- Expands foundational patent protection for Galmed's
innovative first-in- class drug Aramchol through the end of
2034
- This patent provides protection for Aramchol per se,
not limited to any therapeutic application, and protects its use in
the treatment of NASH & Fibrosis
TEL
AVIV, Israel, Feb. 8, 2023
/PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD)
("Galmed" or the "Company"), a clinical-stage biopharmaceutical
company for liver, metabolic and inflammatory diseases announced
today that the United States Patent and Trademark Office (USPTO)
granted Galmed United States Patent 11,571,431 B2, which is
expected to provide exclusivity of Aramchol meglumine salt until
December 2034. With the latest
patent, Galmed is fortifying the IP protection of its lead
compound, Aramchol, extending Aramchol's IP protection until end of
2038 (for its longest-term patent in US).
Similar composition of matter patents have been granted in
Canada, Europe, Australia, China, Hong-Kong, Korea, Israel, Japan
and other territories for Aramchol salts. Specifically, the
invention provides the Aramchol amine salts and use thereof in
medical treatment having advantageous physicochemical properties.
In particular, the N-methylglucamine (meglumine) salt has been
shown to possess advantageous properties, including increased
solubility, as well as increased absorption and exposure, which
correlate with higher bioavailability. These patents further
confirm Galmed's innovative drug developments are covered by the
same level of robust protection as traditional new chemical
entities.
In total, Galmed's research and development platform has
produced a patent portfolio comprising over 20 issued patents
covering key pharmaceutical markets.
"This new patent which covers critical compositions of matter
enhances our already robust patent portfolio, further strengthening
and extending the potential commercial horizon for Aramchol,"
said Allen Baharaff, President and Chief Executive Officer of
Galmed Pharmaceuticals. "We expect that this long patent runway
will assist us in maximizing the full therapeutic potential of
Aramchol, which we are currently investigating across a number
of potential anti-fibrotic indications."
Galmed Pharmaceuticals Ltd.
We are a biopharmaceutical company focused on the development of
Aramchol. Historically, we have focused almost exclusively on
developing Aramchol for the treatment of liver disease. We are also
collaborating with the Hebrew
University in the development of Amilo-5MER, a 5 amino acid
synthetic peptide.
Forward-Looking Statements:
Forward-looking statements relate to anticipated or expected
events, activities, trends or results as of the date they are made.
Because forward-looking statements relate to matters that have not
yet occurred, these statements are inherently subject to risks and
uncertainties that could cause our actual results to differ
materially from any future results expressed or implied by the
forward-looking statements. Many factors could cause our actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements, including, but
not limited to, our ability to identify, evaluate and complete any
strategic alternative that yields value for our shareholders; the
timing and cost of our any pre-clinical or clinical trial, for our
product candidates; completion and receiving favorable results of
any pre-clinical or clinical trial; regulatory action with respect
to Aramchol or any other product candidate by the U.S. Food and
Drug Administration, or the FDA, or the European Medicines
Authority, or EMA, including but not limited to acceptance of an
application for marketing authorization, review and approval of
such application, and, if approved, the scope of the approved
indication and labeling; the commercial launch and future sales of
Aramchol and any future product candidates; our ability to comply
with all applicable post-market regulatory requirements for
Aramchol or any other product candidate in the countries in which
we seek to market the product; our ability to achieve favorable
pricing for Aramchol or any other product candidate; our
expectations regarding the commercial market for non-alcoholic
steato-hepatitis, or NASH, in patients or any other targeted
indication; third-party payor reimbursement for Aramchol or any
other product candidate; our estimates regarding anticipated
capital requirements and our needs for additional financing; market
adoption of Aramchol or any other product candidate by physicians
and patients; the timing, cost or other aspects of the commercial
launch of Aramchol or any other product candidate; our ability to
obtain and maintain adequate protection of our intellectual
property; the possibility that we may face third-party claims of
intellectual property infringement; our ability to manufacture our
product candidates in commercial quantities, at an adequate quality
or at an acceptable cost; our ability to establish adequate sales,
marketing and distribution channels; intense competition in our
industry, with competitors having substantially greater financial,
technological, research and development, regulatory and clinical,
manufacturing, marketing and sales, distribution and personnel
resources than we do; the development and approval of the use of
Aramchol or any other product candidate for additional indications
or in combination therapy; our ability to maintain the listing of
our ordinary share on The Nasdaq Capital Market; and our
expectations regarding licensing, acquisitions and strategic
operations. We believe these forward-looking statements are
reasonable; however, these statements are only current predictions
and are subject to known and unknown risks, uncertainties and other
factors that may cause our or our industry's actual results, levels
of activity, performance or achievements to be materially different
from those anticipated by the forward-looking statements. We
discuss many of these risks in our Annual Report on Form 20-F for
the year ended December 31, 2021
filed with the SEC on May 2, 2022 in
greater detail under the heading "Risk Factors" and elsewhere in
the Annual Report, in our Reports on Form 6-K filed with the SEC on
August 4, 2022 and November 16, 2022 and this press release. Given
these uncertainties, you should not rely upon forward-looking
statements as predictions of future events. All forward-looking
statements attributable to us or persons acting on our behalf speak
only as of the date hereof and are expressly qualified in their
entirety by the cautionary statements included in this report. We
undertake no obligations to update or revise forward-looking
statements to reflect events or circumstances that arise after the
date made or to reflect the occurrence of unanticipated events. In
evaluating forward-looking statements, you should consider these
risks and uncertainties.
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SOURCE Galmed Pharmaceuticals Ltd.