Rock Creek Pharmaceuticals Announces Japanese, European and U.S. Patent Developments and Valuation Initiative for Lead Compound
SARASOTA, Florida, May 5, 2016 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (OTCQB: RCPI), a clinical-stage drug development company focused on the application of its lead compound to treat acute and chronic inflammatory conditions, announced today recent additions to the Company's intellectual property (IP) portfolio. As exemplified below, the Company continues to protect existing IP and to enhance and develop additional IP.
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The Company has recently received a Decision to Grant a Patent from the Japanese Patent Office (Patent Application No: 2014-528385) for a pharmaceutical composition or dietary supplement containing anatabine or a derivative or isomer thereof. This decision marks the first approved patent for the Company in Japan, which is the second largest drug market in the world, worth close to $80B. Numerous Japanese companies in-license drugs and compounds from overseas for development in Japan.
Additionally, as previously disclosed in a November 2015 filing, the Company received from the European Patent Office a Notification of Intent to Grant a European patent for the administration of Anatabine to treat autism spectrum and seizure disorders. The Company is now pleased to announce that patent "EP2701704 – Methods of Administering Anatabine to Treat Autism Spectrum Disorders and Seizure Disorders" was granted and published on April 13, 2016.
Finally, The U.S. Patent and Trademark Office issued a Notice of Allowance on March 14, 2016 to the Company for Application No. 14/167,285 entitled, "Methods of Providing Anti-inflammation Support." This will be the first U.S. issued patent regarding "use" of anatabine or anatabine citrate for treating inflammation, providing further support to the Company's focus on developing anti-inflammatory therapeutics. The Company expects the patent to be issued within the next several months.
The Company's IP portfolio currently includes a composition of matter patent for anatabine citrate, a patent for large scale anatabine synthesis, and numerous US and foreign patents pending for "use" of anatabine and salts thereof, and its isomers and derivatives for inflammatory conditions. Those conditions include, but are not limited to, such diseases as psoriasis, thyroiditis, arthritis, Alzheimer's disease, and multiple sclerosis, as well as a recently published "patent pending" application for use of anatabine in various conditions of inflammatory lung disease.
As reported in November of 2014, Rock Creek Pharmaceuticals had retained a major, national intellectual property advisory and investment bank (IP Advisor) to value and monitor the growth of the Company's IP. Since that disclosure, the Company has achieved a number of milestones, further developed the Company's clinical assets, and defined and embarked upon a commercial development pathway in dermatology, all of which has reinforced and enhanced the Company's IP positions. Given the current market capitalization of the Company, together with the Company's belief that its assets and technology are undervalued in the market place, management has decided to re-engage the IP Advisor to recalculate and update the valuation analysis of the Company's intellectual property. This may position the Company for potential alternative capital sourcing strategies.
Michael Mullan (MBBS, PhD), Chairman and Chief Executive Officer of Rock Creek Pharmaceuticals, commented, "Comprehensive intellectual property protection is critical for the realization of the value of our pharmaceutical products under development. We are therefore pleased to report the continuing issuance of patent protection of our claimed products and their use in a wide selection of human and animal inflammatory diseases."
Dr. Mullan also addressed the recent volatility in the Company's common stock, "The market pricing of the Company's stock likely reflects significant concerns that the Company will be able to continue to finance its development activities and operations. In that regard, based on peer-reviewed scientific publications and regulatory agency controlled clinical data, coupled with an expanding intellectual property portfolio, we are exploring a variety of capital options that we believe are potentially available to us. Therefore, as an adjunct to the ongoing mutual commitment between the Company and the investors in the convertible note, we are evaluating various strategic alternatives, which will ultimately rely on the value of our intellectual property."
About Anatabine Citrate:
Rock Creek Pharmaceuticals' compound is a small molecule, cholinergic agonist that exhibits anti-inflammatory pharmacological characteristics, distinct from other anti-inflammatory drugs available such as biologics, steroids and non-steroidal anti-inflammatories. The Company's lead compound has been investigated extensively in pre-clinical (in vitro and in vivo) studies resulting in several peer reviewed and published scientific journal articles, covering models of multiple sclerosis, Alzheimer's disease, and autoimmune thyroiditis. All these studies demonstrated the anti-inflammatory effects of the Company's compound. In addition, the Company's compilation of human exposure, safety and tolerability data, has provided important insights for ongoing clinical and regulatory pharmaceutical development.
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 and acute inflammatory diseases.
For more information, visit: http://www.rockcreekpharmaceuticals.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, failure to obtain sufficient capital resources to fund our development program and operations, results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, including the continued development and approval of anti-inflammatory drug candidates, the effect of any competitive products, our ability to license and protect our intellectual property, our significant payables, 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, pending litigation matters, 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, 2015 filed on March 22, 2016. 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.
CONTACT:
Investor Contact:
PCG Advisory Group
Stephanie Prince
646.762.4518
sprince@pcgadvisory.com
Media Contact:
PCG Advisory Group
Sean Leous
646 863 8998
sleous@pcgadvisory.com
Company Contact:
Rock Creek Pharmaceuticals, Inc.
2040 Whitfield Ave. Suite 300
Sarasota Florida, 34243
1-844-727-0727
IR@rockcreekpharma.com
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