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Rock Creek Pharmaceuticals Provides Update of its European Drug Development Regulatory Strategy and selects Quotient Clinical for its early development programs
Date:7/31/2014

SARASOTA, Fla., July 31, 2014 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI) announced today that it has initiated the development of its lead molecule, Anatabine Citrate, in Europe; and that it has selected Quotient Clinical, The Translational Pharmaceutics Company, based in the United Kingdom (UK) to run its early development programs.

The Company expects to file a Clinical Trial Application (CTA) by the end of the third quarter with the Medicines Healthcare products Regulatory Agency (MHRA) seeking regulatory approval to initiate its clinical trials. Upon CTA approval, a safety and tolerability study will be initiated to investigate escalating doses of Anatabine Citrate. At the same time, Quotient Clinical will employ its RapidFACT™ (Rapid Formulation development And Clinical Testing) service to identify the next generation of oral Anatabine Citrate formulations for progression into multiple pivotal Phase 2 proof of concept studies.

Michael J. Mullan MBBS (MD) PhD, Rock Creek Pharmaceutical's Chairman and CEO, said, "We are excited to be working with the Quotient Clinical team who provide a unique blend of services that integrate formulation development, real time GMP manufacturing and rapid clinical testing. These are exactly the resources and expertise our lead compound needs to expedite the drug development process to prepare us for phase II clinical trials expected to begin in 2015. "

Mark Egerton, Chief Executive Officer, Quotient Clinical said "Anatabine Citrate represents a potential new and exciting medicine for inflammatory disorders. We are delighted that Rock Creek have selected Quotient Clinical to progress their drug candidate through early development. Our Translational Pharmaceutic
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SOURCE Rock Creek Pharmaceuticals, Inc.
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