BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical
company utilizing artificial intelligence to develop transformative
medicines in neuroscience and immuno-oncology, today announced that
the United States Patent and Trademark Office (“USPTO”) has allowed
U.S. Patent Application No. 17/496,470 with claims pertaining to a
method 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. The patent, when issued, is expected to have an
expiration date of Dec. 29, 2037, subject to patent term adjustment
(“PTA”), patent term extension (“PTE”), and terminal disclaimers.
The Company also announced that it has received an issue
notification from the USPTO for U.S. Patent Application No.
17/993,422, from which U.S. Patent No. 11,890,272 (the “272
patent”) is expected to issue on Tuesday, Feb. 6, 2024. The ‘272
patent claims a method of treating agitation associated with
schizophrenia or bipolar disorder through oromucosal administration
of about 120 mcg to about 180 mcg of dexmedetomidine where the
patient has a QT interval of less than 470 msec. This patent, when
issued, is expected to have an expiration date of July 17, 2040,
subject to PTA, PTE, and terminal disclaimers. It will be submitted
for listing in the United States Food and Drug Administration's
(“FDA”) Approved Drug Products with Therapeutic Equivalence
Evaluations (commonly known as the "Orange Book") in addition to
the seven currently listed U.S. patents for IGALMI™
(dexmedetomidine) sublingual film. Collectively, these eight
patents will in general extend patent protection for
IGALMI until Jan. 12, 2043.
“We continue to build a robust intellectual property (“IP”)
portfolio that supports our strategic focus of expanding the
BXCL501 indication for the potential acute treatment of agitation
associated with Alzheimer’s disease in the at-home and care
settings,” said Vimal Mehta, Ph.D., CEO of BioXcel
Therapeutics. “At the same time, we have strengthened the IP
portfolio for our marketed product IGALMI and reinforced our
strategy into the at-home treatment of bipolar disorders or
schizophrenia-related agitation. Through this additional patent
protection and expected initiation of our two upcoming late-stage
Phase 3 registrational trials, we believe we are
well-positioned to potentially expand our market
opportunities for addressing the full spectrum of agitation in all
treatment settings and bringing important new and needed treatment
options to patients and caregivers.”
About BXCL501In 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 IGALMI™ (dexmedetomidine) sublingual
film
INDICATION
IGALMI™ (dexmedetomidine) sublingual film is a prescription
medicine, administered under the supervision of a health care
provider, that 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 www.igalmi.com.
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 Statements This 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 (the “Securities Act”)
and Section 21E of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”). 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 benefit
of patent protection relating to BXCL501 and IGALMI; 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 other 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,
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 Information
CorporateBioXcel TherapeuticsErik
Kopp1.203.494.7062ekopp@bioxceltherapeutics.com
Investor RelationsBioXcel TherapeuticsBrennan
Doyle1.475.355.8462bdoyle@bioxceltherapeutics.com
MediaRusso PartnersDavid
SchullT: 858-717-2310David.schull@russopartnersllc.comScott
StachowiakT: 646-942-5630Scott.stachowiak@russopartnersllc.com
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