Savara announced that it has acquired global development and commercialization rights to Apulmiq (Linhaliq) inhaled liposomal ciprofloxacin from Grifols. According to Savara, the deal includes an upfront payment to Grifols and regulatory milestone payments if the product is approved, plus potential royalties and sales milestones. In February 2020, Grifols acquired the rights to Aradigm’s entire inhaled ciprofloxacin portfolio after Apulmiq developer Aradigm declared bankruptcy. Grifols had previously licensed the inhaled ciprofloxacin products in 2013.
Phase 3 development of Apulmiq has run into several roadblocks. In January 2018, the FDA issued a complete response letter to Aradigm’s NDA for Apulmiq for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis patients. The FDA continued to have concerns regarding data from Phase 3 trials of Apulmiq, Aradigm announced in February 2019. The company also withdrew its MAA for Linhaliq for the same indication in October 2019 after learning that CHMP was unlikely to adopt a positive opinion regarding the application.
Savara said that it expects to coordinate with regulatory agencies on planning for a new Phase 3 study, saying “Key learnings from previous studies of inhaled antibiotics for NCFB will be leveraged in order to optimize patient population and endpoints in the study.” University of Dundee Professor James Chalmers, Chair of the EMBARC European Bronchiectasis Registry, who testified in favor of approval of Linhaliq at a 2018 meeting of the FDA’s Antimicrobial Drugs Advisory Committee, is still supportive.
Chalmers said, “I am excited that Savara will be advancing this important investigational therapy. I look forward to working with Savara on the confirmatory Phase 3 study that will benefit from the learnings of previous clinical studies of Apulmiq and other inhaled antibiotics in NCFB. Bronchiectasis patients have no approved drug options available and I believe many patients could substantially benefit from an effective inhaled antibiotic.”
Savara CEO Rob Neville commented, “We are very excited about Apulmiq and believe it represents a transformational addition to our pipeline. Acquiring the rights provides us with another high potential Phase 3 program that leverages our core capabilities in inhaled orphan drug development and complements our existing pipeline. With an estimated prevalence of more than 150,000 NCFB patients in the US and potentially more in Europe, Apulmiq could represent a game-changing opportunity in a therapeutic area with little competition and significant unmet need. Our goal is to offer a novel pharmaceutical treatment option to patients living with this chronic and debilitating disease.”
The company’s pipeline also includes Molgradex inhaled human granulocyte-macrophage colony-stimulating factor (GM-CSF) and AeroVanc inhaled vancomycin. Savara recently announced that it would halt ongoing trials of those drugs due to the COVID-19 pandemic.
Read the Savara press release.
