Cipla update on renegotiation for development & commercialization of Pulmazole

Cipla announced that on 15 April 2019 its US subsidiary Cipla Technologies LLC (CipTec) had entered into a definitive agreement (Agreement) with Pulmatrix, Inc., USA (Pulmatrix) for the co-development and commercialization of Pulmazole (PUR 1900) an inhaled iSPERSE formulation of the antifungal drug Itraconazole; for the treatment of allergic bronchopulmonary aspergillosis (ABPA) for patients with asthma.

Discussions to renegotiate the terms of the Agreement are now in progress. Due to the delays in patient enrolment for the Phase 2a clinical study managed by Pulmatrix, the Joint Steering Committee has terminated the Phase 2a clinical study in order to commence a new Phase 2b study with longer dose duration and efficacy endpoints, upon Agreement negotiations with Pulmatrix being successful. It's Cipla's position that under the terms of the Agreement it has the right to suspend additional funding under certain circumstances. The renegotiated agreement may include, amongst other things a reallocation of costs and a grant of rights to CipTec (and/or its affiliates) to develop and commercialize Pulmazole in select markets outside the United States. Updates on this amendment to the Agreement and other related developments will be provided in the future.

 

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