Savara Obtains Global Rights to Develop and Commercialize Apulmiq
Management to Host Conference Call / Webcast with Bronchiectasis Expert Dr.
“We are very excited about Apulmiq and believe it represents a transformational addition to our pipeline,” said
Under the terms of the agreement, Savara has obtained the worldwide rights to develop and commercialize Apulmiq. Savara provided an upfront payment and, if regulatory approval is obtained, Grifols will be eligible for regulatory milestone payments as well as royalties and potential tiered sales milestones upon commercialization.
“I am excited that Savara will be advancing this important investigational therapy,” said
The Company expects to work with regulatory agencies to plan a confirmatory Phase 3 study. Key learnings from previous studies of inhaled antibiotics for NCFB will be leveraged in order to optimize patient population and endpoints in the study.
Apulmiq is an investigational inhaled liposomal ciprofloxacin being evaluated for the treatment of NCFB and was granted Orphan Drug Designation as well as designated a Qualified Infectious Disease Product (QIDP). Apulmiq was previously evaluated in two Phase 3 clinical studies (ORBIT-3 and ORBIT-4) in a total of 582 patients. On the time-to-exacerbation primary endpoint in those studies, treatment with Apulmiq resulted in a statistically significant benefit in one study, however the difference in the other study showed a positive trend but did not reach statistical significance. Apulmiq also reduced the frequency of exacerbations (in the pooled analysis) as well as the density of Pseudomonas aeruginosa bacteria and demonstrated an encouraging safety profile. In 2018, a New Drug Application (NDA) for Apulmiq received a Complete Response Letter (CRL) from the
NCFB is an orphan, chronic, and progressive respiratory disorder that is characterized by dilated airways with thickened and scarred walls due to infection and inflammation. Symptoms include persistent cough, dyspnea, fatigue, and recurrent infective pulmonary exacerbations that often lead to hospitalization and are associated with higher mortality. With an estimated prevalence of more than 150,000 patients in the
Savara management will host a conference call/webcast, with guest speaker Dr.
Approximately one hour after the call, a telephone replay will be available and will remain available through
Savara is an orphan lung disease company. Savara’s pipeline comprises Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP), in Phase 2a development for nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (CF) and CF-affected individuals with chronic NTM lung infection; and AeroVanc, a Phase 3-stage inhaled vancomycin for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF. Savara’s strategy involves expanding its pipeline of potentially best-in-class products through indication expansion, strategic development partnerships and product acquisitions, with the goal of becoming a leading company in its field. Savara’s management team has significant experience in orphan drug development and pulmonary medicine, identifying unmet needs, developing and acquiring new product candidates, and effectively advancing them to approvals and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/).
Forward Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements regarding our excitement about Apulmiq and belief that it represents a transformational addition to our pipeline, that 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, that there is an estimated prevalence of more than 150,000 NCFB patients in the