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BioXcel Therapeutics Announces USPTO’s Allowance of Patent Application for Method of Treating Agitation in Alzheimer’s Disease Using Oromucosal Formulations of Dexmedetomidine

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BioXcel Therapeutics, Inc. announces the issuance of a new patent for the treatment of agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form. This strengthens the company's strategic focus on bringing to market BXCL501 for potential acute treatment of agitation for Alzheimer’s patients. The patent is expected to have an expiration date of Dec. 29, 2037, subject to patent term adjustment, patent term extension, and terminal disclaimers. Additionally, the company has received an issue notification for another patent related to the treatment of agitation associated with schizophrenia or bipolar disorder through oromucosal administration.
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The receipt of an issue notification for a new method of use patent by BioXcel Therapeutics represents a significant fortification of the company's intellectual property portfolio, particularly for their product BXCL501. This development is crucial for the company as it extends the commercial exclusivity period for BXCL501, potentially delaying generic competition until at least December 29, 2037. This extension can be attributed to patent term adjustments and extensions that compensate for delays during the patent prosecution process or for time taken in regulatory approval.

From a legal standpoint, the broad claims covering various film formulations, tablets, or wafers suggest that the company is seeking to cover all possible oromucosal delivery mechanisms for dexmedetomidine, thus broadening the scope of their market exclusivity. The implications for stakeholders include sustained revenue streams from BXCL501 and a stronger negotiating position in potential partnership or licensing deals. However, the strength of the patent claims will ultimately be tested in potential litigation scenarios, where generic competitors may challenge the validity or enforceability of the patent.

The approval of a patent for the method of treating agitation in Alzheimer’s patients with BXCL501 is a significant milestone in the treatment landscape for this condition. Agitation in Alzheimer’s disease is a common and distressing symptom and the development of an effective treatment option is of high clinical importance. The use of dexmedetomidine in a water-soluble dosage form for oromucosal administration is a novel approach that could offer several benefits over existing treatments, such as potentially faster onset of action and ease of use, which can be particularly advantageous in acute agitation scenarios.

For stakeholders, the clinical impact of BXCL501 will depend on the outcomes of ongoing and future clinical trials. If the trials demonstrate significant efficacy and safety, it could lead to a high adoption rate among healthcare providers. However, the long-term benefits and drawbacks will hinge on real-world effectiveness and the potential side effects that may become apparent post-commercialization. Moreover, the expansion of the patent to include treatment of agitation associated with schizophrenia or bipolar disorder could indicate the company's strategy to broaden the application of its technology to other areas of unmet medical need.

From a market perspective, the strengthening of market exclusivity for BXCL501 through additional patents is a strategic move that could have a positive impact on BioXcel Therapeutics' market position. The company's focus on utilizing artificial intelligence to develop transformative medicines is an emerging trend in the biopharmaceutical industry that could set BioXcel apart from competitors. The potential to treat agitation in Alzheimer’s, schizophrenia and bipolar disorder patients with a single drug could position BXCL501 as a versatile and valuable product in the neuroscience market.

Investors should note the potential for increased market share and revenue growth stemming from this expanded patent protection. However, they should also consider the risks associated with the drug's clinical trial outcomes and market adoption rates. The company's stock performance may be influenced by the perceived value of the patent portfolio and the anticipated success of BXCL501 in the market. It's also important to monitor the competitive landscape and any regulatory changes that could affect the drug's market potential.

Aligns with Company’s strategic focus on bringing to market BXCL501 for potential acute treatment of agitation for Alzheimer’s patients 

IGALMI™ market exclusivity further strengthened with receipt of issue notification for additional method of use patent (total of 8 U.S. patents, including 4 method of use patents) 

NEW HAVEN, Conn., Feb. 05, 2024 (GLOBE NEWSWIRE) -- 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 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 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

Corporate
BioXcel Therapeutics
Erik Kopp
1.203.494.7062
ekopp@bioxceltherapeutics.com

Investor Relations
BioXcel Therapeutics
Brennan Doyle
1.475.355.8462
bdoyle@bioxceltherapeutics.com

Media
Russo Partners
David Schull
T: 858-717-2310
David.schull@russopartnersllc.com

Scott Stachowiak
T: 646-942-5630
Scott.stachowiak@russopartnersllc.com


The new patent is for the treatment of agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form.

The ticker symbol for BioXcel Therapeutics, Inc. is BTAI.

The new patent is expected to have an expiration date of Dec. 29, 2037, subject to patent term adjustment, patent term extension, and terminal disclaimers.

The '272 patent' claims a method of treating agitation associated with schizophrenia or bipolar disorder through oromucosal administration.
BioXcel Therapeutics Inc

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About BTAI

bioxcel therapeutics, inc. is a clinical stage biopharmaceutical company focused on drug development that utilizes novel artificial intelligence to identify the next wave of medicines across neuroscience and 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 indices. the company's two most advanced clinical development programs are bxcl501, a sublingual thin film formulation designed for acute treatment of agitation resulting from neurological and psychiatric disorders, and bxcl701, an immuno-oncology agent designed for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer.