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Cara Therapeutics, Inc. (CARA) Earns Milestone Payment From Maruishi Pharmaceutical For Completion Of Phase 1 Clinical Trial Of I.V. CR845 In Japan


7/16/2014 6:53:18 AM

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SHELTON, Conn., July 16, 2014 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain by selectively targeting kappa opioid receptors, today announced that it has earned a $500,000 milestone payment from Maruishi Pharmaceutical Company, Ltd., for the completion of Maruishi's Phase 1 clinical trial of the I.V. formulation of Cara's novel kappa opioid agonist, CR845, in Japan.

"We are very pleased with the rapid progress that the Maruishi team has made in successfully completing its Phase 1 single and multiple ascending dose trial of I.V. CR845 in a Japanese population," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "We look forward to Maruishi moving I.V. CR845 into the next phase of clinical development."

Cara and Maruishi entered into a license agreement in April 2013. Under the terms of the agreement, Maruishi has exclusive rights to develop, manufacture and commercialize CR845 for acute pain and uremic pruritus in Japan. Cara received an up-front payment, including an equity investment, in the aggregate amount of $23 million and is eligible to receive further milestone payments related to pre-defined clinical and regulatory events in Japan and the U.S., as well as royalties on Japanese sales of any marketed products containing CR845.

About CR845

CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain. In multiple randomized, double-blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in pain intensity and opioid-related side effects. In over 400 subjects dosed to date, I.V. CR845 was found to be safe and well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body's peripheral nervous system and have demonstrated efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

About Maruishi Pharmaceutical Company, Ltd.

Maruishi, an Osaka-based company which commenced operations in 1888, has a strong presence in the Japanese market as a specialty pharma developing, manufacturing, and marketing anesthetics, including the top product Sevofrane®, disinfectants, and as a leading producer of Japanese Pharmacopoeia drugs. With its recent implementation of a new business strategy for 'Full Coverage' within the perioperative and disinfectant fields, Maruishi continues to develop innovative new products to improve the quality-of-life (QOL) of patients.

For more information on the company, please visit:

http://www.maruishi-pharm.co.jp/english/about/message/index.html.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the future clinical development of CR845 by Maruishi in Japan and about Cara's potential receipt of future milestone payments and royalties based on Maruishi's clinical and regulatory development of products containing CR845, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements may include, but are not limited to, the timing and success of Maruishi's clinical and regulatory development of CR845. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.

CONTACT: CORPORATE CARA CONTACT: Derek Chalmers President & CEO 203-567-1500 CORPORATE MARUISHI CONTACT: Hideharu Tominaga Officer and Director Phone: +81-6-6964-3150 hideharu_tominaga@maruishi-pharm.co.jp MEDIA CONTACT: Laura Bagby 6 Degrees 872-206-5475 lbagby@6degreesPR.com INVESTOR CONTACT: Jesse Baumgartner Stern Investor Relations 212-362-1200 Jesse@sternir.com
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