Helsinki/New Delhi: Aplagon Oy (“Aplagon”) and Cadila Pharmaceuticals Sweden AB have announced a development and commercialization agreement for Aplagon’s lead APAC product. APACs are proprietary, locally acting, potent antithrombotic products, which target blood vessel wall injury.
Under the agreement, Cadila Pharmaceuticals Sweden AB together with its parent company Cadila Pharmaceuticals Limited, India (“Cadila Pharmaceuticals”) will undertake formulation development and commercial-scale manufacturing of Aplagon’s APAC product.
Aplagon and Cadila Pharmaceuticals will conduct multicentre, randomized Phase I/II and Phase II/III clinical studies in India in a selected first indication to prevent vascular intervention-related blood vessel occlusions. Following additional pre-clinical studies required in India, it is anticipated that the first Indian clinical trial will start recruiting in 2019.
Cadila Pharmaceuticals will co-invest a significant part of the projected costs of the clinical studies and will, in return, receive the commercialization rights for India and a share of future commercialization proceeds outside India. Aplagon will receive a royalty on Indian sales and will retain commercialization rights for APAC products in other jurisdictions outside India. The financial terms of the deal remain confidential.