GlobeNewswire Inc | Jun 8, 2021 07:00AM EDT

June 08, 2021

MALVERN, Pa., June 08, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that ANJESO (meloxicam) injection has achieved approvals at over 100 formularies across the U.S. in under one year of commercialization. ANJESOs presence on formularies is expected to drive usage through regular availability at both hospitals and ambulatory care centers covered by these formularies.

Over the past year, Baudax Bio has made significant progress with the ongoing commercial rollout of ANJESO. We have now achieved formulary listing at 100 institutions across the U.S., and we were able to secure these in less than one full year on the market, said Gerri Henwood, President and CEO of Baudax Bio. We continue to receive positive feedback from physicians and we continue to see increases in new accounts, units sold, reorder rates, and usage patterns across the surgical setting. We remain committed to the successful launch of ANJESO and are well prepared for the anticipated increase in demand as the marketplace moves toward a more normal pace of hospital procedures.

AboutANJESO

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 was launched in the U.S. in June 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. 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 NanoCrystalplatform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystalis a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bios first commercial product ANJESO began in mid-2020. ANJESO is 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, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visitwww.baudaxbio.com.

Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bios 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 and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bios 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 the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO or disruption in supply chain, Baudax Bios ability to maintain regulatory approval for ANJESO, Baudax Bios ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bios ability and that of Baudax Bios third party manufacturers to successfully scale-up the commercial manufacturing process for ANJESO, Baudax Bios ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bios ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bios ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bios ability to comply with the financial and other covenants under its credit facility, Baudax Bios ability to manage costs and execute on its operational and budget plans, the accuracy of Baudax Bios estimates of the potential market for ANJESO, Baudax Bios ability to achieve its financial goals; and Baudax Bios 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 Bios business and future results included in Baudax Bios 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 PartnersSam Martin / Claudia Styslinger(212) 600-1902baudaxbio@argotpartners.com

Media Contact:

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