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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) March 18, 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 two press releases relating
to its clinical trials for pimagedine:
A. Eternal Review Committee Issues Recommendations on
Action Trials of Alteon's Pimagedine
RAMSEY, N.J., March 18 /PRNewswire/ -- Alteon Inc. (Nasdaq:
ALTN) announced that yesterday it received recommendations from its
External Safety Monitoring Committee (ESMC) to complete ACTION I, a
phase III trial of pimagedine in Type I diabetic patients with
overt nephropathy, and to discontinue ACTION II, a phase III trial
of pimagedine in Type II diabetic patients with overt nephropathy.
Alteon is reviewing the possible discontinuation of the ACTION
II trial based on the ESMC's observation of an increased incidence
of side effects in the Type II patient population. The final
decision will be made promptly after review and consultation with
the Food and Drug Administration (FDA) and Alteon's commercial
partner, Genentech, Inc.
The ESMC recommended continuation of the ACTION I trial, which
is currently scheduled for completion and data release prior to the
end of 1998, as planned. This ESMC does not review data from the
End-Stage Renal Disease (ESRD) trial, a third pivotal clinical
trial currently under way. A separate independent committee
overseeing the ESRD trial met on March 12, 1998, and recommended
the continuation of this trial after a review of unblinded data.
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 cross-links,
thereby potentially impacting the events that lead to disease
states associated with diabetes and aging. Three pivotal clinical
trials evaluating pimagedine for the complications of diabetes are
ongoing: the two Phase III ACTION (A Clinical Trial In Overt
Nophropathy) trials in diabetic patients with progressive kidney
disease, and a Phase III trial in patients with end-stage renal
disease. ALT-711, Alteon's lead A.G.E. cross-link breaker, is
expected to enter human clinical trials later this year.
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.
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B. FDA CONCURS WITH COMMITTEE RECOMMENDATIONS
ON ALTEON'S PIMAGEDINE
--Alteon Gets Nod to Complete ACTION I Trial;
Will Discontinue ACTION II Trial--
Ramsey, NJ, March 23, 1998 -- Alteon announced today that following
a further review of the safety and efficacy data from both the
ACTION I and ACTION II clinical trials of pimagedine, the U.S. Food
and Drug Administration (FDA) has concurred with the recent
recommendations of the independent External Safety Monitoring
Committee (ESMC) to complete the ACTION I Trial, as planned, and
discontinue the ACTION II Trial.
ACTION I, a Phase III pivotal clinical trial of pimagedine in Type
1 diabetics with progressive kidney disease, commenced in January
1994 and involves 690 patients at 56 clinical sites in North
America. As a result of the ESMC's and FDA's unblinded review and
recommendation, Alteon and corporate partner Genentech, Inc., will
now move to complete the on-drug period of this trial in August
1998, with data expected to be unblinded and released in the fourth
quarter of 1998. The ESMC meeting last week was the last scheduled
review of ACTION I prior to completion of this trial.
ACTION II, a Phase III pivotal clinical trial of pimagedine in Type
2 diabetics with progressive kidney disease, will be discontinued
because of an insufficient risk/benefit ratio based upon data
currently available.
The third pivotal Phase III trial of pimagedine, in diabetic
patients with end-stage renal disease (ESRD), is ongoing. A
separate independent committee overseeing the ESRD trial met on
March 12, 1998, and recommended the continuation of this trial
after a review of the unblinded data.
The National Institute of Diabetes and Digestive and Kidney
Diseases estimates that of the 16 million people in the U.S. who
are diabetic, 10.3 million have been diagnosed with the disease.
There are approximately 800,000 new cases of diabetes diagnosed
each year. Of the estimated 1 million people with Type 1 diabetes,
35-40% develop significant kidney disease by the age of 50, while
10-15% of patients with Type 2 diabetes develop kidney disease at
some time during their lives. About 100,000 diabetic patients have
end-stage renal disease as a result of their diabetes.
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 aging, including kidney disease,
nerve damage, atherosclerosis and retinopathy. Alteon's approach
is to inhibit or break A.G.E.s or their chemical cross-links,
thereby potentially impacting the events that lead to disease
states associated with diabetes and aging. Two pivotal clinical
trials evaluating pimagedine for the complications of diabetes are
ongoing. ACTION I (A Clinical Trial in Overt Nephropathy) in
diabetic patients with progressive kidney disease; and a Phase III
trial in patients with end-stage renal disease (ESRD). ALT-711,
Alteon's lead A.G.E. cross-link breaker, is expected to enter human
clinical trials later this year. Alteon is also pursuing the
development of a novel series of glucose lowering agent 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.
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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: March 23, 1998
