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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): September 14, 1999
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La Jolla Pharmaceutical Company
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(Exact Name of Registrant as Specified in Charter)
Delaware 0-24274 33-0361285
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(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
6455 Nancy Ridge Drive, San Diego, California 92121
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (858) 452-6600
N/A
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(Former Name or Former Address, if Changed Since Last Report)
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ITEM 5. OTHER EVENTS
On September 14, 1999, La Jolla Pharmaceutical Company (the "Company")
issued a joint press release with Abbott Laboratories ("Abbott") announcing that
the Company had regained the rights to its experimental lupus drug, LJP 394,
following termination by Abbott of a license and development agreement between
the Company and Abbott. A copy of this press release is attached hereto as
Exhibit 99.1.
On September 14, 1999, the Company issued a press release announcing
that it is restructuring operations while it is evaluating the results of a
clinical trial of its experimental lupus drug, LJP 394. The Company further
announced that its Board of Directors had set a special meeting of stockholders,
the primary purpose of which is to put forth to the stockholders a proposed
one-for-five reverse split of the Company's Common Stock. A copy of this press
release is attached hereto as Exhibit 99.2.
ITEM 7. EXHIBITS
Pursuant to General Instruction F of Form 8-K, the following documents
are incorporated by reference herein and attached as exhibits hereto:
<TABLE>
<CAPTION>
EXHIBIT DESCRIPTION
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<C> <S>
99.1 La Jolla Pharmaceutical Company and Abbott Laboratories joint
press release of September 14, 1999 regarding the termination
by Abbott Laboratories of the license and development
agreement between La Jolla Pharmaceutical Company and Abbott
Laboratories.
99.2 La Jolla Pharmaceutical Company press release of September 14,
1999 regarding the restructuring of La Jolla Pharmaceutical
Company and the scheduled special meeting of stockholders.
</TABLE>
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this current report to be signed on its behalf by
the undersigned hereunto duly authorized.
La Jolla Pharmaceutical Company
Date: September 16, 1999 By: /s/ WOOD C. ERWIN
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Wood C. Erwin
Chief Financial Officer
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EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT DESCRIPTION
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<C> <S>
99.1 La Jolla Pharmaceutical Company and Abbott Laboratories joint
press release of September 14, 1999 regarding the termination
by Abbott Laboratories of the license and development
agreement between La Jolla Pharmaceutical Company and Abbott
Laboratories.
99.2 La Jolla Pharmaceutical Company press release of September 14,
1999 regarding the restructuring of La Jolla Pharmaceutical
Company and the scheduled special meeting of stockholders.
</TABLE>
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EXHIBIT 99.1
LJP
THERAPEUTICS FOR ANTIBODY MEDIATED
LA JOLLA PHARMACEUTICAL DISEASES AND INFLAMMATION
COMPANY
DATE: September 14, 1999
CONTACT: Richard W. Krawiec, Ph.D., VP, Investor Relations
La Jolla Pharmaceutical Co.
Matt Kuhn, Abbott Laboratories, 847-937-2993
RELEASE DATE: Immediate
LA JOLLA PHARMACEUTICAL REGAINS RIGHTS
TO EXPERIMENTAL LUPUS DRUG FOLLOWING TERMINATION
OF LICENSE AGREEMENT BY ABBOTT LABORATORIES
San Diego, CA/Abbott Park, IL, September 14, 1999 - La Jolla Pharmaceutical
Company (Nasdaq: LJPC) and Abbott Laboratories (NYSE: ABT) today announced that
Abbott has terminated its license and development agreement for the experimental
lupus drug, LJP 394. Abbott is returning all rights to the compound to La Jolla
Pharmaceutical, based on the results of analyses conducted by Abbott and an
independent third-party of a Phase II/III clinical trial of LJP 394, which
studied the compound's effects on patients with systemic lupus erythematosus,
including those with lupus nephritis.
