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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): JANUARY 8, 1999
VIMRX PHARMACEUTICALS INC.
(Exact name of registrant as specified in charter)
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DELAWARE 0-19153 06-1192468
(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification No.)
2751 CENTERVILLE ROAD, SUITE 210, WILMINGTON, DELAWARE 19808
(Address of principal executive offices) (Zip Code)
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Registrant's telephone number, including area code: (302) 998-1734
NOT APPLICABLE
(Former name or former address, if changed since last report)
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ITEM 5. OTHER EVENTS.
On January 8, 1999, VIMRX Pharmaceuticals Inc. (the "Registrant") issued a press
release announcing the issuance by the FDA of an "approvable letter" stating
that the application for premarket approval of the Isolex(R) Cell Selection
System is approvable subject to the submission of additional information needed
primarily to finalize labeling and the inspection of manufacturing facilities.
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.
VIMRX Pharmaceuticals Inc.
(Registrant)
By: /s/ Francis M. O'Connell
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Francis M. O'Connell
Chief Financial Officer
Dated: January 8, 1999
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SCHEDULE A
PRESS RELEASE OF VIMRX PHARMACEUTICALS INC.
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NEXELL THERAPEUTICS RECEIVES FDA APPROVABLE LETTER
FOR ISOLEX(R) 300 AND 300I CELL SELECTION SYSTEM
Irvine, CA, and Wilmington, DE, January 08, 1999 Nexell Therapeutics Inc., a
majority-owned subsidiary of VIMRX Pharmaceuticals Inc. (NASDAQ: VMRX),
announced today that the U.S. Food and Drug Administration (FDA) has issued an
approvable letter for the Isolex(R) Cell Selection System. In the letter, the
FDA states that the premarket approval application (PMA) for the Isolex(R) 300,
and the supplement for the fully automated Isolex(R) 300i, are approvable
subject to the submission of additional information needed primarily to finalize
labeling and the inspection of manufacturing facilities.
"The FDA's decision is important because the Isolex(R), upon final approval,
will address a health care market need for a cell selection system to support
cancer treatment in the United States," said L. William McIntosh, president and
CEO of Nexell Therapeutics Inc. "Further, gaining an approvable decision from
the FDA on our lead product is a critical business milestone for Nexell. We will
work closely with the FDA to submit the requested data to finalize labeling in a
timely manner and complete the facility inspections."
Upon final approval from the FDA, the Isolex(R) would be the only cell selection
system commercially marketed in the United States. The Isolex(R) Cell Selection
System is currently marketed in the European Union as a component of cancer
treatment for both positive selection of stem cells and negative removal (or
depletion) of tumor cells from bone marrow or peripheral blood. In addition, the
Isolex(R) is available for use in Hungary, Israel, New Zealand, Poland and
Slovenia. Nexell is currently seeking clearance to market the Isolex(R) in
Australia, Canada, Japan and various countries in Eastern Europe and the
Mediterranean region.
Stem cell transplantation using bone marrow or peripheral blood is performed
following high-dose chemotherapy in an effort to restore a patient's blood and
immune cell production. This procedure carries the risk that some tumor cells
will be given back to the patient with the stem cells. In transplantation with
cell selection, a patient's stem cells are isolated further from the other
components of bone marrow and blood. Stem cell selection is intended to reduce
tumor cells in the transplant product and thus may be beneficial to patients
receiving high-dose chemotherapy for cancer.
NEXELL THERAPEUTICS INC.
Located in Irvine, California, Nexell Therapeutics Inc. is a biotechnology
company majority-owned by VIMRX Pharmaceuticals Inc. (NASDAQ:VMRX) and minority-
owned by Baxter Healthcare Corporation, the principle domestic operating
subsidiary of Baxter International Inc. Nexell is developing and marketing
innovative ex vivo cell therapies for cancer, autoimmune, metabolic and genetic
diseases. Nexell's lead product, the Isolex(R) Cell Selection System, is
marketed in a number of countries and is currently under final review by the FDA
in the United States. 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 success of
the Company's clinical trials, delays in receiving FDA or other regulatory
approvals and the development of competing therapies and/or technologies by
other companies.
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NOTE TO INVESTORS AND EDITORS: VIMRX and Nexell's press releases are available
on the Internet through www.vimrx.com and through BusinessWire's web site at
http://www.businesswire.com. The releases also are available at no charge
through BusinessWire's fax-on-demand service at 800-411-8792.
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