Rock Creek Pharmaceuticals Receives New Dietary Ingredient Notification Response
Sep 12 14
Rock Creek Pharmaceuticals, Inc. announced 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(R) and CigRx(R) 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.
Rock Creek Pharmaceuticals, Inc. Announces Earnings Results for the Second Quarter Ended June 30, 2014; Announces Clinical Update on its Investigational New Drug Application
Aug 11 14
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
Aug 6 14
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.