Aplagon and Cadila Pharmaceuticals to develop APAC first-in-class antithrombotics targeting vascular

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.

APACs 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, which 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.

"We are excited to partner with Cadila Pharmaceuticals, one of the largest privately held pharmaceutical companies in India. This collaboration will leverage Cadila Pharmaceutical’s excellent manufacturing operations as well as clinical and commercialization capabilities to facilitate the development of APAC through large Phase I-III clinical studies in a cost-efficient and timely way. This is a true win-win partnership for both parties," said Aki Prihti, CEO of Aplagon.

Hans Wigzell, Chairman, Cadila Pharmaceuticals Sweden AB, said, "As a first-in-class treatment with multiple mechanisms of action, APAC is a truly innovative product for the prevention of blood vessel occlusions related to vascular interventions.  We plan to pursue FDA fast track indications, which should result in reduced development time as well as reaching important patient populations for which no appropriate treatment exists. Our collaboration with Aplagon will also fulfill part of our mission to offer innovative products to patients in India at affordable prices."