Under the terms of the agreement, Bharat Serums and Vaccines (BSV) will develop and manufacture the product for marketing by Actavis in Europe, Australia, South Africa and Turkey.
Actavis will obtain its marketing authorizations based on BSV’s dossier which will be licensed to Actavis on an exclusive basis and will source all of its product requirements exclusively from BSV.
The product is said to be a sterile lyophilized injectable product, presenting significant technological and regulatory challenges. The total worldwide sales of the product are close to $300 million. BSV and Actavis will be working closely together to obtain the marketing authorization in Europe and other countries.