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IMS CARBICARB ENTERING CLINICALS

Executive Summary

IMS CARBICARB ENTERING CLINICALS as treatment for carbon dioxide toxicity. The firm is investigating the buffered sodium bicarbonate agent as an alternative to sodium bicarbonate, the current therapy for carbon dioxide toxicity in emergency situations. The drug was discovered at the University of Colorado. International Medical Systems is the exclusive licensee of the university's patent. Carbicarb will be the generic firm's first effort to bring a new therapeutic agent to market. IMS also develops and markets disposable medication dispensing systems. The continued development of Carbicarb is part of an "expansion program" instituted by a new IMS management group following a recent leveraged buyout. The company was acquired by an IMS management group along with the San Francisco-based investment firm Robertson, Colman & Stephens. The management group is led by IMS President and CEO Randall Wall. The deal was finalized Aug. 29; terms were not disclosed. Wall disclosed the company's plans for "bringing [Carbicarb] to market as soon as possible" in an Aug. 1 letter to employees. Outlining the new management's plans, Wall said: "We are planning to accelerate our search for appropriate new products and new markets for our existing products. This includes expanding the number of drugs applied to IMS delivery systems as well as developing new devices." IMS specializes in injectables. The firm is currently seeking FDA pre-market approval for a needle-guard device and is "interested" in the area of self-administrable, injectable systems for use in patient-controlled analgesia. The firm will also be looking to expand its generic drug business in new markets, such as oncology. The company's new management has been in discussions with FDA on ways to resolve a dispute between the company and the agency over drug applications for three parenterals. The firm is seeking ANDAs for I.V. bretylium tosylate and I.V. isoproterenol, and an NDA for dextrose 5% injection. FDA had refused the applications earlier this year and IMS had challenged the decision, requesting a hearing.

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