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[ILEX ONCOLOGY, INC. LOGO]
PRESS RELEASE
Contact: Millennium Pharmaceuticals Inc.:
Maureen Suda (media): 617-551-2959
Clare Midgley (investor): 617-679-7480
ILEX Oncology Inc.:
Jill Scoggins (media): 210-391-5592 or 210-949-8687
Ann Stevens (investor): 210-949-8230
Berlex Laboratories Inc.:
Rich Salem (media): 973-487-2371 or 908-875-3047
Joanne Marion (investor): 973-487-2164
U.S. FOOD AND DRUG ADMINISTRATION ADVISORY COMMITTEE
RECOMMENDS NEW TREATMENT, CAMPATH(R), FOR
PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
BETHESDA, MD., DEC. 14, 2000--The Oncologic Drugs Advisory Committee
(ODAC) to the U.S. Food and Drug Administration (FDA) today voted 14 to 1 to
recommend accelerated approval of Millennium & ILEX Partners L.P.'s (M&I
Partners) CAMPATH(R) (alemtuzumab) investigational humanized monoclonal antibody
for patients with chronic lymphocytic leukemia (CLL) who have been treated with
alkylating agents and have failed fludarabine therapy. CLL is the most prevalent
form of adult leukemia, affecting approximately 120,000 patients in the United
States and Europe.
CLL is characterized by an accumulation of leukemic cells in the bone
marrow, blood and other tissues, causing bone marrow dysfunction and enlargement
of the lymph nodes, liver and spleen. Patients with CLL suffer from numerous
disease-related symptoms, including fatigue, bone pain, night sweats and loss of
appetite and weight. Investigators believe CAMPATH works by targeting the CD52
antigen, which is prevalent on cancerous B lymphocytes, to clear the blood and
bone marrow of cancer cells.
SUMMARY OF DATA
The FDA Advisory Committee reviewed efficacy data for a pivotal Phase
II (single arm) clinical trial (Study 211) involving 93 patients with CLL as
well as two earlier supporting trials involving 32
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U.S. FOOD AND DRUG ADMINISTRATION ADVISORY COMMITTEE RECOMMENDS NEW TREATMENT,
CAMPATH(R), FOR PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
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CLL patients (Study 005) and 24 CLL patients (Study 009) respectively. Seventy
percent or more of the patients participating in each of these trials had
advanced disease (Rai Stage III/IV). All of the study participants in Study 211
had received previous therapy with alklylators and were refractory to (had
failed) fludarabine therapy. In the pivotal trial (Study 211) an objective
response rate of 33 percent (31 of 93 patients) was observed with a median
duration of response of about seven months. In Study 211 seven (23 percent)
subjects had objective responses of more than one year. In the two supporting
trials objective responses of 29 percent (Study 009) and 22 percent (Study 005)
were reported. Three (43 percent) responders in Study 009 and two (29 percent)
responders in Study 005 had objective responses lasting more that one year.
Improvement/remission of disease-related symptoms and improvement in
hematological parameters were noted in most responders who had symptoms or
hematological compromise at initiation of CAMPATH therapy.
In Study 211, there was 30 percent mortality on study or within six
months after completion of the study. Half of these were determined to be due to
the progression of the disease and half due to complications. Adverse events
associated with CAMPATH therapy include infusion-related events, infections and
hematological toxicity. Common infusion-related toxicities included fever,
rigors, nausea, vomiting, rash and hypotension. Most of these events were mild
(National Cancer Institute Common Toxicity Criteria Grade 1/2) and were
controlled with premedication and appeared to decrease in occurrence over the
duration of therapy. Infections of any severity were reported in about 50
percent of the study population. Half of these infections were serious in
nature. Opportunistic infections were reported in about one-fourth of the study
population. Hematological toxicities reported in the study included anemia,
neutropenia and thrombocytopenia. Serious hematological toxicity (National
Cancer Institute Common Toxicity Criteria Grade 3/4) noted in the study or
shortly after completion of study drug therapy resolved within two months after
discontinuation of therapy.
REACTION TO THE VOTE
"As a researcher dedicated to finding new treatments for CLL, I am
excited and pleased that CAMPATH is one step closer to providing an option that
may help patients enjoy their lives for a longer
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U.S. FOOD AND DRUG ADMINISTRATION ADVISORY COMMITTEE RECOMMENDS NEW TREATMENT,
CAMPATH(R), FOR PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
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period," said Dr. Michael J. Keating, deputy chairman of the Department of
Leukemia at the University of Texas M.D. Anderson Cancer Center in Houston and
principal CAMPATH clinical investigator.
