Baudax Bio receives notice of allowance for U.S. Patent Application covering use of ANJESO® for the treatment of moderate to severe pain

Rhea-AI Summary

Baudax Bio (NASDAQ:BXRX) announced a Notice of Allowance from the USPTO for patent No. 16/297,095, related to administering intravenous meloxicam (ANJESO^®). This patent covers multiple dosing methods for treating moderate to severe pain, potentially reducing rescue analgesia use for up to 48 hours. The patent is expected to be issued soon and will join eight others in the FDA’s Orange Book, providing exclusivity until March 2039. This strengthens Baudax's position against generic competition.

Positive

• Notice of Allowance for patent No. 16/297,095 enhances ANJESO's market exclusivity.
• Patent protects against generic competition until March 2039.
• ANJESO's potential to reduce reliance on rescue analgesics boosts its clinical value.

Negative

• None.

MALVERN, Pa., Aug. 22, 2022 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, announced today that the United States Patent and Trademark Office (“USPTO”) has provided a Notice of Allowance for patent application No. 16/297,095, titled “Methods of administering intravenous meloxicam in a bolus dose”, which includes claims covering the use of multiple doses of ANJESO^® for the treatment of moderate to severe pain resulting in a reduction in summed pain intensity difference and also a reduction in the use of rescue analgesia 48 hours following the first dose. (the “’095 Application”). A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application. A patent from the recently allowed application is expected to be issued in the coming months. Once issued, the ‘095 Application will be eligible for listing in the United States Food and Drug Administration’s (FDA) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations as it relates to ANJESO^®.

Once issued, the ‘095 Application will be the second ANJESO^® patent to be listed in the Orange Book with an expiry date of March 2039. Upon issuance, the ‘095 application will join seven other patents listed in the Orange Book, amongst others owned or licensed by Baudax that currently provide exclusivity to the ANJESO^® franchise. The ‘095 Application emphasizes ANJESO’s^® potential to treat moderate to severe pain while potentially reducing the use of rescue analgesics.

“We are pleased by the progress we have made in the United States Patent and Trademark Office and the continued recognition of the inventive nature of our ANJESO^® franchise,” said Gerri Henwood, Baudax Bio’s President and Chief Executive Officer. “The ‘095 Application is expected to provide a significant barrier for generic entry and are expected to be joined by other patents currently pending in the USPTO.”

About ANJESO^®

ANJESO^® (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO^® is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. As a non-opioid, Baudax Bio believes ANJESO^® has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO^® was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. Baudax Bio markets ANJESO^®, the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO^®, the Company has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including statements relating to Baudax Bio’s patent portfolio, and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market, economic and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to maintain listing on the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

CONTACT:

Investor Relations Contact:

Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:

Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com

FAQ

What does the Notice of Allowance for BXRX's patent mean?

The Notice of Allowance indicates that the USPTO intends to grant a patent for BXRX's intravenous meloxicam, enhancing its market exclusivity.

How will the new patent affect BXRX's ANJESO product?

The new patent will help protect ANJESO from generic competition, potentially maintaining its market position until 2039.

What is the significance of patent No. 16/297,095 for BXRX?

Patent No. 16/297,095 covers multiple dosing methods for ANJESO, which could improve pain management outcomes for patients.

When is the patent for BXRX's intravenous meloxicam expected to be issued?

The patent is expected to be issued in the coming months following the Notice of Allowance.