IntelGenx and Aquestive Therapeutics Enter Worldwide Collaboration Agreement for Tadalafil
May 08 2019 - 7:00AM
IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leading
oral drug delivery company, today announced that it has entered
into a definitive worldwide agreement with Aquestive Therapeutics,
Inc. (NASDAQ:AQST) (“Aquestive”), a specialty pharmaceutical
company focused on developing and commercializing differentiated
products to solve therapeutic problems, for the co-development and
commercialization of Tadalafil oral films (the “Agreement”) for the
treatment of erectile dysfunction (“ED”).
Under the terms of the Agreement, IntelGenx and
Aquestive will each grant to the other exclusive worldwide licenses
to their respective intellectual property relating to tadalafil
oral film formulation and manufacturing. The companies will jointly
undertake further co-development and commercialization of Tadalafil
oral film products, and will equally share (50/50) net profits from
worldwide product sales. In connection with the Agreement,
Aquestive has also granted a non-exclusive, royalty bearing U.S.
license to any of its intellectual property that may relate to the
formulation and manufacturing of IntelGenx’s rizatriptan oral film
product, RIZAPORT®. IntelGenx will pay Aquestive a royalty equal to
10% of all payments received by IntelGenx from third parties for
U.S. product related milestones and sales
“We are pleased to collaborate with Aquestive
given the synergy of our oral film technologies, particularly
pertaining to the development and commercialization of tadalafil
oral films,” said Dr. Horst G. Zerbe, President and CEO of
IntelGenx. “The launch of a partnered tadalafil oral film in the
U.S. has the potential to bring a product to market sooner and
maximize the commercial opportunity for IntelGenx, Aquestive, and
our respective shareholders.”
“IntelGenx is a natural partner for our
tadalafil oral film program,” said Dan Barber, Chief Operating
Officer of Aquestive. “This partnership will allow us to continue
to stay focused on advancing our commercial portfolio and late
stage CNS programs, while working with IntelGenx to realize the
full potential for tadalafil oral film on a global basis. We are
also pleased to provide access to our extensive intellectual
property portfolio for IntelGenx’s RIZAPORT® product.”
Aquestive previously submitted new drug
application (“NDA”) for its tadalafil oral film for the treatment
of ED to the U.S. Food and Drug Administration (“FDA”). In November
2018, Aquestive received a complete response letter (“CRL”) from
the FDA requesting limited additional data from healthy volunteers.
Under the terms of the Agreement, both companies will cooperate in
responding to the FDA’s CRL.
About Aquestive
Therapeutics
Aquestive Therapeutics is a specialty
pharmaceutical company that applies innovative technology to solve
therapeutic problems and improve medicines for patients. Aquestive
is advancing a late-stage proprietary product pipeline to treat CNS
conditions and provide alternatives to invasively-administered
standard of care therapies. The company also collaborates with
pharmaceutical partners to bring new molecules to market using
proprietary, best-in-class technologies, like PharmFilm®, and has
proven capabilities for drug development and commercialization. For
more information about the company, please visit
www.aquestive.com.
About IntelGenx
Established in 2003, IntelGenx is a leading oral
drug delivery company primarily focused on the development and
manufacturing of innovative pharmaceutical oral films based on its
proprietary VersaFilm™ and VetaFilm™ technology platforms.
IntelGenx's highly skilled team provides
comprehensive pharmaceuticals services to pharmaceutical partners,
including R&D, analytical method development, clinical
monitoring, IP and regulatory services. IntelGenx's
state-of-the-art manufacturing facility, which was established for
oral film technology platforms, offers by supporting lab-scale to
pilot- and commercial-scale production. More information about the
company can be found at www.intelgenx.com.
Forward Looking Statements
This document may contain forward-looking
information about IntelGenx's 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's 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's 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's annual report on Form
10-K, filed with the United States Securities and Exchange
Commission and available at www.sec.gov, and also filed with
Canadian securities regulatory authorities at 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. Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Source: IntelGenx Technologies Corp.
For IntelGenx
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
stephen@intelgenx.com
Or
Andre Godin, CPA, CA
Executive Vice-President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
For Aquestive
Media inquiries:
Christopher Hippolyte
212-364-0458
christopher.hippolyte@syneoshealth.com
Investor inquiries:
Stephanie Carrington
646-277-1282
stephanie.carrington@icrinc.com
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