BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical
company utilizing artificial intelligence to develop transformative
medicines in neuroscience and immuno-oncology, today reported that
the European Patent Office (EPO) granted the Company’s European
Patent No. 3,562,486 (the “486 patent”) on March 13, 2024. The 486
patent covers the use of dexmedetomidine administered sublingually
to treat agitation in individuals with dementia. The patent
encompasses a broad range of dosage forms, including films such as
BXCL501 (sublingual dexmedetomidine), wafers, and tablets, at
dexmedetomidine doses ranging from 3 mcg to 100 mcg.
“We have made great progress in building our intellectual
property portfolio, with more than 100 patent applications in
prosecution and multiple patents issued to date,” said Vimal Mehta,
Ph.D., CEO of BioXcel Therapeutics. “The 486 patent aligns with our
focus on expanding our patent portfolio for BXCL501 into Europe,
and, together with the United States and Japan, extends our BXCL501
franchise patent protection to three major markets. We believe this
represents a strong foundation to potentially expand our
commercialization of BXCL501 into additional geographies, if
approved.”
The 486 patent comes on the heels of the U.S. Patent and
Trademark Office (USPTO) recently allowing U.S. Patent Application
No. 17/496,470 with claims pertaining to methods of treating
agitation in patients with Alzheimer’s disease using the oromucosal
administration of 60 mcg of dexmedetomidine in a water-soluble
dosage form. The broad claims encompass film formulations such as
BXCL501 (sublingual dexmedetomidine), tablets, or wafers.
Additionally, in the United States, the Company currently has
eight patents for IGALMI™ listed in the United States Food and Drug
Administration's (FDA) Approved Drug Products with Therapeutic
Equivalence Evaluations (commonly known as the "Orange Book"). The
Company also received notice that the USPTO has allowed U.S. Patent
Application No. 18/216,890 with claims pertaining to a method of
treating agitation using an oromucosal formulation of
dexmedetomidine or a pharmaceutically acceptable salt thereof
through the administration of an initial dose of 60 mcg, 80 mcg, 90
mcg, 120 mcg or 180 mcg of dexmedetomidine and, after at least two
hours, administering an oromucosal formulation of dexmedetomidine
or a pharmaceutically acceptable salt thereof in a second dose of
40 mcg, 60 mcg, 80 mcg or 90 mcg of dexmedetomidine, where the
patient has a QT interval of less than 470 msec. The patent, when
issued, is expected to have an expiration date of July 17, 2040,
subject to patent term adjustment, patent term extension, and
terminal disclaimers. The Company expects that this patent, when
issued, will be submitted for listing in the Orange Book with the
eight currently listed U.S. patents for IGALMI™ (dexmedetomidine)
sublingual film. Collectively, these nine patents will in general
extend patent protection for IGALMITM until January 12, 2043.
About IGALMI™ (dexmedetomidine) sublingual
film
INDICATION
IGALMI™ (dexmedetomidine) sublingual film is a prescription
medicine, administered under the supervision of a health care
provider, which is placed under the tongue or behind the lower lip
and is used for the acute treatment of agitation associated with
schizophrenia and bipolar disorder I or II in adults. The safety
and effectiveness of IGALMI™ has not been studied beyond 24 hours
from the first dose. It is not known if IGALMI™ is safe and
effective in children.
IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects,
including:
Decreased blood pressure, low blood pressure upon
standing, and slower than normal heart rate, which may be more
likely in patients with low blood volume, diabetes,
chronic high blood pressure, and older patients. IGALMI™ is taken
under the supervision of a healthcare provider who will monitor
vital signs (like blood pressure and heart rate) and alertness
after IGALMI is administered to help prevent falling or fainting.
Patients should be adequately hydrated and sit or lie down after
taking IGALMI and instructed to tell their healthcare provider if
they feel dizzy, lightheaded, or faint.
Heart rhythm changes (QT interval
prolongation). IGALMI™ should not be given to patients
with an abnormal heart rhythm, a history of an irregular heartbeat,
slow heart rate, low potassium, low magnesium, or taking other
drugs that could affect heart rhythm. Taking IGALMI™ with a history
of abnormal heart rhythm can increase the risk of torsades de
pointes and sudden death. Patients should be instructed to tell
their healthcare provider immediately if they feel faint or have
heart palpitations.
Sleepiness/drowsiness. Patients should not
perform activities requiring mental alertness, such as driving or
operating hazardous machinery, for at least 8 hours after taking
IGALMI™.
Withdrawal reactions, tolerance, and decreased
response/efficacy. IGALMI™ was not studied for longer than
24 hours after the first dose. Physical dependence, withdrawal
symptoms (e.g., nausea, vomiting, agitation), and decreased
response to IGALMI may occur if IGALMI is used longer than 24
hours.
The most common side effects of IGALMI™ in
clinical studies were sleepiness or drowsiness, a prickling or
tingling sensation or numbness of the mouth, dizziness, dry mouth,
low blood pressure, and low blood pressure upon standing.
These are not all the possible side effects of IGALMI™. Patients
should speak with their healthcare provider for medical advice
about side effects.
