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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):
February 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
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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 its new late-stage
development product, designated RLO903, targets the treatment of prostate cancer
in the United States, Canada and Europe, a market estimated at over $2 billion.
The Company stated that RL0903 greatly enriches their development pipeline.
Roberts acquired rights from Hydro Med Sciences to a patented hydrogel
implant delivery technology for use in the Phase III development of a LHRH
agonist for the hormonal treatment of prostate cancer. In consideration of
milestone payments and royalties on future sales, Roberts received exclusive
rights to develop and market this LHRH-Hydrogel implant for the U.S., Canada
and Europe.
The LHRH agonist, a Roberts' therapeutic, is a synthetic gonadrotropic
hormone releasing factor agonist that, due to its long-term inhibition of
pituitary release of gonadotropins, can block both ovarian and testicular
function. The hydrogel implant employs a proprietary technology that delivers
therapeutic agents at a controlled, constant release rate for up to a year. It
is a retrievable subcutaneous implant that can be inserted in a physician's
office using a local anesthetic.
The LHRH-Hydrogel Implant offers potentially significant benefits over
standard drug therapies for prostate cancer that employ gonadrotropin hormone
releasing agonists and involve administration regimens ranging from low-dosage
daily injections to high-dosage implants or depot injections of 3 to 4 months
duration. The LHRH-Hydrogel Implant should have distinct advantages by
providing a more potent, reliable administration of smaller amounts of
therapeutic agent over a longer time.
Separately, Roberts stated that year-end 1998 results will soon be announced
and the Company expects that in the fourth quarter of the year it will have
achieved, by a wide margin, a record level of revenues.
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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: February 9, 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.
