Posted: 23 May 2023
Avecho Biotechnology Limited has today announced it has secured a licensing and development agreement with Arthur Group, entering a strategic partnership for the development of a series of cancer drugs solubilised using TPM®.
Avecho has previously demonstrated that TPM can dissolve poorly–water soluble injectable drugs that require adverse solvents or surfactants to dissolve. Replacing adverse excipients with TPM, a form of Vitamin E, supports safer, clinician preferred dosage forms. A large number of high potency oncology drugs have poor aqueous solubility, and require adverse solvents such as cremophor, that come with a range of adverse side effects. These side effects include hypersensitivity, hyperlipidaemia, abnormal lipoprotein patterns, aggregation of erythrocytes and peripheral neuropathy.
Founded in December 2015, Arthur Pharma focuses on the research and development, manufacturing,and marketing of complex generic, 505B2, and NCE pharmaceutical products globally, with a focus on North American, European, and Asian market. The company has research and development centresin Princeton, and Monmouth Junction, New Jersey, USA, and Zhejiang, China, which can develop tablets, capsules, injections, semi–solid and other dosage forms. Through the CMO cooperation, the company has several API, oncology, PFS, injector pen cartridge, lyophilization injectable and oral solid manufacturing facilities in North America and Asia andhas over one hundred development and marketing partners in Asia, the United States, Canada, and Europe. Arthur Group currently develops and manufactures 23 commercial oncology products.
Cremophor–free formulations hold promising potential for the oncology injection market. In addition to being safer, such innovative formulations are expected to boost productivity levels in hospitals, as cremaphor prevents the use of standard hospital equipment such as polyvinyl chloride infusion bags. Cremophor–free formulations are expected to simplify patient management by eliminating the need for premedication to prevent hypersensitivity. It is anticipated that cremaphor free oncology products, made possible using TPM, could displace existing oncologyproducts that contain the adverse excipient.
Arthur Group CEO, Dr Isaac Liu, said: “We are very interested to begin formulation work with TPM. Should it prove possible to replace cremaphor or other adverse excipients in existing oncology therapies with a form of vitamin E that is safe for injection,we would anticipate the product to have significant global interest. We are interested in extending the cooperation into a portfolio of cancer drugs.”
Arthur Group CSO, Dr Gopi Chand Inti, said: “After learning about TPM, we thought it should help to reduce the adverse reactions and risks associated with existing oncology medications. We already have significant experience in the development of injectable products using standard excipients, so we are confident we can complete the development of new formulations using TPM.” The agreement is a promising extension of Avecho’s TPM business development program andwill initially encompass five oncology drugs.
The combined market in the US for these commercial products is approximately US $2.92 billion1.Arthur Group will pay for all formulation, non–clinical and clinical development of the products. Avecho will receive 30% of any revenue from licensing and 30% of the net profit from commercialisation of these products in the future.
Avecho CEO, Dr Paul Gavin, said:“Working with credible third parties like Arthur Group to leverage the tested capabilities of TPM in enhancing the performance of its cancer drug portfolio, is deeply rewarding for our team and supportive of our Company’s current commercial focus. Arthur Group will start with initial formulation screening of its licensed drugs to determine which are most compatible with TPM –the most receptive drugs to be prioritised first.”
The Arthur Group has already determined the research and development work required for each molecule across four stages; formulation development, non–clinical testing, clinical trials and registration. It is anticipated that the initial formulation step will take 12–18 months.
