Inhalation CDMO Vectura and inhaled drug developer Aerami Therapeutics (formerly Dance Biopharm) have signed an agreement for development of inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH), the companies said. Aerami will pay nothing up front, but will make milestone payments and pay development fees and royalties on any sales. Aerami will also purchase Fox nebulizer devices from Vectura as part of the deal.
Vectura was developing inhaled imatinib (VR325) itself before the company announced that it would transform into a CDMO in 2019. Aerami says that it plans to initiate a Phase 1 trial of inhaled imatinib delivered via the Fox nebulizer in the second half of 2020. The company also said that it will seek orphan disease designation for the product for the treatment of PAH.
Aerami COO Timm Crowder said, “Despite multiple products being available to treat the symptoms of PAH patients, it remains a fatal disease with substantial unmet needs. We believe that inhaled imatinib has the potential to improve PAH patients’ lives based on the significant efficacy demonstrated in a proof of concept Phase 3 trial completed with oral imatinib. We look forward to working with Vectura, the PAH patient and clinician community to initiate clinical development this year.”
Vectura CEO Will Downie commented, “Pulmonary arterial hypertension is a rare, progressive, fatal disease with approximately 500-1000 new cases diagnosed each year in the US alone according to the National Organization for Rare Disorders. In working together with Aerami, this program has the potential to impact the lives of patients around the world. Our deep inhalation expertise, especially now as a CDMO, perfectly complements the scientific capability of Aerami in the biotechnology field. We look forward to developing a strong partnership for years to come.”
Read the Vectura press release.
Read the Aerami Therapeutics press release.