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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): May 31, 2007
Critical Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware 000-50767 04-3523569
(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
60 Westview Street, Lexington, Massachusetts 02421
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (781) 402-5700
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
|_| Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)
|_| Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12)
|_| Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
|_| Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01. Other Events.
On May 31, 2007, Critical Therapeutics, Inc. (the "Company") announced that the
U.S. Food and Drug Administration (the "FDA") has approved the Company's New
Drug Application for twice-daily 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. ZYFLO CR is not indicated for use in the
reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR can be
continued during acute exacerbations of asthma. The Company, together with its
co-promotion partner Dey, L.P. ("DEY"), expects to begin marketing ZYFLO CR in
the United States in the fall of 2007.
In March 2007, the Company and DEY, an affiliate of Germany-based Merck KGaA,
entered into an agreement for the co-promotion of ZYFLO CR and ZYFLO(R)
(zileuton tablets), the immediate-release formulation of zileuton. DEY's
200-person sales force began promoting ZYFLO on April 30, 2007. Upon the launch
of ZYFLO CR, the Company's and DEY's combined sales force of 240 representatives
will begin promoting ZYFLO CR to approximately 15,000 allergists, pulmonologists
and primary care physicians across the United States.
Forward-Looking Statements
Any statements in this Current Report on Form 8-K about future expectations,
plans and prospects for Critical Therapeutics, Inc., including, without
limitation, statements regarding possible therapeutic benefits, market
acceptance and future sales of ZYFLO CR; the anticipated success of the
co-promotion arrangement with DEY; the progress, timing and success of the
product launch for ZYFLO CR; prospects, plans and objectives of management; 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 market and sell ZYFLO CR, 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; patient, physician and third-party payor acceptance of ZYFLO CR as a safe
and effective therapeutic product; adverse side effects experienced by patients
taking ZYFLO CR; our heavy dependence on the commercial success of ZYFLO CR; our
ability to maintain regulatory approvals to market and sell ZYFLO CR; 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; 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, ZYFLO CR, 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.
In addition, the statements in this Form 8-K reflect the Company's expectations
and beliefs as of the date of this Form 8-K. The Company anticipates that
subsequent events and developments will cause the Company's expectations and
beliefs to change. However, while the Company may elect to update these
forward-looking statements publicly at some point in the future, the Company
specifically disclaims 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 the Company's views as of any date subsequent
to the date of this Form 8-K.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: May 31, 2007 CRITICAL THERAPEUTICS, INC.
By: /s/ Frank E. Thomas
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Frank E. Thomas
President and Chief Executive Officer