FDA Approves Cayston

U.S. Food and Drug Administration Approves Cayston (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa

FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb 23, 2010 - Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston (aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa). Cayston's safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second (FEV1) of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

Cayston is administered at a dose of 75 mg three times daily over a 28-day period and is delivered via the Altera® Nebulizer System, a portable, drug-specific delivery device using the eFlow® Technology Platform, developed by PARI Pharma GmbH. PARI Pharma also contributed to the development of Cayston's drug formulation for delivery with the Altera Nebulizer System. Cayston will be available in the United States by the end of next week through certain specialty pharmacies.

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, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. We look forward to making Cayston available to the cystic fibrosis community as soon as possible.

CF is a chronic, debilitating genetic condition that affects the respiratory and digestive systems of approximately 70,000 people worldwide, including 30,000 people in the United States. Chronic respiratory tract infection with P. aeruginosa contributes to the decline in pulmonary function, which is often associated with morbidity and mortality among CF patients.

Since its founding in the 1950s, the Cystic Fibrosis Foundation has worked to advance the care and treatment of cystic fibrosis and we are pleased with the progress to date, said Robert J. Beall, PhD, President and Chief Executive Officer, Cystic Fibrosis Foundation. However, a significant need for new treatments remains for people with cystic fibrosis, particularly for those with chronic pseudomonal infection. As the first new inhaled antibiotic approved for use in cystic fibrosis in more than a decade, Cayston therefore represents an important therapeutic option in the care of patients with cystic fibrosis.

Cayston received conditional marketing authorizations in the European Union and Canada in September 2009 and was approved in Australia in January 2010. Applications for marketing approval of Cayston are currently pending in Switzerland and Turkey.

Reimbursement and Access to Care

Gilead also announced today the establishment of a program designed to minimize barriers to access for Cayston for uninsured, privately insured and government-insured people with cystic fibrosis.

Additionally, Gilead is launching the Cayston® Access Program, a call center developed with Cystic Fibrosis Foundation Pharmacy, LLC, a wholly owned subsidiary of the Cystic Fibrosis Foundation. The program will assist people with cystic fibrosis and members of their care team with insurance verification, referral to participating specialty pharmacies, claims support and co-pay assistance. For information about the Cayston Access Program, call 1-877-7CAYSTON (877-722-9786) or visit www.cayston.com.

About Cayston

Cayston (aztreonam for inhalation solution) 75 mg is an inhaled antibiotic for patients with cystic fibrosis who have P. aeruginosa. Aztreonam has potent in vitro activity against gram-negative aerobic pathogens including P. aeruginosa. Cayston contains aztreonam formulated with lysine, a proprietary formulation of aztreonam developed specifically for inhalation. Aztreonam formulated with arginine has previously been approved by FDA for intravenous administration.

Cayston is administered three times a day for a 28-day course, followed by 28 days off of Cayston therapy. Cayston is administered by inhalation and should only be used with an Altera Nebulizer System. Patients should use a bronchodilator before administration of Cayston.

About the Altera Nebulizer System and eFlow Technology

Cayston is administered by inhalation using the Altera Nebulizer System, an inhalation delivery device optimized specifically for use with Cayston. Cayston should only be administered with the Altera Nebulizer System. Cayston should not be mixed with any other drugs in the Altera Nebulizer Handset. Altera Nebulizer Systems are consistent with the specifications of the customized eFlow Nebulizer System used exclusively in all Cayston clinical trials.

The Altera Nebulizer System uses eFlow Technology to enable aerosolization of medication via a vibrating, perforated membrane that has thousands of small holes to produce the aerosol mist. The Altera Nebulizer System and eFlow Technology are proprietary to PARI Pharma.

Important Safety Information

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cayston and other antibacterial drugs, Cayston should only be used to treat patients with CF known to have P. aeruginosa in the lungs.

Cayston is contraindicated in patients with a known allergy to aztreonam.

Severe allergic reactions have been reported following administration of aztreonam for injection to patients with no known history of exposure to aztreonam. In addition, allergic reaction with facial rash, facial swelling and throat tightness was reported with Cayston in clinical trials. If allergic reaction to Cayston does occur, stop administration of Cayston and initiate treatment as appropriate.

Caution is advised when administering Cayston to patients if they have a history of beta-lactam allergy, although patients with known beta-lactam allergy have received Cayston in clinical trials and no severe allergic reactions were reported. A history of allergy to beta-lactam antibiotics such as penicillins, cephalosporins, and/or carbapenems may be a risk factor, since cross-reactivity may occur.

Bronchospasm is a complication associated with nebulized therapy, including Cayston. Reduction of 15 percent or more of FEV1 immediately following administration of study medication after pretreatment with a bronchodilator was observed in 3 percent of patients treated with Cayston.

In clinical trials, patients with increases in FEV1 during a 28-day course of Cayston were sometimes treated for pulmonary exacerbations when FEV1 declined after the treatment period. Healthcare providers should consider a patient's baseline FEV1 measured prior to Cayston therapy and the presence of other symptoms when evaluating whether post-treatment changes in FEV1 are caused by a pulmonary exacerbation.

Prescribing Cayston in the absence of known P. aeruginosa infection in patients with CF is unlikely to provide benefit and increases the risk of development of drug-resistant bacteria.

Adverse reactions occurring in more than 5 percent of patients treated with Cayston compared to placebo in Phase III studies were cough (54 percent versus 51 percent), nasal congestion (16 percent versus 12 percent), wheezing (16 percent versus 10 percent), pharyngolaryngeal pain (12 percent versus 11 percent), pyrexia (13 percent versus 6 percent), chest discomfort (8 percent versus 6 percent), abdominal pain (7 percent versus 5 percent) and vomiting (6 percent versus 4 percent).

About PARI Pharma

PARI Pharma focuses on the development of aerosol delivery devices and comprehensive inhalation drug development to advance aerosol therapies where drug and device can be optimized together. Based on PARI's 100-year history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration customized with advanced delivery platforms, such as eFlow (lower respiratory) and Vibrent (upper respiratory) Technologies. PARI Pharma partners with pharmaceutical companies to develop new or improved therapies. PARI Pharma has several clinical development programs ongoing, either partnered or on its own, for cystic fibrosis, asthma, chronic obstructive pulmonary disease, respiratory syncytial virus (RSV) infection, and treatments for lung transplant patients among other indications. More information is available at www.paripharma.com.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that physicians may not see advantages of Cayston over other therapies and may therefore be reluctant to prescribe the product. In addition, safety issues may arise or the results from the clinical study may be otherwise inadequate to support full regulatory approval of Cayston in jurisdictions where conditional marketing approval was granted, such as the European Union and Canada. Further, Gilead may not obtain marketing approval of Cayston in Switzerland and Turkey, where applications are also pending. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the third quarter ended September 30, 2009, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Full U.S. prescribing information for Cayston is available at www.cayston.com.

Cayston is a registered trademark of Gilead Sciences, Inc.

For more information on Gilead, please call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com.

Contact: Gilead Sciences, Inc. Patrick O'Brien, 650-522-1936 (Investors) Cara Miller, 650-522-1616 (Media)

Posted: February 2010

Related Articles:

Cayston (aztreonam lysine) FDA Approval History

View comments

Hide
(web3)