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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):
April 2, 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, through its wholly owned
subsidiary Roberts Laboratories Inc., has received an exclusive
license from Pfizer Inc. to develop and market Sampatrilat, a
novel new compound to treat essential hypertension and congestive
heart failure. The agreement provides for transfer of data and
assignment of patent rights to Roberts from Pfizer.
Sampatrilat incorporates, in a single substance, two different but
complimentary modes of activity. It is a potent inhibitor of angiotensin
converting enzyme (ACE) and therefore offers benefits of ACE inhibitors
such as captopril. Sampatrilat also inhibits neutral endopeptidase which,
in turn results in an elevation of atrial natriuretic factor (ANF), the
body's own natural diuretic. This dual mode of activity may offer patients
and managed care providers the potential advantages of a treatment regime
involving fewer drugs, reduced risks, and lower costs in comparison to
existing therapies.
Today, treatment of uncomplicated essential hypertension follows a step
therapy paradigm with the initial treatment usually being an ACE inhibitor.
However, normalization of blood pressure may require the addition of a
second drug, generally a diuretic, in combination with the ACE inhibitor.
This type of step therapy, involving two and sometimes three drugs, can
have consequences in the form of side effects that include the separate and
additive adverse reactions of the different products.
Diuretics commonly employed with ACE inhibitors can produce side effects
that include potassium depletion, gout, elevated blood lipids, and
abnormalities in sugar metabolism. Because ANF is a natural diuretic that
does not possess these properties, the use of Sampatrilat in hypertension
or heart failure patients may confer, through the administration of a
single drug, all the advantages of a pure ACE inhibitor with the addition
of greater natriuresis (sparing the use of diuretics).
The Company noted that this is their second strategic alliance, in the
past few months, with a major pharmaceutical company for development of
compounds representing significant new therapeutic potentials for very
large markets.
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ROBERTS PHARMACEUTICAL CORPORATION
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(Registrant)
Date: April 8, 1997 By: /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
