Akorn, Inc. Signs a Definitive Exclusive Development and Supply Agreement with Sofgen to Develop and Commercialize an ANDA Drug Product.BUFFALO GROVE Buffalo Grove A village of northeast Illinois, a suburb of Chicago. Population: 43,300. , Ill. -- Akorn, Inc. (AMEX AMEX See: American Stock Exchange :AKN AKN King Salmon Airport (Alaska) AKN Altona-Kaltenkirchen-Neumünster (public transportation system in the north of Hamburg, Germany) AKN Net Cargo Ship (Auxiliary, Cargo, Net) ) today announced that it has signed a definitive exclusive development and supply agreement to develop and commercialize an ANDA ANDA abbr. abbreviated new drug application drug product. Sofgen Pharmaceuticals is a privately held pharmaceutical company located in Sunrise, Florida Sunrise is a city in Broward County, Florida, United States. Originally called "Sunrise Golf Village,"City of Sunrise History the name did not sit well with the retirees whom developers wanted to attract, so a change was made to "Sunrise. . Sofgen is responsible for the formulation and development of the drug, the manufacture of clinical product batches, and the documentation necessary to support the Chemistry, Manufacturing and Control (CMC (Common Messaging Calls) A programming interface specified by the XAPIA as the standard messaging API for X.400 and other messaging systems. CMC is intended to provide a common API for applications that want to become mail enabled. 1. ) section of an ANDA to be filed by Akorn. Upon regulatory approval Sofgen will supply finished dosage form product to Akorn. Akorn will fund and is responsible for the pivotal bio study, filing the ANDA and upon regulatory approval, the marketing, distribution and sales of the drug. Akorn will own the ANDA and has exclusive marketing rights in the United States and Canada. The drug is indicated for the treatment of nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. associated with cancer chemotherapy. The drug is also indicated for anorexia in patients associated with weight loss related to AIDS. The current market size of the drug is approximately $125 million. Akorn is forecasting product launch of the drug to occur in 2008. Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "This agreement highlights several Akorn strategies. The drug is a specialty type niche pharmaceutical, with no current generic competitors and compliments our strategies in AIDS and cancer drug products. Drug products for these markets are being developed internally and externally through our business partners, Fidia, Natco and Serum. We are excited to join forces with Sofgen Pharmaceuticals." Ruben Minski, Sofgen's President and Chief Executive Officer stated, "Our Company is infused with a strong belief in the growing need for precisely the sort of generic drugs and advance delivery technologies like the one we are partnering with Akorn. The trends are clearly in our favor, with our development and manufacturing capabilities and Akorn marketing expertise, we are heading for success." About Akorn, Inc. Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey Somerset is a census-designated place and unincorporated area located at the eastermost section within Franklin Township, in Somerset County, New Jersey. As of the United States 2000 Census, the CDP population was 23,040. Somerset housed one of the first Marconi Wireless Stations. 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 Sofgen Pharmaceuticals Sofgen is part of an Industrial Conglomerate with strong emphasis in the Healthcare and related businesses, including soft gelatin gelatin or animal jelly, foodstuff obtained from connective tissue (found in hoofs, bones, tendons, ligaments, and cartilage) of vertebrate animals by the action of boiling water or dilute acid. manufacturing facilities in South America and a Pharmaceutical Division with a distribution network that reaches 27 different countries around the globe. Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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 All actions that are authorized or sanctioned by law and instituted in a court or a tribunal for the acquisition of rights or the enforcement of remedies. , 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. compliance issues at our Decatur, Illinois manufacturing facility. Other factors besides those listed there could also adversely affect our results. |
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