Gilead Sciences receives FDA approval for new inhaled antibiotic in treatment of CF

CF Foundation's $1 Million Investment Helped Drug Known as Cayston(R) Become a Reality

The U.S. Food and Drug Administration approved an important new inhaled antibiotic called Cayston® (aztreonam for inhalation solution) today for the treatment of cystic fibrosis. The drug was made possible by significant support from the Cystic Fibrosis Foundation, including a $1 million investment by a Foundation subsidiary to help develop the therapy.

Developed by Gilead Sciences, Inc., Cayston offers a much-needed antibiotic alternative for CF patients who battle recurrent lung infections and develop resistance to existing antibiotics. Lung infections are the leading cause of death in CF.

Cayston is the first CF drug to advance — from beginning to end — through the Cystic Fibrosis Foundation's Therapeutics Development Program, which is designed to speed the creation of new CF therapies. In addition, Cystic Fibrosis Services, Inc, a wholly owned subsidiary of the Foundation, will be one of only several pharmacies in the country distributing the drug.

Cayston will be available by the end of next week.

"The approval of Cayston demonstrates that our drug development model is working and making a real difference in the lives of people with cystic fibrosis," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. "We are delighted to have a new antibiotic in the arsenal to help fight the life-threatening infections associated with this disease, as we continue to push forward with other therapies that address the underlying cause of CF."

The Foundation supported Cayston at each stage of development, from providing an initial therapeutics development award, to making the Foundation's clinical trials network available to test the drug in patients, to advocating with the FDA for the drug's approval.

"The Cystic Fibrosis Foundation's early funding and ongoing support for Cayston played an important role in bringing this new therapy to patients," said Bruce Montgomery, M.D., senior vice president, head of Respiratory Therapeutics, Gilead Sciences. "We are thrilled to help meet an urgent medical need for CF patients, and to support the Foundation's mission to improve the lives of people with this terrible disease."

Cayston is administered with a new device called the Altera(R) Nebulizer System that allows patients to take the medicine in less than five minutes, a fraction of the time required for other inhaled antibiotics. This shortened delivery time reduces the burden on patients, who – on average – have a treatment regimen of three-to-four hours per day.