Akorn, Inc. and Hameln Pharmaceuticals gmbh Announce the Signing of the Exclusive License and Supply Agreement for two Orphan Drug NDA's: Calcium-DTPA and Zinc-DTPA.BUFFALO GROVE, Ill. -- Akorn, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :AKRN.OB) and Hameln Pharmaceuticals gmbh (Hameln), a leading private German pharmaceuticals company, today announced the signing of the Exclusive License and Supply Agreement for two Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the NDA's: Calcium-DTPA and Zinc-DTPA. Akorn and Hameln announced the signing of a Binding Term Sheet on October 20, 2004 and had agreed to enter into the License and Supply Agreement by November 30, 2004. The two drugs were approved on August 11, 2004 by 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. , and are indicated as antidotes for the treatment of radioactive poisoning, specifically internal contamination with plutonium, americium americium (ămərĭ`shēəm), artificially produced radioactive chemical element; symbol Am; at. no. 95; mass no. of most stable isotope 243; m.p. about 1,175°C;; b.p. about 2,600°C;; sp. gr. 13. , or curium curium (ky r`ēəm), artificially produced radioactive chemical element; symbol Cm; at. no. 96; mass no. of most stable isotope 247; m.p. about 1,340°C;; b.p. 3,110°C;; sp. gr. . Akorn is currently in discussions with the U.S. Government to secure a purchase order to stockpile these two drugs in the event of a "dirty bomb" or any potential nuclear threat or accident. Akorn anticipates receipt of these drugs from Hameln in December 2004 and expects revenues to commence at that time. Under the terms of the License and Supply Agreement, Akorn will pay a one-time license fee of 1.5 million euros for an exclusive license for five years, which may be extended by the parties for successive two-year periods. Orphan drug exclusivity status is granted by the U.S. FDA for a period of seven years from the date of approval of the 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 . Akorn will be responsible for marketing and distributing both drugs in the United States and Canada and the two companies will share revenues 50:50, subject to adjustments. Hameln will be responsible for the manufacturing of both drugs for Akorn. Akorn will be responsible for the payment of any annual FDA establishment fees and for the cost of any post approval studies. Arthur S. Przybyl, president and chief executive officer of Akorn, stated, "These two drugs address a real need and provide safety and a treatment for the public in the event of a terrorist act involving a "dirty bomb" or any other nuclear accident. Akorn will work diligently with U.S. Government officials in order to adequately stockpile and supply these two drugs. Furthermore, I look forward to a long standing business relationship with Hameln." Christoph Kerstein, managing director of Hameln, stated, "We are very glad to have found a very active sales partner - within such a short period of time. We really hope for a successful and long lasting co-operation with Akorn and intend to bring more products to the U.S. market in the future. All those organizations which asked us when and where they could buy the Calcium-DTPA and Zinc-DTPA can now finally get their answer, and this should be good news." 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 Hameln Pharmaceuticals gmbh. Hameln Pharmaceuticals is a specialized manufacturer and marketer of injectables, with a focus on hospital products. In more than 40 countries worldwide, the company sells generics under its own brand. Hameln Pharmaceuticals also provides a full service range of product development and registration procedures. Any statements made by Akorn, Inc. ("we", "us", "our", "Akorn" or the "Company") in this press release that are forward looking are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. The Company cautions readers that important factors may affect the Company's actual results and could cause such results to differ materially from forward-looking statements made by or on behalf of the Company. Such factors include, but are not limited to, risks and uncertainties relating to (i) the ability to generate cash from operations sufficient to meet the Company's working capital requirements Capital requirements Financing required for the operation of a business, composed of long-term and working capital plus fixed assets. , (ii) the necessity of complying with various regulatory procedures in the manufacture of drug products, (iii) the Company's ability to acquire, develop, finance, test, produce and market new products, including the availability of materials to produce products, (iv) the resolution of the FDA compliance issues at the Company's Decatur, Illinois manufacturing facility and the outcome of other 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. involving the Company, (v) patent protection for the Company's intellectual property or trade secrets, and (vi) other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission including, but not limited to, those risks referenced under the caption "Factors That May Affect Future Results" in Item 1 of the Company's 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. for the fiscal year ended December 31, 2003. |
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