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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 or 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Date of report (Date of earliest event reported) May 24, 1999
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ALTEON INC.
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(Exact Name of Registrant as Specified in Charter)
Delaware 0-19529 13-3304550
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(State or Other Juris- (Commission (I.R.S. Employer
diction of Incorporation) File Number) Identification No.)
170 Williams Drive, Ramsey, New Jersey 07446
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (201) 934-5000
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(Former Name or Former Address, If Changed Since Last Report)
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Item 5. Other Events.
On May 24, 1999, Alteon Inc. issued the following press
release:
"ALTEON TO SEEK NEW PARTNER
FOR CONTINUED DEVELOPMENT OF PIMAGEDINE
"Ramsey, New Jersey, May 24, 1999 - Alteon Inc. (Nasdaq: ALTN)
announced today that after meeting with its clinical consultants
and the U.S. Food and Drug Administration (FDA) it has decided to
seek a new corporate partner to help fund the continued development
of pimagedine, a compound designed to inhibit the progression of
kidney disease in Type I diabetic patients. Alteon will explore
the possibility of a Phase III pivotal trial program with
proteinuria (urinary protein) as a primary endpoint, although the
detailed clinical strategy has yet to be determined. Additionally,
a European clinical strategy for the compound is being evaluated.
"Analyses of a pivotal Phase III trial of pimagedine in Type 1
diabetic patients with kidney disease (ACTION I) show that although
pimagedine reduced the risk of doubling of serum creatinine, it did
not reach statistical significance in this primary endpoint.
Pimagedine therapy did result in a statistically significant and
clinically meaningful reduction of urinary protein excretion.
Pimagedine also reduced, to a statistically significant extent, LDL
cholesterol and triglycerides as well as the progression of
retinopathy. In addition, diastolic blood pressure, not
prospectively defined as clinical endpoint, was reduced in a
statistically significant manner. Patients in the ACTION I trial
were exposed to optimal medical therapy, including the use of ACE
inhibitors, the only therapy approved for diabetic nephropathy as
well as tight glycemic and blood pressure control. Pimagedine
results were over and above this standard treatment.
"'The therapeutic options available to the Type 1 diabetic patient
population with progressive kidney disease are limited,' said
Kenneth I. Moch, President and Chief Executive Officer of Alteon,
'and therefore we believe it is imperative to continue pimagedine's
development.'
"Data analyses from the ACTION I trial of pimagedine provide strong
evidence of pimagedine's activity in proteinuria, a secondary
endpoint of the ACTION I trial. Recently the National Kidney
Foundation (NKF) issued a statement recommending routine testing
for proteinuria, especially in high risk groups, such as people
with diabetes, high blood pressure or close relative of individuals
with those conditions. According to the position paper issued as
part of NKF's Proteinuria Albuminuria Risk Assessment Detection and
Elimination (PARADE) program, excess protein in the urine is not
just an indicator of kidney disease, it is also the cause of
progressive loss of kidney function. Additionally, proteinuria is
an early warning sign of stroke and heart disease. Therefore,
strategies to reduce the levels of protein in the urine can slow
down the rate of kidney failure and decrease other health risks.
"'We are expanding active discussions with major pharmaceutical and
biotechnology companies in the U.S. and abroad regarding potential
partnerships for pimagedine as well as for A.G.E. crosslink breaker
compounds,' said Mr. Moch. 'We will direct Alteon's current
resources to the development of ALT-711, our lead A.G.E. crosslink
breaker, as well as advancing our series of glucose lowering
agents. ALT-711 has completed a series of Phase I human clinical
testing and is expected to enter Phase II trials this year. We
will soon be issuing the final report from the Phase I program.'
"Alteon is a leader in the discovery and development of
pharmaceutical products for the treatment of the complications of
diabetes and age-related diseases. Alteon's proprietary technology
focuses on Advanced Glycosylation End-products, or A.G.E.s, formed
as a result of circulating blood glucose reacting with proteins.
A.G.E.s have been shown to be a causative factor in many of the
complications of diabetes and age-related diseases, including
kidney disease, nerve damage, atherosclerosis and retinopathy.
Alteon's approach is to inhibit or break A.G.E.s or their chemical
crosslinks, thereby potentially impacting such disease states. The
company is continuing its evaluation of its lead A.G.E.-formation
inhibitor, pimagedine, based on the results of the Phase III trial
of pimagedine in Type 1 diabetic patients with progressive kidney
disease. Alteon's lead A.G.E. crosslink breaker, ALT-711, has
completed a series of Phase I human clinical trials and is expected
to enter Phase II trials in 1999. Alteon is also pursuing the
development of a novel series of glucose lowering agent (GLA)
compounds.
# # #
"Any statements contained in this press release that relate to
future plans, events or performance are forward-looking statements
that involve risks and uncertainties including, but not limited to,
those relating to technology and product development, regulatory
approval processes, intellectual property rights and litigation,
competitive products, ability to obtain financing, and other risks
identified in Alteon's filings with the Securities and Exchange
Commission. Actual results, events or performances may differ
materially. Alteon undertakes no obligation to publicly release
the result of any revision to these forward-looking statements that
may be made to reflect events or circumstances after the date
hereof or to reflect the occurrence of unanticipated events.
"This press release is also available at
http://www.alteonpharma.com"
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SIGNATURE
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.
Alteon Inc.
By: /s/ Kenneth I. Moch
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Kenneth I. Moch
President and
Chief Executive Officer
Date: June 1, 1999
