EATONTOWN, N.J., Nov. 24 /PRNewswire/ -- Roberts Pharmaceutical
Corporation (Amex: RPC) announced today that its new drug Agrylin(TM)
(anagrelide hydrochloride) has successfully completed both clinical and
labeling reviews by the Health Protection Branch (HPB) and the product is
cleared for marketing in Canada. Agrylin will be marketed in Canada by the
Company's wholly owned subsidiary Roberts Pharmaceutical Canada. Roberts
expects to initiate the product's launch in Canada in early January 1998.
With Canadian approval and with the product having been launched in the US
earlier this year, Agrylin is the first drug cleared for marketing by both the
FDA and HPB for the treatment of essential thrombocythemia, a life-threatening
condition characterized by elevated blood platelet counts. This condition
results in an abnormally high incidence of adverse events associated with
thrombosis (blood clotting), including heart attack and stroke.
Off-label therapies which have been employed to treat excessive platelet
counts have distinct disadvantages that include: anemia (reduction in red
blood cells); leukopenia (reduction in white blood cells); and in some
therapies, suspected leukemogenesis (development of leukemia). In contrast,
at therapeutic doses, Agrylin does not produce significant changes in either
red or white blood cell counts and the drug has not been shown to be
leukemogenic.
"Agrylin is the first drug to emerge from our product pipeline with the
potential for worldwide marketing," said John T. Spitznagel, Roberts President
and CEO. "The product was launched in the US late in March of this year,
essentially at the close of our first quarter. Six months later, Agrylin
accounted for over 10% of total US product sales recorded by the Company for
the first-nine months of the year. With the drug's approval in Canada,
Roberts has accomplished an important step in its strategic plan to expand the
product's growth opportunities to include the international marketplace.
Agrylin is presently under review for approval in the European Union, a market
which exceeds the combined sizes of the US and Canada."
Roberts Pharmaceutical Corporation, with operating subsidiaries in the
United States, Canada, and the United Kingdom, focuses on licensing,
acquiring, developing and commercializing innovative pharmaceuticals. The
Company's first pipeline products, ProAmatine(R) and Agrylin(TM) were recently
launched in the US as the first FDA cleared drugs to, respectively, treat
orthostatic hypotension and essential thrombocythemia.
This and past press releases of Roberts Pharmaceutical Corporation are
available through PR Newswire's Company News On-Call fax service at
1-800-758-5804, extension 760975 and on the internet at
http://www.prnewswire.com and http://www.robertspharm.com.
This release may contain forward-looking statements which reflect
management's current views of future events and operations. These
forward-looking statements are based on assumptions and external factors,
including assumptions relating to regulatory action and competing products.
Any changes in such assumptions or external factors could produce
significantly different results.
SOURCE Roberts Pharmaceutical Corporation
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CONTACT: Stuart Z. Levine, Ph.D., Director of Investor Relations of Roberts Pharmaceutical Corporation, 732-389-1182, ext. 3064
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