01.05.2008 20:17:00
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Critical Therapeutics Signs Definitive Agreement to Merge with Cornerstone BioPharma
Critical Therapeutics, Inc. (NASDAQ: CRTX) and Cornerstone BioPharma
Holdings, Inc., a privately-held company, today announced the signing of
a definitive merger agreement. Cornerstone is a specialty pharmaceutical
company focused on developing and commercializing prescription
medications for respiratory disorders. The stock-for-stock transaction
is targeted to close in the fourth quarter of 2008.
"The merger between Critical Therapeutics and
Cornerstone creates a specialty pharmaceutical company focused on
respiratory diseases,” said Trevor Phillips,
Ph.D., president and chief executive officer of Critical Therapeutics. "It
brings together Cornerstone’s suite of
products marketed to respiratory specialists with Critical Therapeutics’
ZYFLO CRTM (zileuton) extended-release tablets
for the treatment of asthma. After reviewing alternatives during a
strategic review process over the past six months, we believe that the
product synergies created by a merger with Cornerstone offer the best
opportunity to drive stockholder value.”
Craig Collard, Cornerstone’s president and
chief executive officer, said, "We believe
this transaction will allow both companies to maximize the value of our
marketed products and better exploit our commercial resources. We
believe that the critical mass we aim to achieve as a specialty
pharmaceutical company can enhance significantly our standing in the
market.”
The principal commercial assets of the combined company will comprise a
number of marketed products including the following:
ZYFLO CRTM: FDA-approved
ZYFLO CR™ (zileuton) extended-release
tablets, a leukotriene synthesis inhibitor for the prophylaxis 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;
Spectracef®: FDA-approved Spectracef®
(cefditoren pivoxil), a third-generation cephalosporin for the
treatment of pathogens commonly associated with respiratory diseases
in adults and adolescents 12 years of age and older; and
AlleRx®: AlleRx®
Dose Pack family of products used for the temporary relief of symptoms
associated with allergic rhinitis.
Product Development Plans
The combined company’s clinical and
preclinical pipeline will include a number of product candidates. The
combined company will implement a strategic review of its product
development pipeline and is expected to pursue line extensions of
Spectracef® as part of the life cycle plan
for that product with any new products targeted for launch during the
two years following the closing of the transaction. Following the
strategic review, the combined company may seek to maximize the value of
any non-core programs through out-licensing, divestiture or spin-off
transactions.
Details of the Proposed Transaction
The merger will take the form of a stock-for-stock merger intended to
qualify as a tax-free reorganization. Under the terms of the agreement,
all outstanding shares of Cornerstone’s
common stock will be converted into and exchanged for shares of Critical
Therapeutics’ common stock and all
outstanding Cornerstone options and warrants will be assumed by Critical
Therapeutics and become options and warrants to acquire Critical
Therapeutics’ common stock. The merger
agreement provides for Critical Therapeutics to issue in the merger to
Cornerstone stockholders, and assume Cornerstone options and warrants
that will represent, an aggregate of 101.5 million shares of Critical
Therapeutics’ common stock, subject to
adjustment as a result of a reverse stock split to occur in connection
with the closing of the merger. Following the transaction, Cornerstone’s
stockholders will own approximately 70 percent, and Critical Therapeutics’
stockholders will own approximately 30 percent, of the combined company’s
common stock, after giving effect to shares issuable pursuant to
outstanding Cornerstone options and warrants, but without giving effect
to any shares issuable pursuant to outstanding Critical Therapeutics
options and warrants.
The merger agreement has been approved by the Boards of Directors of
both companies and requires approval by the stockholders of Cornerstone.
In addition, Critical Therapeutics’
stockholders are required to approve the issuance of Critical
Therapeutics’ stock to Cornerstone’s
stockholders in the merger. In connection with the execution of the
definitive agreement, Healthcare Ventures and Advanced Technology
Ventures, who together hold approximately 19 percent of the issued and
outstanding common stock of Critical Therapeutics, have entered into
agreements whereby they have agreed to vote their shares in favor of the
merger. In addition, holders of a majority of the shares of Cornerstone’s
issued and outstanding common stock have entered into agreements whereby
they have agreed to vote their Cornerstone shares in favor of the merger
and refrain from selling any of the Critical Therapeutics shares they
receive in the merger for six months following the closing of the
transaction.
