CORRECTING & REPLACING Cidara Receives Orphan Drug Designation for Novel Echinocandin, CD101 IV, in Candidemia & Invasive Can...
10 February 2016 - 11:40PM
Business Wire
Orphan designation follows QIDP and Fast
Track status for CD101 IV
Headline of release should read: Cidara Receives Orphan Drug
Designation for Novel Echinocandin, CD101 IV, in Candidemia and
Invasive Candidiasis (instead of Cidara Receives Orphan Drug
Designation for Novel Echinocandin, CU101 IV, in Candidemia and
Invasive Candidiasis)
The corrected release reads:
CIDARA RECEIVES ORPHAN DRUG DESIGNATION FOR
NOVEL ECHINOCANDIN, CD101 IV, IN CANDIDEMIA AND INVASIVE
CANDIDIASIS
Orphan designation follows QIDP and Fast
Track status for CD101 IV
Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company
developing novel anti-infectives and immunotherapies to treat
fungal and other infections, today announced that the U.S. Food and
Drug Administration (FDA) has granted orphan drug designation to
its antifungal drug candidate, CD101 IV, for the treatment of
candidemia and invasive candidiasis.
Orphan drug designation of CD101 provides Cidara eligibility for
seven years of market exclusivity in the United States upon FDA
approval, a waiver from payment of User Fees, an exemption from
performing clinical studies in pediatric patients, and tax credits
for the cost of the clinical research. The seven-year period of
marketing exclusivity provided through orphan designation combined
with an additional five years of marketing exclusivity provided
from the previously announced QIDP designation positions CD101 IV
for a total of 12 years of potential marketing exclusivity to be
granted at the time of FDA approval.
“This designation underscores the need for new drugs to treat
severe fungal infections and is another in a series of milestones
that demonstrate the promise of our novel, long-acting
echinocandin, CD101 IV,” said Jeff Stein, Ph.D., president and CEO
of Cidara. “Our Phase 1 data demonstrating the safety and
tolerability of up to three doses of high exposure, once-weekly
CD101 IV enables us to initiate our Phase 2 study in candidemia
early this year. We believe CD101 IV has the potential to become a
best-in-class echinocandin antifungal.”
Cidara is developing CD101 IV for the treatment and prevention
of serious fungal infections that are associated with high
mortality rates and rising drug resistance. Current standards of
care for invasive fungal infections, including azoles, have
multiple limitations including drug interactions and dose-limiting
toxicities. First-generation echinocandins require daily IV dosing,
limiting their use primarily to the inpatient setting.
In January of 2016, Cidara reported data from the company’s
Phase 1 multiple ascending dose (MAD) clinical trial of CD101 IV,
which demonstrated excellent safety and tolerability across a broad
range of doses. The company plans to initiate a Phase 2 candidemia
trial in the first half of 2016.
About Candidemia/Invasive Candidiasis
Systemic Candida infections include candidemia and related cases
of invasive candidiasis. Candida is the leading cause of
bloodstream infections within U.S. hospitals. Systemic Candida
infections are considered to be serious and life-threatening, with
up to 47 percent mortality. These infections represent a
significant public health issue, particularly in highly vulnerable
patient populations at risk for infection, such as the elderly,
post-surgical, critically ill and other hospitalized patients with
serious medical conditions.
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on the
discovery, development and commercialization of novel
anti-infectives for the treatment of diseases that are inadequately
addressed by current standard-of-care therapies. Cidara's initial
product portfolio comprises two formulations of the company's novel
echinocandin, CD101. CD101 IV is a long-acting therapy for the
treatment and prevention of serious, invasive fungal infections.
CD101 topical is for the treatment of vulvovaginal candidiasis
(VVC) and recurrent VVC (RVVC), a prevalent mucosal infection. In
addition, Cidara has developed a proprietary immunotherapy
platform, Cloudbreak™, designed to create compounds that direct a
patient's immune cells to attack and eliminate pathogens that cause
infectious disease. Cidara is headquartered in San Diego,
California. For more information, please visit www.cidara.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 regarding
the effectiveness, safety, long-acting nature, anticipated human
dosing and other attributes of CD101 IV and its potential to treat
infections, the incidence of fungal infections, and the
effectiveness of and treatment protocols for competitive therapies.
Risks that contribute to the uncertain nature of the
forward-looking statements include: the success and timing of
Cidara’s preclinical studies and 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 Form 10-Q filed with the United States
Securities and Exchange Commission (SEC), under the heading “Risk
Factors.” 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: http://www.businesswire.com/news/home/20160210005427/en/
INVESTORS:Westwicke Partners, LLCRobert H. Uhl,
858-356-5932Managing Directorrobert.uhl@westwicke.comorMEDIA:Sam
Brown Inc.Chris Seger,
631-428-1517christopherseger@sambrown.com
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