FDA Designates Regado's REG1 in PCI as a Fast Track Development Program

Print 19 March 2014

Enrollment in the Phase 3 REGULATE-PCI Trial is Ongoing for Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

BASKING RIDGE, N.J., March 10, 2014 /PRNewswire/ -- Regado Biosciences, Inc. (Nasdaq: RGDO), a biopharmaceutical company focused on the development of actively controllable therapeutics, today announced that the United States Food and Drug Administration (FDA) has designated REG1 for anticoagulant therapy to be used in patients with coronary artery disease during percutaneous coronary interventions (PCI) as a Fast Track development program. The FDA's Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions that fill an unmet medical need, with the overall goal of getting new drugs to patients earlier. 

"We are pleased that the FDA has designated REG1 as a Fast Track development program in our lead indication of PCI," said David J. Mazzo, Ph.D., Chief Executive Officer of Regado Biosciences. "We continue to believe that REG1 has the potential to become a new standard of care for anticoagulation in interventional cardiology. We intend to continue our Phase 3 REGULATE-PCI study with the goal of bringing this important new therapy to patients as quickly as possible."

Robert M. Califf, M.D., Professor of Medicine at the Duke University Medical Center in Durham, N.C., Chairman of Regado Biosciences' Medical Advisory Board and recognized thought leader, said, "If REGULATE-PCI meets its primary endpoints, REG1 will offer a clinically meaningful advantage versus currently available therapies by enabling interventional cardiologists to actively control anticoagulation during PCI. Fast Track designation is an important step in the process of demonstrating REG1's promise to improve outcomes for patients."

REG1 is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen, for use during revascularization procedures such as PCI. These procedures put patients at risk for therapy-related ischemic and bleeding complications. REG1 is designed to improve patient outcomes, enable physicians to have direct therapeutic control and provide efficiencies leading to significant pharmacoeconomic benefits. REG1 is currently being evaluated in the Phase 3 REGULATE-PCI trial.

(For more information on REGULATE-PCI, please visit: http://www.clinicaltrials.gov/ct2/show/NCT01848106)

ABOUT REGADO BIOSCIENCES

Regado Biosciences, Inc., is a biopharmaceutical company focused on the discovery and development of novel, oligonucleotide-based actively controllable therapeutics. Our initial focus is on applications in the acute and sub-acute cardiovascular therapeutic area. The company's lead product candidate, REG1, is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen. REG1 is currently being evaluated in the REGULATE-PCI trial, a worldwide Phase 3 study enrolling 13,200 patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), a hospital-based procedure used to mechanically open or widen obstructed coronary arteries. Regado's actively controllable product candidates have the potential to improve patient outcomes and enhance the patient experience, provide direct therapeutic control to physicians and reduce overall treatment costs. More information can be found at www.regadobio.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing of the REGULATE-PCI trial, the effect of the FDA's fast track designation for REG1, and the timing of and prospects for any regulatory approval of REG1. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from those projected in forward-looking statements include the "Risk Factors" described in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on Nov. 8, 2013, and in the Company's other periodic filings with the SEC. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company has no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

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