Summit develops and manufactures generic prescription and new over-the-counter (OTC) pharmaceutical products administered to patients by means of a nasal spray. The company plans to submit the first of several applications to the U.S. Food & Drug Administration (FDA) in mid-2010 in order to receive approval to manufacture and market its generic products starting in 2011 and 2012.
The company is also developing new OTC nasal spray products for which it will apply for patents and plans to begin manufacturing in the first quarter of 2010. Several patent applications are expected to be filed in 2010 relating to the company’s OTC products.
To date, Summit has secured a partnership with a publicly traded generic-drug manufacturing company to jointly develop generic versions of five FDA-approved nasal spray products, including one to treat osteoporosis and others used to treat migraine headaches. The company has also secured a contract manufacturing agreement with a company to develop and make a new nasal spray product to treat pain.
“We are pleased with the excellent progress we have made thus far toward commercializing our products, reducing healthcare costs and creating jobs,” said Greg Plucinski, chief operating officer at Summit Biosciences. “We secured our first partnership agreement in June, completed the acquisition of our fully equipped manufacturing facility in August and are currently focused on developing our pipeline products.”
The Kentucky Economic Development Finance Authority (KEDFA) preliminarily approved Summit Biosciences for funding up to $250,000 in the form of a forgivable loan from the Cabinet for Economic Development’s High-Tech Pools, which are used to build technology-based and research-intensive companies and projects. KEDFA also preliminarily approved Summit Biosciences for tax incentives up to $500,000 under the Kentucky Business Investment (KBI) program. KBI incentives can be earned through corporate income tax credits and wage assessments.
“Summit Biosciences is the type of company that will make a great impact on the Bluegrass region,” said Commerce Lexington President & CEO Bob Quick. “Summit is working diligently on developing products that will reduce healthcare costs, as well as creating high-tech jobs for our citizens.
Summit Biosciences Inc. is a specialty pharmaceutical company focused on developing, manufacturing and commercializing generic and innovative nasal spray drug products.
The company provides contract development and manufacturing services to partners and clients for a wide variety of nasally delivered drug products and delivery systems. Summit’s operations are compliant with FDA current Good Manufacturing Practices (cGMPs) and are capable of supporting any stage of product development, from conceptual to commercial.
Summit Biosciences Inc. manufacturing plant, laboratories and headquarters are located on the University of Kentucky's Coldstream Research Campus in Lexington, KY.
For more information: Summit Biosciences
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