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Re: Simonsays2 post# 11894

Thursday, 12/19/2013 10:16:23 AM

Thursday, December 19, 2013 10:16:23 AM

Post# of 30442
This help! -- Room Temperature Device and Other Manufacturing Initiatives Progressing. Apricus continues to make progress with its next-generation, room temperature version of Vitaros. This new version is expected to have a targeted shelf life of at least 24 months and will not require refrigeration. The Company has contracted with an additional manufacturing partner that will serve as a second source of global supply for Vitaros. The Company expects this second manufacturing site, located in Canada, will be ready to supply cold chain Vitaros product to its commercialization partners in the second half of 2014. The site will also serve as the primary manufacturing site for the ongoing room temperature Vitarosdevelopment program. Apricus believes this next-generation, room temperature version will be a key driver of Vitarosmarket growth and expansion in 2015 http://pennyomega.com/img/apri.jpg

SAN DIEGO, May 25, 2012 (CRWENewswire) — Apricus Biosciences, Inc. (“Apricus Bio” or the “Company”) (Nasdaq:APRI) (http://www.apricusbio.com) announced today that the Canadian Intellectual Property Office issued a Notice of Allowance for a Canadian patent on certain methods of manufacture for the Company’s platform NexACT(R) drug delivery technology.

Specifically, the patent covers the synthesis of Dodecyl 2-(N, N-Dimethylamino)-Propionate (DDAIP) by a transesterification chemical process. DDAIP opens up the tight junctions between cells, allowing drugs to be delivered to the bloodstream.

The patent application (No. 2,706,680), entitled “Crystalline Salts of Dodecyl 2-(N, N-Dimethylamino)-Propionate, is a divisional application of the already issued Canadian Patent No. 2,338,139 bearing the same title and covering crystal salts of DDAIP. When issued, this patent will protect this method of manufacture of DDAIP in Canada, and provides patent exclusivity to May 2020.

The transesterification approach to synthesizing DDAIP represents an advance in the manufacturing process of this technology. The resulting product contains relatively lower levels of by-products and unreacted reactants, which are undesirable and difficult to remove by conventional methods. The Company expects this method to bring significant cost savings for the finished product. This will be the 17th patent granted for this technology worldwide, with two applications pending in this patent family.

In addition, the New Zealand Intellectual Property Office issued a Notice of Acceptance for New Zealand patent application number 576,242, entitled “Stabilized Prostaglandin E Composition,” which claims formulations of Vitaros(R), Apricus Bio’s lead product candidate for the treatment of erectile dysfunction. When issued, this patent will grant exclusive rights to certain pharmaceutical compositions of Vitaros(R)–including its room temperature formulation in New Zealand. It will provide patent exclusivity until October 2027.

“These new patent allowances serve to further strengthen our global intellectual property positions,” said Bassam Damaj, President and Chief Executive Officer of Apricus Bio. “We continue to pursue an aggressive patent strategy that we believe will protect the DDAIP compound and method of manufacture including those relating to our more advanced room temperature formulations, and we will meaningfully expand the market exclusivity of our products in important territories.”

Apricus Bio currently owns approximately 144 issued patents and 143 patent applications, including eight allowed patent applications, on its NexACT(R) technology, its acquired products, and on other products and technologies throughout the world. Patents covering Vitaros(R), for erectile dysfunction, have been issued in Australia, Canada, Eurasia, Europe, Hong Kong, Israel, Japan, Mexico, New Zealand, Singapore, South Africa, South Korea, Turkey, Taiwan, and the United States.
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