I don’t expect SRDX will receive much royalty income from elbion’s Naltrexone Depot if and when it is marketed. Cephalon & Alkermes are marketing essentially the same product (VIVITROL) and have the first to market advantage. Even so, VIVITROL has not been the blockbuster Cephalon hoped for (see #msg-20019925 & #msg-20186705).
VIVITROL is an extended-release Medisorb formulation of naltrexone, where naltrexone is encapsulated in polylactide co-glycolide (PLG) microspheres. VIVITROL is delivered via intramuscular injection once a month.
elbion Naltrexone Depot also is an encapsulated preparation of naltrexone in microspheres. Naltrexone Depot will probably be delivered via intramuscular injection once a month. Assuming that the LACTIZ technology of DrugAbuse Sciences is still being used for Naltrexone Depot, then the polymer is poly (D,L-lactide; PL) rather than the PLG polymer used in Medisorb. A minor difference in my opinion.
VIVITROL was approved by the FDA in April 2006 and launched in June 2006. In March 2007, Alkermes and Cephalon submitted a Marketing Authorization Application (“MAA”) for VIVITROL to regulatory authorities in the United Kingdom and Germany. The MAA for VIVITROL was submitted under a decentralized procedure, in which the United Kingdom will act as the Reference Member State and Germany will act as the Concerned Member State for the application. If successful, a filing under the decentralized procedure would result in a simultaneous approval of VIVITROL as a treatment for alcohol dependence in these two countries. See Alkermes’ SEC form 10K filed 6/14/2007 for more detail.
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