Aplagon and Cadila Pharmaceuticals Sweden AB have announced a development and commercialisation 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, will undertake formulation development and commercial-scale manufacturing of Aplagon’s APAC product.
Aplagon and Cadila Pharmaceuticals will conduct multicentre, randomised 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 commercialisation rights for India and a share of future commercialisation proceeds outside India. Aplagon will receive a royalty on Indian sales and will retain commercialisation rights for APAC products in other jurisdictions outside India. The financial terms of the deal remain confidential.
APACs, which were discovered by Aplagon scientists, are heparin proteoglycan mimetics. These biologics are being developed as first-in-class treatments for unmet patient needs associated with the prevention and management of both the short- and long -term complications of vascular intervention-related blood vessel occlusions. In the first instance, Aplagon is pursuing the development of APACs for selected indications where no current treatments exist.
APACs are named after their unique dual antiplatelet (AP) and anticoagulant (AC) activity. However, they carry additional important and distinct properties compared with current antithrombotic therapies which are used systemically. APACs target the vascular injury site and act locally. This means they avoid systemic exposure and thereby reduce the risk of bleeds, the main side effect and safety hazard of antithrombotics. By beneficially influencing vascular smooth muscle cells in addition to inhibiting blood clotting, APACs are also able to address long-term complications of vascular interventions.