UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
September 10, 2015
Date of Report (Date of Earliest
Event Reported)
IntelGenx Technologies Corp.
(Exact Name of Registrant as Specified in its Charter)
Delaware |
000-31187 |
870638336 |
(State or other jurisdiction of |
(Commission File |
(IRS Employer Identification |
incorporation) |
Number) |
No.) |
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6425 Abrams, Ville St- Laurent,
Quebec, Canada |
H4S 1X9 |
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(Address of principal executive
offices) |
(Zip Code) |
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Registrant's telephone number, including area code: (514)
331-7440
Check the appropriate box below if the Form 8K fining is
intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the
Securities Act (17CFR230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17CFR 240.14a -12)
[ ] Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b))
[ ] Pre-commencement communication pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c))
Item 8.01 Other Events - News Release
IntelGenx Corp. and RedHill Biopharma Ltd. Announce Positive
Outcome of the Decentralized Procedure for Approval of RIZAPORT in Europe.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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INTELGENX
TECHNOLOGIES CORP. |
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Dated: September 10,
2015 |
By: /s/ Horst G. Zerbe |
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Horst G. Zerbe |
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President and Chief Executive Officer
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IntelGenx Corp. and RedHill
Biopharma Ltd Announce Positive
Outcome of the Decentralized Procedure for Approval
of
RIZAPORTin
Europe.
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The German Federal Institute for Drugs and Medical Devices (BfArM) has
confirmed that the European Marketing Authorization Application (MAA)
submitted for RIZAPORT is approvable under
the European Decentralized Procedure
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IntelGenx and RedHill will submit the final required documentation to
the German and Luxembourg regulatory authorities next week, which is
expected to lead to marketing approval of RIZAPORT
in both countries and, will continue to collaborate to obtain approvals in other Decentralized Procedure (DCP) European territories.
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RIZAPORT, an oral thin film formulation of rizatriptan, presents an
attractive therapeutic alternative for migraine sufferers. The thin
film has a pleasant taste and dissolves rapidly in the mouth without
the need for water. Its pocket size packaging makes it ideal for
migraine sufferers to carry on the go. Patients can also take their medication without further exacerbating nausea, which is an important
factor when selecting a product to treat migraine, according to a
survey of US migraine sufferers conducted by the Brand Institute Inc.
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RedHill and IntelGenx continue to work with the FDA to advance
potential approval of the U.S. New Drug Application (NDA) submitted by the companies.
Saint Laurent, Canada September 10,
2015 IntelGenx Corp.
(TSXV: IGX) (OTCQX: IGXT) and RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE:
RDHL), today announced the positive outcome of the
Decentralized Procedure (DCP) confirming that RIZAPORT is
approvable in Europe.
The announcement follows the issuance of
the Final Assessment Report from the Reference Member State (RMS), the Federal
Institute for Drugs and Medical Devices of Germany (BfArM), and the agreement of
all the Concerned Member States (CMS) in DCP that RIZAPORT is approvable. The regulatory process will now enter its final
phase known as the national licensing phase during which the National Agencies
in the individual countries will issue the marketing licenses that allow
RIZAPORT to be marketed in each country.
"We are very
pleased that RIZAPORT has received a positive recommendation supporting its
approval in key European markets, said Dr.
Horst G. Zerbe, President and CEO of IntelGenx. "This successful milestone is the result of the highly
cooperative effort between IntelGenx and RedHill".
According to the Oral Thin Film
Market, 2015-2025 report from Roots Analysis Business
Research & Consulting, RIZAPORT would be the first oral thin film, bioequivalent to MAXALT® Lingua (rizatriptan
orally disintegrating tablets (ODT) in 5 and 10mg), for the acute treatment of
migraine with or without aura in adults, filed for marketing application in
Europe.
