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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): July 2, 1999
NEXELL THERAPEUTICS INC.
(Exact name of registrant as specified in charter)
DELAWARE 0-19153 06-1192468
(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation.)
9 Parker, Irvine, CA 92618
(Address of principal executive offices) (Zip code)
Registrant's telephone number, including area code: (949) 470-9011
Not applicable
(Former name or former address, if changed since last report)
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Item 5. Other Events.
On July 6, 1999, Nexell Therapeutics Inc.(the "Registrant") issued a
press release announcing that the U.S. Food and Drug Administration ("FDA")has
given the Registrant approval to market its Isolex(R) Magnetic Cell Selection
Systems, including the Isolex(R) 300 and the Isolex(R) 300i, in the United
States. FDA approval was effective July 2, 1999. A copy of the press release is
attached as Schedule A hereto.
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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.
NEXELL THERAPEUTICS INC.
(Registrant)
By: /s/ William A. Albright
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William A. Albright
Senior Vice President, Chief
Financial Officer and Secretary
Dated: July 8, 1999
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Schedule A
Press Release of Nexell Therapeutics Inc.
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NEXELL THERAPEUTICS RECEIVES APPROVAL TO MARKET
ISOLEX(R) CELL SELECTION SYSTEMS IN THE UNITED STATES
Only Commercially Available Systems Enter Expanding Market for
Stem Cell Selection
IRVINE, CA, July 6, 1999 - Nexell Therapeutics Inc. (NASDAQ:NEXL) announced
today that the U.S. Food and Drug Administration (FDA) has given the Company
clearance to market its Isolex(R) Magnetic Cell Selection Systems in the United
States. The semi-automated Isolex(R) 300 and fully-automated Isolex(R) 300i,
along with the reagent kit and disposable sets used in each selection procedure,
will be sold for the selection of hematopoietic stem cells and the removal of
tumor cells from autologous peripheral blood as a component of aggressive cancer
treatment. They are the only stem cell selection systems commercially available
in the United States.
"This approval is not only a milestone for Nexell Therapeutics but an important
step forward in the application of stem cell selection technology to clinical
medicine," said Richard L. Dunning, Chairman and CEO of Nexell Therapeutics Inc.
"The United States is the largest and most dynamic market for cell selection in
the world. The commercial availability of the Isolex(R) systems in the U.S.
will increase access by oncologists and their patients to state-of-the-art
transplantation techniques, while giving researchers the technological platform
to explore new frontiers in cell therapy."
The launch of the Isolex(R) systems will take place over the next several months
and initially focus on the conversion of existing Isolex(R) investigational
sites to commercial status and the installation of Isolex(R) systems at sites
currently operating CellPro Ceprate SC devices. These sites have continued to
use the Ceprate SC system under a limited supply agreement with Baxter
Healthcare Corporation created to provide treatment for patients in need of stem
cell selection in the interim between cessation of CellPro's business operations
and Isolex(R) approval.
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Growth in Stem Cell Selection
Stem cell transplantation is currently performed after high-dose chemotherapy
(HDC) in an effort to restore a cancer patient's blood and immune cell
production capacity which is destroyed in this aggressive form of cancer
treatment. Conventional grafts from bone marrow or peripheral blood carry the
risk that tumor cells will be given back to the patient along with the desired
stem cells. In transplantation with cell selection, a patient's stem cells are
isolated from their blood, thereby substantially reducing tumor cells in the
graft. This may reduce the chances of cancer relapse potentially caused by
these cells and produce a better long-term outcome. Improvements in
transplantation techniques, including the wider use of cell selection, have also
contributed to a significant reduction in the morbidity and mortality associated
with conventional transplantation.
As a result, HDC with transplantation has grown at an average annual rate of 21
percent over the past 10 years. Although still under study in high risk or
metastatic breast cancer, HDC with transplant is now standard therapy in
multiple myeloma, acute myeloid leukemia in first remission, and intermediate-
grade non-Hodgkins lymphoma. Within the clinical transplant community,
increasing adoption of cell selection to improve graft purity is expected to
drive even more dramatic growth in selection procedures. In 1998 there were
approximately 6,000 selections performed worldwide; by 2002 this number may
exceed 30,000.
"Transplant surgeons and clinical oncologists clearly understand the logic of
stem cell selection because increasing the purity of the graft by eliminating
tumor cells fits with their ultimate treatment goal: to achieve minimum residual
disease in the patient," said L. William McIntosh, President of Nexell
Therapeutics Inc. "Now that we can actively market the advantages of selection,
we expect the number of selected transplant procedures to increase significantly
over the next few years. In addition, we will promote the unique features of
the Isolex(R), including full automation, cGMP processing, and closed system
technology to significantly reduce potential contamination of the final stem
cell product, that make it the best cell selection system in the world."
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The Isolex(R) Magnetic Cell Selection Systems
The Isolex(R) 300 and Isolex(R) 300i are automated devices for the clinical
separation of various types of cells from peripheral blood. The Isolex(R) cell
selection platform is versatile and can be used for a number of cell selection
approaches, including the positive selection of a desired or target cell
population from cell populations, such as tumor cells, that are potentially
harmful to the patient.
The Isolex(R) 300i is fully automated, integrating all steps of the stem cell
selection process into one continuous procedure that takes about 2.5 hours. The
system uses a highly specific anti-CD34 stem cell antibody and paramagnetic
beads to target and capture CD34+ stem cells. The Isolex(R) 300i achieves high
purity and yield of selected cells and its unique, patented stem cell release
system leaves the selected cell surface virtually free of the antibodies and
paramagnetic beads. Total automation of the sterile, closed-path procedure
enhances consistency of the final cell product by greatly reducing the potential
for contamination and errors in processing. Thus the Isolex(R) 300i is ideally
positioned to help cell processing laboratories meet the increasing level of
regulatory and quality scrutiny to which they are being subjected.
The Isolex(R) cell selection systems are currently marketed in the European
Union and Canada and are available for use in Hungary, Israel, New Zealand,
Poland, and Slovenia. Nexell is seeking clearance to market the Isolex(R)
systems in Australia, Japan and various countries in Eastern Europe and the
Mediterranean region. There are also a number of Isolex(R) systems currently in
use in investigational protocols for gene therapy and dendritic cell therapy,
engineered transplants with alternative donors and for autoimmune diseases, and
depletion of specific T-cell subsets such as CD4 or CD8 cells.
Located in Irvine, California, Nexell Therapeutics Inc. (NASDAQ:NEXL), formerly
VIMRX Pharmaceuticals Inc., is a cell therapy company whose mission is to put
the power of the cell into the hands of healers. Nexell is developing and
marketing innovative diagnostics and ex vivo cell therapies for cancer,
autoimmune, metabolic and genetic diseases. Nexell's lead product is the
Isolex(R) Magnetic Cell Selection System. In addition, Nexell markets an
extensive line of cell therapy preparation, storage and expansion products
including the Cryocyte(TM) and Lifecell(R) brands.
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The Private Securities Litigation Reform Act of 1995 provides a "safe harbor"
for certain forward-looking statements. The forward-looking statements contained
in this release are subject to certain risks and uncertainties. Actual results
could differ materially from current expectations. Among the factors which could
affect the Company's actual results and could cause results to differ from those
contained in the forward-looking statements contained herein are: the timely
commencement and success of the Company's clinical trials and other research
endeavors, delays in receiving FDA or other regulatory approvals, the
development of competing therapies and/or technologies, the terms of any future
strategic alliances, the possible need for additional capital, and any
additional factors described from time to time in the Company's periodic reports
on Form 10-K and 10-Q, and any prospectus describing the Company's securities.
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