UK company Cortecs International has signed a new agreement with the Center for Clinical and Basic Research and Osteometer BioTech A/S of Ballerup in Denmark. Under the terms of the deal, Osteometer will finance and CCBR, a leading osteoporosis research establishment, will carry out the further clinical trials necessary to satisfy European regulatory requirements for the registration and commercialization of Cortecs' oral calcitonin formulation. The product is currently in clinical trials for the treatment of osteoporosis.
Certain trials may be performed under a US Investigational New Drug application to support an eventual US New Drug Application. Subject to the results of ongoing trials, expected within this year, and additional data required for registration purposes, Cortecs says it intends to file a Product License Application during 1996.
In return for financing this phase of the product's development, Osteometer will receive royalty payments on Cortecs' oral calcitonin income.
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