Akorn Announces Development and Supply Agreement with Hyaluron For Two Injectable ANDA Suspension Drug Products.BUFFALO GROVE Buffalo Grove A village of northeast Illinois, a suburb of Chicago. Population: 43,300. , Ill. -- Akorn, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :AKRX) today announced the signing of a development and supply agreement with Hyaluron Contract Manufacturing, Inc. (HCM HCM hypertrophic cardiomyopathy. ), an innovative leader in aseptic aseptic /asep·tic/ (-tik) free from infection or septic material. a·sep·tic adj. Of, relating to, or characterized by asepsis. formulation and filling of liquid parenterals located in Burlington, Massachusetts Burlington is a town in Middlesex County, Massachusetts, United States. The population was 22,876 at the 2000 census. History Burlington was first settled in 1641 and was officially incorporated on February 28, 1799. . The Agreement provided for two ANDA ANDA abbr. abbreviated new drug application injectable suspension products with a 2006 market size of approximately $220 million, according to IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. sales data. One of the ANDA drug products represents an injectable sustained release pharmaceutical. This product will be available in both prefilled syringe and vial configurations. The second ANDA drug product is indicated as an anti-inflammatory and will be available in multiple packaging configurations. Hyaluron will manufacture both drug products for Akorn, who will be responsible for marketing and distributing them within the United States. Akorn will coordinate the bioequivalency clinical trials, prepare the ANDA Regulatory filings and will own both ANDAs. Financial terms of the agreement were not disclosed. The products are expected to launch in 2010. Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated "We are excited to be working with Hyaluron on these two opportunities. Both products will be key growth drivers for our company, similar to our upcoming Vancomycin vancomycin (văn'kōmī`sĭn), antibiotic resembling penicillin in the way it acts. It is derived from the bacterium Streptomyces orientalis, which was isolated from soil of India and Indonesia. capsule, Tetanus Diphtheria diphtheria (dĭfthēr`ēə), acute contagious disease caused by Corynebacterium diphtheriae (Klebs-Loffler bacillus) bacteria that have been infected by a bacteriophage. It begins as a soreness of the throat with fever. Vaccine and Akten[R] product launches. The addition of injectable suspensions to Akorn's portfolio complements our line of injectable drug products that includes both proprietary and generic drugs." Shawn Kinney, Hyaluron's President stated, "Our decision to partner with Akorn is reflective of our commitment to provide our clients--from newly established firms to large-scale commercial enterprises--innovative solutions to all their formulation and filling needs. We look forward to working with Akorn, and to the opportunities this collaboration presents to make a lasting contribution to the market for sterile injectable products." 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 Hyaluron Contract Manufacturing, Inc. Hyaluron Contract Manufacturing, Inc. is a leader in aseptic manufacturing of filled liquid parenterals. Since 1999, HCM has been offering its customers in the pharmaceutical and biotechnology industries innovative and unique solutions to assist them in bringing their products to market. At the core of HCM's business is a commitment to quality, regulatory compliance and on-time delivery, as well as courteous and professional communication. HCM is located in Burlington MA. For further information, visit: www.hyaluron.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. 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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