THOUSAND OAKS, Calif. & MELBOURNE, Australia— Amgen Inc. and Medicines Development for Global Health (MDGH), a non-profit biopharmaceutical company, reported today that the companies have entered into a license agreement for AMG 634, a phosphodiesterase type 4 (PDE4) inhibitor. The compound is being investigated for the treatment of tuberculosis (TB) and erythema nodosum leprosum (ENL), an inflammatory cutaneous and systemic complication of Hansen’s disease, which is also known as leprosy.
“Since tuberculosis and erythema nodosum leprosum remain challenging diseases in many countries around the world, Amgen sought an organization that could support the development of AMG 634 to address the global health unmet need,” said Dr. David M. Reese, executive vice president of Research and Development at Amgen. “MDGH’s track record and experience in product development, global health, and neglected infectious diseases makes them an ideal company to further develop AMG 634 for the benefit of patients.”
AMG 634 is currently in Phase 2 development, with a TB study led by the Aurum Institute NPC and an ENL study led by The Leprosy Mission Nepal. Under the terms of the current agreement, MDGH will now have full responsibility for further development and commercialization of AMG 634. However, Amgen has said that the company will continue to support the two Phase 2 clinical trials in ENL and TB that have been scheduled to begin in 2021, by providing study drug to the studies and by funding the ENL study. This support will help to ensure a seamless transition to MDGH.
“We are excited by the potential of AMG 634 for patients with ENL and TB and are honored to take over the stewardship of this compound from Amgen. MDGH is dedicated to developing and delivering medicines for diseases that disproportionally affect people in low- and middle-income countries,” noted Mark Sullivan, founder and managing director of MDGH. “We broke new ground as the first not-for-profit biopharmaceutical company to achieve FDA approval for a treatment for river blindness in 2018, and we will now undertake full development of AMG 634 in hopes of bringing it to patients in need of a treatment for their disease.”
Amgen has also announced the company’s submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, an investigational KRASG12C inhibitor, for the treatment of adult patients with previously treated KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).
“Just over two years since the first patient was dosed, sotorasib is now on track to potentially be the first approved targeted therapy for patients with previously treated NSCLC harboring the KRAS G12C mutation. With this submission to EMA, Amgen is continuing to rapidly advance the KRASG12C inhibitor clinical program to bring this innovative potential therapy to patients globally as quickly as possible,” stated Reese.
Amgen points out that this submission is supported by positive Phase 2 results from the CodeBreak 100 clinical study, in patients with locally advanced or metastatic NSCLC with KRAS G12C mutation whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. And in a Phase 1 study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile. These data are set to be presented at the International Association for the Study of Lung Cancer’s 2020 World Conference on Lung Cancer in January 2021.