IntelGenx Reports Q1, 2011 Results and Highlights Recent Developments
May 11 2011 - 05:00AM
Marketwired
IntelGenx Technologies Corp. (TSX VENTURE: IGX)(OTCBB: IGXT)
("IntelGenx") today announced its financial results for the three
month period ended March 31, 2011 and highlighted recent business
developments. All amounts are in U.S. dollars, unless otherwise
stated.
"The news that the United States District Court of Delaware had
ruled in our favour regarding claim construction at the Markman
Hearing, and the subsequent dismissal of the Biovail litigation,
was an excellent start to the New Year," commented Dr. Horst G.
Zerbe, President and Chief Executive Officer of IntelGenx. "The
dismissal of the litigation allowed us to make significant advances
in partnership discussions for CPI-300, and we are finalising our
response to address FDA's questions from the Complete Response
Letter, which we plan to submit to the Agency by next week. At the
same time we have continued to make substantial progress with our
VersaFilm technology and have, in the past few months, successfully
completed pilot studies for anti-psychotic and insomnia
products."
RECENT DEVELOPMENTS:
CPI-300 Antidepressant Tablet:
On January 4, 2011, we announced that the United States District
Court of Delaware has ruled in our favour regarding claim
construction for the two patent terms at issue in the patent
infringement action brought forward by Biovail. The ruling arose
from a special proceeding required under U.S. patent law called a
"Markman Hearing" wherein both sides presented to the court their
arguments on how they believe the patent terms at issue should be
interpreted.
On February 3, 2011, we announced that the United States
District Court of Delaware had dismissed the lawsuit against us.
Biovail and IntelGenx agreed to dismissal of the action following
the ruling on the Markman Hearing.
We expect to file the amendment to the NDA in the second quarter
of 2011.
Anti-Psychotic Film:
On February 7, 2011, we announced the completion of a pilot
study that indicates that we have successfully developed a novel
oral film, INT0022, which is likely to be bioequivalent to a
leading anti-psychotic in a pivotal bioequivalency study. INT0022
has been developed using our proprietary immediate release
"VersaFilm" drug delivery technology. According to IMS Health, the
global anti-psychotic market was worth $22.5 billion in 2008.
This was a randomized, two-period, two-way crossover study in
healthy male subjects. The study was designed to determine whether
INT0022 will be bioequivalent to a leading anti-psychotic product
in a pivotal bioequivalency study as measured by industry standard
pharmacokinetic measures, peak plasma concentration (Cmax) and area
under the curve (AUC). The study results indicate that INT0022 will
likely be bioequivalent with the brand product and allow us to
advance the product to the pivotal stage.
Insomnia Film:
Subsequent to the end of the quarter, on April 6, 2011 we
announced the completion of a pilot biostudy indicating that we
have developed a novel oral film, INT0020, that suggests
bioequivalency to a leading branded product for the treatment of
insomnia. INT0020 has been developed using our proprietary
immediate release "VersaFilm" drug delivery technology.
This was a randomized, two-period, two-way crossover study in
healthy male subjects. The study was designed to determine whether
INT0020 is bioequivalent to a leading insomnia product as measured
by industry standard pharmacokinetic measures, peak plasma
concentration (Cmax) and area under the curve (AUC). The study
results indicate that INT0020 should meet acceptance criteria for
bioequivalency for both Cmax and AUC once we decide to advance the
product to the larger pivotal bioequivalency study.
FINANCIAL HIGHLIGHTS:
----------------------------------------------------------------------------
In millions of U.S. $ As of quarter ended As of quarter ended
except Per Share Data March 31, 2011 March 31, 2010
----------------------------------------------------------------------------
Cash Equivalents $0.6 $1.1
----------------------------------------------------------------------------
Revenue $0.1 $0.2
----------------------------------------------------------------------------
Expenses $0.7 $1.0
----------------------------------------------------------------------------
Net Loss $0.6 $0.8
----------------------------------------------------------------------------
Loss Per Share $0.01 $0.02
----------------------------------------------------------------------------
About IntelGenx:
IntelGenx is a drug delivery company focused on the development
of oral controlled-release products as well as novel rapidly
disintegrating delivery systems. IntelGenx uses its unique multiple
layer delivery system to provide zero-order release of active drugs
in the gastrointestinal tract. IntelGenx has also developed novel
delivery technologies for the rapid delivery of pharmaceutically
active substances in the oral cavity based on its experience with
rapidly disintegrating films. IntelGenx' research and development
pipeline includes products for the treatment of pain, hypertension,
erectile dysfunction and depressive disorders. More information is
available about the company at www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about
IntelGenx' operating results and business prospects that involve
substantial risks and uncertainties. Statements that are not purely
historical are forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended, and
Section 27A of the Securities Act of 1933, as amended. These
statements include, but are not limited to, statements about
IntelGenx' plans, objectives, expectations, strategies, intentions
or other characterizations of future events or circumstances and
are generally identified by the words "may," "expects,"
"anticipates," "intends," "plans," "believes," "seeks,"
"estimates," "could," "would," and similar expressions. All forward
looking statements are expressly qualified in their entirety by
this cautionary statement. Because these forward-looking statements
are subject to a number of risks and uncertainties, IntelGenx'
actual results could differ materially from those expressed or
implied by these forward looking statements. Factors that could
cause or contribute to such differences include, but are not
limited to, those discussed under the heading "Risk Factors" in
IntelGenx' annual report on Form 10-K for the fiscal year ended
December 31, 2010, filed with the United States Securities and
Exchange Commission and available at www.sec.gov, and also filed
with Canadian securities regulatory authorities and www.sedar.com.
IntelGenx assumes no obligation to update any such forward-looking
statements.
Each of the TSX Venture Exchange and OTC Bulletin Board has
neither approved nor disapproved the contents of this press
release.
Contacts: IntelGenx Technologies Corp. Dr. Horst G. Zerbe
President and CEO +1 514-331-7440 (ext. 201) +1 514-331-0436 (FAX)
horst@intelgenx.com www.intelgenx.com
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