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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) April 8, 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 April 8, 1999, Alteon Inc. issued the following press
release:
"ALTEON UPDATE ON PIMAGEDINE DEVELOPMENT PROGRAM
"Ramsey, New Jersey, April 8, 1999 - Alteon Inc. (Nasdaq: ALTN)
announced today that as part of its ongoing evaluation of the total
pimagedine development program, it has decided to close out its
Phase III trial of pimagedine in End-Stage Renal Disease. If the
company decides to pursue the development of pimagedine for this
indication, it will use this data as a pilot study to allow design
of a definitive Phase III trial in ESRD, which Alteon and its
advisors believe will have a higher probability of showing
statistical significance.
"Alteon will be meeting with the FDA this quarter to discuss
data from the completed Phase III ACTION I trial of pimagedine in
Type 1 diabetic patients with overt nephropathy, or progressive
kidney disease. Continued data analyses of this trial increasingly
support preliminary findings announced in November 1998 that showed
pimagedine therapy provided a statistically significant reduction
in urinary protein, LDL cholesterol and triglycerides, as well as
lowered diastolic blood pressure. In addition, the data indicated
favorable outcomes in measures of renal function, including
creatinine clearance and filtration rate, as well as in the
inhibition of the progression of retinopathy. The trial's primary
endpoint (a 50% reduction in the time to doubling of serum
creatinine), was not met, though positive trend data was observed.
The FDA had previously notified Alteon that if a New Drug
Application is ever filed, it would receive fast track designation.
"'Our ongoing data analyses on pimagedine has provided
increasing evidence of the drug's activity in important secondary
endpoints, particularly proteinuria,' said Kenneth I. Moch,
President and Chief Executive Officer. 'We are encouraged by the
data, and look forward to our discussion with the FDA. If
additional studies for pimagedine are warranted, we will
aggressively seek a new corporate partner for this 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. A meeting is planned with the FDA to discuss next steps
with pimagedine. 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: April 15, 1999
