rise in MS treatment rates within just five years from 12 percent in 1997 to approximately 50 percent in 2002. This trend led to Copaxone becoming one of the first drugs with a designated support program (Shared Solutions). The program offered financial, training, and nurse support as well as educational resources.
Having attained commercial and clinical success with the 20 milliliters injections, Copaxone’s next quantum leap occurred in 2002 with the marketing of the prefilled syringe. This development had significant advantages for patients on chronic therapy, primarily the time required for self-administration, which dropped from an average of 4 minutes to only 38 seconds.
The most recent dramatic clinical development was in 2014 with approval for marketing of a 40 milliliters dosage, thereby enabling chronic patients to administer the injections only three times a week instead of daily. IMS Health recognized this as one of the most successful conversion strategies in the history of the pharma industry.