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T2 Biosystems and Cidara Therapeutics Announce Partnership for Commercial Placement of T2Dx Instruments to Support CD101 Drug Trials
Exclusive pricing program designed to drive uptake of T2 Biosystems' products and accelerate enrollment in Cidara's CD101 trials, targeting deadly sepsis-causing pathogen Candida
LEXINGTON, Mass. and SAN DIEGO, Sept. 06, 2017 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, and Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced an exclusive pricing program for the commercial placement of T2Dx Instruments. The preferred pricing structure will be exclusive to Cidara's clinical trial sites. The program is designed to accelerate enrollment in clinical trials evaluating Cidara's novel echinocandin antifungal CD101 and increase the number of hospitals that adopt T2 Biosystems' products, including the T2Candida Panel and the T2Bacteria Panel following FDA clearance.
Over the past year, the international Phase 2 STRIVE trial evaluating CD101 IV has used T2 Biosystems' T2Candida Panel for clinical trial enrollment. During that period, trial sites using the T2Candida Panel have demonstrated improved enrollment rates compared with those not using T2 Biosystems' product. Through the program announced today, T2 Biosystems will offer exclusive preferred sales terms to all U.S. clinical trial sites for CD101 IV through the completion of the planned Phase 3 trial. T2 Biosystems will place T2Dx Instruments at participating Cidara clinical trial sites that choose to participate in the preferred pricing program. Cidara will provide reimbursement coverage to sites for T2Candida tests that are used to screen patients for enrollment.
While participating in the trial, sites will also have access to the T2Bacteria IVD Panel once cleared by FDA and available commercially in the U.S. Currently, the T2Bacteria Panel is available commercially in Europe, and as a Research Use Only product in the United States. In addition, trial sites will also have access to future T2 Biosystems sepsis panels, including panels that include the superbug Candida auris, when they are commercially released. Recently, T2 Biosystems announced a collaboration with the Centers for Disease Control and Prevention (CDC) to provide research and surveillance tools for managing the emergence and outbreaks of Candida auris, which complements an ongoing European study that has already demonstrated the capability of T2MR technology to identify the superbug in whole blood clinical samples.
"We are confident that this partnership with T2 Biosystems will accelerate enrollment in our planned clinical trials," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara Therapeutics. "The ability to more rapidly diagnose infections with T2 Biosystems' products combined with the potential to more effectively clear those infections with CD101 IV should both save lives and advance antimicrobial stewardship within the nation's hospitals."
Candida is one of the deadliest sepsis-causing pathogens with a startling mortality rate of approximately 40 percent among patients receiving current standard of care. It is one of the leading hospital-acquired bloodstream infections in the United States and half of Candida infections are misdiagnosed as being negative by blood culture. The patient and economic impacts of Candida are tremendous: patients average 40 days in the hospital at a cost of $130,000 each. Studies have also shown that every hour of delayed treatment increases the risk of mortality by nearly eight percent. Blood culture-based diagnostic tests, which are the current standard of care, typically require up to six or more days to deliver a result.
"We believe this partnership will improve patient care by helping to get more therapies to combat sepsis to the market faster, while also making our T2MR platform, which includes the T2Dx Instrument and the T2Candida Panel, along with the T2Bacteria Panel upon FDA clearance, available to many more high-risk patients," said John McDonough, president and chief executive officer of T2 Biosystems. "T2 Biosystems diagnostic products direct the right therapy to the patient in three to five hours instead of the one to six or more days required by today's standard of care which is based on blood culture."
About T2 Biosystems
T2 Biosystems, an emerging leader in the field of in vitro diagnostics, is dedicated to saving lives and reducing the cost of healthcare by empowering clinicians to effectively treat patients faster than ever before. T2 Biosystems is focused on addressing critical unmet needs in healthcare starting with sepsis, one of the deadliest and most expensive conditions in hospitals today. The T2Sepsis SolutionTM is a unique approach that combines the best standard of care for the management of sepsis patients with T2 Biosystems' products, including the T2Dx® Instrument and T2Candida® Panel, and the T2Bacteria® Panel, which is commercially available in Europe and other countries that accept the CE mark and available for the research use only in the U.S. Powered by the proprietary T2 Magnetic Resonance technology, or T2MR®, the T2Sepsis Solution is proven to deliver better patient care and greater cost savings. Hospital customer experience has demonstrated faster time to effective treatment, shortened ICU and hospital lengths of stay, reduced use of unnecessary antifungals, and millions of dollars in savings. T2 Biosystems has an active pipeline of future sepsis products including additional species and antibiotic resistance, as well as tests for Lyme disease and hemostasis. For more information, please visit www.t2biosystems.com.
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on developing new anti-infectives that have the potential to transform the standard of care and save or improve patients' lives. The company is currently advancing its novel echinocandin antifungal, CD101 IV, through Phase 2 and developing CD201, its bispecific antibiotic immunotherapy, for the treatment of multi-drug resistant Gram-negative bacterial infections. CD101 IV has enhanced potency and is the only once-weekly therapy intended for the treatment and prevention of life-threatening invasive fungal infections. CD201 is the first drug candidate selected from Cidara's novel Cloudbreak™ platform, the first immunotherapy discovery platform designed specifically to create compounds that direct a patient's immune cells to attack and eliminate bacterial, fungal or viral pathogens. Cidara recently received a grant for up to $6.9 million from CARB-X (Combating Antibiotic Resistant Bacteria Accelerator) to advance the development of CD201. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
T2 Biosystems Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding uptake or adoption of products, future aspects and anticipated benefits of the pricing program with Cidara Therapeutics, Inc., additional patients, timing of testing patients, anticipated product benefits or access, strategic priorities, product expansion or opportunities, growth expectations or targets and timing or occurrence of FDA filings or clearances or commercial releases. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; (iv) reliance on third parties; (v) competitive factors; (vi) manufacturing or supply disruptions; (v) regulatory factors; (vi) risks related to intellectual property; or (vii) the factors discussed under Item 1A. "Risk Factors" in the company's Annual Report on Form 10-K for the year ended December 31, 2016, filed with the U.S. Securities and Exchange Commission, or SEC, on March 15, 2017, and other filings the company makes with the SEC from time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.
Cidara 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 potential for the partnership with T2 Biosystems to accelerate enrollment in Cidara's clinical trials and the effectiveness, safety, and other attributes of CD101. 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 most recently filed 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.
Darlene Deptula-Hicks, T2 Biosystems
SVP & Chief Financial Officer
Amy Phillips, Feinstein Kean Healthcare
Chris Brinzey, Westwicke Partners
Robert H. Uhl, Westwicke Partners
Christy Curran, Sam Brown Inc.