In addition to approval by Critical Therapeutics’
and Cornerstone’s stockholders, the closing
of the merger is subject to other customary closing conditions as
detailed in the merger agreement. Critical Therapeutics expects to file
a Form S-4 and related proxy statement/prospectus with the U.S.
Securities and Exchange Commission. Depending on the timing of filing
and effectiveness of the Form S-4, the companies currently target the
closing of the merger in the fourth quarter of 2008. In connection with
the transaction, Critical Therapeutics intends to apply for re-listing
of the combined company’s shares on Nasdaq to
trade under the symbol "CRTX.”
Critical Therapeutics plans to institute a reverse stock split, subject
to stockholder approval, to comply with NASDAQ’s
minimum bid price requirement at the time of the merger.
Lazard is acting as exclusive financial advisor and Wilmer Cutler
Pickering Hale and Dorr LLP is acting as legal counsel to Critical
Therapeutics. Jefferies & Company, Inc. is acting as exclusive financial
advisor and Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan,
L.L.P. is acting as legal counsel to Cornerstone.
Executive Management and Organization
Following the closing of the transaction, Craig Collard, president and
chief executive officer of Cornerstone, will be president and chief
executive officer of the combined company. Brian Dickson, M.D., chief
medical officer of Cornerstone, will be the chief medical officer of the
combined company. Steven Lutz, executive vice president, commercial
operations of Cornerstone, will be executive vice president,
manufacturing and trade of the combined company. George Esgro, vice
president, sales and marketing of Cornerstone, will be vice president,
sales and marketing of the combined company.
Following the closing of the transaction, the combined company’s
Board of Directors is expected to consist of five directors, including
two current Cornerstone directors and three independent directors. The
Chairman of the Board of the combined company is expected to be Alastair
McEwan, who is presently the Chairman of Cornerstone’s
Board.
The combined company will be named Cornerstone Therapeutics Inc. and
will be headquartered at Cornerstone’s
offices in Cary, North Carolina.
Conference Call Information
Critical Therapeutics and Cornerstone will host a joint conference call
to discuss the proposed merger and the combined business and strategic
overview of the merged companies. Interested parties may access the
conference call by way of webcast or telephone.
Date: Friday, May 2, 2008
Time: 9:00 a.m. (eastern)
Dial-in information: (877) 407-5790 (U.S. and Canada)
(201) 689-8328 (International)
Webcast Information: www.crtx.com
A live and archived audio webcast of the conference call will be
available for 30 days in the "Investors”
section of Critical Therapeutics’ website.
From the home page, click on "Investors”
and then click on "Webcasts & Presentations.” About Critical Therapeutics, Inc.
Critical Therapeutics, Inc. is developing and commercializing innovative
products for respiratory, inflammatory and critical care diseases.
Critical Therapeutics 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 CRTM
(zileuton) extended-release tablets and ZYFLO®
(zileuton tablets). 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. 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. Critical Therapeutics is developing products for
acute asthma attacks that lead patients to the emergency room and other
urgent care settings. Critical Therapeutics 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 Cornerstone BioPharma Holdings, Inc.
Cornerstone BioPharma Holdings, Inc., located in Cary, North Carolina is
an emerging specialty pharmaceutical company that is focused on the
development and commercialization of niche prescription medications
marketed to respiratory specialists. Cornerstone is actively engaged in
strategic licensing of additional prescription products through
acquisitions, strategic partnerships and new product development.
Important Additional Information Will be Filed with the SEC
Critical Therapeutics plans to file with the U.S. Securities and
Exchange Commission (SEC) a Registration Statement on Form S-4 and file
with the SEC and mail to its stockholders a Proxy Statement/Prospectus
in connection with the transaction. The Registration Statement and the
Proxy Statement/Prospectus will contain important information about
Critical Therapeutics, Cornerstone, the transaction and related matters.
