Akorn, Inc. Announces Positive Phase III Pivotal Trial Results for Akten(R).BUFFALO GROVE, 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 the positive results of a Phase III pivotal trial for Akten[R]. The clinical trial was a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , placebo controlled, multi-centered, 4-arm trial in 209 subjects. The primary efficacy end point for achieving ocular anesthesia (p<0.001) and the secondary end point for duration of anesthesia (p<0.001) were both statistically significant for all three study drug dosages. Akten[R] is an Investigational New Drug (IND) product indicated for ocular anesthesia. Akorn filed a patent for Akten[R] in October 2006. The protocol design was discussed with the U.S. 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. prior to filing the IND in 2006. Akorn now intends to file a 505(b)(2) New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) in the second quarter of 2007. Akten[R] is intended to be used in various surgical and office-based ophthalmic procedures with an estimated market size of six million annual procedures. Abu Alam, PhD, Akorn's Senior Vice President of New Business Development and Clinical Study Director stated, "This is a very important milestone in our Company's history. Akten[R] is expected to be the first ethical drug product internally developed by Akorn. Akten[R] is a unit dose, preservative preservative Any of numerous chemical additives used to prevent or slow food spoilage caused by chemical changes (e.g., oxidation, mold growth) and maintain a fresh appearance and consistency. Antimycotics (e.g. free drug product and is manufactured at our Somerset, NJ facility. Once approved, Akten[R] will be marketed directly by Akorn to ophthalmologists". Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "Akten[R] represents an important proprietary ophthalmic drug product opportunity for Akorn. These trial results will allow us to proceed with the NDA filing in the second quarter of 2007". About Akorn, Inc. Akorn, Inc., headquartered in Buffalo Grove, Illinois This article is about the Chicago suburb, Buffalo Grove, Illinois. For the unincorporated Ogle County community of the same name, see Buffalo Grove, Ogle County, Illinois. , develops, 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. 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. Other factors besides those listed there could also adversely affect our results. |
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