EATONTOWN, N.J. July 29 /PRNewswire/ -- Roberts Pharmaceutical Corporation
(Amex: RPC) announced today that the Israeli Ministry of Health approved the
Company's new drug application for Agrylin(TM) as a treatment for essential
thrombocythemia (ET), a life-threatening condition characterized by elevated
blood platelet counts which results in an abnormally high incidence of heart
attacks and strokes.
Agrylin, which first emerged from Roberts' pipeline in 1997 with approvals
that year from both the U.S. and Canadian regulatory authorities, has been
developed by the Company as a highly selective drug therapy for reducing
elevated blood platelet counts. At therapeutic doses, Agrylin does not
compromise red or white blood cell counts and the drug has not been shown to
be leukemogenic.
In contrast, other therapies -- not specifically approved for ET but
nonetheless used in treating elevated platelets -- have distinct
disadvantages, including: anemia (reduction in red blood cells); leukopenia
(reduction in white blood cells); and, in some therapies, leukemogenesis
(development of leukemia).
John T. Spitznagel, Roberts' President and CEO said, "In addition to being
an important new therapeutic, Agrylin is the first of Roberts' pipeline drugs
with the potential for worldwide marketing and today's announcement reflects
an overall strategy to position the product for growth opportunities
throughout the international marketplace."
"We are also pursuing broader indications for Agrylin with the drug
currently under FDA review for treating polycythemia vera, a chronic
myeloproliferative disorder where an increase in blood platelets is present,"
noted Mr. Spitznagel.
Roberts said that final clearance of Agrylin's labeling for the Israeli
market is expected shortly and that the Company anticipates launching the
product into that country later this year. Whereas Roberts employs its own
sales force to market Agrylin in North America, the product's introduction
into Israel will be handled through an independent distributor.
Roberts Pharmaceutical Corporation, with operating subsidiaries in the
United States, Canada and the United Kingdom, is a fully integrated
pharmaceutical company. Roberts focuses on licensing, acquiring, developing
and commercializing innovative and value-added pharmaceuticals for both niche
and large pharmaceutical markets, with the Company having strategic interests
in the therapeutic categories of gastroenterology, cardiology,
oncology/hematology, and urology.
This and past press releases of Roberts Pharmaceutical Corporation are
available through PR Newswire's Company News On Call fax service at
800-758-5804, extension 760975 and through the Internet at
http://www.prnewswire.com as well as the Company's home page at
http://www.robertspharm.com.
This release contains forward-looking statements which are based on
assumptions and external factors, including assumptions relating to, but not
limited to regulatory action, product pricing, competitive market conditions,
financial data, new product development and other risks or uncertainties
detailed from time to time in Roberts filings with the Securities and Exchange
Commission. These forward-looking statements represent the Company's judgment
as of the date of this release and any changes in the assumptions or external
factors could produce significantly different results.
SOURCE Roberts Pharmaceutical Corporation
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Related links:
http://www.robertspharm.com
Company News On-Call: Roberts Pharmaceutical Corporation
press releases available through Company News On-Call by fax,
800-758-5804, ext. 760975, or at http://www.prnewswire.com
CONTACT:
Stuart Z. Levine, Ph.D., Director of Investor
Relations for Roberts Pharmaceutical Corporation, 732-676-1200,
ext. 3064
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