Raptor Pharmaceutical Corp. recently signed an agreement with Tripex Pharmaceuticals to acquire rights to Quinsair, the first inhaled fluoroquinolone approved as a treatment of respiratory infections caused by Pseudomonas aeruginosa in adult cystic fibrosis patients. The drug originally received marketing authorization from the European Commission and Health Canada in March and June 2015 respectively.
Quinsair is administered twice daily and contains levofloxacin. Raptor expects to launch the drug in Europe and Canada within the first half of 2016, and soon reveal its strategy in pursuing regulatory approval in the United States for the same indication in 2016.
Aside from cystic fibrosis, Quinsair is under investigation for two other orphan diseases: nontuberculous mycobacteria (NTM) respiratory infections, and bronchiectasis, both of which have a very limited range of therapeutic options. At present, Raptor is evaluating the drug’s potential to address these diseases and plans to launch corresponding clinical trials in 2016.
“The Quinsair acquisition is transformational for Raptor and delivers on our strategic focus to develop and commercialize therapies that bring significant relief to patients and families living with life-threatening diseases,” stated Julie Anne Smith, President and CEO of Raptor. “This acquisition expands our portfolio and leverages both our commercial and development expertise in rare diseases. By acquiring Quinsair prior to its launch, we will be able to exclusively shape its commercial strategy and potential in cystic fibrosis and other rare diseases.”
“Quinsair is an important new addition to the options that we can offer adult European and Canadian CF patients today,” stated Patrick Flume, M.D., Professor of Medicine and Pediatrics at the Medical University of South Carolina. “Since it is a new class of inhaled antibiotics, Quinsair’s availability is an important step in addressing an unmet need for the CF community. I’m especially excited about the possibilities to broaden the availability of a drug like this for patients with non-CF bronchiectasis and pulmonary nontuberculous mycobacterial infections, for whom there are limited treatment options.”
According to the agreement, Tripex will be entitled to an upfront payment worth $68.4 million, and up to $34.2 million payable in Raptor common stock, along with contingent payments of up to $350 million in accordance with development, regulatory and commercial milestones. Raptor will also have single-digit contingent payables to two additional parties that contributed to Quinsair’s development. In return, Raptor will be acquiring exclusive global rights and assets to further develop, manufacture and commercialize the drug.
“We are extremely excited to be entering into this agreement with Raptor. We strongly believe Raptor has the global presence and experience in successfully developing and launching orphan products to help realize Quinsair’s full commercial potential and bring this drug to the patients that need it the most,” stated Daniel Burgess, Chief Executive Officer of Tripex Pharmaceuticals.