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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
_____________________________
Date of report (Date of earliest event reported) November 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 November 8, 1999 the Registrant issued the following press
release:
"ALTEON INC. ANNOUNCES PRESENTATION OF FIRST PUBLISHED PHASE III
DATA ON PIMAGEDINE, POTENTIAL THERAPY FOR DIABETIC COMPLICATIONS
"-Data Released at American Society of Nephrology Annual Meeting-
"Ramsey, New Jersey, November 8, 1999-Alteon Inc. (Nasdaq: ALTNC)
announced today that the first data on the Phase III ACTION I
trial of pimagedine in Type 1 diabetic patients with overt
nephropathy has been published and presented at the American
Society of Nephrology (ASN) 32nd Annual Meeting and Scientific
Exposition in Miami Beach, Florida.
"The randomized, double-blind multicenter ACTION I trial examined
the ability of pimagedine to preserve renal function in patients
with Type 1 diabetes and overt diabetic nephropathy. The Phase III
trial involved 690 patients at 56 clinical sites in North America.
Patients received the best available medical therapy, including
ACE inhibitors, plus placebo or pimagedine at a low dose or high
dose level (300 mg or 600 mg BID, titrated for kidney function).
"Alteon reported in November 1998 preliminary data from the ACTION
I trial showing that pimagedine therapy resulted in a
statistically significant and clinically meaningful reduction of
urinary protein excretion. However, the results also showed that
while pimagedine reduced the risk of doubling of serum creatinine,
the study's primary endpoint, the results did not reach
statistical significance for this parameter. Pimagedine also
reduced, to a statistically significant extent, LDL cholesterol
and triglycerides as well as the progression of retinopathy.
"The three abstracts presented at the ASN meeting were as follows:
"1. 'PIMAGEDINE LOWERS TOTAL URINARY PROTEIN AND SLOWS
PROGRESSION OF OVERT DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE 1
DIABETES MELLITUS' was presented as an oral presentation on
Sunday, November 7, 1999 at 4:00 p.m. Representing the ACTION I
Investigator Group are authors Gerald Appel, M.D., Columbia
Presbyterian Medical Center, New York, NY; Kline Bolton, M.D.,
University of Virginia Medical Center, Charlottesville, VA; Barry
Freedman, M.D., North Carolina Baptist Hospital, Winston-Salem,
NC; Jean-Paul Wuerth, M.D., Ph.D. and Kenneth Cartwright, MB ChB,
MFCM, MRCPsych., Alteon, Inc., Ramsey, NJ.
"Pimagedine reduced the level of total urinary protein in a highly
statistically significant manner (low dose p<0.001, high dose
p=0.001, combined p<0.001) in patients exposed to optimal medical
therapy. Statistical significance was reached at the low dose at
each visit from month 6 to month 36. Pimagedine also slowed the
progression of diabetic renal disease, particularly in patients
with less advanced nephropathy and in those demonstrating a
reduction in total urinary protein.
"2. 'PIMAGEDINE REDUCES PROGRESSION OF RETINOPATHY AND LOWERS
LIPID LEVELS IN PATIENTS WITH TYPE 1 DIABETES MELLITUS' was
presented as a poster session on Sunday, November 7, 1999.
Representing the ACTION I Investigator Group are Philip Raskin,
M.D., University of Texas Southwestern Medical Center, Dallas, TX;
Daniel Cattran, M.D., Toronto General Hospital, Toronto, Canada;
Mark Williams, M.D., Ph.D., Joslin Diabetes Center, Boston, MA;
Jean-Paul Wuerth, M.D., Ph.D. and Kenneth Cartwright MB ChB, MFCM,
MRCPsych., Alteon Inc., Ramsey, NJ.
"Progression of retinopathy, measured as an increase by 3 or more
steps in the Early Treatment Diabetic Retinopathy Study (ETDRS)
scale, was observed in 16% of placebo patients, compared to 11% in
low dose patients (odds ratio 0.58, p=0.112), 8% in high dose
patients (odds ratio 0.46, p=0.044), and 10% in the combined
treatment group (odds ratio 0.53, p=0.030). The overall reduction
for placebo, low dose, high dose and combined treatment groups for
total cholesterol was 5.2, 21.3 (p<0.001), 18.3 (p=0.008), and
19.8 (p<0.001) mg/dL, and for LDL cholesterol was 11.7, 22.3
(p=0.012), 23.5 (p=0.009), and 22.9 (p=0.002) respectively. Thus,
pimagedine slowed the progression of retinopathy and lowered lipid
levels in optimally treated patients with Type 1 diabetes
mellitus.
"3. 'PIMAGEDINE SAFETY PROFILE IN PATIENTS WITH TYPE 1 DIABETES
MELLITUS' was published as an abstract. Representing the ACTION I
Investigator Group are authors Frederick Whittier, M.D., Mercy
Medical Center, Canton, OH; Bruce Spinowitz, M.D., New York
Hospital Medical Center of Queens, New York, NY; Jean-Paul Wuerth,
M.D., Ph.D. and Kenneth Cartwright MB ChB, MFCM, MRCPsych., Alteon
Inc., Ramsey, NJ.
"Relevant pimagedine-related adverse events included a transient
flu-like syndrome, anemia, and induction of autoantibodies.
Overall the authors conclude that pimagedine was well tolerated in
the low-dose treatment arm with a safety profile comparable to the
placebo arm.
"Alteon is a leader in the discovery and development of
pharmaceutical products for the treatment of the complications of
diabetes, cardiovascular and other 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 seeking a corporate
partner to help fund the continued development of its 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 currently in dose-escalating studies in preparation
for a Phase II program. Alteon is also pursuing the development of
a novel series of glucose lowering agent (GLA) compounds."
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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: November 12, 1999
