- CONTEPO™ offers a unique mechanism of action and has the
potential to address increasing antibiotic resistance and gaps in
the current antibiotic treatment landscape
- NDA for CONTEPO™ is pending
- Agreement adds a second branded biopharmaceutical to Meitheal’s
portfolio following the commercial licensing agreement for XTMAB-16
in 2023
Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated
biopharmaceutical company based in Chicago and focused on the
development and commercialization of generic injectables,
fertility, biologic, and branded products, today announced it has
acquired North America rights to CONTEPO™ (fosfomycin for
injection) from Nabriva Therapeutics. CONTEPO™ is a novel,
intravenous (IV), broad spectrum antibiotic with demonstrated
activity against most multi-drug resistant (MDR) strains that cause
complicated urinary tract infections (cUTI).
“The strategic addition of CONTEPO™ to our robust product
portfolio provides us with a novel therapeutic with the potential
to address a significant unmet need around increasing antibiotic
resistance,” said Tom Shea, Chief Executive Officer of Meitheal.
“As a fully integrated biopharmaceutical company, Meitheal is
uniquely positioned to advance CONTEPO™ through the final stages of
the regulatory process and, if approved, deliver a consistent
supply of this high-quality antibiotic to patients and providers in
need of an innovative option for drug resistant urinary tract
infections.”
Under the Asset Purchase Agreement, Meitheal acquires North
America rights to CONTEPO™, including any results of development
and regulatory activities, and all intellectual property (IP)
rights, technology, and know-how related to CONTEPO™. In exchange,
Nabriva will receive payment upon closing and a royalty on net U.S.
sales of CONTEPO™.
Fosfomycin for intravenous (IV) administration is marketed
outside the U.S. where it has been approved across nine
indications, including cUTI and other serious bacterial infections.
CONTEPO™ utilizes a new dosing approach to optimize the compound’s
pharmacokinetics and pharmacodynamics and has demonstrated efficacy
by meeting the primary endpoint in the pivotal ZEUS™ trial for
patients with cUTI, including acute pyelonephritis.
“The treatment paradigm for complicated infections in the U.S.
is fragmented and inefficient with increasing antibiotic resistance
rendering many traditional treatment options obsolete,” said Brett
Novak, Meitheal Senior Vice President of Commercial Operations.
“CONTEPO™, with demonstrated efficacy against most contemporary
multi-drug resistant strains and a differentiated mechanism of
action, has the potential to serve as the alternative antibiotic
treatment of choice in appropriate patients, and provide them with
the right spectrum of coverage for complicated UTIs.”
Nabriva submitted the New Drug Application (NDA) to the U.S.
Food & Drug Administration (FDA) for the approval of CONTEPO™
(fosfomycin for injection) for the treatment of cUTI, including
acute pyelonephritis. A decision is expected from the FDA later
this year. In preparation for commercial launch, Meitheal will
establish a full commercial marketing and sales organization in
addition to a medical science liaison (MSL) team to support
clinician needs.
Meitheal’s parent company, Nanjing King-Friend Biochemical
Pharmaceutical Co., Ltd. (NKF), has invested over $300 million in
capital and research and development in recent years to support
sustainable product supply across the Company’s focus areas
including branded biopharmaceuticals.
ABOUT COMPLICATED URINARY TRACT INFECTION Complicated
urinary tract infections (cUTI) represent a serious infection in
patients with underlying functional or structural abnormality of
the urinary tract or in the presence of catheterization, and
includes patients with acute pyelonephritis, regardless of
underlying abnormalities of the urinary tract. An estimated three
million cases of Gram-negative cUTIs are treated in the U.S.
hospital setting annually, where approximately 40 percent of cases
are suspected to be caused by resistant strains. Ineffectively
managed cUTIs can lead to increased treatment failure rates, which
in turn, can result in prolonged hospital stays, recurrence,
re-hospitalization, and mortality – each of which poses a
substantial resource and economic burden on the healthcare and
payer systems.
Among the causes of cUTI is Enterobacteriaceae, which is a
multi-drug resistant (MDR) strain of Gram-negative bacteria.
Enterobacteriaceae produces extended spectrum beta-lactamases
(ESBL), a chemical that can cause some antibiotics to be
ineffective in treating bacterial infections such as cUTI. As a
result, cUTI poses a serious and rapidly emerging health threat for
hospitalized patients, especially those in intensive care
units.
ABOUT CONTEPO™ CONTEPO™ (fosfomycin for injection) is a
novel, potentially first-in-class in the U.S., intravenous
investigational antibiotic with a broad spectrum of Gram-negative
and Gram-positive activity, including activity against most
contemporary multi-drug resistant (MDR) strains such as extended
spectrum β-lactamase (ESBL)-producing Enterobacteriaceae. IV
fosfomycin has been approved for a number of indications and
utilized for over 45 years outside the U.S. to treat a variety of
infections, including cUTIs and other serious bacterial
infections.
ABOUT MEITHEAL PHARMACEUTICALS Founded in 2017 and based
in Chicago, Meitheal Pharmaceuticals is focused on the development
and commercialization of generic injectable medications and, as of
2022, has expanded its focus to include fertility, biologic, and
branded products. Meitheal currently markets over 55 U.S. Food and
Drug Administration (FDA)-approved products across numerous
therapeutic areas including anti-infectives, oncolytics, intensive
care, and fertility. As of the end of May 2024, Meitheal, directly
or through its partners, has over 20 products in the research and
development phase, 14 products planned for launch in 2024, and an
additional 19 products under review by the FDA. Meitheal’s mission
is to provide easy access to fairly priced products through robust
manufacturing, consistent supply, and rapid response to our
customers’ needs. Ranked among the top 100 Crain’s Best Places to
Work in Chicago, Meitheal emulates the traditional Irish guiding
principle we are named for — Meitheal (Mee·hall): working together
toward a common goal, for the greater good.
Learn more about who we are and what we do at
www.meithealpharma.com.
ABOUT NANJING KING-FRIEND BIOPHARMACEUTICAL COMPANY (NKF)
Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF) is a
China-based company principally engaged in the research and
development, production and sales of Active Pharmaceutical
Ingredients (API) and Finished Dosage Form (FDF). Established in
1986 as one of world leading manufacturers of heparin related APIs,
NKF has grown into a fully integrated API and FDF manufacturer in
multiple therapeutic areas including critical care and oncology.
With three U.S. FDA approved manufacturing sites in China and more
than 500 employees, including more than 100 dedicated research and
development experts, NKF strives to meet patient needs globally
with market presence in the U.S., China, EU and across the world.
The Company is publicly listed on Shanghai Stock Exchange with a
market capitalization over U.S. $3.0 billion.
ABOUT NABRIVA THERAPEUTICS PLC Nabriva Therapeutics is a
biopharmaceutical company engaged in the commercialization and
development of innovative anti-infective agents to treat serious
infections. Nabriva Therapeutics received U.S. Food and Drug
Administration approval for XENLETA® (lefamulin injection,
lefamulin tablets), the first systemic pleuromutilin antibiotic for
community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics
also developed CONTEPO™ (fosfomycin for injection), a potential
first-in-class epoxide antibiotic for complicated urinary tract
infections (cUTI), including acute pyelonephritis.
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MEDIA CONTACT Meitheal Pharmaceuticals, Inc. John
Spilman, VP of Corporate Strategy 773 899 5910
info@meithealpharma.com