BUFFALO GROVE, Ill., July 21 /PRNewswire-FirstCall/ -- Akorn, Inc. (OTC Bulletin Board: AKRN) and FDC Limited (FDC), India's second largest manufacturer and marketer of ophthalmic pharmaceutical products, today announced the signing of a Purchase and Supply Agreement. The Agreement will provide Akorn with an ophthalmic finished dosage form product pipeline for exclusive use in the United States and Canada. The ophthalmic products will be developed and manufactured for Akorn by FDC. Akorn will be responsible for U.S. FDA regulatory submissions and will market the products directly in the United States. Innova, Akorn's distributor for ophthalmic products, will be responsible for the direct marketing of these products in Canada. Currently, FDC exports active pharmaceutical ingredients to over 45 countries, including the United States and Canada, and holds drug master files and registration in both countries. Products will be manufactured in India, and FDC is intending to submit approximately four to six ANDA's in the first year of the Agreement. Arthur S. Przybyl, president and chief executive officer of Akorn stated, "We are excited to enter into this Purchase and Supply Agreement with FDC. FDC's expertise in active pharmaceutical ingredients, formulations and manufacturing of finished dosage forms for ophthalmic pharmaceutical products combined with Akorn's sales and marketing capabilities of ophthalmic products create a natural synergy between our two companies. Several products have been targeted for development and U.S. launch. We look forward to a long- standing and successful relationship." Przybyl added, "This Agreement represents a continuation of Akorn's new business development strategy designed to increase Akorn's product offering to our customers." FDC's Director Nandan M. Chandavarkar said, "We are confident that FDC's strengths in manufacturing and Akorn's marketing capabilities will combine well to bring high-quality eye care alternatives to patients in the United States and Canada." About Akorn, Inc. Akorn, Inc. (AKRN) manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company's website at http://www.akorn.com. About FDC Limited FDC Limited (Bombay Stock Exchange: FDC) manufactures ophthalmic and optic drugs in unit and multi-dose formats as well as select active pharmaceutical ingredients (API's) at a US FDA-approved plant in Roha. The API's manufactured at this plant are either exported (more than 80% of the production) or formulated at the company's plants at Goa and are UK MHRA- approved, enabling FDC to market several products (ophthalmic and solid dosage forms) in the UK. Recently FDC commissioned an additional manufacturing plant in Goa, which provides dosage form capabilities with quality systems meeting the highest International GMP Standards. 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 provisions of the Private Securities Litigation Reform Act 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, (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 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 for the fiscal year ended December 31, 2003.
SOURCE Akorn, Inc.