Anew Medical licensed rights to antibodies against VEGF and CD20 – low risk product development.
Acquisition: Anew Biologics, Inc.
We are focused on commercializing several blockbuster biologic drugs (antibodies) whose patents have expired and have been proven by our corporate partner to be highly similar to the Genentech/Roche reference antibodies already on the market. These antibody products are referred to as “biosimilars” or “biogenerics”. Our exclusively-licensed portfolio consists biosimilars of Roche/Genentech’s bevacizumab (anti-VEGF, Avastin®) and rituximab (anti-CD20, Mabthera® and Rituxan®).
These two antibody products still provide annual revenue of over $16 Billion to the Roche/Genentech franchise. These are extremely important biologic drugs that are the mainstay or “gold standard” in the treatment of human solid tumors (bevacizumab). They have proven to have tremendous activity in the treatment of B-cell cancers and autoimmune diseases such as rheumatoid arthritis and systemic lupus (rituximab). Bevacizumab is also used to treat six different eye diseases that include macular degeneration and diabetic retinopathy. Our corporate partners have engineered and cloned cells that produce these antibody proteins with the exact same amino acid sequence, secondary structure, and composition as the Roche/Genentech antibodies, and they perform in cancer patients comparably with the current commercially branded products. Our corporate partner has already commercialized and obtained market approval of these biologics as biosimilars in countries outside of our territories – our Territories include North America, Europe, Israel, and certain countries outside of these major markets.
Our 2022-2023 objectives are to start and complete Phase 3 studies (Phase 1 and Phase 2 studies not required) for submission to FDA to obtain commercial approval in the major markets of our two lead candidate molecules. We plan to seek market approval from the FDA and EMA as a biosimilar to the reference medicinal products in both Europe and in the U.S.A. The management team also has extensive experience in understanding the funding needs and timelines for running a large Phase 3 international study, as we have done this before.