Collaboration combines strengths to develop
and commercialize life-saving antifungal treatment and prophylaxis,
an area of high unmet medical need
Mundipharma acquires exclusive rights to
develop and commercialize rezafungin in all markets outside of the
United States and Japan, which will be retained by Cidara
Cidara to receive upfront payment of $30
million and equity investment of $9 million, co-development
funding, development milestones and tiered royalty stream
Total transaction value could exceed $568
million
Cidara to host conference call today at 8:00
a.m. ET/5:00 a.m. PT
Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Mundipharma
announced today that they have entered into a strategic partnership
to develop and commercialize rezafungin for the treatment and
prevention of invasive fungal infections. Rezafungin is a novel,
once-weekly echinocandin antifungal being developed for the
first-line treatment of candidemia and invasive candidiasis as well
as for the prophylaxis of invasive fungal infections in patients
undergoing allogeneic blood and marrow transplantation, for which
no new therapies have been approved in over 13 years.
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The partnership agreement follows Cidara’s recent announcement
of the successful completion of its STRIVE B Phase 2 trial. Under
the terms of the agreement, in exchange for granting Mundipharma
exclusive commercialization rights to rezafungin outside the U.S.
and Japan, Cidara will receive a $30 million upfront payment and
Mundipharma will make a $9 million equity investment in Cidara.
Cidara will also receive an additional $42 million in near-term
funding to support the global Phase 3 ReSTORE and ReSPECT trials
for the treatment and prevention of fungal infections. In addition,
Cidara is eligible to receive development, regulatory and
commercial milestone payments, representing a total potential
transaction value of $568 million plus double-digit royalties.
Cidara will continue to lead the ongoing global Phase 3 development
programs for rezafungin with the support of Mundipharma. The
companies may pursue additional indications or formulations of
rezafungin.
“This is a transformational collaboration for Cidara, and we
look forward to working closely with our colleagues at Mundipharma,
a highly successful, profitable company with a commercial presence
spanning 120 markets worldwide and annual sales exceeding €2
billion,” said Jeffrey Stein, Ph.D., President and Chief Executive
Officer of Cidara. “Mundipharma is particularly well positioned
globally with established hospital and hematology/oncology business
units to fully leverage the commercial potential of rezafungin.
Through this partnership, both companies fully commit to advancing
rezafungin and helping to save the lives of patients who are highly
vulnerable to these deadly infections.”
“By partnering with Cidara on rezafungin, we continue to serve
our purpose - to move medicine forward,” said Alberto Martinez,
Ph.D., M.B.A., President and Chief Executive Officer of
Mundipharma. “In a world where antifungal resistance is posing a
major threat to the lives of vulnerable immunocompromised patients,
rezafungin shows promise to address a major unmet medical need as
well as potentially providing a wider spectrum of efficacy in a
more convenient administration schedule. With our proven commercial
excellence we are confident that we will maximize the potential of
this differentiated and innovative asset. Rezafungin will be a
significant addition to our pipeline that integrates well with our
overall portfolio and sales force capabilities. We are excited to
work with the team at Cidara to deliver such an important medicine
to patients around the world.”
Conference Call and Webcast
Cidara management will host a conference call and webcast at
8:00 a.m. ET/5:00 a.m. PT today. The live call may be accessed by
dialing (844) 358-8763 for domestic callers and (703) 736-7375 for
international callers and entering the conference code: 6567991.
The webcast will be made available on Cidara’s website at
www.cidara.com under the Investors tab in the Events section.
Following the live audio webcast, a replay will be available on
Cidara's website.
About Invasive Fungal Infections
Invasive fungal infections (IFIs) represent a serious threat to
millions of patients worldwide, resulting in more than 1.5 million
deaths annually and mortality rates ranging from 15 to 65 percent.
These infections continue to be a global health issue, especially
for critically ill patients in hospitals and patients with
compromised immune systems, including cancer and transplant
patients. Approximately 90 percent of IFI-related deaths are
associated with Candida, Aspergillus, and Pneumocystis.
