Mumbai, India ; April 15, 2019: Cipla Technologies LLC ("Cip Tec"), a subsidiary of Cipla Limited (BSE: 500087; NSE: CIPLA EQ; along with its subsidiaries, affiliates and joint ventures, hereafter together referred to as "Cipla") and Pulmatrix, Inc. (NASDAQ: PULM; hereafter referred to as “Pulmatrix”), a clinical stage biopharmaceutical company focused on developing novel inhaled therapeutics to serve unmet needs in respiratory disease, today announced their entry into a Definitive Agreement for the co-development and commercialization of Pulmazole (PUR1900) – an inhaled iSPERSE™ formulation of the antifungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.
Following the Definitive Agreement, Cip Tec will make an upfront payment of $22 million to Pulmatrix in exchange for assignment of all rights for Pulmazole in relation to pulmonary indications to Cip Tec. Thereafter, both parties will equally share costs related to the future development and commercialization of Pulmazole, and equally share worldwide free cash flow from future sales of Pulmazole. Pulmatrix will remain primarily responsible for the execution of the clinical development of Pulmazole, and Cip Tec will be responsible for 2 the commercialization of the product. The partnership will be overseen by a Joint Steering Committee with equal representation from both companies.
With the signing of the Definitive Agreement, Pulmatrix is in a strong position to complete the Phase 2 study entitled: ‘A Randomized, Double-Blind, Multicenter, PlaceboControlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients with Allergic Bronchopulmonary Aspergillosis (ABPA)’. Pulmatrix plans to initiate this study in April 2019.
Umang Vohra, Managing Director and Global Chief Executive Officer of Cipla, 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 2 million patients worldwide but has no labelled drug. Pulmatrix has a capable development team and a strong intellectual property (IP) estate through its iSPERSE™ delivery platform. This creates potential to expand the scope of this collaboration and extract synergies from Cipla’s long-established in-house capability in the development of inhalation therapy solutions.”
Robert W. Clarke, Ph.D., Chief Executive Officer of Pulmatrix, said: "Cipla’s expertise in respiratory drug development and manufacturing strengthens our development program while its global commercialization experience and footprint will enable us to bring this novel therapeutic option to patients suffering from ABPA. This is also an important financial milestone for the company, securing adequate funds to complete the Pulmazole Phase 2 study, along with 50% commitment from Cip Tec for future Pulmazole development and commercialization costs while retaining worldwide rights to 50% of the free-cash-flow from future revenues.”
About ABPA and inhaled itraconazole
ABPA is a disease that occurs most often in patients with underlying asthma or cystic fibrosis, and it is characterized by an exaggerated allergic hypersensitivity response of 3 the immune system to the fungus Aspergillus colonizing and growing in the airways. Oral itraconazole (Sporanox®) is currently used as an adjunctive treatment to corticosteroids in ABPA patients. However, its use is limited by poor bioavailability, variable pharmacokinetics, and toxicity concerns related primarily to the risk of gastrointestinal and cardiac side effects, as well as extensive drug-drug interactions. The Pulmatrix Pulmazole program is the first inhaled dry powder version of itraconazole known to the company to be advanced into clinical development, with the goal of improving upon the known safety and efficacy profile associated with oral Sporanox® by delivering the drug directly to the lung.