(GLOBE NEWSWIRE) – Raptor Pharmaceutical Corp. RPTP, +8.32% announced today that it has signed a definitive agreement with Tripex Pharmaceuticals to acquire Quinsair, the first inhaled fluoroquinolone approved for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adults with cystic fibrosis, expanding its portfolio of rare disease therapies.
Quinsair received marketing authorization by the European Commission and Health Canada in March 2015 and June 2015, respectively. Quinsair, a twice-a-day treatment, contains levofloxacin, a proven antimicrobial active against a wide range of gram negative and gram positive bacteria. Raptor plans to launch Quinsair in Europe and Canada in the first half of 2016, and to discuss the path to potential approval in the same indication in the U.S with the FDA in 2016.
In addition to cystic fibrosis, Quinsair has development potential in two additional orphan diseases with significant unmet need, bronchiectasis (BE) and nontuberculous mycobacteria (NTM) lung infections, for which there are currently few therapeutic options. BE is characterized by abnormal dilatation and destruction of lung bronchi and bronchioles due to chronic recurring infection and long-term inflammation which leads to frequent hospitalizations. NTM are a group of microbes that cause severe and recurrent lung infections, often in individuals who are immune-compromised or who have structural lung disease, such as bronchiectasis. Raptor is evaluating Quinsair’s potential in these therapeutic indications and intends to initiate clinical programs in 2016 in at least one of the indications.
“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.”
Under the terms of the agreement, Raptor will pay $68.4 million upfront, with up to $34.2 million of the closing consideration payable in Raptor common stock at Raptor’s election plus contingent payments of up to $350 million associated with development, regulatory and commercial milestones, a portion of which is payable in Raptor common stock at Raptor’s election, and a single-digit royalty on future global net sales. In addition, Raptor will have single-digit contingent obligations to two additional parties involved in Quinsair’s development. Raptor is acquiring exclusive global rights and assets to develop, manufacture and commercialize Quinsair. The transaction is expected to close in the third quarter of 2015, subject to customary closing conditions including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Act.
“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.
With this acquisition, Raptor is reiterating its 2015 revenue guidance of $80 to $90 million and also maintaining its 2015 guidance for non-GAAP operating expenses, which exclude cost of goods and non-cash expenses, such as stock-based compensation and amortization of transaction-related intangible assets, of between $115 to $125 million.