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Akorn Enters Ophthalmic ANDA Drug Pact

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Akorn, Inc. has signed a definitive agreement with Azad Pharma to develop and supply Latanoprost, Bimatoprost and Travoprost, three ophthalmic ANDA drug products for the treatment of glaucoma. The products are to be manufactured by Taejoon Pharmaceutical Co. Ltd., located in Seoul, South Korea. Azad served as Taejoon’s agent in this agreement. Taejoon and Azad are responsible for completion of the regulatory dossiers and upon ANDA approval, will manufacture and supply the products to Akorn in a blow-fill seal container closure system.

Akorn is responsible for the regulatory filings of the ANDAs and will have exclusive marketing and distribution rights for the products in the U.S. and Canada. Akorn expects to launch the drug products based on their respective patent expiry dates.

Arthur S. Przybyl, Akorn’s president and chief executive officer stated, “This Agreement continues to broaden our product development efforts in ophthalmology. Currently, we have eight ophthalmic ANDA submissions on file with the Office of Generic Drugs, have announced a tentative approval for Diclofenac, and are preparing to file an NDA for Akten, indicated for ocular anesthesia soon after announcing the results of our 200-patient clinical trial in January 2007.

Mike Baronian, Azad Pharma’s chairman and chief executive officer stated, “Azad Pharma’s focus is in Oncology and Ophthalmology and Akorn’s core competence in Ophthalmology in the North American market makes it an ideal partner to penetrate this very exciting market, using Taejoon’s excellent product portfolio.”

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