Raptor Pharmaceutical Corp. recently announced it has signed an agreement with Tripex Pharmaceuticals in order to acquire Quinsair, which is the first inhaled fluoroquinolone that received approval to manage chronic pulmonary infections caused Pseudomonas aeruginosa in adult patients suffering with cystic fibrosis. The acquisition expands the company’s portfolio to further address rare diseases. Cystic fibrosis is a genetic disorder that mainly affects the lungs as well as the pancreas, liver, kidneys and intestine.
Quinsair has earned marketing authorization from both the European Commission (March 2015) and Health Canada (June 2015). The therapy is taken twice-a-day and contains levofloxacin, which is an antimicrobial that has been shown to be effective against a large spectrum of gram negative and gram positive bacteria. Raptor intends to launch Quinsair both in Canada and Europe in 2016 (first half), and to discuss the best approach to maximize its potential approval with the FDA in the United States in 2016.
In addition to cystic fibrosis, Quinsair has the potential to treat two orphan diseases with unmet needs: nontuberculous mycobacteria (NTM) lung infections and bronchiectasis (BE); there are no therapeutic options for these diseases. Patients with BE have an abnormal dilatation and even experience destruction of lung bronchi and bronchioles because of chronic infection and inflammation. The NTM group of microbes causes serious, recurrent infections of the lungs, frequently in patients who are immune-compromised or already are affected with lung diseases such as bronchiectasis. Raptor is now assessing if Quinsair has the potential to address these diseases.
“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. 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,” said Julie Anne Smith, Raptor’s President and CEO.
“Quinsair is an important new addition to the options that we can offer adult European and Canadian CF patients today. 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,” added Patrick Flume from the Medical University of South Carolina.
Daniel Burgess, Chief Executive Officer of Tripex Pharmaceuticals, concluded: “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.
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