EATONTOWN, N.J., Jan. 8 /PRNewswire/ -- Roberts Pharmaceutical
Corporation (Amex: RPC) today announced that it has submitted regulatory
applications for 1) approval in the United States to expand the current
indication for Agrylin(TM) (anagrelide hydrochloride) to include polycythemia
vera and 2) approval to market ProAmatine(R) (midodrine hydrochloride) in the
United Kingdom for the treatment of orthostatic hypotension.
Over the course of the past year, Roberts introduced and has marketed
Agrylin and ProAmatine in the United States as the first FDA cleared drugs,
respectively, to treat essential thrombocythemia and orthostatic hypotension.
Roberts submitted an NDA supplement with the FDA seeking to broaden the
indication and patient population for Agrylin in the US to include
polycythemia vera. Roberts has worldwide rights to Agrylin and the drug was
originally cleared by the FDA in March 1997 for the treatment of essential
thrombocythemia (ET), a life-threatening condition characterized by elevated
blood platelet counts. As a treatment for ET, Agrylin has also been recently
approved in Canada and a product application has been filed for Pan European
approval.
Similar to ET, polycythemia vera (PV) is a chronic myeloproliferative
disorder where an increase in blood platelets is present. The NDA supplement
which has now been submitted to the FDA incorporates new clinical data on the
use of Agrylin in PV patients.
Separately, a Product License Application has been filed with the
Medicines Control Agency in the United Kingdom seeking approval of ProAmatine
for that market. The application was submitted by Monmouth Pharmaceuticals,
Ltd., a wholly owned subsidiary of Roberts.
Located in Guildford, England, Monmouth already markets ProAmatine in
Ireland where it is sold under the name Midon for the treatment of orthostatic
hypotension, a low blood pressure condition which can cause symptoms such as
fatigue, dizziness, blurred vision and fainting. In Europe, Roberts has
exclusive rights to develop and market Midon for Ireland and the UK with the
latter representing a comparatively much larger market potential.
"In the relatively short time since Agrylin and ProAmatine were introduced
into the US market, these products have grown to account for a significant
portion of the Company's revenues," said John T. Spitznagel, Roberts President
and CEO. He continued by noting, "The product filings announced today
represent Roberts commitment to maximizing the potential of its product
pipeline while also reflecting the in-house expertise of our clinical and
regulatory staffs."
Roberts Pharmaceutical Corporation, with operating subsidiaries in the
United States, Canada, and the United Kingdom, focuses on licensing,
acquiring, developing and commercializing innovative pharmaceuticals in
selected therapeutic categories.
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
Related links:
http://www.robertspharm.com
CONTACT:
Stuart Z. Levine, Ph.D., Director of Investor
Relations of Roberts Pharmaceutical Corporation, 732-389-1182,
ext. 3064
CNOC: Roberts Pharmaceutical press releases are available at no
charge through PR Newswire's Company News On-Call fax service and
on PRN's Web Site. For a menu of Roberts Pharmaceutical press
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