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
November 9, 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.) |
6425 Abrams, Ville St- Laurent, Quebec, Canada |
H4S 1X9 |
(Address of principal executive offices) |
(Zip Code) |
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 and RedHill Biopharma Announce First European
Marketing Approval of RIZAPORT™ for Migraines
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.
INTELGENX TECHNOLOGIES CORP.
Dated: November 9, 2015 |
By: /s/ Andre Godin |
|
------------------- |
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Andre Godin |
|
Vice President and Chief Financial Officer
|
IntelGenx and RedHill Biopharma Announce
First European
Marketing Approval of RIZAPORT
for Migraines
|
The German Federal Institute for Drugs and Medical
Devices (BfArM) has granted national marketing approval for RIZAPORT
for the treatment of acute migraines under the European
Decentralized Procedure (DCP) |
|
|
|
IntelGenx and RedHill continue their close cooperation in
order to obtain approvals in additional European countries and in the
U.S., where a New Drug Application (NDA) was submitted and a Complete
Response Letter received |
|
|
|
IntelGenx and RedHill continue to advance their
activities to secure commercialization partners in Europe, the U.S. and
additional territories |
|
|
|
RIZAPORT, an oral thin film formulation of
rizatriptan for acute migraines, offers an innovative therapeutic
alternative for many migraine patients, primarily patients who suffer from
dysphagia or migraine-related nausea |
Saint-Laurent, Canada November 9, 2015 IntelGenx
Corp. (TSXV: IGX) (OTCQX: IGXT) and RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE:
RDHL), today announced that the Federal Institute for Drugs and Medical Devices
of Germany (BfArM) has granted marketing authorization of RIZAPORTTM
5mg and 10mg, an oral thin film formulation of rizatriptan benzoate for
the treatment of acute migraines.
Over 50 million people in Europe are estimated to be affected
by migraines. Approximately 2 million Europeans are prone to migraine attacks
every day1. The worldwide migraine market is expected to exceed $2
billion in sales in 2016.
The national approval of RIZAPORT in Germany was granted under
the European Decentralized Procedure (DCP), in which Germany served as the
Reference Member State. This authorization is the first national marketing
approval of RIZAPORT. Marketing authorization in Luxemburg, the Concerned
Member State, is expected to follow. IntelGenx and RedHill intend to continue to
work together to obtain national phase approvals in other European DCP
territories.
The European approval of RIZAPORTTM is an important
milestone achieved by IntelGenx and RedHill which reflects our teams strong
capabilities as partners, said Dr. Horst G. Zerbe, President and CEO of
IntelGenx. We are committed to bringing RIZAPORTTM to market as soon
as possible as we believe it will be a beneficial treatment for patients
suffering from migraines. This approval will make RIZAPORTTM the
first oral thin film bioequivalent to Maxalt® Lingua.
_____________________________________
1
World Headache Alliance.
Dr. Zerbe further added, This approval in Europe for
RIZAPORTTM further demonstrates my recent quote last week in our
record third quarter results, that IntelGenx is clearly demonstrating that it is
executing its strategy by advancing its strong product portfolio to become one
of the leading drug delivery companies globally.
Dr. Reza Fathi, Ph.D., RedHills Senior VP R&D, said: We
are very pleased to receive German marketing authorization for RIZAPORT. This
is the first drug in RedHills advanced pipeline to gain marketing approval, a
significant milestone for the Company that reflects our teams commitment and
execution capabilities, as well as the successful cooperation with
IntelGenx.
RIZAPORT, an oral thin film formulation of rizatriptan for the
treatment of acute migraines, offers a potentially attractive therapeutic
alternative for many migraine patients. The RIZAPORT oral thin film has a
pleasant taste and dissolves rapidly in the mouth, without the need for water.
It is a therapeutic alternative for patients suffering from dysphagia
(difficulty swallowing), and patients who suffer from migraine-related nausea,
estimated to be approximately 80% of the total migraine patient
population2. Rizatriptan is considered one of the most effective oral
triptans, a class of molecules that constricts blood vessels in the brain to
relieve swelling and other migraine symptoms.