In 2013, the migraine market was estimated
at US $3.1 billion worldwide, with triptans representing 60% of
it, and was
projected to grow to US $5.4 billion by 2023.2
In a survey of US migraine
sufferers conducted by the Brand Institute Inc., Two-thirds (2/3) of the
respondents indicated that they would ask their physicians to switch from their
current formulation, including the oral dissolving tablet (ODT) formulation, to
the thin film when available. The majority of respondents indicated that a
pocket pack is the most convenient package for migraine
sufferers.3
RIZAPORT presents an attractive
therapeutic alternative for migraine sufferers as the thin film dissolves
rapidly in the mouth without the need for water. The thin film has a pleasant
taste and does not have the solid mouth feel of a tablet medication. Its pocket
size packaging makes it ideal for migraine sufferers to carry on the go.
Patients can also take their medication without further exacerbating nausea, one
of the most important attributes when selecting a product to treat migraine
headaches, according to the survey.
IntelGenx and RedHill will continue to
work hard to make RIZAPORT available as soon as possible for patients suffering
from migraine. "Achieving a favorable conclusion
for RIZAPORT in Europe is an important milestone. We believe it is very helpful
for the many patients who would benefit from this treatment. It encourages us to
continue developing new innovative solutions to address unmet medical needs and
to improve patient's convenience" concludes
Dr. Horst G. Zerbe.
IntelGenx and RedHill are actively seeking
commercial partnerships for RIZAPORT worldwide. IntelGenx is also evaluating a
number of drug candidates to add to its development pipeline. For business
development opportunities, please contact us.
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 indications such as
severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS
indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal
health products. More information is available about the company at www.intelgenx.com.
About RedHill Biopharma
Ltd |
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RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) is an emerging
Israeli biopharmaceutical company primarily focused on the development of late
clinical-stage, proprietary, orally-administered, small molecule drugs for the
treatment of inflammatory and gastrointestinal diseases, including cancer.
RedHills current pipeline of proprietary products includes: (i) RHB-105
- an oral combination therapy for the treatment of Helicobacter
pylori infection with successful top-line results from a first Phase III study; (ii)
RHB-104 - an oral combination therapy for the treatment of Crohn's
disease with an ongoing first Phase III study; (iii)
BEKINDA (RHB-102) - a once-daily oral
pill formulation of ondansetron with an ongoing Phase III study in the U.S. for
acute gastroenteritis and gastritis and a European marketing application for
chemotherapy and radiotherapy-induced nausea and vomiting submitted in December
2014; (iv) RHB-106 - an encapsulated bowel preparation licensed to
Salix Pharmaceuticals, Ltd.; (v) YELIVA
(ABC294640) - an orally-administered first-in-class SK2 selective
inhibitor targeting multiple inflammatory, gastrointestinal and oncology
indications with a Phase I/II study initiated for refractory/relapsed diffuse
large B-cell lymphoma (DLBCL); (vi) MESUPRON® - a Phase II-stage first-in-class uPA inhibitor, administered by oral capsule,
targeting gastrointestinal and other solid tumor cancers; (vii) RP101
- currently subject to an option-to-acquire by RedHill, RP101 is a Phase
II-stage first-in-class Hsp27 inhibitor, administered by oral tablet, targeting
pancreatic and other gastrointestinal cancers; (viii)
RIZAPORT (RHB-103) - an oral thin film
formulation of rizatriptan for acute migraines with a U.S. NDA currently under
discussion with the FDA and a European marketing application submitted in
October 2014; and (ix) RHB-101 - a once-daily oral pill
formulation of the cardio drug carvedilol.
Forward-looking
Statements |
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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, 2014, 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.
Neither TSX Venture Exchange nor its
Regulation Services Provider (as that term is defined in policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or accuracy of this
release and the OTCQX has neither approved nor disapproved the contents of this
press release.1
COMPANY CONTACT:
Andre Godin
EVP and Chief Financial Officer
IntelGenx Corp.
T: +1 514-331-7440
andre@intelgenx.com
www.intelgenx.com
1. Roots Analysis Business Research & Consulting, Oral Thin
Film Market, 2015-2025, 2015
2. Migraine 2014, December 2014, Decision
Resources.
3. Brand Institute Inc. (BI ,i.) research for IntelGenx on
proprietary oral rapidly disintegrating thin film formulation of rizatriptan.
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