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FORM 8-K
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
June 10, 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: 732-389-1182
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 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 currently 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
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.
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 11, 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.
