IntelGenx Submits New Drug Application for Anti-Migraine VersaFilm(TM)
SAINT LAURENT, Quebec, March 27, 2013 (GLOBE NEWSWIRE) -- IntelGenx Corp.
(TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx" or the "Company"), a Canadian drug
delivery company focusing on oral drug delivery, today announced that,
together with its co-development partner RedHill Biopharma ("RedHill"), it has
submitted a 505(b)(2) New Drug Application ("NDA") to the U.S. Food and Drug
Administration ("FDA") for the Company's anti-migraine oral film product, a
novel oral thin-film formulation based on its proprietary VersaFilm™
technology containing Rizatriptan, the active drug in Merck's Maxalt-MLT®
orally disintegrating tablets.
The company had previously announced a successful a pre-NDA meeting with the
FDA following the successful completion of a bioequivalency study
demonstrating that its oral film product is bioequivalent with Maxalt MLT®, a
leading branded anti-migraine product manufactured by Merck & Co. According to
Merck's most recent annual report, sales of Maxalt® were $638 million in 2012.
The thin-film formulation of Rizatriptan has been developed in accordance with
the co-development and commercialisation agreement with RedHill Biopharma Ltd.
(Nasdaq:RDHL) (TASE:RDHL) using IntelGenx' proprietary immediate release
"VersaFilm™" drug delivery technology.
IntelGenx' orally disintegrating film consists of a thin (30 – 50 µm)
polymeric film which disintegrates rapidly upon oral administration, thereby
releasing the active drug Rizatriptan and making it available for rapid
absorption. The film does not require water for administration.
On announcing the news, IntelGenx' President and CEO Dr. Horst Zerbe commented
"We are very excited with this filing as we believe that our Rizatriptan film
is the first oral film product for the treatment of migraine for which a
505(b)(2) NDA has been submitted to FDA. We believe that the product has
significant market potential as it is therapeutically equivalent to
Maxalt-MLT® orally disintegrating tablets, is easy to use, and offers
significant cost advantages over orally disintegrating tablets due to the fact
that manufacturing costs of orally disintegrating tablets are generally higher
than those of orally disintegrating films as they often require lyophilization
of the drug and a complicated, and therefore very expensive, packaging
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' development pipeline includes
products for the treatment of severe depression, hypertension, erectile
dysfunction, benign prostatic hyperplasia, migraine, insomnia, idiopathic
pulmonary fibrosis, allergies and pain management. 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, 2012, 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 OTCQX has neither approved nor
disapproved the contents of this press release.
CONTACT: Dr. Horst G. Zerbe,
President and CEO
IntelGenx Technologies Corp.
T: +1 514-331-7440 (ext. 201)
F: +1 514-331-0436
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