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Rock Creek Pharmaceuticals Receives New Dietary Ingredient Notification (NDIN) Response

SARASOTA, Fla., Sept. 12, 2014 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug development company focused on chronic inflammatory disease and neurologic disorders, announced today it has received a written response from the U.S. Food and Drug Administration (FDA) in response to the New Dietary Ingredient Notification (NDIN) for the formulations of Anatabloc® and CigRx® submitted by the Company in June 2014. The letter indicated that the FDA considers anatabine citrate, a principal ingredient in these products, to be a drug, because anatabine citrate is intended to provide anti-inflammatory support, and is the subject of a previously filed Investigational New Drug Application (INDA).

The NDIN submission came in response to a previously issued FDA letter to the Company, which indicated that an NDIN was required before the Company's supplements could be marketed. In August 2014, the Company voluntarily suspended CigRx and Anatabloc sales, as the Company conducts an internal review and analysis of its supplement business, which is expected to be complete by year end 2014.

Michael Mullan, MBBS, PhD, Chairman and CEO of Rock Creek Pharmaceuticals, remarked, "We are conducting an internal review of our nutritional supplement business and will embark on the course best suited for the Company, its shareholders and customers. Concurrently, we are advancing our lead compound as a drug into human clinical trials." 

As previously disclosed, the Company is pursuing a clinical development program in the United Kingdom under a Clinical Trial Application (CTA) currently anticipated to be filed within the next four months. The Company has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration, which is on clinical hold pending additional data for the Agency to review.

About Anatabine Citrate:

Rock Creek Pharmaceuticals' anatabine citrate is a small molecule, cholinergic agonist, which exhibits anti-inflammatory pharmacological characteristics. The Company has sponsored extensive pre-clinical in vitro and in vivo studies resulting in peer reviewed and scientific journal articles, covering inflammatory models of Multiple Sclerosis, Alzheimer's Disease, and Auto-Immune Thyroiditis. In addition, the Company's compilation of human exposure, safety and tolerability data, provides important insights for future clinical pathway progression.

About Rock Creek Pharmaceuticals, Inc.:

Rock Creek Pharmaceuticals, Inc. is an emerging drug development company focused on the discovery, development and commercialization of new drugs, formulations and compounds that provide therapies for chronic inflammatory disease, neurologic disorders and behavioral health.

For more information, visit:


Ted Jenkins
Vice President, Corporate Strategy, Development, Investor Relations
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL  34243
Direct: 941-251-0488

Stephanie Carrington/ Jennifer Long
Integrated Corporate Relations, Inc. (ICR): Redefining Strategic Communications
685 Third Avenue, 2nd Floor,
New York, NY 10017
(646) 277-1282/(203) 682-8289

Forward Looking Statements
Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as "believes," "expects," "anticipates," "estimates," "intends," "plans," "targets," "projects" and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, including the continued development and market acceptance of our nutraceutical dietary supplements products, the effect of any competitive products, our ability to license and protect our intellectual property, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, potential litigation by or against us, any governmental review of our products or practices and the outcome of the ongoing investigations as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2013 filed on March 17, 2014 and our latest 10-Q Report filed on August 11, 2014. We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time.

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SOURCE Rock Creek Pharmaceuticals, Inc.
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