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Cidara Receives Orphan Drug Designation for Novel Echinocandin, CD101 IV, in Candidemia and Invasive Candidiasis
February 10, 2016 at 7:00 AM EST

Orphan designation follows QIDP and Fast Track status for CD101 IV

SAN DIEGO--(BUSINESS WIRE)--Feb. 10, 2016-- 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.

Source: Cidara Therapeutics, Inc.

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