Baudax Bio™ Launches as a New Pharmaceutical Company Aimed at Advancing Promising, Non-Opioid Analgesic Therapies
November 21 2019 - 7:00AM
Baudax Bio, Inc. (NASDAQ:BXRX) today announced its launch as an
independent, publicly traded pharmaceutical company focused on
advancing non-opioid analgesics and other products for the hospital
and other acute care settings. Beginning tomorrow, November
22, 2019, Baudax will trade on the NASDAQ Capital Market under the
ticker symbol “BXRX.” When-issued trading under the symbol “BXRXV”
continues until market close today.
“Baudax Bio will pursue the development of
therapeutics, specifically focusing on innovative products for
acute care settings where there is an urgent need and the potential
for the greatest impact for patients,” said Gerri Henwood,
President and Chief Executive Officer of Baudax Bio. “We have
rights to a pipeline of innovative product candidates, including
intravenous (IV) meloxicam, our lead product candidate, and over
time we may seek to expand our pipeline. In the near-term,
our primary goal is to continue next steps following our successful
U.S. Food and Drug Administration (FDA) appeal and to prepare a
comprehensive response package. If approved, we believe IV
meloxicam approval, ANJESOTM, will be a novel non-opioid option for
the management of moderate to severe pain.”
Baudax launches with $19 million in funding from
Recro Pharma, Inc., its former parent company, and holds the rights
to a pipeline of pharmaceutical assets, including:
- IV Meloxicam
– Baudax holds exclusive global rights to IV
meloxicam, a post-Phase 3 non-opioid analgesic developed for the
treatment of moderate to severe pain. If approved, IV
meloxicam will be a novel IV non-opioid option for the management
of moderate to severe pain. IV meloxicam successfully
completed three Phase III clinical studies, including two Phase III
efficacy studies and one Phase III safety study, four Phase II
clinical studies, as well as other safety studies. Baudax
recently received a written decision from the FDA granting an
appeal for a Complete Response Letter the Company received relating
to its IV meloxicam New Drug Application (NDA). Baudax is now
in the process of preparing a comprehensive response to the FDA
that includes proposed labeling and certain other information.
- Two Neuromuscular Blocking
Agents and A Reversal Agent – Baudax holds exclusive
global rights to two novel neuromuscular blocking agents (NMBs) and
a proprietary chemical reversal agent specific to these NMBs which
were licensed from Cornell University in 2017. The reversal
agent is a proprietary agent that rapidly reverses the NMB
compounds. Used together, these agents allow for a very rapid
induction of neuromuscular blockade for surgical settings, followed
by a rapid reversal of the neuromuscular blockade. These
novel agents have the potential to meaningfully reduce procedure
recovery time in operating room or post-acute care settings,
resulting in valuable cost savings to hospitals and ambulatory
surgical centers. RP-1000 is an intermediate duration
clinical-stage NMB drug candidate with one completed Phase I trial
and with plans to initiate an additional dose escalation Phase I
trial in the first half of 2020. RP-2000 is an ultra-short acting
NMB drug candidate which is currently completing early pre-clinical
and drug product work.
- Intranasal
Dexmedetomidine – Baudax holds rights to intranasal
dexmedetomidine (Dex-IN), a non-opioid alpha-2 adrenergic agonist
being developed for possible uses in pain or sedation. IV
dexmedetomidine (Precedex®) has a long history of use in the U.S.
and Europe as a short-term sedative with both analgesic or
anxiolytic properties and is widely used in intensive care unit
settings and for procedural sedation. Baudax’s Dex-IN
demonstrated pain relief and a favorable tolerability profile in
early-stage, placebo-controlled clinical studies. Baudax is
pursuing potential product partnering for Dex-IN.
Experienced Leadership Team
Baudax Bio is led by a team of pharmaceutical
industry veterans, including:
- Gerri Henwood, President
and Chief Executive Officer, who brings over three decades
of senior leadership experience in biopharmaceuticals, healthcare
and life sciences, including as Founder, President and CEO of both
Recro Pharma and Auxilium Pharmaceuticals.
