08.10.2007 12:30:00
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Critical Therapeutics and Dey, L.P. Launch Perforomist(TM) (Formoterol Fumarate) Inhalation Solution
Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced that the
Company has commercially launched Perforomist™
(formoterol fumarate) Inhalation Solution (Perforomist) with its
marketing partner, Dey, L.P. (DEY), a subsidiary of Mylan Inc.
(NYSE: MYL). Perforomist™ Inhalation
Solution is indicated for long-term, twice-daily maintenance treatment
of bronchoconstriction for emphysema and chronic bronchitis, also known
as Chronic Obstructive Pulmonary Disease (COPD).
Critical Therapeutics and DEY entered into an agreement in June 2007 for
the co-promotion of Perforomist. Under the agreement, Critical
Therapeutics has agreed to provide a minimum number of product details
each month to a targeted group of physicians. In exchange, DEY will pay
Critical Therapeutics a co-promotion fee under a calculation based on
retail sales above a pre-specified forecast of Perforomist, which will
be available nationwide through retail pharmacies, hospitals, long-term
care facilities, and home healthcare companies.
Critical Therapeutics and DEY also co-promote ZYFLO CR™
(zileuton) extended-release tablets, which was approved by the U.S. Food
and Drug Administration (FDA) in May 2007 and launched in September
2007. ZYFLO CR and ZYFLO® (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 and ZYFLO are not indicated for use in
the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO
CR and ZYFLO can be continued during acute exacerbations of asthma.
Critical Therapeutics and DEY are promoting ZYFLO CR, ZYFLO and
Perforomist to a targeted group of approximately 18,000 allergists,
pulmonologists and primary care physicians throughout the United States.
About Perforomist™ Inhalation Solution Indication
Perforomist™ Inhalation Solution
is indicated for the long-term, twice-daily (morning and evening)
administration in the maintenance treatment of bronchoconstriction in
patients with chronic obstructive pulmonary disease (COPD) including
chronic bronchitis and emphysema.
Important Safety Information Perforomist™ Inhalation Solution belongs to
a class of medications known as long-acting beta2-adrenergic
agonists (LABAs). LABAs may increase the risk of asthma-related death.
Data from a large placebo-controlled US study comparing the safety of
another LABA (salmeterol) or placebo added to usual asthma therapy
showed an increase in asthma-related deaths in patients receiving
salmeterol. This finding with salmeterol may apply to formoterol (a
LABA), the active ingredient in Perforomist™
Inhalation Solution.
Perforomist™ Inhalation Solution should not
be used in patients with acutely deteriorating COPD or to treat acute
symptoms. Acute symptoms should be treated with fast-acting rescue
inhalers. Perforomist™ Inhalation Solution
should not be used with other medications containing LABAs. Do not use
more than one nebule twice daily. Perforomist™
Inhalation Solution should be used with caution in patients with
cardiovascular disorders. Perforomist™
Inhalation Solution is not a substitute for inhaled or oral
corticosteroids. The safety and efficacy of Perforomist™
Inhalation Solution in asthma has not been established.
In COPD clinical trials, the most common adverse events reported with
Perforomist™ Inhalation Solution were
diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and
insomnia.
Please see full Prescribing Information, including Boxed Warning, at www.perforomist.com or call 800-755-5560 and ask for Customer Service.
About COPD
COPD refers to a number of chronic lung disorders in which the airways
to the lungs become narrowed and breathing becomes increasingly
difficult. The most common forms of COPD are chronic bronchitis and
emphysema, and many patients suffer from a combination of the two
diseases.
COPD is the fourth leading cause of death in America, behind heart
disease, cancer and stroke. Twelve million Americans have been diagnosed
with COPD and at least another 12 million have symptoms but are not
diagnosed. COPD is not well understood or recognized –
most Americans have not heard of it, not even those who may be living
with the condition. The most common cause of COPD is cigarette smoking,
which is responsible for an estimated 80 to 90 percent of COPD cases.
Estimates of the total incidence of COPD in America range from 24 to 30
million.
About Nebulization
Of the three types of devices used to deliver bronchodilators –
nebulizers, metered-dose inhalers, and dry powder inhalers – nebulizers require no special technique or coordination, as the
medication is converted into a fine mist that the patient inhales
through a mouthpiece or face-mask while breathing naturally. Because
nebulization is an easy, effective, and thorough method of delivering
medicine directly into the lungs, many COPD patients ask for it,
particularly as their symptoms worsen.
With Perforomist™ Inhalation Solution,
nebulization may become a more widely used treatment option for many
COPD patients at earlier treatment stages who could benefit from
twice-daily maintenance dosing of a nebulized LABA such as Perforomist™
Inhalation Solution. For example, this new COPD treatment may be a
valuable clinical option for many patients who are not adequately
controlled with short-acting bronchodilators.
