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Akorn, Inc. (AKRN) Signs A Definitive Agreement With Fidia Farmaceutici, S.p.A. To Develop Four ANDA Drug Products For Commercialization


5/2/2006 11:45:57 AM

BUFFALO GROVE, Ill.--(BUSINESS WIRE)--May 2, 2006--Akorn, Inc. (AMEX:AKN - News) today announced that it has signed a definitive agreement with Fidia Farmaceutici S.p.A., a privately-held pharmaceutical company located in Abano Terme (Padova), Italy, to develop four ANDA drug products. The two companies had previously signed a Letter of Intent on October 13, 2005, to develop these four drugs.

The four products include one ointment and one cream for topical application, and two tablet formulations used in the immuno compromised anti-viral market. The combined current market size of the four drugs is approximately $1.0 billion. Fidia will be responsible for product development and manufacturing of all four products including clinical development of the two tablet formulations while Akorn will be responsible for the clinical development of the ointment and cream formulations along with sales and marketing efforts. According to the signed agreement, Akorn will make milestone development fee payments to Fidia and have exclusive rights to market these four drugs in both the United States and Canada.

Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "These drug products represent an important future revenue opportunity for Akorn. Fidia has the expertise and capabilities to develop these four drugs."

Emilio Mauri, Fidia's Managing Director stated, "We are pleased to extend our successful business partnership with Akorn, which represents a milestone in our commitment to making available high quality drug products in the U.S. and Canadian markets."

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.

About Fidia Farmaceutici S.p.A.

Fidia Farmaceutici S.p.A. is an Italian pharmaceutical company that operates worldwide to develop and market innovative healthcare products, mainly based on sodium hyaluronate (HA) and its derivatives. With many years of experience in the U.S. and Canada with injectable and topical products, Fidia is now actively working to make available at the international level, fully integrated generic finished products, thanks to its facilities and state of the art equipment for oral, topical, and injectable forms.

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.

Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual results may vary materially, and there are not guarantees about the performance of our stock.

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. Such factors include, but are not limited to, risks and uncertainties relating to the resolution of the FDA compliance issues at our Decatur, Illinois manufacturing facility. Other factors besides those listed there could also adversely affect our results.

Contact: Akorn, Inc. Arthur S. Przybyl, 847-279-6100 or Fidia Farmaceutici S.p.A. Emilio Mauri, +39 049 8232 770

Source: Akorn, Inc.


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