Pulmatrix and Cipla Technologies have signed a definitive agreement to jointly develop and commercialise Pulmazole to treat allergic bronchopulmonary aspergillosis (ABPA) in asthma patients.
Pulmazole is an inhaled iSPERSE (inhaled small particles easily respirable and emitted) formulation of itraconazole, an anti-fungal drug.
Patients with asthma or cystic fibrosis often suffer from ABPA, an infection which causes an exaggerated allergic hypersensitivity response from the immune system.
Currently, ABPA is treated with oral formulation of itraconazole in adjunction with corticosteroids. However, the drug is linked with poor bioavailability, variable pharmacokinetics and toxicity concerns.
The inhaled Pulmazole medication is intended to improve upon the established safety and efficacy profile of the oral formulation.
Cipla Technologies will pay $22m in upfront payment to Pulmatrix. In return, Cipla will get all rights to Pulmazole in pulmonary indications.
The partners intend to equally share costs for the future development and commercialisation of Pulmazole, as well as worldwide free cash flow from future sales of the medication.
Pulmatrix will carry out the clinical development of the therapeutic, while Cipla Technologies will be responsible for its commercialisation.
Cipla managing director and global CEO Umang Vohra said: “Pulmazole will be Cipla’s entry into the branded respiratory space and will serve a vital unmet medical need for the treatment of ABPA, a condition that possibly impacts over two million patients worldwide but has no labelled drug.”
The deal also provides Pulmatrix with the funds needed to conduct a Phase II clinical trial of the product.
During the randomised multi-centre trial, Pulmazole’s safety, tolerability and pharmacokinetics will be assessed in adult patients with asthma and allergic bronchopulmonary aspergillosis.
Pulmatrix CEO Robert Clarke said: “This is also an important financial milestone for the company, securing adequate funds to complete the Pulmazole Phase II study, along with 50% commitment from Cip Tec for future Pulmazole development and commercialisation costs while retaining worldwide rights to 50% of the free-cash-flow from future revenues.”
A joint steering committee will be established to supervise the collaboration.