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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 Exchange Act of 1934
Date of Report (Date of earliest event reported):
December 21, 1998
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
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(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 today announced that the Food and
Drug Administration (FDA) cleared the Company's platelet reducing drug
Agrylin(R) (anagrelide hydrochloride) for use in a broader patient population.
With the now amended labeling for Agrylin, Roberts said it would be able
to expand the marketing of the drug beyond essential thrombocythemia (ET) to
include polycythemia vera (PV), chronic myelogenous leukemia (CML), and other
myeloproliferative disorders.
Clearance of the Company's supplemental NDA provides for broader use of
Agrylin as the only drug indicated for treating thrombocythemia (elevated blood
platelet count) in ET, PV, CML, and other myeloproliferative disorders.
Specifically, Agrylin is indicated for the treatment of patients with
thrombocythemia, secondary to myeloproliferative disorders, to reduce the
elevated platelet count and the risk of thrombosis (blood clotting) and to
ameliorate associated symptoms including thrombo-hemorrhagic events (e.g., heart
attack and stroke).
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: December 22, 1998 By: /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.
