Akorn, Inc. Signs Exclusive Definitive Agreement For the Development and Supply of Three Ophthalmic ANDA Drug Products
10 January 2007 - 1:16AM
Business Wire
Akorn, Inc. (AMEX: AKN) today announced that it has signed a
Definitive Agreement with Azad Pharma, a privately-held
pharmaceutical company located in Toffen, Switzerland, to develop
and supply Latanoprost, Bimatoprost and Travoprost, three
ophthalmic ANDA drug products for the treatment of glaucoma. The
total United States market size for these three products is $870M,
according to 2006 IMS data. The drug products are expected to be
manufactured by Taejoon Pharmaceutical Co. Ltd., located in Seoul,
South Korea. Azad is the Agent for Taejoon Pharmaceuticals 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
ANDA�s and will own the ANDA�s. As part of this Agreement, Akorn
will have exclusive Marketing and Distribution rights for the three
drug products in the U.S. and Canada. Akorn expects to launch and
market 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. �This Agreement with Azad and Taejoon represents
Akorn�s first Business Development partnership in the Pacific Rim.�
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.� About Akorn,
Inc. Akorn, Inc., headquartered in Buffalo Grove, Illinois,
develops, manufactures and markets sterile specialty
pharmaceuticals. Akorn has manufacturing facilities located in
Decatur, Illinois and Somerset, New Jersey and markets and
distributes an extensive line of hospital and ophthalmic
pharmaceuticals. Additional information is available at the
Company�s website at www.akorn.com. About Azad Pharma AG Azad
Pharma AG is a recognized generic manufacturer, principally in the
fields of ophthalmology, prostaglandins, and parenteral drugs, both
with regard to the supply of API and finished dosage form finished
products. Additional information is available at the Company�s
website at www.azad.ch. Materials in this press release may contain
information that includes or is based upon forward-looking
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