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: http://www.rockcreekpharma.com
CONTACT:
Ted Jenkins
Vice President, Corporate Strategy, Development, Investor
Relations
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL 34243
Direct: 941-251-0488
tjenkins@rockcreekpharma.com
Stephanie Carrington/
Jennifer Long
Investors/Media
Integrated Corporate Relations, Inc. (ICR): Redefining Strategic
Communications
685 Third Avenue, 2nd Floor,
New York, NY 10017
(646) 277-1282/(203) 682-8289
stephanie.carrington@icrinc.com
jen.long@icrinc.com
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.