10.29.07
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted an NDA for paliperidone palmitate to the FDA. The drug -- a once-monthly atypical antipsychotic intramuscular injection for the treatment of schizophrenia -- is a long-acting injectable ester of the API in Invega, which utilizes NanoCrystal Technology developed by Elan. Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, L.P.
Under the terms of Elan’s license agreement with J&JPRD, Elan is eligible to receive payments upon the achievement of certain milestones, as well as royalty payments based on sales of the injectable formulation, if the product is successfully commercialized.
"We are very pleased to see this product application being filed with the U.S. regulatory authorities," commented Shane Cooke, chief financial officer and head of Elan Drug Technologies. "If the product is approved for marketing by the regulators, we look forward to the successful launch of this product in the U.S. and other territories. This is the first long-acting injectable product developed and submitted to a health authority using Elan’s NanoCrystal Technology and marks a significant milestone in the advancement of the technology."
Under the terms of Elan’s license agreement with J&JPRD, Elan is eligible to receive payments upon the achievement of certain milestones, as well as royalty payments based on sales of the injectable formulation, if the product is successfully commercialized.
"We are very pleased to see this product application being filed with the U.S. regulatory authorities," commented Shane Cooke, chief financial officer and head of Elan Drug Technologies. "If the product is approved for marketing by the regulators, we look forward to the successful launch of this product in the U.S. and other territories. This is the first long-acting injectable product developed and submitted to a health authority using Elan’s NanoCrystal Technology and marks a significant milestone in the advancement of the technology."