Current Report Filing (8-k)
December 06 2017 - 8:19AM
Edgar (US Regulatory)
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
December 5, 2017
Date of Report (Date of Earliest Event
Reported)
IntelGenx Technologies Corp.
(
Exact Name of Registrant as Specified in its Charter)
Delaware
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000-31187
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870638336
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(State or other jurisdiction of
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(Commission File
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(IRS Employer Identification
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incorporation)
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Number)
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No.)
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6420 Abrams, Ville St- Laurent, Quebec, Canada
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H4S 1Y2
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(Address of principal executive offices)
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(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 1.02
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Termination of a Material Definitive
Agreement.
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On December 5, 2017, IntelGenx Corp. (the Company), a wholly
owned subsidiary of IntelGenx Technologies Corp., announced it has received
notice that RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange:
RDHL) (RedHill) intends to terminate its agreement with the Company for the
co-development and commercialization of RIZAPORT®. The termination notice
follows receipt of a communication by the U.S. Food and Drug Administration
(FDA) indicating that, based on an initial review of the 505(b)(2) New Drug
Application (NDA) resubmission for RIZAPORT® 10 mg, the Agency will require
additional information before the NDA resubmission is deemed complete and
permitted a full review. The questions raised by the FDA, which triggered the
current resubmission, primarily related to third party chemistry, manufacturing
and controls, and the packaging and labeling of the product. The FDA raised no
questions or deficiencies relating to RIZAPORT®s safety and bio-equivalence
data and did not require additional clinical trials.
On December 5, 2017, the Company issued a press release
attached hereto as Exhibit 99.1
The information furnished pursuant to this Item 8.01, including
Exhibit 99.1, shall not be deemed filed for purposes of Section 18 of the
United States Securities Exchange Act of 1934, as amended (the Exchange Act),
or otherwise subject to the liabilities under that Section and shall not be
deemed to be incorporated by reference into any filing under the United States
Securities Act of 1933, as amended, or the Exchange Act, except as expressly set
forth by specific reference in such filing
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: December 6, 2017
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/s/
Horst G. Zerbe
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Horst G. Zerbe
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President and Chief Executive Officer
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