Akorn Announces Submission of an ANDA Drug Product Developed Jointly with Sofgen Pharmaceuticals
BUFFALO GROVE, Ill.--Akorn, Inc. (NASDAQ:AKRX) today announced the submission of an ANDA drug product developed jointly with Sofgen Pharmaceuticals. Akorn is requesting an Expedited Review of the ANDA drug product, which is identical to the reference listed drug (RLD). Akorn entered into the definitive exclusive development and supply agreement with Sofgen on August 10, 2006 in order to commercialize an ANDA drug product. The drug is indicated for the treatment of nausea and vomiting associated with cancer chemotherapy. The current market size of the drug is approximately $180 million, and represents a 40% market size increase since the signing of the definitive agreement.
This ANDA submission is the result of a joint collaboration between Akorn and Sofgen. Sofgen was responsible for the formulation and development of the drug, the manufacture of clinical batches, and the documentation necessary to support the Chemistry, Manufacturing and Control section of the ANDA. Upon regulatory approval, Sofgen will manufacture the drug product for Akorn. Akorn funded the pivotal bioequivalence (BE) study, submitted the ANDA and upon regulatory approval, is responsible for the marketing, distribution and sales of the drug. Akorn will own the ANDA and has exclusive marketing rights in the United States and Canada.
Abu Alam, Ph.D., Senior Vice President of New Business Development and BE Study Director stated, "This is a very important milestone for Akorn, based upon the successful attainment of bioequivalence results. Akorn's formulation was demonstrated to be bioequivalent to the RLD."
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "Akorn and Sofgen worked closely to develop and submit this ANDA, and I would like to thank all the project individuals for their diligent and expeditious efforts. We believe that this product will be a key revenue contributor to our business. This oral drug product is intended to complement the generic injectable anti-cancer drug products being developed for Akorn by Serum Institute of India. We expect to begin ANDA submissions for our generic injectable anti-cancer products in the fourth quarter of 2007."
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.
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.
Contacts
Akorn, Inc.
Arthur S. Przybyl
President and CEO
(847) 279 6100
This ANDA submission is the result of a joint collaboration between Akorn and Sofgen. Sofgen was responsible for the formulation and development of the drug, the manufacture of clinical batches, and the documentation necessary to support the Chemistry, Manufacturing and Control section of the ANDA. Upon regulatory approval, Sofgen will manufacture the drug product for Akorn. Akorn funded the pivotal bioequivalence (BE) study, submitted the ANDA and upon regulatory approval, is responsible for the marketing, distribution and sales of the drug. Akorn will own the ANDA and has exclusive marketing rights in the United States and Canada.
Abu Alam, Ph.D., Senior Vice President of New Business Development and BE Study Director stated, "This is a very important milestone for Akorn, based upon the successful attainment of bioequivalence results. Akorn's formulation was demonstrated to be bioequivalent to the RLD."
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "Akorn and Sofgen worked closely to develop and submit this ANDA, and I would like to thank all the project individuals for their diligent and expeditious efforts. We believe that this product will be a key revenue contributor to our business. This oral drug product is intended to complement the generic injectable anti-cancer drug products being developed for Akorn by Serum Institute of India. We expect to begin ANDA submissions for our generic injectable anti-cancer products in the fourth quarter of 2007."
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.
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.
Contacts
Akorn, Inc.
Arthur S. Przybyl
President and CEO
(847) 279 6100
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