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rock creek pharmaceuticals i (RCPI) Details

Rock Creek Pharmaceuticals, Inc., a pharmaceutical company, focuses on the research, development, and commercialization of compounds and formulations targeting inflammatory and neurological disorders. It also develops treatments for neurologic conditions, such as cigarette addiction. The company develops its products for various target indications, including the inflammatory and painful conditions osteoarthritis, ulcerative colitis, psoriasis, smoking cessation, and Hashimoto's thyroiditis. The company was formerly known as Star Scientific, Inc. and changed its name to Rock Creek Pharmaceuticals, Inc. in June 2014. Rock Creek Pharmaceuticals, Inc. is headquartered in Sarasota, Florida.

rock creek pharmaceuticals i (RCPI) Top Compensated Officers

Chairman and Chief Executive Officer
Total Annual Compensation: --
President, Director, Chairman of Compensation...
Total Annual Compensation: --
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $226.5K
Vice President of Sales and Marketing
Total Annual Compensation: $348.6K
Compensation as of Fiscal Year 2013.

rock creek pharmaceuticals i (RCPI) Key Developments

Rock Creek Pharmaceuticals, Inc. Announces Earnings Results for the Second Quarter Ended June 30, 2014; Announces Clinical Update on its Investigational New Drug Application

Rock Creek Pharmaceuticals, Inc. announced earnings results for the second quarter ended June 30, 2014. For the three months ended June 30, 2014, the company reported net sales of $0.7 million (gross sales less cash discounts, product discounts and product return allowance) compared to $2.5 million for the same period in 2013. The decrease of 71% was attributable exclusively to decreased Anatabloc(R) sales volume driven by significantly reduced promotion and marketing expenditures associated with the administrative status of Anatabloc(R) during the period. The company had a net loss of approximately $12.7 million for the three months ended June 30, 2014, compared to a net loss of approximately $8.7 million for the same period in 2013. The increase in net loss for the three months ended June 30, 2014 was primarily due to increases in stock-based compensation and severance costs, offset by lower sales and marketing expenses and legal expenditures. For the three months ended June 30, 2014, the company had a basic and diluted loss per share of $0.07, compared to a basic and diluted loss per share of $0.05 for the comparable period in 2013. The company has announced that it has received written comments from the U.S. Food and Drug Administration (FDA) indicating that the company's Investigational New Drug (IND) application is being placed on clinical hold until the company submits additional detail regarding the pre-clinical submissions. The company is coordinating with the FDA and working diligently at attaining an effective IND so as to begin clinical safety trials as soon as practicable. In the interim, the company will continue to prosecute a parallel clinical development program in the United Kingdom under a Clinical Trial Application (CTA) currently anticipated to be filed by the end of the third quarter of 2014. Upon CTA approval, the company expects to conduct European clinical safety trials shortly thereafter. Assuming a timely CTA approval, the company currently expects to launch Phase II clinical trials in 2015 for specific inflammatory diseases and potentially for nicotine addiction. With regard to the nutritional supplement business, the company filed a New Dietary Ingredient Notification (NDIN) in June 2014 as a measure to address certain provisions in the December 2013 FDA warning letter. Although the company does not believe that an NDIN is a prerequisite to the lawful marketing of the nutritional supplement, the NDIN was voluntarily submitted to provide the FDA with preclinical and clinical data concerning the supplement. In addition, the company is also voluntarily suspending its sale of CigRx(R) and Anatabloc(R) until such time as the company can complete its review of the FDA's response to the company's pending NDIN, which has not yet been received, as well as a review of how the nutritional supplement business may affect the company's drug development program. However, the company does anticipate these actions will bring the FDA warning letter matter to a close.

Rock Creek Pharmaceuticals, Inc. Appoints Lee M. Canaan and Edward J. McDonnell as Directors

Rock Creek Pharmaceuticals, Inc. announced that the company has made two key independent appointments to the company's Board of Directors with the recent election of Ms. Lee M. Canaan, CFA and Mr. Edward J. McDonnell, MPH. as new directors. Both Ms. Canaan and Mr. McDonnell have substantial expertise, experience and knowledge relevant to the Company's mission and anticipated needs. Currently Ms. Canaan is the portfolio manager of a private money management firm she founded in 2003. Most recently, Mr. McDonnell serves as President at Compliance Management Consulting, an independent consulting service, that provides expert advice, regulatory vulnerability assessments and compliance management know how to FDA regulated industries since 2000.

Rock Creek Pharmaceuticals, Inc. Initiates Development of its Lead Molecule, Anatabine Citrate, in Europe

Rock Creek Pharmaceuticals, Inc. announced that it has initiated the development of its lead molecule, Anatabine Citrate, in Europe; and that it has selected Quotient Clinical 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(TM) (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. Rock Creek Pharmaceutical's Antabine Citrate is a small molecule, cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics via the inhibition of NF-kB (nuclear factor kappa-light-chain-enhancer of activated B cells). NF-kB is a key protein complex which plays a pivotal role in regulating response to cellular inflammation. The Company has sponsored extensive pre-clinical in vitro and in vivo studies resulting in peer reviewed and published scientific journal articles, covering inflammatory models of Multiple Sclerosis, Alzheimer's Disease, and Auto-Immune Thyroiditis. In addition, the company's unusual compilation of human exposure, safety and tolerability data, provides important insights for future clinical pathway progression.


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