Akorn, Inc. Announces Positive Phase III Pivotal Trial Results for Akten(R)

Announced the positive results of a Phase III pivotal trial for Akten®.

BUFFALO GROVE, IL, USA | Jan 23, 2007 |
Akorn, Inc. (AMEX: AKN - News) today announced the positive results of a Phase III pivotal trial for Akten®. The clinical trial was a randomized, placebo controlled, multi-centered, 4-arm trial in 209 subjects. The primary efficacy end point for achieving ocular anesthesia (p less than 0.001) and the secondary end point for duration of anesthesia (p less than 0.001) were both statistically significant for all three study drug dosages.

Akten® is an Investigational New Drug (IND) product indicated for ocular anesthesia. Akorn filed a patent for Akten® in October 2006. The protocol design was discussed with the U.S. FDA prior to filing the IND in 2006. Akorn now intends to file a 505(b)(2) New Drug Application (NDA) in the second quarter of 2007. Akten® is intended to be used in various surgical and office-based ophthalmic procedures with an estimated market size of six million annual procedures.

Abu Alam, PhD, Akorn's Senior Vice President of New Business Development and Clinical Study Director stated, "This is a very important milestone in our Company's history. Akten® is expected to be the first ethical drug product internally developed by Akorn. Akten® is a unit dose, preservative free drug product and is manufactured at our Somerset, NJ facility. Once approved, Akten® will be marketed directly by Akorn to ophthalmologists".

Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "Akten® represents an important proprietary ophthalmic drug product opportunity for Akorn. These trial results will allow us to proceed with the NDA filing in the second quarter of 2007".

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.

Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, these include statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.

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Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled "Cautionary Statement Regarding Forward-Looking Statements" in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Other factors besides those listed there could also adversely affect our results.

SOURCE: Akorn, Inc.

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