Navigation Links
Rock Creek Pharmaceuticals Receives New Dietary Ingredient Notification (NDIN) Response
Date:9/12/2014

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.

Logo - http://photos.prnewswire.com/prnh/20140912/145661


'/>"/>
SOURCE Rock Creek Pharmaceuticals, Inc.
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. AMG Medical Inc. Selects Saddle Creek for Multichannel Fulfillment
2. A Forever Recovery Battle Creek, MI: Increasing Recreational Drug Use in Colleges Creates Risk for Addictions
3. Creekridge Capital Continues Vendor Growth within Technology
4. Star Scientific and Rock Creek Pharmaceuticals Report on the Beneficial Nutritional Effects of Anatabine in an Animal Model of Ulcerative Colitis
5. Creekridge Capital Announces Record Volume
6. Creekridge Capital Adds Revolving Credit Specialist
7. Creekridge Capital Expands Healthcare Sales Team
8. Creekridge Capital Launches Vendor Sales Training Program
9. Creekridge Capital Grows Healthcare Sales Team
10. Creekridge Breaks Monthly and Quarterly Volume Records
11. Rock Creek Pharmaceuticals Issues Update On US Investigational New Drug Application
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/30/2020)... , ... May 29, 2020 , ... ... statement in response to the U.S. announcement that it will terminate its relationship ... Administration’s announcement that it plans to terminate its relationship with the World Health ...
(Date:5/30/2020)... ... ... During a crisis, the platitude “stay strong” is well-intended, but difficult to put ... through hardship. Recent research conducted by PsychTests.com reveals that mentally tough people ... stay strong in the face of adversity. It seems that resilience isn’t just a ...
(Date:5/28/2020)... ... May 28, 2020 , ... When Sean Fitzgerald was in business ... able to help provide the physical care services needed to keep older adults in ... houses themselves. Now Fitzgerald is pleased to be in a position to help provide ...
Breaking Medicine Technology:
(Date:5/28/2020)... ... 28, 2020 , ... Today the National Kidney Registry (NKR) ... now be reimbursed for lost wages and travel/lodging costs for any donation-related complications ... include lost wage reimbursement for donation, travel & lodging reimbursement for donation, donation ...
(Date:5/27/2020)... ... May 27, 2020 , ... Productive Plastics, a leading ... face shields to be used as personal protective equipment (PPE) to combat ... single use, made to be worn by frontline healthcare professionals and for any ...
(Date:5/27/2020)... ... May 27, 2020 , ... ... practices in the United States, has aligned with the Strategic Radiology (SR) coalition ... of Virginia to join the SR coalition, which has 28 member practices in ...
(Date:5/26/2020)... ... May 26, 2020 , ... ... mechanism through which certain infections can impact the brain causing post infectious ... Disorders Associated with Streptococcal Infections) and PANS (Pediatric Acute-onset Neuropsychiatric Syndrome) could ...
(Date:5/26/2020)... ... 26, 2020 , ... Today TRC Companies (“ TRC ”) announced the release ... help business owners and leaders assess whether their organizations are prepared to move forward ... TRC is intended to assist business leaders evaluate their readiness relative to CDC guidance ...
Breaking Medicine News(10 mins):