London, UK--(Marketwire - September 27, 2007) -
For Immediate Release 27 September 2007
ZYFLO CR(TM)(ZILEUTON) EXTENDED-RELEASE TABLETS LAUNCHED IN THE US
LONDON, UK, and Lexington, MA, USA - 27 September 2007 -- SkyePharma PLC (LSE:
SKP) and its US marketing partner, Critical Therapeutics, Inc (Nasdaq: CRTX)
announce the nationwide US launch today of ZYFLO CR(TM)(zileuton)
extended-release tablets for the prevention and chronic treatment of asthma in
adults and children 12 years of age and older.
With a combined 240-person U.S. sales force Critical Therapeutics, and its
co-promotion partner Dey L.P., an affiliate of Merck KGaA, will target
approximately 18,000 allergists, pulmonologists and primary care physicians
throughout the US.
At an analyst day held by Critical Therapeutics on Tuesday 25 September 2007,
the inclusion of zileuton in new guidelines issued by the National Asthma
Education and Prevention Programme (NAEPP) was highlighted by Allan Luskin,
M.D., Clinical Associate Professor of Medicine, University of Wisconsin and
Director of the Respiratory Institute, Dean Medical Center, Madison, Wisconsin,
who spoke to the audience as part of an expert physician panel. Dr Luskin said,
"At least one-third of asthma patients' medications do not provide them with the
necessary relief from their symptoms. The new NAEPP guidelines which now
recommend zileuton as a therapeutic alternative, will be widely distributed
amongst leading respiratory specialists and will incorporate new treatment
options, which may improve clinical control for asthma patients."
ZYFLO CR(TM)and ZYFLO are the only FDA-approved leukotriene synthesis inhibitors
for the prophylaxis and chronic treatment of asthma in adults and children 12
years of age and older. ZYFLO CR(TM)and ZYFLO are not indicated for use in the
reversal of bronchospasm in acute asthma attacks, but can be continued during
acute exacerbations of asthma. Leukotrienes are inflammatory mediators in asthma
that can trigger asthma symptoms, including inflammation, swelling,
bronchoconstriction and mucus secretion.
ZYFLO CR(TM)uses SkyePharma's proprietary Geomatrix(R) drug delivery technology,
which controls the amount and rate of drug released into the body.
Frank Condella, CEO of SkyePharma PLC said: "We are delighted with the launch of
ZYFLO CR(TM)in the US. ZYFLO CR(TM)will provide physicians with an additional
treatment option for the many asthmatics who have not been able to gain
symptomatic control despite their current therapies."
For further information please contact:
SkyePharma PLC
Frank Condella, Chief Executive Officer
Ken Cunningham, Chief Operating Officer +44 207 491 1777
Peter Grant, Finance Director
Financial Dynamics (London enquiries)
David Yates / Deborah Scott +44 207 831 3113
Trout Group (US enquiries)
Christine Labaree / Seth Lewis +1 617 583 1308
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new
formulations of known molecules to provide a clinical advantage and life-cycle
extension. The Company has eleven approved products in the areas of oral,
inhalation and topical delivery. The Group's products are marketed throughout
the world by leading pharmaceutical companies. For more information, visit
www.skyepharma.com.
About Critical Therapeutics
Critical Therapeutics, Inc. is developing and commercializing innovative
products for respiratory, inflammatory and critical care diseases. The Company
owns worldwide rights to two FDA-approved drugs for the prevention and chronic
treatment of asthma in patients 12 years of age and older: twice-daily ZYFLO
CR(TM)(zileuton) extended-release tablets and ZYFLO(R) (zileuton tablets).
Critical Therapeutics is working to develop products for adjunctive use in acute
asthma attacks that lead patients to the emergency room and other urgent care
settings. The Company also is developing therapies directed toward the body's
inflammatory response. Critical Therapeutics is located in Lexington, Mass. For
more information, please visit www.crtx.com.
About ZYFLO CR(TM)and ZYFLO(R)
ZYFLO CR(TM)and ZYFLO(R) (zileuton tablets) are the only FDA-approved
leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of
asthma in adults and children 12 years of age and older. ZYFLO CR(TM)and
ZYFLO(R) are not indicated for use in the reversal of bronchospasm in acute
asthma attacks, but can be continued during acute exacerbations of asthma.
Leukotrienes are inflammatory mediators in asthma that can trigger asthma
symptoms, including inflammation, swelling, bronchoconstriction and mucus
secretion. ZYFLO CR(TM)uses SkyePharma PLC's (LSE: SKP) proprietary
Geomatrix(R) drug delivery technology, which controls the amount and rate of
drug released into the body.
The recommended dose of ZYFLO CR(TM)is two 600 mg extended-release tablets twice
daily, within one hour after morning and evening meals, for a total daily dose
of 2400 mg. The recommended dose of ZYFLO(R) is one 600 mg immediate-release
tablet four times a day for a total daily dose of 2400 mg.
ZYFLO CR(TM)and ZYFLO(R) are contraindicated in patients with active liver
disease or transaminase elevations greater than or equal to three times the
upper limit of normal. A small percentage of patients treated with ZYFLO CRTM
(2.5%) and ZYFLO(R) (1.9%) in placebo-controlled trials showed an increased
release of a liver enzyme known as ALT and bilirubin (an orange or yellowish
pigment in bile). As a result, the level of liver enzymes in patients treated
with ZYFLO CR(TM)and ZYFLO(R) should be measured by a simple blood test. It is
recommended that physicians perform this test before administering ZYFLO CRTM
and ZYFLO(R) and repeat the test on a regular basis while patients are on the
medication. Patients taking ZYFLO CR(TM)and theophylline should reduce the
theophylline dose by 50%. Patients taking ZYFLO CR(TM)and propranolol or
warfarin should be monitored and doses adjusted as appropriate. Most common side
effects associated with the use of ZYFLO CR(TM) and ZYFLO(R) are sinusitis,
nausea and pharyngolaryngeal pain and abdominal pain, upset stomach and nausea,
respectively.
For full prescribing information for ZYFLO CRTM, please visit www.zyflocr.com or
call Critical Therapeutics' toll free telephone number 1-866-835-8216 to request
medical information.
For full prescribing information for ZYFLO(R), please visit www.zyflo.com or
call Critical Therapeutics' toll free telephone number 1-866-835-8216 to request
medical information.
This information is provided by RNS
The company news service from the London Stock Exchange