<PAGE>
CONTACTS:
Larry G. Stambaugh
Chairman, President and CEO Ethan Denkensohn (Investors)
Dale A. Sander Kathy Jones, Ph.D. (Media)
Chief Financial Officer Burns McClellan
(858) 453-4040 (212) 213-0006
FDA ADVISORY COMMITTEE DECLINES TO RECOMMEND
APPROVAL OF MAXAMINE-Registered Trademark-
FOR ADVANCED METASTATIC MELANOMA
San Diego, CA, December 13, 2000 - Maxim Pharmaceuticals (Nasdaq NM: MAXM,
SSE: MAXM) ) announced today that the Oncologic Drugs Advisory Committee to
the U.S. Food and Drug Administration (FDA) has declined to recommend
approval of the Company's lead drug candidate Maxamine-Registered Trademark-
(histamine dihydrochloride) as an adjuvant to interleukin-2 (IL-2) for the
treatment of patients with advanced metastatic melanoma that have liver
metastases.
"While today's outcome is disappointing, the Maxamine Phase III study remains
the only randomized, multi-center, well-controlled trial conducted to date that
has demonstrated a significant survival benefit in this patient population,"
said Larry G. Stambaugh, Maxim's Chairman and Chief Executive Officer. "These
data, and the data from our other clinical trials, leave us confident in the
value of Maxamine as an adjunct to immunotherapy. Our take home message from the
meeting was that the Phase III trial demonstrated a survival benefit, but was
not adequate as a single study to support approval. We will now work with the
FDA to develop a strategy to support the approvability of this drug in this
patient population. Fortunately, Maxim has a sound financial position to weather
a delay in the approval process."
"We will continue our other existing and planned research and clinical programs,
including the two Phase III trials and four Phase II trials that we currently
have underway in cancer and hepatitis C," said Dale Sander, Senior Vice
President, Finance and Chief Financial Officer. "The results of the U.S. Phase
III trial and the follow-on Phase II trial confirmed that Maxamine
<PAGE>
provides a survival benefit to advanced metastatic melanoma patients with liver
metastases, and is a therapy that we believe is well-tolerated. The results of
our other studies in renal cell carcinoma, acute myelogenous leukemia and
hepatitis C also give us positive clinical evidence of the potential for
Maxamine. We will certainly continue to aggressively develop this promising
drug, including the additional Phase III trials we have already planned to
commence in 2001."
In March 2000 the Company completed its 305-patient U.S. Phase III trial of
Maxamine in advanced metastatic melanoma. The Phase III trial demonstrated that
combination therapy using Maxamine plus the cytokine IL-2 significantly improved
the survival of advanced metastatic melanoma patients with liver involvement (p
= 0.0040) compared to treatment with IL-2 alone. Treatment with the combination
of Maxamine and IL-2 increased median survival from 5.0 to 9.1 months, tripled
survival rates at 24 months, and improved quality of life over treatment with
IL-2 alone.
At the ODAC meeting the Company presented additional data from the U.S. Phase
III trial, including survival results updated for 18 months of follow up (the
original NDA submission was based on a minimum 12-month follow up of all
patients):
- After 18 months of follow up, patients with liver metastases treated
with the combination of Maxamine and IL-2 significantly improved
survival as evaluated by the application of the unadjusted Log-Rank
Test to Kaplan Meier survival curves (p = 0.0033) compared to patients
treated with IL-2 alone. The updated results are more statistically
significant than was reported after 12 months of follow up (p =
0.0040).
- For all patients randomized into the study, those treated with the
combination of Maxamine and IL-2 improved survival with a trend toward
significance (p = 0.0526 under the unadjusted Log-Rank Test) compared
to patients treated with IL-2 alone. The updated results are stronger
than was reported after 12 months of follow up (p = 0.125).
The Company also reported the interim results from a follow-on U.S.
