Raptor Pharmaceutical Corp., recently announced it has reached an agreement with Tripex Pharmaceuticals over the rights to Quinsair, a first-of-its-kind inhaled fluoroquinolone indicated for chronic respiratory infections caused by Psuedomonas aeruginosa in adult cystic fibrosis patients.
Quinsair was granted marketing authorization by the European Commission and Health Canada earlier this year. The treatment is administered twice daily, and contains broad acting levofloxacin. Raptor expects to launch the drug in EU and Canada within the first half of 2016, and begin pursuing regulatory approval in the United States next year.
Quinsair is also being tested as a potential treatment for bronchiectasis (BE) and nontuberculous mycobacteria (NTM) lung infections, which currently have very limited treatment options. The company is currently exploring Quinsair’s effectiveness in these two orphan diseases and plans to start clinical testing in either BE or NTM 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.”
The Raptor-Tripex agreement stipulates that Tripex will be entitled to an upfront payment of $68.4 million, followed by a payment of up to $34.2 million of the closing consideration in Raptor common stock, and contingent payments of up to $350 million upon reaching development, regulatory and commercial milestones. Raptor also retains single-digit contingent obligations to two parties involved in Quinsair’s development, along with acquiring exclusive global rights to the drug’s development, manufacturing and commercialization. The transaction is expected to be completed within the third quarter of 2015.
For cystic fibrosis patients, Psuedomonas aeruginosa is an ever-present health threat, as the bacterial infection is among the most pervasive and deadly in the CF patient population. The continued development and commercialization of therapies that target Psuedomonas aeruginosa is therefore critical to improving patient outcomes for those with the disease. “We are extremely excited to be entering into this agreement with Raptor,” stated Daniel Burgess, Chief Executive Officer of Tripex Pharmaceuticals. “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.”