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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON DC 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) APRIL 5, 1999
LEUKOSITE, INC.
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(Exact Name of Registrant as Specified in Charter)
DELAWARE 0-22769 04-3173859
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(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
215 FIRST STREET, CAMBRIDGE, MA 02142
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (617) 621-9350
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ITEM 5. OTHER EVENTS.
On April 5, 1999, LeukoSite, Inc., along with ILEX Oncology,
Inc., announced that the companies have met with the U.S. Food and Drug
Administration for a pre-Biologics License Application meeting on the
clinical development of CAMPATH-Registered Trademark- for the treatment
of patients with refractory chronic lymphocytic leukemia. A copy of the
press release dated April 5, 1999 providing the update on
CAMPATH-Registered Trademark- is incorporated herein by reference and a
copy is filed herewith as Exhibit 99.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND
EXHIBITS.
(C) EXHIBITS.
Exhibit 99, Press Release dated April 5, 1999.
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SIGNATURES
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.
LEUKOSITE, INC.
By: /s/ AUGUSTINE LAWLOR
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Augustine Lawlor,
Vice President, Corporate Development and
Chief Financial Officer
Dated: April 6, 1999
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Exhibit 99
CONTACTS
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FOR LEUKOSITE, INC.:
Augustine Lawlor Theresa McNeely
LeukoSite, Inc. Feinstein Kean Partners Inc.
(617) 621-9350 ext. 4020 (617) 577-8110
[email protected] www.fkpi.com
www.leukosite.com
FOR ILEX ONCOLOGY, INC.:
Deborah Sibley
Investor Relations
(210) 949-8287
For Immediate Release
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LeukoSite and ILEX Oncology Provide Update on CAMPATH -Registered Trademark-
Clinical Development Program
-Companies to File for US Marketing Approval in Mid-1999-
CAMBRIDGE, MA, and SAN ANTONIO, TX, April 5, 1999 - LeukoSite, Inc. (Nasdaq:
LKST) and ILEX Oncology, Inc. (Nasdaq: ILXO) announced that they have met
with the U.S. Food and Drug Administration (FDA) for a pre-BLA meeting on the
clinical development of CAMPATH -Registered Trademark- for the treatment of
patients with refractory chronic lymphocytic leukemia (CLL). The companies
plan to file a Biologics License Application (BLA) with the FDA in mid-1999.
LeukoSite and ILEX plan to present results of the Phase II pivotal trial at
the annual meeting of the European Hematology Association in Barcelona,
Spain, June 9-12, 1999. The trial involved 93 patients with confirmed CLL who
had failed standard, second-line (fludarabine) therapy. Twenty centers in the
U.S. and Europe participated in the study. Efficacy in the trial is being
evaluated according to criteria established by the National Cancer Institute.
The pivotal Phase II trial builds on a substantial body of data in CLL and
lymphoma patients.
"We are very encouraged by the initial evaluation of the results of the
pivotal trial and by the progress we have made in assembling the BLA," said
Christopher Mirabelli, Ph.D., president and chief executive officer of
LeukoSite. "We look forward to completing the work necessary to submit the
BLA." CAMPATH -Registered Trademark- is the most advanced of four LeukoSite
products in clinical development.
"We recognize and appreciate the FDA's direction and effort in helping us
move closer to regulatory review," said Richard Love, president and chief
executive officer of ILEX. "The progress we have made with CAMPATH
- -Registered Trademark- supports our timeline for its development and future
commercialization." The drug represents the lead product in the ILEX
portfolio of ten innovative oncology compounds.
--more--
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CAMPATH -Registered Trademark-, which received "fast track" designation from
the FDA, is expected to undergo a six-month priority review by the FDA under
the Prescription Drug User Fee Act. The review period begins with the
submission of a completed BLA. The FDA has also granted orphan product
designation to CAMPATH -Registered Trademark- for CLL.
CLL is the most prevalent form of adult leukemia, affecting approximately
120,000 patients in the U.S. and Europe. CLL is characterized by an
accumulation of malignant white blood cells (lymphocytes) in the bone marrow
and other tissues, causing lymph note, liver and spleen enlargement and bone
marrow dysfunction. Standard front line therapy consists of alkylating agent
based drug regimens. Fludarabine is the only approved drug for the treatment
of patients who have failed alkylating agents. No approved therapy is
available for patients who fail fludarabine therapy. The median survival time
for fludarabine resistant patients is six to nine months.
CAMPATH -Registered Trademark- is a humanized monoclonal antibody to the
leukocyte antigen CD52, which is expressed on lymphocytes and which is not
detected on hematopoietic stem cells. CAMPATH -Registered Trademark- is
designed to combat CLL by selectively depleting lymphocytes. Normal
lymphocyte populations and immune function are restored in responders at
varying times after discontinuation of CAMPATH -Registered Trademark- therapy.
LeukoSite and ILEX are developing CAMPATH -Registered Trademark- through a
joint venture that was established in May 1997. In addition to CLL, the
companies intend, subject to receipt of regulatory approvals, to begin
clinical studies to evaluate the use of the drug for the treatment of
multiple sclerosis and transplant rejection.
LeukoSite is a biotechnology company developing proprietary drugs designed to
block disease-promoting actions of white blood cells. The focus of
LeukoSite's research and development is on drugs for the treatment of cancer,
and inflammatory, autoimmune and viral diseases. LeukoSite has nine research
and development programs underway and four drug candidates in clinical
development. The Company is collaborating with Warner-Lambert Co., Roche
Bioscience, Kyowa Hakko Kogyo Co., Ltd., Genentech, Inc. and MorphoSys AG.
News releases issued by LeukoSite, Inc. are available thorough PR Newswire's
"Company News On-Call," by calling 800-758-5804 and entering the Company's
extension number 114510.
ILEX Oncology, Inc. is a drug development company focused exclusively on
accelerated development of drugs for the treatment and prevention of cancer.
The company does this in two ways: by advancing a diversified portfolio of
anticancer drugs through its ILEX Products subsidiary, and, by offering drug
development services on a contract basis to pharmaceutical and biotech
companies through its ILEX Oncology Services subsidiary. These complementary
businesses draw from the company's core expertise: relationships with
international oncology experts, strategic alliances that provide unparalleled
access to patient recruitment for clinical trials, and simultaneous European
and US drug development and approval capabilities.
Further information about ILEX Oncology, Inc. can be found on the World Wide
Web at: http://www.ilexoncology.com
--more--
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CERTAIN STATEMENTS CONTAINED HEREIN, SUCH AS THE COMPANIES' INTENTION TO FILE
A BLA WITH THE FDA IN MID-1999, 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, RISKS IN TECHNOLOGY AND PRODUCT DEVELOPMENT, FAILURE TO
SUCCESSFULLY COMPLETE CLINICAL TRIALS, FAILURE TO RECEIVE MARKET CLEARANCE
FROM REGULATORY AGENCIES, COMPETITIVE RISKS AND THOSE RISKS AND UNCERTAINTIES
DISCUSSED IN FILINGS MADE BY LEUKOSITE, INC. AND ILEX ONCOLOGY, INC. WITH THE
SECURITIES AND EXCHANGE COMMISSION. THE COMPANIES DISCLAIM ANY OBLIGATION TO
UPDATE THESE FORWARD-LOOKING STATEMENTS.
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