Phase II study (M0103) in the United States in advanced metastatic
melanoma that supports and confirms the results of the U.S. Phase III
study. The M0103 study was commenced subsequent to completion of
enrollment of the U.S. Phase III study to provide the top-enrolling
centers in the Phase III study a vehicle to allow them to continue to
treat new patients with the Maxamine combination. All patients
enrolled in the M0103 study have similar inclusion criteria and are
being treated with the Maxamine/IL-2 combination using the same
protocol as the U.S. Phase III trial. To date, 126 patients have been
enrolled in the study. Also, included in the M0103 study is additional
research regarding the biologic activity underlying the mechanism of
action for the Maxamine combination therapy. The 33 liver metastases
patients enrolled in the M0103 study to date have achieved a
10.0-month median survival, consistent with the results of the U.S.
Phase III study.
<PAGE>
During the ODAC meeting the FDA expressed concerns regarding certain
issues related to the U.S. Phase III trial, including patient
randomization and purported demographic imbalances between the
Maxamine and control arms of the study. The FDA suggested that
purported imbalances influenced the survival benefit the Company
reported for the patients with liver metastases treated with the
Maxamine combination. The FDA also suggested that an additional
clinical trial focusing on metastatic melanoma patients with liver
metastases will likely be required to support approval. The Company
reported that it has not had the opportunity to review the underlying
components and details of the analyses performed by the FDA, and these
results are inconsistent with the analyses performed by the Company
under the approved statistical plan for the Phase III trial. The
analyses performed by the Company under the statistical plan indicate
that the statistically significant results from the Phase III trial
are related to the effect of Maxamine as an adjuvant for the treatment
of patients with liver metastases, as opposed to resulting from any
differences in geographic region, demographics or known prognostic
factors within the treatment arms.
COMPANY OVERVIEW
Maxim Pharmaceuticals is a late-stage biopharmaceutical company
developing advanced drugs and therapies for cancer and infectious
diseases. In addition to the recently completed Phase III trial in
advanced metastatic melanoma, Maxamine is also currently being tested
in two additional Phase III cancer clinical trials in 12 countries for
advanced metastatic melanoma and acute myelogenous leukemia. Phase II
trials of Maxamine are also underway for the treatment of hepatitis C
and advanced renal cell carcinoma. The Company has also developed
product candidates based on its MaxDerm-TM- technology that are
designed for the treatment of medical conditions for which topical
therapy is appropriate such as oral mucositis, herpes, decubitus
ulcers, shingles, burns and related conditions. Lastly, Maxim is
developing small-molecule inhibitors and activators of caspases, key
enzymes that modulate and carry out the cellular signaling pathways
involved in programmed cell death, also known as apoptosis. Compounds
that can either inhibit caspases or induce caspases may form the basis
for important new drugs for a wide variety of disease targets, such as
cancer, cardiovascular disease and other degenerative diseases.
THIS NEWS RELEASE CONTAINS CERTAIN FORWARD-LOOKING STATEMENTS THAT
INVOLVE RISKS AND UNCERTAINTIES. SUCH FORWARD-LOOKING STATEMENTS
INCLUDE STATEMENTS REGARDING THE EFFICACY AND INTENDED UTILIZATION OF
MAXAMINE, MAXDERM AND THE CASPASE MODULATOR COMPOUNDS, AND REGARDING
THE COMPANY'S CLINICAL TRIALS. SUCH STATEMENTS ARE ONLY PREDICTIONS
AND THE COMPANY'S ACTUAL RESULTS MAY DIFFER MATERIALLY FROM THOSE
ANTICIPATED IN THESE FORWARD-LOOKING STATEMENTS. FACTORS
<PAGE>
THAT MAY CAUSE SUCH DIFFERENCES INCLUDE THE RISK THAT PRODUCTS THAT
APPEARED PROMISING IN EARLY RESEARCH AND CLINICAL TRIALS DO NOT
DEMONSTRATE SAFETY OR EFFICACY IN LARGER-SCALE CLINICAL TRIALS AND THE
RISK THAT THE COMPANY WILL NOT OBTAIN APPROVAL TO MARKET ITS PRODUCTS.
THESE FACTORS AND OTHERS ARE MORE FULLY DISCUSSED IN THE COMPANY'S
PERIODIC REPORTS AND OTHER FILINGS WITH THE SECURITIES AND EXCHANGE
COMMISSION.
Note: Maxamine-Registered Trademark-, Maxamine Therapy-TM-,
MaxDerm-TM-, and the Maxim logo are trademarks of the Company.
Editor's Note: This release is also available on the Internet at:
http://www.maxim.com
