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FORM 8-K
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities and Exchange Act of 1934
Date of Report (Date of earliest event reported):
June 8, 1999
ROBERTS PHARMACEUTICAL CORPORATION
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(exact name of registrant as specified in its charter)
New Jersey 1-1-432 22-2429994
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification
incorporation) Number)
Meridian Center II
4 Industrial Way West
Eatontown, New Jersey 07724
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(Address of principal executive offices, including zip code)
Registrant's telephone number, including area code: 732-676-1200
(Former name or former address, if changed from last report)
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Item 5. Other Events
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Roberts Pharmaceutical Corporation announced today 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. Agrylin is the first of Roberts' pipeline
products for which the Company has worldwide rights.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
ROBERTS PHARMACEUTICAL CORPORATION
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(Registrant)
Date: June 10, 1999 /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
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FORWARD LOOKING STATEMENTS
Certain statements included in Item 5 of this form 8-K are intended to
be, and are hereby identified as, forward looking statements for purposes of the
safe harbor provided by Section 21E of the Securities Exchange Act of 1934, as
amended, and Section 27A of the Securities Act of 1933, as amended. The
Registrant cautions readers that forward looking statements, including, without
limitation, those relating to the Registrant's future business prospects,
revenues, cost of sales, intangible dispositions and write-offs, continuing
operations and discontinued operations, and liquidity and capital resources, are
subject to certain risks and uncertainties, including, without limitation, the
ability of the Registrant to secure regulatory approval in the United States and
in foreign jurisdictions for the Registrant's developmental pipeline drugs, the
efforts of the Registrant's competitors and the introduction of rival
pharmaceutical products which may prove to be more effective than the
Registrant's products, general market conditions, the availability of capital,
and the uncertainty over the future direction of the healthcare industry, that
could cause actual results to differ materially from those indicated in the
forward looking statements.
