The Lubrizol Corporation has announced the licensing of its novel excipient polymer technology, Apisolex excipient, to Welton Pharma (Welton). The license allows Welton to use the Apisolex excipient worldwide to develop and commercialise a novel formulation of SN-38 to treat colorectal and associated gastro-intestinal cancers.
Introduced to the market last year, the patented Apisolex excipient is a polyamino-acid polymer designed for parenteral applications. The use of the Apisolex excipient has been proven to increase the solubility of active pharmaceutical ingredients (APIs) by as much as 50,000 fold with the goal of increasing the API’s efficacy in the body.
Lubrizol continues to invest in expanding the reach of the Apisolex excipient in the market and nurturing relationships with drug product manufacturers that are facing insoluble API challenges.
Kevin Song, PhD Global Marketing Director, Lubrizol Life Science Health said: “We are continuously innovating to solve challenges for our customers and partners. By delivering differentiated solubility-enhancing solutions to the market, we enable the acceleration of life changing drug products to patients who need them.”
Welton is looking to bring life-saving solutions for the treatment of colorectal cancer that impacts 1.9 million people worldwide (2020)1. Combining Welton’s formulation expertise and Lubrizol’s Apisolex excipient, Welton plans to develop a novel formulation of SN-38 to overcome its solubility challenges in water, which has hindered its clinical development. Welton seeks to develop a stable, ready-to-use formulation having higher bioavailability and shorter infusion time to enhance the clinical outcome for cancer patients. In the next 12 months, Welton will focus on advancing their lead formulation with the Apisolex excipient into nonclinical testing and developing plans for the first in-human studies.
Kevin Sill, PhD, Welton CEO and cofounder said: “We are thrilled to have access to both this critical excipient and the expertise of Lubrizol. We will be relying on the strong patent protection of the Apisolex excipient, coupled with supply and supporting data as we advance our product.”