Product developed by acquired Lumira Capital portfolio company, Corus, wins FDA approval

admin Pharmasset, Portfolio News

Gilead’s Inhaled Antibiotic for Lungs Wins Approval  
 
Feb. 22 (Bloomberg) — Gilead Sciences Inc., the world’s largest maker of HIV treatments, won U.S. approval of an inhaled antibiotic for lung infections in cystic fibrosis patients.  
The Food and Drug Administration cleared sales of the medicine, given the brand name Cayston, the company said today in a statement. Outside advisers to the FDA backed the product’s safety and effectiveness in a 15-2 vote on Dec. 10.  
 
Cystic fibrosis causes mucus to build in the lungs, leading to repeated infections that are the most common cause of death from the disease. FDA approval will expand access to Gilead’s medicine, which has been available since August 2007 to patients with limited treatment options who are at risk for their cystic fibrosis getting worse.  
“All of us at Gilead extend our thanks to the investigators and to the people with cystic fibrosis who took part in the Cayston clinical trials,” said Norbert Bischofberger, Gilead’s executive vice president, research and development, in the company’s statement. “We look forward to making Cayston available to the cystic fibrosis community as soon as possible.”  
 
Cayston was given conditional marketing approval in Canada and the European Union in September. Annual sales of the medicine may reach $161.7 million by 2014, according to the average estimate of four analysts surveyed by Bloomberg. That’s a fraction of the $4 billion Foster City, California-based Gilead aims to bring in with its new combination HIV pill entering the final stages of testing.  
 
Cystic Fibrosis Patients  
An estimated 30,000 people in the U.S. have cystic fibrosis and about 12 million Americans are carriers of a gene that causes it, according to the National Heart Lung and Blood Institute, a U.S. agency.  
Cayston targets infections caused by Pseudomonas aeruginosa bacteria. The drug is a proprietary combination of aztreonam, a chemical already approved for intravenous use, and the amino acid lysine.