Akorn, Inc. Announces First ANDA Submission For Serum Institute Of India, Ltd.

Main Category: Cancer / Oncology
Article Date: 07 Dec 2007 - 3:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Akorn, Inc. (NASDAQ:AKRX) announced that it has submitted the first Abbreviated New Drug Application (ANDA) with the Office of Generic Drugs on behalf of Serum Institute of India, Ltd. Akorn and Serum announced the signing of an exclusive drug development and distribution agreement for 16 anti-cancer injectable products in October 2004. Since then, Serum has constructed and validated a dedicated, state-of-the art manufacturing facility for producing liquid and lyophilized oncolytic drug products.

The submitted ANDA is a drug product that is given as a treatment for many different types of cancer, and has an estimated U.S. market size of approximately $53 million. Akorn expects to launch the drug product in 2010.

Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "We are excited to announce this new drug product submission. This drug application represents the initial expansion of our product pipeline into anti-cancer injectables. Our partnership with Serum also includes development projects for four vaccine products and a Rabies monoclonal antibody."

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 http://www.akorn.com.

About Serum Institute of India, Ltd.

Serum Institute is the world's fifth largest vaccine manufacturer. Its products are being exported to 137 countries across the globe. Serum Institute is now the largest producer of measles and DTP vaccines in the world. An average of more than one out of every two children immunized in the world has received at least one vaccine from Serum Institute. Additional information is available at the Company's website at www.seruminstitute.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.

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.

Akorn, Inc.