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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):
March 17, 1997
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: 908-389-1182
Meridian Center II
4 Industrial Way West
Eatontown, New Jersey 07724
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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 announced today that the Food and
Drug Administration (FDA) has approved AGRYLIN for U.S. marketing, and the
Company expects to begin shipping within 10 days.
AGRYLIN (anagrelide HC1) is the first drug approved by FDA for the
treatment of essential thrombocythemia, a life-threatening condition
characterized by elevated blood platelet counts. This condition results in an
abnormally high incidence of adverse events associated with thrombosis (blood
clotting), including heart attack and stroke. AGRYLIN is indicated for the
treatment of essential thrombocythemia to reduce elevated platelet counts and
the risk of thrombosis. Associated symptoms are also improved.
Until now, unapproved therapies have been employed to treat excessive
platelet counts, but they have distinct disadvantages that include: leukopenia
(reduction in white cells); anemia (reduction in red cells); and in some
therapies, suspected leukemogensis (development of leukemia). Because of these
potentially serious side effects, clinicians have been particularly reluctant
to treat young adults with unapproved therapies.
In Contrast, at therapeutic doses, AGRYLIN does not produce significant
changes in white or red cell counts and has not been shown to be leukemogenic.
The drug's labeling provides guidelines for treatment of asymptomatic young
adults with essential thrombocythemia.
A total of 551 patients with essential thrombocythemia were treated with
AGRYLIN in three clinical trials. Adverse reactions to AGRYLIN were mild and
self-limiting and included headache, palpitations, diarrhea, and abdominal
pain. More than 2,300 patients in the U.S. have been receiving the drug under a
compassionate protocol.
AGRYLIN has been granted priority status by the Canadian regulatory
authorities and European filings are scheduled for later this year.
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ROBERTS PHARMACEUTICAL CORPORATION
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(Registrant)
Date: March 20, 1997 By: /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
