IntelGenx Technologies Corp. (TSX VENTURE: IGX)(OTCBB: IGXT)
("IntelGenx") today reported its financial results for the fourth
quarter and fiscal year ended December 31, 2010 and provided a
summary of key financial and operational developments. All amounts
are denominated in U.S. dollars, unless otherwise stated.
FISCAL YEAR FINANCIAL HIGHLIGHTS:
Cash and cash equivalents at December 31, 2010 were
approximately $1.1 million compared to approximately $1.5 million
at December 31, 2009.
Net cash provided by financing activities was approximately $2.1
million in fiscal 2010 compared with approximately $2.1 million the
previous year.
Revenue and other income totalled $1.3 million in the year ended
December 31, 2010 compared to $1.3 million in the year ended
December 31, 2009.
Total expenses increased by approximately $1.1 million to $4.4
million in fiscal 2010. The increase includes approximately $1.1
million related to legal expenses incurred in the defense of the
patent infringement lawsuit filed in August 2009 by Biovail
Laboratories SLR ("Biovail") in the U.S. District Court of Delaware
that was subsequently dismissed by the Court on February 3,
2011.
The loss per common share increased by $0.01 to $0.08 in 2010
(2009: loss of $0.07).
"Fiscal 2010 was a defining year for the company. Although we
spent the year under the cloud of the Biovail litigation, we were
unwavering in our belief that this proceeding would end in our
favour. Our perseverance in robustly defending CPI-300 was rewarded
after year-end with a positive outcome from the Markman hearing and
the subsequent dismissal of the case in February 2011. This
decision now paves the way for the imminent submission of our
response to the FDA's Complete Response Letter for CPI-300 which,
in our opinion, should lead to an approval and commercial launch
later this year," commented Dr. Horst G. Zerbe, President and CEO
of IntelGenx.
Dr. Zerbe added, "Although many people will remember fiscal 2010
by the litigation, we believe the most important accomplishment of
the company was the acceleration of our thin film business. We
emerged from this past fiscal year with two film products
successfully tested in man and a third in clinical trials, our
first development partnership for a thin film, and an industry
leading pipeline of future thin film products. Through our work in
the past fiscal year, we are now positioned to push several other
thin films products forward and to expand our development and/or
commercialization partnerships."
Key Developments:
Private Placement Financing:
On August 27, 2010 we announced the closing of a private
placement offering of 6,500,000 units, raising gross proceeds of
CAD$2.6 million.
CPI-300 Antidepressant Tablet:
Background:
CPI-300 is a higher strength of the antidepressant bupropion
HCl, the active ingredient in Wellbutrin XL®.
In April 2009 we submitted a New Drug Application ("NDA") to the
FDA for CPI-300.
In August 2009 Biovail filed suit against us in the U.S.
District Court of Delaware for patent infringement, under the
provisions of the "Hatch-Waxman Act", with respect to Biovail's
U.S. Patent No. 6,096,341.
In January 2010, due to bankruptcy of the former manufacturing
site, we announced a manufacturing site change for CPI-300 and
identified Pillar5 Pharma Inc. ("Pillar5") as the new manufacturing
facility.
In February 2010 we received a Complete Response Letter ("CRL")
from the FDA which lists two main issues which need to be addressed
before obtaining final approval: 1) qualification of Pillar5 as the
commercial manufacturing site and 2) an observed food effect, which
was seen with CPI-300 and the reference product.
In March 2010 the U.S. Patent and Trademark Office issued patent
number US 7,674,479 for CPI-300. The patent will be listed in the
FDA's Orange Book and will provide broad protection for CPI-300
against generic copies.
In May 2010 we acquired from Cary Pharmaceuticals ("Cary"), our
former development partner, Cary's 50% ownership stake in CPI-300
along with all rights to, and interest in, all regulatory aspects,
including the NDA, and we assumed responsibility for the costs
associated therewith.
In June 2010 we met with the FDA to discuss our response to the
CRL, who confirmed that it agrees with the clinical plan that we
proposed to address the previously observed food effect and to
demonstrate bioequivalency of product manufactured at the new
manufacturing site.
Subsequent to the end of fiscal 2010, in January 2011 we learned
that the United States District Court of Delaware had ruled in our
favour regarding the two patent terms at issue in the patent
infringement action brought forward by Biovail.
Subsequent to the end of fiscal 2010, in February 2011 we
learned that the Court had dismissed the lawsuit against us.
Neuropathic Pain Tablet:
Background:
In April 2009 we announced, together with our former development
partner, Cynapsus Therapeutics Inc. (formerly Cannasat Therapeutics
Inc., "Cynapsus"), positive Phase 1b results for INT0010, a buccal
formulation of THC (dronabinol) for the symptomatic management of
Multiple Sclerosis (MS) induced neuropathic pain and chemotherapy
induced nausea.
Progress in fiscal 2010:
In March 2010 we executed a Letter of Intent with Cynapsus under
which we would acquire a fifty-percent ownership stake in, and an
exclusive worldwide license to develop and commercialize,
INT0010.
In November 2010 we acquired exclusive rights to, and ownership
of, INT0010. Under the terms of a royalty based licensing agreement
with PediPharm Ltd., we obtained worldwide rights to US Patent
7,592,328 and all corresponding foreign patents and patent
applications to exclusively develop and further provide
intellectual property protection for INT0010.
In December 2010 we executed a license agreement with Cynapsus,
whereby, for forgiveness of debt and a royalty on future sales of
the product, we acquired full control of, and interest in, INT0010
going forward.
Anti-Migraine Film:
In April 2010 we executed a binding term-sheet with RedHill
Biopharma Ltd., an Israeli corporation ("RedHill"), to co-develop
and license IntelGenx' first oral thin film product based upon our
proprietary VersaFilm technology. The product is intended for the
rapid relief of migraine headaches.
In August 2010 we executed a co-development and
commercialization agreement with RedHill under which RedHill has
obtained certain exclusive worldwide rights to market and sell,
either itself or through a commercial partner, our rapidly
dissolving anti-migraine oral film product. In return, we will
receive upfront, milestone and external development fees totalling
up to $2.1 million from RedHill.
Erectile Dysfunction Film:
In September 2010 we completed a pilot study that indicates that
we have successfully developed a novel oral film, INT007, which is
likely to be bioequivalent, in a pivotal bioequivalency study, to a
leading branded tablet containing a phosphodiesterase type 5
(PDE-5) inhibitor for the treatment of erectile dysfunction. INT007
has been developed using our proprietary immediate release
VersaFilm drug delivery technology.
Anti-Psychotic Film:
Subsequent to the end of the fiscal year, in February 2011 we
completed 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.
VersaFilm Manufacturing:
In January 2010 we formed a strategic alliance with LTS Lohmann
Therapie-Systeme AG ("LTS") for the exclusive manufacturing of
pharmaceutical products developed by us using our VersaFilm drug
delivery technology.
Manufacturing Partnership and Ownership Position in
Manufacturing Facility:
In April 2010 we executed an agreement with Pillar5 Pharma Inc.
("Pillar5") whereby we undertake to use our best efforts to ensure
that distributors of our oral solid dose pharmaceutical products
developed for commercial production be directed to Pillar5 for
purposes of negotiating a manufacturing agreement requiring Pillar5
to manufacture those products. As consideration for this
undertaking, Pillar5 issued 114 voting common shares of Pillar5 to
us, representing 10% of the issued and outstanding shares of
Pillar5. The shares will be held in escrow and are forfeitable by
us until or unless Pillar5 achieves certain revenue targets from
the manufacture of products licensed by us, and are subject to
restrictions on transfer.
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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