Safety First Trust Principal-Protected Trust Certificates Linked TO A U.S.-Europe-Japan Basket Structured Product (AMEX:AKN)
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Akorn, Inc. (AMEX:AKN) 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) 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.
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 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.
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