EATONTOWN, N.J., June 8 /PRNewswire/ -- Roberts Pharmaceutical Corporation
(Amex: RPC) today announced that the Japanese Ministry of Health and Welfare
has granted orphan drug status to Agrylin(R), Roberts' platelet reducing drug.
Roberts said that orphan drug status in Japan indicates a high priority
health care situation that provides for a number of incentives for a drug's
development for that marketplace. These include funding grants, tax benefits,
and fast track reviews.
Agrylin was developed by Roberts and first approved in the U.S. in 1997 as
the only drug indicated for the treatment of essential thrombocythemia (ET), a
condition characterized by excessively high levels of blood platelet cells.
Patients with ET are at risk for thrombosis (blood clotting) with
corresponding risks for thrombo-hemorrhagic events (heart attack and stroke).
The drug has since been approved in Canada and Israel and the FDA has
granted broader indications to include polycythemia vera, chronic myelogenous
leukemia, and other myeloproliferative disorders. Roberts also plans to seek
approval in Europe where the product is currently available on a named patient
basis. Additionally, earlier this year, Yuhan Corporation, a pre-eminent
Korean pharmaceutical company, signed an agreement for exclusive future
distribution rights for Agrylin in that market.
Roberts said Agrylin is the first of its pipeline products for which the
Company has worldwide rights. "It is evident from today's and prior
announcements regarding Agrylin that we are committed to positioning this
product for growth in the international pharmaceutical market," said John T.
Spitznagel, Roberts President and CEO.
Roberts Pharmaceutical Corporation, with operating subsidiaries in the
United States, Canada and the United Kingdom, focuses on value-added specialty
pharmaceuticals in the therapeutic categories of gastroenterology, urology,
oncology/hematology, and cardiology/neurology. Roberts actively pursues its
strategy of Search & Develop to identify and acquire novel post-discovery drug
candidates to advance through late-stage clinical development while also
pursuing opportunities to acquire and enhance the potential of commercially
available specialty medicines.
This and past press releases of Roberts Pharmaceutical Corporation are
available through the Internet at the Roberts' 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,
unaudited 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
CONTACT:
Media: Stuart Z. Levine, Ph.D., V.P.
Corporate Communications of Roberts Pharmaceutical Corporation,
732-676-1200, ext. 3064
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