Patients should tell their healthcare provider about
their medical history, including if they suffer from any
known heart problems, low potassium, low magnesium, low blood
pressure, low heart rate, diabetes, high blood pressure, history of
fainting, or liver impairment. They should also tell their
healthcare provider if they are pregnant or breastfeeding or take
any medicines, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Patients should
especially tell their healthcare provider if they take any drugs
that lower blood pressure, change heart rate, or take anesthetics,
sedatives, hypnotics, and opioids.
Everyone is encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at
1-833-201- 1088 or medinfo@bioxceltherapeutics.com.
Please see full Prescribing Information at igalmi.com.
About BXCL501 In indications other than those
approved by the U.S. Food and Drug Administration (FDA) as IGALMI™
(dexmedetomidine) sublingual film, BXCL501 is an investigational
proprietary, orally dissolving film formulation of dexmedetomidine,
a selective alpha-2 adrenergic receptor agonist. BioXcel
Therapeutics believes that BXCL501 potentially targets an important
mediator of agitation, and the Company has observed anti-agitation
results in multiple clinical trials across several neuropsychiatric
disorders. BXCL501 is under investigation by BioXcel Therapeutics
for the acute treatment of agitation associated with dementia due
to probable Alzheimer’s disease and for the acute treatment of
agitation associated with bipolar I or II disorder or schizophrenia
in the at-home setting. The safety and efficacy of BXCL501 for
these investigational uses have not been established. BXCL501 has
been granted Breakthrough Therapy designation by the FDA for the
acute treatment of agitation associated with dementia and Fast
Track designation for the acute treatment of agitation associated
with schizophrenia, bipolar disorders, and dementia.
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a
biopharmaceutical company utilizing artificial intelligence to
develop transformative medicines in neuroscience. Its wholly owned
subsidiary, OnkosXcel Therapeutics, is focused on the development
of medicines in immuno-oncology. The Company’s drug re-innovation
approach leverages existing approved drugs and/or clinically
validated product candidates together with big data and proprietary
machine learning algorithms to identify new therapeutic
indications. For more information, please
visit bioxceltherapeutics.com.
Forward-Looking StatementsThis press release
includes “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. We intend such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 27A
of the Securities Act of 1933, as amended and Section 21E of the
Securities Exchange Act of 1934, as amended. All statements
contained in this press release other than statements of historical
fact should be considered forward-looking statements, including,
without limitation, the Company’s expectations as to the timing and
benefits of patent protection relating to BXCL501 and IGALMI, in
the EU, Japan and the U.S.; and the Company’s potential addressable
market for treatment with its products and product candidates. When
used herein, words including “anticipate,” “believe,” “can,”
“continue,” “could,” “designed,” “estimate,” “expect,” “forecast,”
“goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,”
“predict,” “project,” “should,” “target,” “will,” “would” and
similar expressions are intended to identify forward-looking
statements, though not all forward-looking statements use these
words or expressions. In addition, any statements or information
that refer to expectations, beliefs, plans, projections,
objectives, performance or other characterizations of future events
or circumstances, including any underlying assumptions, are
forward-looking. All forward-looking statements are based upon the
Company’s current expectations and various assumptions. The Company
believes there is a reasonable basis for its expectations and
beliefs, but they are inherently uncertain. The Company may not
realize its expectations, and its beliefs may not prove correct.
Actual results could differ materially from those described or
implied by such forward-looking statements as a result of various
important factors, including, without limitation: that it is
difficult and costly to protect our proprietary rights; obtaining
and maintaining patent protection depends on compliance with
various procedural, document submission, fee payment and other
requirements imposed by governmental patent agencies; and we may be
subject to claims challenging the inventorship or ownership of our
patents and other intellectual property, as well as the important
factors discussed under the caption “Risk Factors” in its Quarterly
Report on Form 10-Q for the quarterly period ended September 30,
2023, as such factors may be updated from time to time in its other
filings with the SEC, including without limitation its Annual
Report on Form 10-K for the fiscal year ended December 31, 2023,
which are accessible on the SEC’s website at www.sec.gov. These and
other important factors could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. Any such forward-looking statements
represent management’s estimates as of the date of this press
release. While the Company may elect to update such forward-looking
statements at some point in the future, except as required by law,
it disclaims any obligation to do so, even if subsequent events
cause our views to change. These forward-looking statements should
not be relied upon as representing the Company’s views as of any
date subsequent to the date of this press release.
Contact InformationCorporateBioXcel TherapeuticsErik
Kopp1.203.494.7062ekopp@bioxceltherapeutics.com
Investor RelationsBioXcel TherapeuticsBrennan
Doyle1.475.355.8462bdoyle@bioxceltherapeutics.com
MediaRusso Partners David
Schull T: 858-717-2310 David.schull@russopartnersllc.com
Scott
Stachowiak T: 646-942-5630 Scott.stachowiak@russopartnersllc.com
Source: BioXcel Therapeutics, Inc.
IGALMI™ is a trademark of BioXcel Therapeutics, Inc.BT BIOXCEL
THERAPEUTICS is a registered trademark of BioXcel Therapeutics,
Inc. All other trademarks are the properties of their
respective owners.Copyright © 2024, BioXcel Therapeutics, Inc. All
rights reserved.
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