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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): April 8, 1998
LXR BIOTECHNOLOGY INC.
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(Exact name of Registrant as specified in its charter)
DELAWARE 1-12968 68-0282856
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
1401 MARINA WAY SOUTH, RICHMOND, CALIFORNIA 94804
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(Address of principal executive offices) (Zip code)
Registrant's telephone number, including area code: (510) 412-9100
Not Applicable
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(Former Name or Former Address, if Changed Since Last Report)
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INFORMATION TO BE INCLUDED IN THE REPORT
ITEM 5. OTHER EVENTS
(a) On April 14, 1998, LXR Biotechnology Inc. (the "Company") issued a
press release, a copy of which is attached herein as Exhibit 99.1, relating to
the Company's ongoing drug research efforts.
(b) On April 8, 1998, Mark J. Tomei resigned from the Board of Directors
of the Company. On April 10, 1998, Dr. Donald H. Picker resigned from the Board
of Directors of the Company. Dr. Picker will continue to serve as the Company's
President and Chief Operating Officer.
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ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits
99.1 Press Release Issued by the Company on April 14, 1998.
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SIGNATURE
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.
LXR BIOTECHNOLOGY INC.
Date: April 15, 1998 By: /s/ L. David Tomei
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L. David Tomei, Chief Executive Officer
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EXHIBIT INDEX
Exhibit
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99.1 Press Release Issued by the Company on April 14, 1998
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Exhibit 99.1
Contact: L. David Tomei, Chairman & CEO
Leah Wong, Corporate Communications
LXR Biotechnology, Inc.
510.412.9100
LXR BIOTECHNOLOGY INC. ANNOUNCES THAT THE FDA WILL REQUIRE
ADDITIONAL PRECLINICAL DATA ON CP-CARDIOSOL
Richmond, CA - April 14, 1998 -- LXR Biotechnology(R) Inc. (AMEX:LXR), announced
today that the commencement of its planned CP-Cardiosol clinical trial has been
delayed by a request from the Food and Drug Administration (FDA, Division of
Anesthetic, Critical Care and Addiction Drug Products) for additional
preclinical data. In March 1998, LXR submitted an Investigational New Drug (IND)
application to the FDA requesting permission to test the product during heart
bypass surgery. The Company believes that it will be able to fully respond to
the FDA's request by the third quarter 1998.
"We understand that the FDA reviewers would like us to follow certain animals
for potential delayed adverse effects following administration with CP-Cardiosol
to supplement the short term safety and efficacy data we already have," said L.
David Tomei, chairman and chief executive officer. "Submissions to the FDA for
similar cardioplegia products are relatively rare and the FDA is pursuing a
thorough review which we hope will lead to even more confidence in this product.
We already have obtained preclinical evidence that would lead us to believe that
these studies will go well, but we expect to fully respond to the FDA's request
in the third quarter 1998, following which the FDA will review the additional
data."
In fourth quarter 1997, LXR submitted an Investigational Device Exemption (IDE)
application to the FDA for the use of its apoptosis modulating compound
HK-Cardiosol(TM), a heart protectant solution for transplantation which is
identical in formulation to CP-Cardiosol. The IDE was approved by the FDA in
January 1998. LXR anticipates the first clinical use of this compound in human
trials in Summer 1998. Although HK-Cardiosol is considered a medical device,
CP-Cardiosol is considered to be a drug and therefore subject to different
review procedures within the FDA.
Under FDA regulations, the FDA reviews an IND submission and normally responds
within 30 days often requesting further data or clarification prior to approval
to begin human trials. During this 30 day period, the commencement of the
CP-Cardiosol was delayed by the FDA putting the product on "clinical hold"
pending the submission and review of the requested additional preclinical data.
LXR will respond rapidly and completely to this request in order to minimize
delays in product development.
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LXR Biotechnology Inc. is a biopharmaceutical company engaged in research and
development of innovative therapeutics designed to treat diseases through the
control of apoptosis or gene-directed cell death. LXR's compounds include
HK-Cardiosol(TM), a heart proctectant solution for heart transplantation and
Elirex(TM) for heart attack.
Statements in this press release that are not historical are forward looking
statements. These forward looking statements are subject to certain risks and
uncertainties that could cause actual results to differ materially from those
anticipated in any forward looking statements, all of which are difficult to
predict and many of which are beyond the control of the Company, including, but
not limited to the risks and uncertainties related to new and developing
technologies, dependence on collaborative partners, the inherent complexity and
uncertainty regarding the development of new pharmaceutical and medical device
products, LXR's early stage of development, the results of research and
development efforts, results of future clinical trials, future capital needs and
the uncertainty of additional funding and government regulations or approval of
clinical trials, and other factors which are detailed in the Company's periodic
reports and registration statements filed with the Securities and Exchange
Commission. LXR does not undertake to revise or update any forward looking
statements to reflect events or circumstances that may arise after the date
hereof.
For more information, visit LXR Biotechnology's web site at
http://www/.lxr.com.
