Hemispherx Biopharma Enters Agreement with Schering Plough
1.12.1999, 11:07
PHILADELPHIA (PROTEXT) - Hemispherx Biopharma, Inc. (Amex:
HEB) today announced that it has entered into a multi-year drug-
production agreement with Schering-Plough Products L.L.C.,
regarding Hemispherx's antiviral product, Ampligen(R).
The Ampligen(R) product is currently being clinically
developed by Hemispherx in both the North American and European
markets for potential treatment of various chronic viral
diseases. The new drug production program will be conducted at
Schering's major facilities in San Juan, Puerto Rico, and
replaces small, regionally based facilities that Hemispherx used
until recently.
Under terms of the Agreement, Hemispherx will use the Schering
facility as its principal manufacturing platform for the U.S.;
the Agreement may also be expanded to include other territories.
Schering is a world leader with various parenteral (injectable)
medications including its flagship antiviral product, interferon
alpha (Intron A).
William A. Carter, M.D., Chairman and CEO of Hemispherx, said,
"This agreement represents a rare example of an exciting synergy
that blends our well-recognized research and development
capabilities, under the supervision of Dr. Carol Smith, with
Schering's world-class experience. Schering's expertise and
professional capabilities are widely recognized by world
regulatory authorities including the EMEA (European Medical
Evaluation Agency) and the FDA (U.S. Food and Drug
Administration). Indeed, that expertise led to marketing approval
for more than 20 different diseases for a single drug product,
Intron A".
Hemispherx said that the new Agreement also offered previously
unprecedented "economies of scale" and "superior technology" in
the overall drug-manufacturing process. Dr. Carter noted that
production of final dosage forms of Ampligen(R) at the Schering
facilities would be essential to launching a successful overall
clinical enterprise by providing accelerated manufacturing of the
highest quality product for its consumers, especially those ill
with chronic, debilitating and/or life threatening diseases.
Hemispherx already makes available "ready-to-use" Ampligen(R)
drug dosage units to certain patients in North America and Europe
(through its subsidiary, Hemispherx Europe) under its global
"expanded access" programs, while simultaneously conducting Phase
III clinical research to obtain full-marketing approval. The
Company said the Schering Agreement was a major new step to
facilitate successful clinical ventures in other major life
threatening viral diseases, which could eventually expand to
require several metric tons of drug product annually.
Dr. Carter added, "When combined with the efficient
distribution and marketing channels being actively developed
through strategic alliances, our Company's antiviral drug
technology is now elegantly leveraged for strong growth and
potential profitability. This integrated 'systems management'
approach, we believe, may epitomize the successful 21st Century
pharmaceutical development/product launch model. Combining
efficiency, experience, R and D innovation and creative marketing
strategies, we can meet the anticipated needs of all the
constituencies we serve -- namely, physicians, patients and
health-care insurers."
Hemispherx Biopharma, Inc. is a biopharmaceutical company
specializing in new therapeutic approaches to HIV/AIDS, Chronic
Fatigue Syndrome (CFS) and hepatitis B/C utilizing the immune
system. It has offices in Philadelphia, Belgium and France and
new drug development facilities in the Washington, D.C., area.
Hemispherx was recently listed on the "Russell 2000" Index of
small capitalization stocks.
Information contained in this news release other than
historical information, should be considered forward-looking and
is subject to various risk factors and uncertainties. For
instance, the strategies and operations of Hemispherx involve
risks of competition, changing market conditions, changes in laws
and regulations affecting these industries and numerous other
factors discussed in this release and in the Company's filings
with the Securities and Exchange Commission. Accordingly, actual
results may differ materially from those in any forward-looking
statements. ots Original Text Service: Hemispherx Biopharma,
Inc. Internet: http://www.newsaktuell.de Contact: William A.
Carter, M.D., CEO & Chairman of Hemispherx Biopharma, Inc., 215-
988-0080; or William Jenks of Broadgate Consultants, 212-232-
2222, or fax, 212-232-3232, for Hemispherx Biopharma; or Investor
Relations, Harris Freedman, 212-572-0762, or fax, 212-572-0764
Web site: http://www.broadgate.com Web Site:
http://www.hemispherx.com
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