tivity on peripheral COMT. The company intends to develop CERC-406 as an oral adjunctive medication for patients with residual cognitive impairment symptoms. The company selected CERC-406 as its major preclinical candidate from its COMTi platform. The company has also observed that CERC-406 has an off-rate on brain COMT that is slower than tolcapone, implying a good duration of effect. In preclinical studies it appears that CERC-406 might have favorable drug distribution and metabolism properties, suggesting that it has the potential to be administered orally on a once or twice daily basis. Similarly, CERC-425 is an orally active small molecule, COMT inhibitor also being explored for neurologic conditions. The company anticipates developing CERC-406 for the improvement of executive function and working memory in patients with diseases of impaired motoric functions, where a new therapy with efficacy in residual cognitive symptoms might be associated with improved functional outcomes. The company anticipates advancing the characterization of the safety and efficacy of CERC-406 and CERC-425 in preclinical animal studies, to advance manufacturing of product for clinical trials, and to file their IND, subject to the availability of additional funding. Sales and Marketing The company promotes Poly-Vi-Flor, Tri-Vi-Flor, Millipred, Veripred, Ulesfia, Cefaclor, Karbinal, Aciphex Sprinkles, and Flexichamber through a sales force of representatives and territory managers. Strategy The company’s strategy includes improving sales of the existing products in its portfolio, including by identifying and investing in growth opportunities, such as new treatment indications and new geographic markets; acquiring or licensing rights to clinically meaningful and differentiated products that are already on the market for pediatric use or product candidates that are in late-stage development for pediatric indications that are near market launch; and pursuing targeted clinical-stage development assets that are differentiated product candidates for rare neurological disorders or orphan diseases. Intellectual Property The company has issued patents covering the compounds and compositions of CERC-301, CERC-611, CERC-406 and CERC-425. The patent portfolios for its advanced programs are as follows: CERC-301: The company possesses worldwide rights to manufacture, use, and sell certain NR2B antagonist compounds. The CERC-301 patent portfolio consists of three patent families. The first family consists of patents that have issued in the United States (U.S.), Australia, Canada, Germany, France, the United Kingdom, Switzerland, and Japan. The patents in the first family include composition of matter and use claims of varying scope, including picture claims to CERC-301 or a pharmaceutically acceptable salt thereof. The expiration date of the U.S. patent in the first family is August 31, 2026, not including any patent term extension or market exclusivity period, which might apply. The second family consists of patents that have issued in the U.S., Germany, France, and the United Kingdom. The patents in the second family include composition of matter claims (in the U.S. patent) and use claims that generically cover CERC-301. The expiration date of the U.S. patent is June 3, 2022, not including any patent term extension or market exclusivity period. The third family consists of patent applications in the U.S., Argentina, Australia, Brazil, Canada, China, Europe, India, Japan, Mexico, Russia, South Korea, and Taiwan, with claims to compositions of matter, methods of use, and methods of manufacture. Any patents issuing from these applications would expire in December 2035 at the earliest, not including any patent term adjustment, patent term extension, or market exclusivity period. CERC-611: The company possesses worldwide rights to manufacture, use, and sell CERC-611. The CERC-611 patent portfolio consists of two patent families. The first family consists of patents that have issued in the U.S., Australia, Canada, China, Eurasia, Europe, Japan, Singapore, South Africa, South Korea, Ukraine, and Vietnam; and approximately 20 inte
cerecor inc (CERC:NASDAQ CM)
540 Gaither Road
Rockville, MD 20850
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