SCIENTURE, LLC
(“the “Company”), a wholly owned subsidiary
of SCIENTURE HOLDINGS, INC.
(NASDAQ: SCNX), focused on developing and
commercializing novel branded, specialty pharma products, today
announced that the U.S. Patent and Trademark Office (USPTO) has
issued a new patent, No. 12,156,869 (the ‘869 patent), further
strengthening the intellectual property position and coverage for
the Company’s SCN-102 product. The ‘869 patent is in addition to
the previously granted patent for SCN-102 by the USPTO, No.
11,890,273 (the ‘273 patent).
The ‘869 patent and the ‘273 patent, both
titled, “LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE,” cover
stable, liquid pharmaceutical compositions of Losartan and methods
of treating patients in need of Losartan by administration of the
novel formulations described.
“The two issued patents demonstrate our
accomplished development capabilities for novel products and our
commitment to bring to market high value products that address
unique and underserved patient needs,” said Shankar Hariharan,
Ph.D., CEO of Scienture, LLC. “We are pleased to note that the NDA
filed for SCN-102 is currently under review at the FDA.”
“We are pleased with the issuance of these two
patents supporting SCN-102, a transformative therapy containing
Losartan, one of the most widely prescribed molecules in its
class,” remarked Narasimhan Mani, Ph.D, MBA, President of
Scienture, LLC. “SCN-102 on receiving final NDA approval, has the
potential to address needs of patients who can benefit from a
ready-to-use oral liquid formulation of Losartan.”
“This announcement is extremely exciting and
reaffirms the optimism of the Board and management team in relation
to the recent merger with Scienture. This is a clear demonstration
of the value Scienture, LLC brings to the combined company and its
shareholders,” said Suren Ajjarapu, Chairman of the Board,
Scienture Holdings, Inc.
About SCN-102
Scienture LLC’s product candidate SCN-102,
(Losartan Oral Suspension 10mg/mL), is a ready to use oral
suspension of Losartan for increased patient convenience and ease
of dosing. The Company believes that SCN-102, if approved by the
FDA, would be the first liquid formulation of Losartan on the
market that does not require compounding and has reduced dosing
volume and long term shelf life at room temperature storage.
About Losartan
Losartan is an ARB (Angiotensin II Receptor
Blocker) for treating hypertension and is one of the highest
prescribed molecules for this indication. It is currently available
in the market as an oral solid product. IQVIA data (MAT September
2024) indicates a total annual sales of $312 million and an annual
prescription volume of 67 million for Losartan in the US
market.
About Hypertension
Hypertension (high blood pressure) is a
cardiovascular condition, when the pressure in the blood vessels is
too high (140/90 mmHg or higher). According to the CDC,
hypertension, or high blood pressure, affects nearly half of adults
in the United States, or 119.9 million people. Hypertension is
defined as a systolic blood pressure of 140 mmHg or higher, and
diastolic blood pressure of 90 mmHg or higher. Hypertension is a
risk factor for stroke and heart disease, which are leading causes
of death in the U.S. Factors that increase the risk of having high
blood pressure include: older age, genetics, being overweight or
obese, not being physically active, high-salt diet and drinking too
much alcohol. Hypertension is clinically diagnosed if, when blood
pressure is measured on two different days, the systolic blood
pressure readings on both days is ≥140 mmHg and/or the diastolic
blood pressure readings on both days is ≥ 90 mmHg.
About Scienture, LLC
Scienture, LLC is a Commack, NY based branded,
specialty pharmaceutical company. We are a highly experienced team
of industry professionals who are passionate about developing and
bringing to market unique specialty products that provide enhanced
value to patients and healthcare systems. Our assets in development
are across therapeutics areas, indications and cater to different
market segments.. Learn more at https://www.scienture.com/.
About Scienture Holdings,
Inc.
SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”),
through its wholly owned subsidiaries, Scienture, LLC and Integra
Pharma Solutions, LLC, is a comprehensive pharmaceutical product
company focused on providing enhanced value to patients, physicians
and caregivers by offering novel specialty products to satisfy
unmet market needs. Our products in development at Scienture, LLC,
are across therapeutic areas, indications and cater to different
market segments and channels. Integra Pharma Solutions, LLC, is a
licensed pharmaceutical wholesaler and sells brand, generic and
non-drug products to healthcare markets including government
organizations, hospitals, clinics and independent pharmacies
nationwide.
Cautionary Statements Regarding
Forward-Looking Statements
This press release contains certain statements
that may be deemed to be “forward-looking statements” within the
federal securities laws, including the safe harbor provisions under
the Private Securities Litigation Reform Act of 1995. Statements
that are not historical are forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Forward-looking
statements relate to future events or our future performance or
future financial condition. These forward-looking statements are
not historical facts, but rather are based on current expectations,
estimates and projections about our company, our industry, our
beliefs and our assumptions. Such forward-looking statements
include, but are not limited to, statements regarding our or our
management team’s expectations, hopes, beliefs, intentions or
strategies regarding the future, including for our SCN-102 product
or any other products we may launch. In addition, any statements
that refer to projections, forecasts or other characterizations of
future events or circumstances, including any underlying
assumptions, are forward-looking statements. In some cases, you can
identify forward-looking statements by the following words:
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “may,” “ongoing,” “plan,” “potential,” “predict,”
“project,” “should,” or the negative of these terms or other
similar expressions, but the absence of these words does not mean
that a statement is not forward-looking. Forward-looking statements
are subject to a number of risks and uncertainties (some of which
are beyond our control) that may cause actual results or
performance to be materially different from those expressed or
implied by such forward-looking statements. Accordingly, readers
should not place undue reliance on any forward-looking statements.
These risks include risks relating to agreements with third
parties; our ability to raise funding in the future, as needed, and
the terms of such funding, including potential dilution caused
thereby; our ability to continue as a going concern; security
interests under certain of our credit arrangements; our ability to
maintain the listing of our common stock on the Nasdaq Capital
Market; claims relating to alleged violations of intellectual
property rights of others; the outcome of any current legal
proceedings or future legal proceedings that may be instituted
against us; unanticipated difficulties or expenditures relating to
our business plan; and those risks detailed in our most recent
Annual Report on Form 10-K and subsequent reports filed with the
SEC.
Forward-looking statements speak only as of the
date they are made. Scienture Holdings, Inc. undertakes no
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise
that occur after that date, except as otherwise provided by
law.
Contacts:
SCIENTURE, LLC
Scienture, LLC20 Austin BoulevardCommack, New
York 11725Phone: (631) 670-6039Email: IR@Scienture.com
SCIENTURE HOLDINGS, INC.
SCIENTURE HOLDINGS, INC.6308 Benjamin Rd, Suite
708Tampa, Florida 33634Phone: (866) 468-6535Email:
IR@Rxintegra.com
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