Healthcare Industry News:  Akorn 

Biopharmaceuticals Ophthalmology

 News Release - November 13, 2006

Akorn, Inc. and FDC Limited Sign Exclusive Development and Supply Agreement for Two Ophthalmic Suspension Drug Products

BUFFALO GROVE, Ill.--(HSMN NewsFeed)--Akorn, Inc. (AMEX:AKN ) and FDC Limited (MUMBAI:FDC), a leading ophthalmic drug company in India, today announced that they have signed an exclusive development and supply agreement for two ophthalmic suspension drug products. The two drug products currently have a combined U.S. market size of approximately $170 million.

Under the terms of the Agreement, FDC will fund the development and be responsible for manufacturing the two ophthalmic suspension drug products. Akorn will be responsible for marketing the two drug products in the U.S. and will receive 40% of the gross profit, while FDC will receive 60% of the gross profit generated from sales of the two drug products. Akorn will absorb the cost of the ANDA regulatory filings, FDC will own the ANDAs, and Akorn has agreed to annual minimum unit sales requirements in order to maintain U.S. marketing exclusivity.

Arthur S. Przybyl, Akorn's President and Chief Executive Officer, stated, "This Agreement further strengthens our expanding partnership with FDC. We remain impressed with FDC's blow-fill-seal technology and its use in ophthalmic products. So far this year, we have filed two ANDAs for FDC and look forward to several more."

Nandan Chandavarkar, FDC Limited Managing Director, stated, "FDC is excited about working with Akorn on these suspension products. We believe that our strong product development and manufacturing capabilities are very well complemented by Akorn's strengths in sales and marketing."

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 FDC Limited

FDC Limited (Bombay Stock Exchange:FDC) manufactures ophthalmic and oral drugs in unit and multi-dose formats as well as select active pharmaceutical ingredients (APIs) at a U.S. FDA-approved plant in Roha. The APIs manufactured at this plant are either exported (more than 80% of the production) or formulated at the company's plants in Goa and are U.K. MHRA-approved, enabling FDC to market several products (ophthalmic and solid dosage forms) in the U.K. Recently, FDC commissioned an additional manufacturing plant in Goa, which provides dosage form capabilities with quality systems meeting the highest International GMP Standards.

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. Other factors besides those listed there could also adversely affect our results.


Source: Akorn

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