Bharat Serums and Vaccines Limited (BSV), one of the top ten Indian biopharmaceutical companies, has entered into an exclusive licensing , manufacturing and supply agreement with Actavis for marketing one of BSV's anti-infective generic formulations.
Under the terms of the agreement, BSV will develop and manufacture the product for marketing by Actavis in Europe, Australia, South Africa and Turkey. The financial details of the agreement are not disclosed.
Actavis, one of the world's leading generic pharmaceutical companies, 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 a sterile lyophilized injectable product, presenting significant technological and regulatory challenges. The total worldwide sales of the product are close to USD 300 million. BSV and Actavis will be working closely together to obtain the marketing authorization in Europe and other countries.
This arrangement is a result of the business model that BSV has focused on building in the recent past and is a significant collaboration after its tie up with a leading Indian pharma company for its novel oncology product. BSV has allocated substantial resources towards the research and development of pharmaceutical products in the areas of Novel Drug Delivery, Biotechnology and Biologicals. BSV has an exciting pipeline of novel products and 'difficult generics' and is in discussions with potential partners for commercialization of these products. The novel products include certain new biological entities and novel drug delivery systems. These products would be the 'first time' in the world and the patents for these products will belong to BSV. The anti-infective product is from the drug delivery research and comes under the category of difficult generics. BSV is seeking various partnering models including licensing, co-development, etc. to commercialize its products.