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
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.