Akorn, Inc. Receives U.S. IND Clearance for the Clinical Development of AK-1015, an NDA Drug Product for Ocular Anesthesia.BUFFALO GROVE Buffalo Grove A village of northeast Illinois, a suburb of Chicago. Population: 43,300. , Ill. -- Akorn, Inc. (AMEX AMEX See: American Stock Exchange :AKN AKN King Salmon Airport (Alaska) AKN Altona-Kaltenkirchen-Neumünster (public transportation system in the north of Hamburg, Germany) AKN Net Cargo Ship (Auxiliary, Cargo, Net) ) today announced that it has received U.S. IND clearance to initiate the pivotal, clinical trial for AK-1015 in 200 patients. AK-1015, an ophthalmic new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) will pursue an indication for ocular anesthesia. The clinical trial will begin in August 2006. Akorn has signed an agreement with a CRO firm for the deployment of the protocol and monitoring of the clinical trial. Akorn intends to file the NDA in 2007 with a potential product launch in 2008. The AK-1015 formulation was developed internally at the Somerset, NJ facility. Akorn already has a targeted sales force to optimize and create market penetration Noun 1. market penetration - the extent to which a product is recognized and bought by customers in a particular market penetration - the act of entering into or through something; "the penetration of upper management by women" . The U.S. market for this drug is approximately 5 million ophthalmic procedures per year. Akorn recently filed a U.S. patent for AK-1015 with supporting claims. Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "AK-1015 is our first internally developed NDA drug supported through an IND with clinical trials to help build our ophthalmic specialty pharmaceutical product line. The four arm clinical trial in 200 patients is intended to support the NDA filing for the indication of ocular anesthesia." About Akorn, Inc. Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois
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