NOVATO, Calif., Aug. 20, 2015 (GLOBE NEWSWIRE) — Raptor Pharmaceutical Corp. (Nasdaq:RPTP) 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.
Conference Call and Webcast Information
Further comments regarding this acquisition will be discussed during a conference call and live audio webcast at 5:30 p.m. EDT (2:30 p.m. PDT) today. The live call may be accessed by dialing (877) 710-6201 for domestic callers or (616) 548-5611 for international callers and using the conference ID number 14694258. A live webcast of the conference call will be available online from the investor relations section of the company website at www.raptorpharma.com. After the call, a webcast replay will be available on the Raptor website for 90 days. A telephone replay of the call will be available by dialing (855) 859-2056 for
domestic callers, or (404) 537-3406 for international callers, and using the conference ID number 14694258.
About QuinsairTM (levofloxacin inhalation solution)
Quinsair is a proprietary inhaled formulation of levofloxacin, a fluoroquinolone antibiotic, which is approved in the EU and in Canada for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis. Administration of Quinsair with a high efficiency nebulizer allows for the delivery of high concentrations of active drug
directly to the site of infection in approximately five minutes. Quinsair is contraindicated in patients with hypersensitivity to levofloxacin, a history of tendon disorders related to fluoroquinolones, epilepsy, or who may be pregnant or breast feeding. Quinsair’s safety was evaluated in two double-blind, placebo-controlled studies and in an active comparator study in which the most frequently reported adverse reactions were cough/productive cough, dysgeusia, and fatigue/asthenia.
About Cystic Fibrosis
Cystic fibrosis (CF) is a rare, life-threatening genetic disease affecting more than 75,000 people in North America, Europe and Australia. CF is caused by a mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Defective or missing CFTR protein causes poor flow of salt and water into or out of the cell in several organs, including the lungs. This leads to the buildup of abnormally thick secretions that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death.
About Raptor Pharmaceutical
Raptor Pharmaceutical Corp. is a global biopharmaceutical company focused on the development and commercialization of lifealtering therapeutics that treat rare, debilitating and often fatal diseases. The company is engaged in multiple therapeutic areas such as nephropathic cystinosis, Huntington’s disease (HD), pediatric nonalcoholic steatohepatitis (NASH), and mitochondrial diseases including Leigh’s syndrome. Raptor holds several orphan drug designations, including orphan drug exclusivity for nephropathic cystinosis in the U.S. and EU, and orphan drug designation for HD in the U.S. and EU. Raptor holds intellectual property for the use of cysteamine in HD and other neurodegenerative disorders including Parkinson’s disease and Rett syndrome. For additional information, please visit www.raptorpharma.com.