Akorn, Inc. and Cipla, Ltd. Announce the Signing of an Exclusive Drug Manufacturing and Supply Agreement For an Oral Anti-Infective 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) ) and Cipla, Ltd., a leading Indian pharmaceutical company located in Mumbai, India, today announced the signing of an exclusive drug manufacturing and supply agreement for an oral anti-infective ANDA ANDA abbr. abbreviated new drug application drug product. Under the terms of the ten-year agreement, Cipla will be responsible for the manufacturing and supply of the drug using Akorn's formulation, and Akorn will be responsible for the ANDA regulatory submission and clinical development, and for the purchase of specialized manufacturing equipment. Akorn will pay Cipla milestone fees for Cipla's assistance with ANDA development and submission. Pursuant to the agreement, Akorn will purchase the product from Cipla and Cipla will supply the product to Akorn on an exclusive basis in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Akorn will own the ANDA in the United States. The total market size for the oral ANDA anti-infective drug product is approximately $100 million. Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "Together with Cipla, we are strongly committed to expediting the clinical development activities necessary to introduce this product to the market. The commercialization of this ANDA drug product is a top priority". About Akorn, Inc. Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois
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 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 relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc 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. Other factors besides those listed there could also adversely affect our results. |
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