Gilead Sciences, Inc. (Nasdaq: GILD) today announced that its
head-to-head Phase III clinical trial of Cayston® (aztreonam for
inhalation solution) versus tobramycin inhalation solution (TIS) in
cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P.
aeruginosa) achieved one of its co-primary endpoints of
non-inferiority for mean percent change in forced expiratory volume
in one second (FEV1) percent predicted after 28 days of treatment.
Patients receiving Cayston had a mean increase in FEV1 percent
predicted from baseline to Day 28 of 8.35 percent compared to 0.55
percent for patients receiving TIS, which meets the statistical
definition of superiority. Safety results were similar across both
arms of the study, with lower incidence of cough in patients
receiving Cayston. These data were presented during a late-breaker
oral session today at the 33rd European Cystic Fibrosis Conference
(ECFC) in Valencia, Spain.
In the study, 268 patients were randomized to receive Cayston or
TIS over a 24-week treatment period. Approximately 85 percent of
patients in the study had received at least three courses of
inhaled tobramycin in the 12 months prior to randomization. Final
six-month study results will become available for presentation at a
scientific conference later this year.
“Inhaled antibiotic therapy has become the standard of care for
treatment of chronic pseudomonal infection in people living with
cystic fibrosis,” said Tacjana Pressler,
MD, DSc, Copenhagen Cystic Fibrosis Center, National
University Hospital, Copenhagen, Denmark. “As new inhaled
antibiotic treatment options such as Cayston emerge, it is
important that we have head-to-head clinical trial data comparing
different treatment approaches. Results from this study suggest
that Cayston may represent an important advance in anti-pseudomonal
therapy for cystic fibrosis patients.”
Cayston was approved by the U.S. Food and Drug Administration
(FDA) in February 2010 and by the Australian Therapeutic Goods
Administration (TGA) in January 2010. Cayston received conditional
marketing authorizations in the European Union (EU) and Canada in
September 2009. These conditional approvals are contingent upon
results from this Phase III study. Gilead plans to begin submitting
data from this study to regulatory agencies later this year.
“Given the chronic nature of pseudomonal infection and the
potential for antibiotic resistance, it is important that cystic
fibrosis patients have multiple treatment options,” said Norbert W.
Bischofberger, PhD, Gilead’s Executive Vice President, Research and
Development and Chief Scientific Officer. “This head-to-head study,
along with other pipeline programs such as our ongoing Phase IIIb
study in cystic fibrosis patients with Burkholderia cepacia,
underscores Gilead’s commitment to developing new treatments for
cystic fibrosis and other serious respiratory conditions
representing significant unmet medical need.”
About Study
205-0110
Study 205-0110 is an open-label, multicenter, randomized,
parallel group study designed to assess the comparative safety and
efficacy of Cayston and TIS in adult and pediatric cystic fibrosis
patients with P. aeruginosa. Of the 273 adult and pediatric
patients enrolling at investigative sites across Europe and the
United States, 268 patients were randomized to receive 28-day,
intermittent, repeating courses of either Cayston (n=136) or TIS
(n=132) over a 24-week treatment period. The co-primary endpoints
were non-inferiority of Cayston for mean percent change in FEV1
percent predicted at Day 28 compared to baseline and superiority of
Cayston for mean change in FEV1 percent predicted across three
treatment cycles (six months).
The mean age of patients in the trial was 25.5 years, with 59
patients (22 percent) younger than 18 years of age. At baseline,
the mean percent predicted FEV1 was 52.3 percent for the Cayston
group and 52.2 percent for the TIS group. The mean respiratory
symptoms scores, as assessed by the Cystic Fibrosis
Questionnaire-Revised (CFQ-R), a patient-reported outcome tool
(PRO) that measures health-related quality of life in cystic
fibrosis patients, were 62.9 and 58.0 for the Cayston and TIS
groups, respectively, at baseline. A total of 115 and 113 patients
in the Cayston and TIS groups, respectively, had received at least
three courses of inhaled tobramycin in the 12 months prior to
randomization.
Patients receiving Cayston had a mean increase from baseline to
Day 28 in FEV1 percent predicted of 8.35 percent compared to 0.55
percent for those receiving TIS, a treatment difference of 7.8
percent (p=0.0001; 95 percent CI: 3.86, 11.73). Mean changes in the
CFQ-R respiratory symptoms score from baseline at Day 28 were 8.02
for Cayston and 2.49 for TIS, a treatment difference of 5.53
(p=0.005; 95 percent CI: 1.65, 9.41). Treatment differences between
Cayston and TIS in FEV1 and on the CFQ-R respiratory symptoms scale
were greater in the subpopulation of patients who had received at
least three courses of inhaled tobramycin over the 12 months prior
to randomization.
The most common adverse events reported over 28 days of
treatment with Cayston or TIS, respectively, were cough (24 percent
vs. 35 percent), productive cough (10 percent vs. 18 percent), sore
throat (7 percent vs. 5 percent), hemoptysis (coughing up of blood
or blood-stained sputum, 5 percent vs. 6 percent) and rales
(crackling sounds made by the lungs during inhalation, 4 percent
vs. 8 percent).
About Cystic
Fibrosis
CF is a chronic, debilitating genetic condition that affects the
respiratory and digestive systems of approximately 70,000 people
worldwide. 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.
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
the FDA for intravenous administration.
Cayston is administered three times a day for a 28-day course,
followed by at least 28 days off of Cayston therapy. Patients
should use a bronchodilator before administration of Cayston.
Cayston is administered by inhalation and should only be used with
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.
In the EU, Cayston is referred to as aztreonam lysine 75 mg
powder for nebuliser solution and can only be used with the Altera
Nebuliser System or with the Altera Nebuliser Handset (including
the Altera Aerosol Head) connected to a universal eFlow Technology
controller (e.g., eBase Controller or eFlow®rapid Control Unit).
For full Cayston EU prescribing information, please consult the
European Summary of Product Characteristics (SmPC).
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. Altera is a drug-specific nebulizer system and its
Instructions for Use specify that it is only to be used with
Cayston. Altera is not an ultrasonic nebulizer and it is not a
general purpose electronic aerosol generator nebulizer. No
medication other than Cayston should be used in the
Altera Nebulizer System.
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 U.S. Prescribing
Information
Cayston is approved as a treatment to improve respiratory
symptoms in cystic fibrosis (CF) patients with P. aeruginosa.
Cayston’s safety and efficacy have not been established in
pediatric patients below the age of 7, patients with FEV1 of less
than 25 percent or greater than 75 percent predicted, or patients
colonized with Burkholderia cepacia.
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, respectively, 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 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 risks related to Gilead’s ability to submit data from
the clinical study to the regulatory authorities in the timelines
currently anticipated. In addition, there is a risk that the
results from the clinical study may be inadequate to support full
regulatory approval of Cayston in jurisdictions where conditional
marketing approval was granted, such as the European Union and
Canada. 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. Gilead directs readers to its
Quarterly Report on Form 10-Q for the quarter ended March 31, 2010.
Gilead claims the protection of the Safe Harbor contained in the
Private Securities Litigation Reform Act of 1995 for
forward-looking statements. 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.
In Europe, for medical information
about Cayston or to obtain the European Summary of Product
Characteristics, please contact Gilead’s EU Medical Information
department at intlmed.info@gilead.com.
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