Akorn, Inc. Signs a Definitive Exclusive Development and Supply Agreement with Sofgen to Develop and Commercialize an ANDA Drug
10 8월 2006 - 8:00PM
Business Wire
Akorn, Inc. (AMEX:AKN) today announced that it has signed a
definitive exclusive development and supply agreement to develop
and commercialize an ANDA drug product. Sofgen Pharmaceuticals is a
privately held pharmaceutical company located in Sunrise, Florida.
Sofgen is responsible for the formulation and development of the
drug, the manufacture of clinical product batches, and the
documentation necessary to support the Chemistry, Manufacturing and
Control (CMC) section of an ANDA to be filed by Akorn. Upon
regulatory approval Sofgen will supply finished dosage form product
to Akorn. Akorn will fund and is responsible for the pivotal bio
study, filing the ANDA and upon regulatory approval, the marketing,
distribution and sales of the drug. Akorn will own the ANDA and has
exclusive marketing rights in the United States and Canada. The
drug is indicated for the treatment of nausea and vomiting
associated with cancer chemotherapy. The drug is also indicated for
anorexia in patients associated with weight loss related to AIDS.
The current market size of the drug is approximately $125 million.
Akorn is forecasting product launch of the drug to occur in 2008.
Arthur S. Przybyl, Akorn's President and Chief Executive Officer
stated, "This agreement highlights several Akorn strategies. The
drug is a specialty type niche pharmaceutical, with no current
generic competitors and compliments our strategies in AIDS and
cancer drug products. Drug products for these markets are being
developed internally and externally through our business partners,
Fidia, Natco and Serum. We are excited to join forces with Sofgen
Pharmaceuticals." Ruben Minski, Sofgen's President and Chief
Executive Officer stated, "Our Company is infused with a strong
belief in the growing need for precisely the sort of generic drugs
and advance delivery technologies like the one we are partnering
with Akorn. The trends are clearly in our favor, with our
development and manufacturing capabilities and Akorn marketing
expertise, we are heading for success." About Akorn, Inc. Akorn,
Inc. 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 www.akorn.com. About
Sofgen Pharmaceuticals Sofgen is part of an Industrial Conglomerate
with strong emphasis in the Healthcare and related businesses,
including soft gelatin manufacturing facilities in South America
and a Pharmaceutical Division with a distribution network that
reaches 27 different countries around the globe. Materials in this
press release may contain information that includes or is based
upon forward-looking statements within the meaning of the
Securities 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
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consult any further disclosures we make on related subjects in our
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discussion in the section entitled "Cautionary Statement Regarding
Forward-Looking Statements" in our most recent Annual Report on
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to differ materially from expected and historical results. Such
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relating to the resolution of the FDA compliance issues at our
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