Market Potential Exceeds That of North America
EATONTOWN, N.J., July 9 /PRNewswire/ -- Roberts Pharmaceutical Corporation
(AMEX: RPC) announced today that it has submitted a Manufacturing
Authorization Application (MAA) for European approval of its new drug Agrylin
(TM). The application has been filed with the European Medicines Evaluation
Agency (EMEA) in accordance with the centralized procedure for approval of new
drugs within the 15-country European Union (EU).
In late March of 1997, the Food and Drug Administration approved the U.S.
marketing of Agrylin (anagrelide HCl) as the first drug indicated for treating
essential thrombocythemia, a life-threatening condition characterized by
elevated blood platelet levels. Additionally, the product is currently under
review for potential approval in Canada where the Health Protection Branch has
given Agrylin "Priority Review" status.
The EU regulatory authorities have accepted Agrylin as a "List B" product,
a category given to products considered to represent new drug treatments or
important therapeutic advances. Dr. David Jeffreys, Director of the Licensing
Division of the Medicines Control Agency (U.K.) and Professor Silvio
Garattini, Director of the Mario Negri Institute (Milan, Italy) have agreed to
act, respectively, as rapporteur and co-rapporteur in reviewing the Agrylin
application.
Under the European centralized procedure, a successful MAA grants product
approval throughout the EU, a market potential for Agrylin that could
significantly exceed that of North America. "Given the size of the EU market,
the filing of this new drug application represents a substantial growth
opportunity for Agrylin," said Dr. Robert A. Vukovich, President and CEO of
Roberts. He concluded by noting, "As our first Pan-European filing, this is
also a major advancement in our strategy to develop innovative drugs for
global markets."
Roberts Pharmaceutical Corporation, with operating subsidiaries in the
United States, Canada, and the United Kingdom, focuses on new health care
solutions through the acquisition and development of specialty
pharmaceuticals. The Company's first proprietary product, ProAmatine(R), was
recently launched in the U.S. as the first FDA cleared drug to treat
orthostatic hypotension. Agrylin(TM), Roberts second pipeline product, has
since been launched in the U.S.
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 on the internet at
http://www.prnewswire.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, 908-389-1182, ext. 3064
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