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Akorn, Inc. (AMEX:AKN) and Serum Institute of India, Ltd. today announced that they have entered into a Definitive Development and Exclusive Distribution Agreement for Rabies monoclonal antibody. The Agreement finalizes a previously executed Memorandum of Understanding dated April 4, 2006 with respect to both companies collaboration in developing and distributing monoclonal antibody drugs. The term of the Agreement is ten years following the first commercial sale of products. Recently, Serum has entered into a Definitive Agreement with a third party that gives Serum the right to appoint a distributor for the marketing and distribution of Rabies monoclonal antibody products. Serum has agreed to appoint Akorn as the exclusive distributor for Rabies monoclonal antibody. In exchange for Akorn receiving exclusive marketing and distribution rights to North, Central, and South America, Akorn has agreed to help fund product development through milestone payments. These milestone payments include the successful completion of Phase I, Phase II, and Phase III clinical trials leading to eventual receipt of CBER approval for a BLA license. BLA approval is targeted to occur in 2012 and Akorn expects to fund these milestone payments with cash flow provided from operations. As the exclusive marketing and distribution partner for Rabies monoclonal antibody, Akorn will receive 40% of the revenues from product sales in North America and 50% of the revenues from product sales in Central and South America. As part of the Agreement, Serum also grants Akorn the first option right to obtain exclusive marketing rights in North, Central, and South America for a second monoclonal antibody product, Anti-D human monoclonal antibody. The terms for Anti-D would be consistent with the terms and conditions for the Rabies monoclonal antibody product. Additionally, Serum has granted Akorn the first option right to expand the Territory to include Europe in exchange for annual product sales requirements in Europe. The current market size in North, Central, and South America and Europe for Rabies monoclonal antibody is approximately $100 million. The current market size in North, Central, South America and Europe for Anti-D monoclonal antibody is approximately $500 million. Arthur S. Przybyl, President and Chief Executive Officer of Akorn stated, �We are very excited to enter into this Agreement with Serum. This Agreement represents Akorn�s first biologic development and distribution product opportunity. In the future, we expect to continue to build our platform for development and eventual commercialization of additional biologic and vaccine products with Serum Institute. �Also, after my recent visit to India, I have observed that Serum continues to make excellent progress on a new manufacturing plant dedicated to our anti-cancer injectable and lyophilized drug products. We expect our ANDA�s filings to commence in 2007.� Dr. Cyrus S. Poonawalla, Chairman and Managing Director of Serum Institute of India Ltd., stated, �We look forward to this product development and distribution Agreement for this biologic product as a continuing step towards strengthening the long-term relationship with Akorn.� 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 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 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. The securities offered in this placement have not been registered under the Securities Act of 1933, as amended, or state securities laws, and cannot be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from the registration requirements. As part of the transaction, the company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable. This news release is neither an offer to sell nor a solicitation of an offer to buy any of the securities discussed herein and is being issued under Rule 135c of the Securities Act of 1933. 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. (AMEX:AKN) and Serum Institute of India, Ltd. today announced that they have entered into a Definitive Development and Exclusive Distribution Agreement for Rabies monoclonal antibody. The Agreement finalizes a previously executed Memorandum of Understanding dated April 4, 2006 with respect to both companies collaboration in developing and distributing monoclonal antibody drugs. The term of the Agreement is ten years following the first commercial sale of products. Recently, Serum has entered into a Definitive Agreement with a third party that gives Serum the right to appoint a distributor for the marketing and distribution of Rabies monoclonal antibody products. Serum has agreed to appoint Akorn as the exclusive distributor for Rabies monoclonal antibody. In exchange for Akorn receiving exclusive marketing and distribution rights to North, Central, and South America, Akorn has agreed to help fund product development through milestone payments. These milestone payments include the successful completion of Phase I, Phase II, and Phase III clinical trials leading to eventual receipt of CBER approval for a BLA license. BLA approval is targeted to occur in 2012 and Akorn expects to fund these milestone payments with cash flow provided from operations. As the exclusive marketing and distribution partner for Rabies monoclonal antibody, Akorn will receive 40% of the revenues from product sales in North America and 50% of the revenues from product sales in Central and South America. As part of the Agreement, Serum also grants Akorn the first option right to obtain exclusive marketing rights in North, Central, and South America for a second monoclonal antibody product, Anti-D human monoclonal antibody. The terms for Anti-D would be consistent with the terms and conditions for the Rabies monoclonal antibody product. Additionally, Serum has granted Akorn the first option right to expand the Territory to include Europe in exchange for annual product sales requirements in Europe. The current market size in North, Central, and South America and Europe for Rabies monoclonal antibody is approximately $100 million. The current market size in North, Central, South America and Europe for Anti-D monoclonal antibody is approximately $500 million. Arthur S. Przybyl, President and Chief Executive Officer of Akorn stated, "We are very excited to enter into this Agreement with Serum. This Agreement represents Akorn's first biologic development and distribution product opportunity. In the future, we expect to continue to build our platform for development and eventual commercialization of additional biologic and vaccine products with Serum Institute. "Also, after my recent visit to India, I have observed that Serum continues to make excellent progress on a new manufacturing plant dedicated to our anti-cancer injectable and lyophilized drug products. We expect our ANDA's filings to commence in 2007." Dr. Cyrus S. Poonawalla, Chairman and Managing Director of Serum Institute of India Ltd., stated, "We look forward to this product development and distribution Agreement for this biologic product as a continuing step towards strengthening the long-term relationship with Akorn." 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 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 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. The securities offered in this placement have not been registered under the Securities Act of 1933, as amended, or state securities laws, and cannot be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from the registration requirements. As part of the transaction, the company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable. This news release is neither an offer to sell nor a solicitation of an offer to buy any of the securities discussed herein and is being issued under Rule 135c of the Securities Act of 1933. 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.