EATONTOWN, N.J., Dec. 21 /PRNewswire/ -- Roberts Pharmaceutical
Corporation (Amex: RPC) today announced that the Food and Drug Administration
(FDA) cleared the Company's platelet reducing drug Agrylin(R) (anagrelide
hydrochloride) for use in a broader patient population.
With the now amended labeling for Agrylin, Roberts said it would be able
to expand the marketing of the drug beyond essential thrombocythemia (ET) to
include polycythemia vera (PV), chronic myelogenous leukemia (CML), and other
myeloproliferative disorders.
Roberts noted that earlier this year it had submitted an NDA supplement
seeking to broaden the drug's indication to include PV. Agrylin had been
previously cleared for marketing as the only drug indicated for the treatment
of ET, a condition characterized by excessively high blood platelets. PV is
another chronic myeloproliferative disorder where an increase in blood
platelets is present.
Clearance of the Company's supplemental NDA provides for even broader use
of Agrylin as the only drug indicated for treating thrombocythemia (elevated
blood platelet count) in ET, PV, CML, and other myeloproliferative disorders.
Specifically, Agrylin is indicated for the treatment of patients with
thrombocythemia, secondary to myeloproliferative disorders, to reduce the
elevated platelet count and the risk of thrombosis (blood clotting) and to
ameliorate associated symptoms including thrombo-hemorrhagic events (e.g.,
heart attack and stroke).
Patients with excessive blood platelets are predisposed to an abnormally
high incidence of life-threatening events associated with thrombosis.
Therapies not approved, but nonetheless employed to treat excessive platelet
counts have distinct disadvantages that include: leukopenia (reduction in
white cells); anemia (reduction in red cells); and, in some therapies,
leukemogenesis (development of leukemia).
In contrast, Agrylin selectively reduces platelet cells and, at
therapeutic doses, it does not compromise white or red blood cell counts and
the drug has not been shown to be leukemogenic.
Roberts Pharmaceutical Corporation, with operating subsidiaries in the
United States, Canada and the United Kingdom, focuses on innovative and value-
added therapeutics for gastroenterology, cardiology, neurology,
oncology/hematology, and urology. Roberts actively pursues its strategy of
"Search & Develop" to identify and acquire novel drug candidates to advance
through late-stage development into the market while also pursuing
opportunities to acquire and bring commercially available specialty
pharmaceuticals to their full potential.
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 may contain 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:
http://www.prnewswire.com/comp/760975.html or fax,
800-758-5804, ext. 760975
CONTACT:
Stuart Z. Levine, Ph.D., Director of Investor
Relations of Roberts Pharmaceutical Corporation, 732-676-1200,
ext. 3064
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