About Rezafungin
Rezafungin is a novel echinocandin antifungal and the only
once-weekly drug candidate being developed for the first-line
treatment and prevention of serious invasive fungal infections.
Rezafungin has a unique pharmacokinetic profile with a prolonged
half-life and front-loaded plasma exposure which, in contrast to
all other echinocandins, allows for once-weekly IV therapy for
inpatient and outpatient use. The U.S. Food and Drug Administration
(FDA) has designated rezafungin as a Qualified Infectious Disease
Product (QIDP) with Fast Track status and orphan drug designation
related to its use in the treatment of candidemia and invasive
candidiasis.
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on the
discovery, development and commercialization of novel
anti-infectives that have the potential to transform the standard
of care and save or improve patients’ lives. Cidara is currently
advancing its novel echinocandin antifungal, rezafungin acetate, in
a Phase 3 clinical trial for the first-line treatment of candidemia
and/or invasive candidiasis (ReSTORE) and plans to commence a
second Phase 3 trial of once-weekly rezafungin for prophylaxis
against invasive fungal infections in patients undergoing
allogeneic blood and marrow transplantation (ReSPECT) initially in
Europe and Canada. In addition to its robust rezafungin clinical
program, Cidara is applying its proprietary Cloudbreak® platform to
develop antiviral conjugates (AVCs) for the prevention and
treatment of influenza and other viral diseases. The Cloudbreak
platform is designed to discover compounds that both directly kill
pathogens and direct a patient’s immune system to attack and
eliminate pathogens. Cidara is headquartered in San Diego,
California. For more information, please visit www.cidara.com.
About Mundipharma
Mundipharma is a global network of privately-owned independent
associated companies whose purpose is to move medicine forward.
With a high performing and learning organisation that strives
for innovation and commercial excellence through partnerships, we
successfully transformed and diversified our portfolio of medicines
to create value for patients, payers and wider healthcare systems
across important therapeutic areas such as Diabetes, Respiratory,
Oncology, Pain and Biosimilars.
For more information please visit: www.mundipharma.com
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements relating to
the transformational nature and value of Cidara’s collaboration
with Mundipharma, Cidara’s ability to develop new anti-infectives
that are innovative or address unmet needs, including Cidara’s
ability to successfully complete the ReSTORE and ReSPECT Phase 3
clinical trials, Cidara’s ability to complete development of,
obtain regulatory approval for and commercialize rezafungin
including Cidara’s ability to receive milestone payments for the
achievement of development milestones, the potential for rezafungin
to successfully treat or prevent invasive fungal infections and
represent an improvement over current approaches, and the ability
of Cidara’s Cloudbreak program to successfully identify and develop
product candidates to prevent and/or treat viral diseases, and
other diseases. Risks that contribute to the uncertain nature of
the forward-looking statements include: the success and timing of
Cidara’s clinical trials; regulatory developments in the United
States and foreign countries; changes in Cidara’s plans to develop
and commercialize its product candidates; Cidara’s ability to
obtain additional financing; Cidara’s ability to obtain and
maintain intellectual property protection for its product
candidates; and the loss of key scientific or management personnel.
These and other risks and uncertainties are described more fully in
Cidara’s most recent filings with the United States Securities and
Exchange Commission. All forward-looking statements contained in
this press release speak only as of the date on which they were
made. Cidara undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made.
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version on businesswire.com: https://www.businesswire.com/news/home/20190903005286/en/
CIDARA - INVESTOR CONTACT: Robert H. Uhl Westwicke
Partners, LLC Managing Director (858) 356-5932
robert.uhl@westwicke.com
CIDARA - MEDIA CONTACT: Andrea Cohen Sam Brown Inc. (917)
209-7163 andreacohen@sambrown.com
MUNDIPHARMA - MEDIA CONTACTS: Helen Laurence Makara
Health Communications Limited +44 (0) 23 81 247 327
helen@makarahealth.com
Patrice Grand Mundipharma +44 (0) 1223 397 890
patrice.grand@mundipharma.com
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