EATONTOWN, N.J., June 10 /PRNewswire/ -- Roberts Pharmaceutical
Corporation (Amex: RPC) today announced that the U.S. Department of Commerce,
Patent and Trademark Office has approved the Company's patent for a new and
highly improved process for manufacturing Agrylin(TM). The process was
developed by Roberts' scientists.
Agrylin was first introduced into the U.S. by Roberts in March, 1997 and
is the only drug cleared by the Food and Drug Administration (FDA) for
treating essential thrombocythemia, a life-threatening condition characterized
by excessive counts of blood platelets.
Commercially, Agrylin is presently prepared by a long and difficult
synthesis involving a starting material possessing environmentally unfriendly
properties. The new process, which eliminates this precursor material and
greatly simplifies the synthesis, represents both an environmentally sound and
a significantly more economical method of manufacture.
As an orphan drug, Agrylin received seven years marketing exclusivity from
the FDA when it was approved in 1997. The new process, when implemented,
should improve production economies for Roberts sufficient enough to impose
significant commercial disadvantages on potential generic manufacturers when
the product's orphan drug status expires. The new process patent is effective
until August, 2017.
Roberts plans to manufacture validated lots of Agrylin using this new
synthetic process and expects to submit a supplemental filing to the FDA for
this new process in 1999.
The Company also noted that a second patent is pending submission for the
synthesis of Agrylin. In addition, Roberts said it filed a patent application
covering a drug formulation method for protecting and enhancing the stability
of active pharmaceutical ingredients which the Company intends to apply to a
gastrointestinal compound in its development pipeline.
Roberts Pharmaceutical Corporation, with operating subsidiaries in the
United States, Canada and the United Kingdom, focuses on licensing, acquiring,
developing and commercializing innovative pharmaceuticals.
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, product pricing,
competitive market conditions, financial data, 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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CONTACT: Stuart Z. Levine, Ph.D., Director of Investor Relations of Roberts Pharmaceutical Corporation, 732-389-1182, ext. 3064
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