August 21, 2015
By Alex Keown, BioSpace.com Breaking News Staff
NOVATO, Calif. – Raptor Pharmaceutical Corp. is beefing up its rare disease portfolio with the $453 million acquisition of Quinsair, first inhaled fluoroquinolone approved for the management of chronic pulmonary infections in adults with cystic fibrosis, the company announced this morning.
Quinsair is a twice-per-day treatment that contains levofloxacin, an antimicrobial active against a wide range of gram negative and gram positive bacteria. Raptor will begin selling Quinsair in Europe and Canada in the first part of 2016. Quinsair was approved by the European Commission and Health Canada in March 2015 and June 2015, respectively. Raptor said it will continue to seek approval in the United States with the U.S. Food and Drug Administration (FDA). Raptor said it hopes U.S. regulatory approval will be granted about the same time the drug will be available in Europe and Canada.
People diagnosed with cystic fibrosis sometimes have trouble clearing mucus in the lungs, which provides a place for bacteria to develop, causing the likely increase of infections.
Julie Anne Smith, president and chief executive officer of Raptor, said acquiring Quinsair before its commercial launch will allow Raptor to shape its commercial strategy as well as any further uses in the treatment of cystic fibrosis.
“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,” Smith said in a statement. “This acquisition expands our portfolio and leverages both our commercial and development expertise in rare diseases.”
Smith added the acquisition of Quinsair will expand the company’s pipeline of drugs with multiple late-stage orphan indication opportunities.News of the acquisition was received positively at the opening bell of the NASDAQ this morning. The was up more than 3 percent, trading at $12.52 per share.
Earlier this month, Raptor received regulatory approval for the expanded use of Procysbi (cysteamine bitartrate), the company’s delayed-release capsules used to treat children ages two to six with nephropathic cystinosis, a life-threatening metabolic lysosomal storage disorder that causes toxic accumulation of cystine in all cells, tissues, and organs in the body.
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. 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 company said.
Patrick Flume, a professor of medicine and pediatrics at the Medical University of South Carolina, said the availability of a medication like Quinsair is important in addressing “unmet needs” for patients with cystic fibrosis. He added he was also excited about the possibility of the drug being available for the treatment of non-cystic fibrosis bronchiectasis and pulmonary nontuberculous mycobacterial infections.
Raptor struck the deal with Tripex Pharmaceuticals which includes $68.4 million in upfront payments with the remaining $385 million associated with development, regulatory and commercial milestones, the company said in a statement. The transaction is expected to be completed in the third quarter of 2015, barring any regulatory situations.
Raptor said the acquisition will not negatively impact its revenue guidance of $80 to $90 million.