- Ryan D. Lake, Chief
Financial Officer, who brings almost 20 years of senior
financial and life sciences leadership experience. He also
currently serves as the Chief Financial Officer for Recro Pharma,
Inc. Previously, he served in executive leadership positions at
Aspire Bariatrics, Inc., DSM Biomedical, and Kensey Nash
Corporation.
- Stewart McCallum, MD, Chief
Medical Officer, who brings over 20 years of
pharmaceutical and healthcare industry experience. Prior to
Baudax, Dr. McCallum served as Chief Medical Officer of Recro
Pharma. Before that, he served in roles of increasing
responsibility at GlaxoSmithKline plc. Dr. McCallum joined
industry from academia where he was a Surgeon and Professor of
Urology at Stanford University Medical Center and the VA Palo Alto
Health Care System.
- John Harlow, Chief
Commercial Officer, who brings over 20 years of branded
pharmaceutical experience, including commercial leadership roles in
marketing, sales and operations. Prior to Baudax, Mr. Harlow
served in roles of increasing responsibility at several world-class
pharmaceutical companies including J&J, Novartis, King
Pharmaceuticals (acquired by Pfizer), Shionogi, and Endo
Pharmaceuticals.
In addition to Gerri Henwood, Baudax has
appointed the following directors to the board:
- Alfred F. Altomari, Chairman of the Board – CEO of Agile
Therapeutics
- Wayne B. Weisman – Partner, SCP Vitalife
- William Ashton – Principal, Harrison Consulting Group
- Winston J. Churchill – Partner, SCP Vitalife
About Baudax Bio
Baudax Bio is a pharmaceutical company focused
on therapeutics for acute care settings. The Company’s lead
product candidate is a proprietary intravenous (IV) form of
meloxicam, a non-opioid, long-acting preferential COX-2 inhibitor.
IV meloxicam has successfully completed two pivotal Phase III
clinical efficacy trials, a large double-blind placebo-controlled
Phase III safety trial, four Phase II clinical efficacy trials, as
well as other safety studies. Upon IV meloxicam approval, ANJESOTM,
will be a novel non-opioid option for the management of moderate to
severe pain. As a non-opioid, IV meloxicam 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. For more information please visit
www.baudaxbio.com.
Cautionary Statement Regarding 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,"
"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 this
press release 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. Baudax Bio assumes no obligation to
update any such forward-looking statements. Factors that could
cause Baudax Bio’s actual performance to materially differ from
those expressed in the forward-looking statements set forth in this
press release include, without limitation: the Company’s ability to
execute its strategy for further development and commercialization
of IV meloxicam, the Company’s ability to execute its strategic
initiatives, the Company’s ability to adequately resolve the
outstanding labeling issues with the FDA for IV meloxicam, and the
time frame associated with any such resolution; the Company’s
ability to raise future financing for continued product development
and IV meloxicam commercialization; with regard to the Company’s
clinical trial results, whether there may be changes in the
interpretation by the FDA of the data of the Company’s clinical
trials and the length, cost and uncertain results and timing of our
ongoing clinical trials; with regard to the potential commercial
opportunity of IV meloxicam, whether any FDA approval of IV
meloxicam will include labeling restrictions and the potential that
IV meloxicam does not receive regulatory approval or does not
receive reimbursement by third party payors, that IV meloxicam is
not accepted by the medical community, including physicians,
patients, health care providers and hospital formularies or that a
commercial market for IV meloxicam does not develop; the Company’s
ability to manage costs and execute on its operational and budget
plans; the Company’s ability to achieve its financial goals; the
Company’s ability to obtain, maintain and successfully enforce
adequate patent and other intellectual property protection; the
Company’s lack of operating history as a standalone business; risks
relating to the separation from Recro, including, among others,
failure to achieve the anticipated benefits from the separation,
reliance on Recro and other third parties to provide certain
services post-separation, and the Company’s ability to satisfy
liabilities and potential indemnification obligations in connection
with the separation. The forward-looking statements in this press
release 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.
CONTACT:
Investor Relations Contact: Argot PartnersSam Martin / Claudia
Styslinger(212) 600-1902sam@argotpartners.com
claudia@argotpartners.com
Baudax Bio Ryan D. Lake (484) 395-2436 rlake@baudaxbio.com
Media Contact: Argot Partners David Rosen (212) 600-1902
david.rosen@argotpartners.com
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