Investors and security holders are urged to read the Registration
Statement and the Proxy Statement/Prospectus carefully when they are
available.
Investors and security holders will be able to obtain free copies of the
Registration Statement and the Proxy Statement/Prospectus and other
documents filed with the SEC by Critical Therapeutics through the web
site maintained by the SEC at www.sec.gov.
In addition, investors and security holders will be able to obtain free
copies of the Registration Statement and the Proxy Statement/Prospectus
from Critical Therapeutics by contacting Critical Therapeutics, Inc.,
Attn: Chief Financial Officer, 60 Westview Street, Lexington, MA 02421.
Critical Therapeutics, and its directors and executive officers, may be
deemed to be participants in the solicitation of proxies in respect of
the transactions contemplated by the merger agreement. Information
regarding Critical Therapeutics’ directors
and executive officers is contained in Critical Therapeutics’
Annual Report on Form 10-K for the year ended December 31, 2007, as
amended, and its proxy statement dated April 25, 2008, which are filed
with the SEC. As of April 30, 2008, Critical Therapeutics’
directors and executive officers beneficially owned approximately
10,334,319 shares, or 22.9 percent, of Critical Therapeutics’
common stock.
Safe Harbor for Forward-Looking Statements
Statements in this press release regarding the proposed transaction
between Critical Therapeutics and Cornerstone; the expected timetable
for completing the transaction; future financial and operating results,
including targeted product milestones; benefits and synergies of the
transaction; future opportunities for the combined company; the
strategy, future operations, financial position, future revenues and
projected costs; prospects, plans and objectives of management; and any
other statements about the Critical Therapeutics or the Cornerstone
management team’s future expectations,
beliefs, goals, plans or prospects constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995. Any statements that are not statements of historical fact
(including statements containing the words "believes,” "plans,” "could,” "anticipates,” "expects,” "estimates,” "plans,” "should,” "target,” "will,” "would”
and similar expressions) should also be considered to be forward-looking
statements. There are a number of important factors that could cause
actual results or events to differ materially from those indicated by
such forward-looking statements, including: the ability to consummate
the transaction; the ability to successfully integrate our operations
and employees; the ability to realize anticipated synergies and cost
savings; the ability to develop and maintain the necessary sales,
marketing, distribution and manufacturing capabilities to commercialize
our products, including ZYFLO CR; the ability to transition our
management teams effectively; patient, physician and third-party payor
acceptance of our products, including ZYFLO CR, as safe and effective
therapeutic products; our ability to maintain regulatory approvals to
market and sell our products, including ZYFLO CR; the ability to
successfully enter into additional strategic licensing, collaboration or
co-promotion transactions on favorable terms, if at all; Critical
Therapeutics’ potential inability to maintain
compliance with NASDAQ listing requirements; adverse side effects
experienced by patients taking our products; 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; Critical Therapeutics’
ability to obtain the substantial additional funding required to conduct
our development and commercialization activities; Critical Therapeutics’
dependence on its strategic collaboration with MedImmune, Inc.; the
ability to obtain, maintain and enforce patent and other intellectual
property protection for our products, discoveries and drug candidates;
and the other factors described in Critical Therapeutics’
Annual Report on Form 10-K for the year ended December 31, 2007, as
amended, filed with the SEC and other filings that Critical Therapeutics
makes with the SEC. 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 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. Our forward-looking
statements do not reflect the potential impact of any future
acquisitions, mergers, dispositions, business development transactions,
joint ventures or investments we may make. These forward-looking
statements should not be relied upon as representing our views as of any
date after the date of this release.
ZYFLO® is a registered trademark of Critical
Therapeutics, Inc.
ZYFLO CRTM is a trademark of Critical
Therapeutics, Inc.
Spectracef® is a registered trademark of
Meiji Seika Kaisha, Ltd.
AlleRx® is a registered trademark of
Cornerstone BioPharma, Inc.
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