IntelGenx and RedHill submitted a New Drug Application (NDA) to
the FDA in 2013 seeking marketing approval of RIZAPORT in the U.S. In 2014, the
companies received a Complete Response Letter (CRL) from the FDA which raised
questions primarily related to CMC. It is noted that no deficiency was raised
relating to the safety or bio-equivalence data of RIZAPORT. IntelGenx and
RedHill reported that they believe that FDA approval of the RIZAPORT NDA is
subject to the satisfactory resolution of the remaining CMC questions. IntelGenx
and RedHill continue their cooperative effort to work with the FDA in order to
address and resolve all remaining CMC questions and to secure a compliant source
of the raw material.
About RIZAPORT:
RIZAPORT is a proprietary oral thin film formulation of
rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck
& Co.s Maxalt®. RIZAPORT 5mg and 10mg was approved for marketing in
Germany in October 2015, under the European Decentralized Procedure. A New Drug
Application for RIZAPORT was also filed with the U.S. FDA in 2013 and a CRL was
received in 2014. Rizatriptan is considered one of the most effective oral
triptans, a class of molecules that constricts blood vessels in the brain to
relieve swelling and other migraine symptoms. The worldwide annual sales of
triptans were estimated to have exceeded $870 million in 20143.
RIZAPORT is based on IntelGenx's proprietary VersaFilm technology. It
dissolves rapidly and releases its active ingredient in the mouth, leading to
efficient absorption of the drug through the gastrointestinal tract. The
administration method of the RIZAPORT oral thin film, which does not require
the patient to swallow a pill or consume water, along with its pleasant flavor,
presents a potentially attractive therapeutic alternative for many migraine
patients, including those who suffer from migraine-related nausea, estimated to
be approximately 80% of the total migraine patient population.
______________________________
2
Lipton RB, Buse DC, Saiers J, Fanning KM, Serrano D, Reed ML. (2013) Frequency
and burden of headache- related nausea: results from the American Migraine
Prevalence and Prevention (AMPP) study, Headache.2013
Jan;53(1):93-103.
3 EvaluatePharma 2013 WW annual sales report
About IntelGenx:
IntelGenx is a leading drug delivery company focused on the
development of innovative products based on its proprietary oral drug delivery
technologies.
Established in 2003, the Montreal-based company, listed on the
TSX-V and OTC-QX, develops innovative oral drug delivery solutions based on its
proprietary platform technologies, VersaFilmTM, VersaTabTM
and AdVersaTM.
IntelGenx has developed a broad and diverse product portfolio
addressing unmet market needs and offering lifecycle management opportunities.
FORFIVO XLTM, launched in 2012, is the first and only FDA approved
once-daily bupropion HCI 450mg dose in a single tablet for the treatment of
major depressive disorder.
IntelGenx highly skilled team provides comprehensive
pharmaceuticals services to pharmaceutical partners, including R&D, clinical
monitoring, IP protection, analytical method development and regulatory
services. IntelGenx state-of-the art manufacturing facility, established for the
VersaFilmTM technology platform, supports lab-scale to pilot- and
commercial-scale production, offering full service capabilities to our clients.
More information is available about the company at: www.intelgenx.com.
About RedHill Biopharma Ltd.:
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 oncology, inflammatory
and gastrointestinal 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 tumors; (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 marketing authorization received in
Germany in October 2015; and (ix) RHB-101 - a once-daily oral pill formulation
of the cardio drug carvedilol.
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, 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.
Each of the TSX Venture Exchange and OTCQX has neither
approved nor disapproved the contents of this press release.
Source: IntelGenx Technologies Corp.
For more information, please contact:
Edward Miller
Director, Investor Relations
IntelGenx
Corp.
T: +1 514-331-7440 (ext. 217)
edward@intelgenx.com
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