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
Date of
report (Date of earliest event reported): November 22, 2017
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CORMEDIX
INC.
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(Exact
Name of Registrant as Specified in Charter)
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Delaware
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001-34673
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20-5894890
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(State
or Other Jurisdictionof Incorporation)
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(CommissionFile
Number)
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(IRS
EmployerIdentification No.)
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400
Connell Drive, Suite 5000, Berkeley Heights, NJ
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07922
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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: (908) 517-9500
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(Former
Name or Former Address, If Changed Since Last Report)
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Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2.
below):
☐
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
☐
Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
☐
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
Indicate
by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of
1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01. Other Events.
On
November 22, 2017, the Opposition Division at the European Patent
Office (EPO) in Munich, Germany held an oral hearing to consider an
opposition brought by TauroPharm GmbH against CorMedix’s
European Patent EP 1,814,562 B1, also known as the Prosl European
Patent, alleging that it lacks novelty and inventive step. The
Prosl European Patent covers the formulation of taurolidine and
citrate with low dose heparin in a catheter lock solution for
maintaining patency and preventing infection in hemodialysis
catheters.
At the
hearing, the panel held that the Prosl European Patent would be
invalidated because it did not meet the requirements of novelty
based on a technical aspect of the European intellectual property
law. CorMedix disagrees with this decision and plans to appeal. Our
appeal will be based, in part, on the written opinion to be issued
by the Opposition Division, which is expected by the first quarter
2018. CorMedix continues to believe that the Prosl European Patent
is indeed novel and that its validity should be maintained. In
addition, the ongoing Unfair Competition litigation brought by
CorMedix against TauroPharm is not affected and will
continue.
Based
on the advice of our U.S. patent counsel, we expect that, due to
differences between the novelty requirements in intellectual
property law in Europe and the U.S., the validity of our U.S.
patent covering Neutrolin will be unaffected by a decision from the
EPO. Importantly, the Company believes that the U.S. Food and Drug
Administration’s (FDA) designation of Neutrolin as a
Qualified Infectious Disease Product (QIDP) provides the most
significant protection for its intellectual property. Having this
designation means that, upon FDA approval for the prevention of
catheter-related blood stream infections in patients with end-stage
renal disease receiving hemodialysis through a central venous
catheter, Neutrolin would have five years of market exclusivity in
the U.S. Beyond this, Neutrolin will have an additional five years
of protection due to its status as a new chemical entity, and a
further six months if granted pediatric exclusivity. Together,
these designations are expected to serve as a significant barrier
to entry in the U.S. marketplace for a period of ten and a half
years following commercial launch and, in any case, would be
effective after any potential patent protection
expired.
Based
on an extensive analysis of the global market potential for
Neutrolin, we believe the U.S. represents a substantially more
valuable commercial market for this product than the European
market. Therefore, we have been focusing most of our resources on
seeking regulatory approval of Neutrolin in the U.S. for multiple,
high-value indications, beginning with the prevention of
catheter-related blood stream infections in hemodialysis patients,
which is currently in Phase 3 development.
Forward-Looking Statements
This
report contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, that are
subject to risks and uncertainties. All statements, other than
statements of historical facts, regarding management’s
expectations, beliefs, goals, plans or CorMedix’s prospects
should be considered forward-looking. Readers are cautioned that
actual results may differ materially from projections or estimates
due to a variety of important factors, including; the risk of
completing the development program for Neutrolin in the U.S.,
including FDA approval; the risk of challenges to our intellectual
property; and the estimated markets for Neutrolin. These and other
risks are described in greater detail in CorMedix’s filings
with the SEC, copies of which are available free of charge at the
SEC’s website at www.sec.gov or upon request from CorMedix.
CorMedix may not actually achieve the goals or plans described in
its forward-looking statements, and investors should not place
undue reliance on these statements. CorMedix assumes no obligation
and does not intend to update these forward-looking statements,
except as required by law.
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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CORMEDIX
INC.
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Date: December 4,
2017
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By:
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/s/
Robert
W. Cook
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Name: |
Robert W.
Cook
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Title: |
Chief
Financial Officer
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