The Advisory Committee's recommendation is not binding, but will be
taken into consideration by the FDA upon completing the review of the CAMPATH
Biologics License Application (BLA), which was submitted to the FDA on Dec. 23,
1999. Additionally, M&I Partners submitted a Marketing Authorization Application
(MAA) for CAMPATH to the European Agency for the Evaluation of Medicinal
Products (EMEA) for evaluation in March 2000, which is currently under review.
Accelerated approval requires that M&I Partners further study the
compound to verify and describe its clinical benefit. A post-approval clinical
trial to examine CAMPATH's safety and efficacy in CLL patients is being planned
and is expected to begin in 2001.
COMPANY PROFILES
CAMPATH was developed by M&I Partners, a 50-50 joint venture of
Millennium Pharmaceuticals Inc. (Nasdaq: MLNM) and ILEX Products Inc., a
subsidiary of ILEX Oncology Inc. (Nasdaq: ILXO). If approved by the FDA, it will
be marketed and distributed in the United States by Berlex Laboratories Inc. of
Richmond, Calif., the U.S. affiliate of Schering AG, Germany (NYSE: SHR).
Millennium Pharmaceuticals Inc., a leading biopharmaceutical company,
applies its comprehensive and integrated science and technology platform for the
discovery and development of breakthrough therapeutic and predictive medicine
products, with a goal of delivering personalized medicine. Through the
industrialization of this gene-to-patient platform, Millennium also strives to
accelerate the process of drug discovery and development. Headquartered in
Cambridge, Mass., Millennium and its affiliates currently employ more than 1,200
people.
ILEX Oncology Inc. is a drug development company focused predominantly
on the accelerated development of drugs for the treatment and prevention of
diseases. The company does this in two ways: by advancing a diversified
portfolio of therapeutic drugs through its ILEX Products subsidiary, and by
offering drug development services on a contract basis to pharmaceutical and
biotech companies
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U.S. FOOD AND DRUG ADMINISTRATION ADVISORY COMMITTEE RECOMMENDS NEW TREATMENT,
CAMPATH(R), FOR PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
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through its ILEX Oncology Services subsidiary. These complementary businesses
draw from the company's core relationships with international oncology experts,
strategic alliances providing access to patient recruitment for clinical trials,
and simultaneous European and U.S. drug development and approval capabilities.
Further information about ILEX can be found on the company's Web site at
www.ilexoncology.com.
Committed to developing novel therapeutics that address unmet medical
needs, Berlex Laboratories Inc. (www.Berlex.com) researches, develops,
manufactures and markets ethical pharmaceuticals in five strategic areas: female
healthcare, oncology, diagnostic imaging, dermatology and therapeutics for
life-threatening and disabling diseases. Berlex Laboratories Inc., the U.S.
affiliate of Schering AG, Germany (NYSE: SHR), has business divisions in
Montville and Wayne, N.J. and in Richmond, Calif.
FOR MILLENNIUM:
This press release contains "forward-looking statements," including
Millennium's expectations of future industry conditions, strategic plans and
forecasts of operational results. Various risks may cause Millennium's actual
results to differ materially, including: uncertainties about its drug discovery
and clinical development processes, uncertainties about obtaining patent
protection for its discoveries and about the commercial limitations imposed by
patents owned or controlled by third parties; Millennium's dependence upon
strategic alliance partners to develop and commercialize products and services
based on its work; uncertainties about obtaining regulatory approvals to market
products and services resulting from its development efforts; and the
requirement for substantial funding to conduct research and development and to
expand commercialization activities. For a further list and description of such
risks and uncertainties, see the reports filed by Millennium with the Securities
and Exchange Commission. Millennium disclaims any intention or obligation to
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
FOR ILEX:
For ILEX: Certain statements contained herein, including the statements
relating to the potential FDA approval and the marketing and distribution of
CAMPATH, are "forward-looking" statements (as such term is defined in the
Private Securities Litigation Reform Act of 1995). Because such statements
include risks and uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Factors that could
cause actual results to differ materially from those expressed or implied by
such forward-looking statements include, but are not limited to, the early stage
of the ILEX's compounds under development; risks in technology and product
development; failure to successfully complete clinical trials; failure to
receive market clearance from regulatory agencies, including the FDA; dependence
on third parties and partners and those risks described in ILEX's Form S-3 filed
March 8, 2000 (Commission file #333-32000), and ILEX's Annual Report on Form
10-K for the year ended December 31, 1999, and in other filings made by ILEX
with the SEC. ILEX disclaims any obligation to update these forward-looking
statements.
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