A month after regaining rights to PUR1800 and other inhaled narrow spectrum kinase inhibitors from Johnson & Johnson, Pulmatrix has announced that it may also reacquire the rights to its Pulmazole intraconazole DPI (PUR 1900). According to the company’s business update, Pulmatrix recently notified Cipla that Cipla breached a 2019 development and commercialization agreement by failing to provide 50% of Pulmazole development costs. The company added that if Cipla fails to reconfirm its commitment to the agreement within 30 days, Pulmatrix will exercise its option to reacquire the rights to Pulmazole for 25% of fair market value and will advance the DPI into Phase 2b without Cipla.
Pulmatrix also said that it has completed a Type C meeting with the FDA necessary to move ahead with clinical development and that it expects to initiate a Phase 1/2 trial in the first quarter of 2022. A Phase 2 trial of Pulmazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients was initiated in July 2019, several months after Pulmatrix finalized the agreement with Cipla subsidiary Cip Tec. The FDA granted Fast Track designation to Pulmazole for the treatment of ABPA in January 2020.
Pulmatrix CEO Ted Raad commented, “We are pleased to now have the kinase inhibitor portfolio back in our proprietary pipeline following the termination of the development and licensing agreement with Johnson & Johnson. We also remain steadfast in our objective to bring Pulmazole to market and address significant unmet need of patients suffering from ABPA. Our recent notice to Cipla Technologies demonstrates that commitment. With our strong balance sheet, we believe that we can fund operations through planned data milestones for PUR1800 and PUR3100 and, if we ultimately re-acquire Pulmazole from Cipla, begin our Ph2b study.”
Read the Pulmatrix press release.
