Compass has entered into the (MOU) to secure a supply of current good manufacturing practice (cGMP) active pharmaceutical ingredients (API) for use in biobetters. Biologics patent expirations will create a market for follow-on products this decade and Compass is keen to enter the sector.
Some companies, including Compass, are pursuing biosimilars, but biobetters are an attractive alternative. By adding its own value Compass will create biobetters which, where possible, will have their own patent protection, said Garth Likes, Compass’ CEO.
Proposed improvements to existing biologics include formulation with polyethylene glycol (PEG) or other carriers to increase efficacy. Modifications to allow less frequent dosing and cut the risk of immunogenicity are also possible.
Canada-based Compass, formerly named Cyplasin Biomedical, will have the rights to the APIs in North, Central and South America, the European Union, and some other geographical areas. PanGen is based in South Korea.
Outsourcing API production to an off-shore supplier is part of efforts to lower costs and cut time to market. Compass is focused on treatment of hepatitis C and intends to provide a low cost alternative to existing products.
GMP production, clinical trials management, regulatory submissions, and sales and marketing will also initially be outsourced, according to the strategy outlined on Compass’ website.
Compass expects to sign a definitive agreement with PanGen within the next 60 days.