About ZYFLO CR and ZYFLO
ZYFLO CR 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 and ZYFLO are not
indicated for use in the reversal of bronchospasm in acute asthma
attacks. Therapy with ZYFLO CR and ZYFLO can be continued during acute
exacerbations of asthma.
The recommended dose of ZYFLO CR 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 is one 600 mg
immediate-release tablet four times a day for a total daily dose of 2400
mg.
ZYFLO CR and ZYFLO 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 CR (2.5%) and ZYFLO (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 and ZYFLO should be measured
by a simple blood test. It is recommended that physicians perform this
test before administering ZYFLO CR and ZYFLO and repeat the test on a
regular basis while patients are on the medication. Patients taking
ZYFLO CR and theophylline should reduce the theophylline dose by 50%.
Patients taking ZYFLO CR and propranolol or warfarin should be monitored
and doses adjusted as appropriate. Most common side effects associated
with the use of ZYFLO CR and ZYFLO are sinusitis, nausea and
pharyngolaryngeal pain and abdominal pain, upset stomach and nausea,
respectively.
For full prescribing information for ZYFLO CR, please visit www.zyflocr.com
or call the Company's toll free telephone number 1-866-835-8216 to
request medical information.
For full prescribing information for ZYFLO, please visit www.zyflo.com
or call the Company's toll free telephone number 1-866-835-8216 to
request medical information.
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™ (zileuton)
extended-release tablets and ZYFLO® (zileuton
tablets). Critical Therapeutics is developing products for 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.
Critical Therapeutics' Forward-Looking Statements
Any statements in this press release about future expectations, plans
and prospects for Critical Therapeutics, Inc., including, without
limitation, statements regarding the anticipated success of our
co-promotion arrangements with DEY, including with respect to Perforomist™
Inhalation Solution; possible therapeutic benefits, market acceptance,
and future sales of Perforomist, ZYFLO CR and ZYFLO; future payments
from DEY under our co-promotion arrangement for Perforomist; the future
use of nebulization as a treatment option for COPD patients; and all
other statements that are not purely historical in nature, constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Without limiting the
foregoing, the words "anticipate," "believe," "could," "estimate,"
"expect," "intend," "may," "plan," "project," "should," "will," "would"
and similar expressions are intended to identify forward-looking
statements. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including risks and uncertainties relating to: our ability to
successfully promote Perforomist pursuant to our co-promotion
arrangement with DEY; our ability to successfully market and sell ZYFLO
CR, ZYFLO and Perforomist, including the success of our co-promotion
arrangement with DEY; our ability to develop and maintain the necessary
sales, marketing, distribution and manufacturing capabilities to
commercialize ZYFLO CR and ZYFLO; patient, physician and third-party
payor acceptance of ZYFLO CR and ZYFLO as safe and effective therapeutic
products; adverse side effects experienced by patients taking ZYFLO CR
and ZYFLO; our heavy dependence on the commercial success of ZYFLO CR
and ZYFLO; our ability to maintain regulatory approvals to market and
sell ZYFLO CR and ZYFLO; our ability to successfully enter into
additional strategic co-promotion, collaboration or licensing
transactions on favorable terms, if at all; conducting clinical trials,
including difficulties or delays in the completion of patient
enrollment, data collection or data analysis; the results of preclinical
studies and clinical trials with respect to our products under
development and whether such results will be indicative of results
obtained in later clinical trials; our ability to obtain the substantial
additional funding required to conduct our research, development and
commercialization activities; our dependence on our strategic
collaboration with MedImmune, Inc.; and our ability to obtain, maintain
and enforce patent and other intellectual property protection for ZYFLO
CR and ZYFLO, our discoveries and our drug candidates. These and other
risks are described in greater detail in the "Risk Factors" section of
our most recent Quarterly Report on Form 10-Q and other filings that we
make with the Securities and Exchange Commission. If one or more of
these factors materialize, or if any underlying assumptions prove
incorrect, our actual results, performance or achievements may vary
materially from any future results, performance or achievements
expressed or implied by these forward-looking statements.
The statements in this press release reflect our expectations and
beliefs as of the date of this release. We anticipate that subsequent
events and developments will cause our expectations and beliefs to
change. However, while we may elect to update these forward-looking
statements publicly at some point in the future, we specifically
disclaim any obligation to do so, whether as a result of new
information, future events or otherwise. These forward-looking
statements should not be relied upon as representing our views as of any
date subsequent to the date of this release.
ZYFLO® is a registered trademark of Critical
Therapeutics, Inc.
ZYFLO CR™ is a trademark of Critical
Therapeutics, Inc.
Perforomist™ is a trademark of Dey, L.P.
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