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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) November 16, 1998
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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.
Alteon Inc. issued the following press release relating to a
preliminary analysis of data from its clinical trial of pimagedine
in Type I diabetic patients with overt nephropathy:
Alteon Announces That Preliminary Analysis of Phase III Trial of
Pimagedine Demonstrates Mixed Results in Type I Diabetic
Patients With Progressive Kidney Disease
RAMSEY, N.J., Nov. 16 /PRNewswire/ -- Alteon Inc. (Nasdaq:
ALTN) announced today results of a preliminary analysis of data
from its Phase III ACTION I (A Clinical Trial In Overt Nephropathy)
trial of pimagedine in Type I diabetic patients with overt
nephropathy. The ACTION I trial was a 5-year study of 690
patients, undertaken at over 50 clinical sites in North America.
Although the ACTION I results showed that pimagedine reduced
the risk of doubling of serum creatinine, the study's primary
endpoint, the data did not reach statistical significance.
Pimagedine therapy resulted in significant improvements in
several key measurements: reduced urinary protein, reduced LDL
cholesterol and triglycerides, and reduced diastolic blood
pressure. Additional data suggested a trend toward improvements in
other measures of renal function including estimated creatinine
clearance and glomerular filtration rate. The drug was generally
well tolerated.
"Clearly, we had hoped for significance in all measurements,"
said James J. Mauzey, Chairman and Chief Executive Officer. "We
believe that these data, while encouraging and very supportive of
our core A.G.E. technology, do not provide the basis for an NDA
filing. After we have further reviewed and discussed these data
with our corporate partner Genentech, Inc., our medical
consultants, clinical investigators and the Food and Drug
Administration, we will issue a statement on the future of
pimagedine."
Alteon is engaged 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 aging, 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 the disease states associated with
diabetes and aging. A second Phase III pivotal clinical trial
evaluating Alteon's lead A.G.E. inhibitor pimagedine in the
treatment of Type 1 and Type 2 diabetic patients with end-stage
renal disease (ESRD) is ongoing. ALT-711, Alteon's lead A.G.E.
crosslink breaker, is in 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 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/ James J. Mauzey
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James J. Mauzey
Chairman of the Board and
Chief Executive Officer
Date: November 16, 1998