The analyses confirmed the findings of the independent Data Monitoring Committee
that were announced on May 12, 1999: 1) that at the time the trial was stopped,
efficacy, as defined by the primary chosen endpoint, time to renal flare, was
not significantly different between the treatment and placebo groups and 2) in
patients receiving LJP 394, circulating antibodies to double-stranded DNA
(dsDNA) were reduced by a statistically significant amount in the presence of
the drug. Despite the reduction in dsDNA antibodies, no correlations with
clinical endpoints were observed.
There were no statistically significant serious safety issues, and clinical site
investigators did not report that any thrombotic events were related to drug
administration. When all reported thrombotic events, including cerebrovascular
accident, embolus, mesenteric occlusion, myocardial infarction, and
thrombophlebitis were pooled, there were more events, though the number was
still not statistically significant, in the group receiving LJP 394 than in the
placebo group.
La Jolla Pharmaceutical is continuing to analyze results from the LJP 394
clinical program. In a separate press release issued today, La Jolla
Pharmaceutical stated that while it is still evaluating the lupus results, it is
restructuring operations to reduce expenses. It will use its resources to
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accelerate the development of its antibody-mediated thrombosis Toleragen(R)
candidate and to partner its xenotransplantation drug candidate.
San Diego-based La Jolla Pharmaceutical Company develops disease-specific
therapeutics using its proprietary Tolerance Technology(R) for major diseases
and conditions caused by antibodies such as lupus, antibody-mediated thrombosis,
a clotting disorder associated with stroke, myocardial infarction, deep-vein
thrombosis, and recurrent fetal loss, and organ rejection in
xenotransplantation. Toleragens under development by the Company are designed to
reduce the levels of disease-causing antibodies in patients suffering from these
conditions. The Company's common stock and warrants trade on The Nasdaq Stock
Market under the symbols: LJPC and LJPCW, respectively. For more information
about the Company, visit our web site: http://www.ljpc.com.
Abbott Laboratories is a global, diversified health care company devoted to the
discovery, development, manufacture and marketing of pharmaceutical, diagnostic,
nutritional and hospital products. The company employs 56,000 people and markets
its products in more than 130 countries. In 1998, the company's sales and net
earnings were $12.5 billion and $2.3 billion, respectively, with diluted
earnings per share of $1.51. Abbott's news releases and other information are
available on the company's web site at http://www.abbott.com.
Statements regarding the analysis of results from clinical trials, as well as La
Jolla Pharmaceutical's drug candidates and drug development plans, are
forward-looking statements involving risks and uncertainties, and a number of
factors, both foreseen and unforeseen, could cause actual results to differ
materially from those anticipated. Clinical trials of LJP 394 may continue to
have negative or inconclusive results. Further, delays in continued testing of
LJP 394 and/or termination of development by the Company would result in delays
or lack of government approval to market the compound. Tolerance or the specific
inactivation of pathogenic B cells is a new technology that has not been proven,
and the development of LJP 394 involves many risks and uncertainties, including,
without limitation, whether LJP 394 can provide a meaningful clinical benefit,
and any positive results observed to date may not be indicative of future
results. La Jolla Pharmaceutical's other drug candidates, none of which has
progressed to clinical trials, involve comparable risks. Interested parties are
urged to review the risks detailed from time to time in La Jolla Pharmaceutical
Company's Securities and Exchange Commission (SEC) filings, including the report
on Form 10-K for the year ended December 31, 1998 and the report on Form 10-Q
for the quarter ended June 30, 1999.
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EXHIBIT 99.2
LJP
THERAPEUTICS FOR
LA JOLLA PHARMACEUTICAL ANTIBODY-MEDIATED DISEASES
COMPANY
DATE: September 14, 1999
CONTACT: Richard W. Krawiec, Ph.D., Vice President, Investor
Relations
RELEASE DATE: Immediate
LA JOLLA PHARMACEUTICAL RESTRUCTURES, FOCUSES ON
THROMBOSIS TOLERAGEN(R) WHILE REVIEWING LUPUS RESULTS
LUPUS ANTIBODY REDUCTION SUPPORTS TOLERANCE TECHNOLOGY(R)
San Diego, CA - September 14, 1999 - La Jolla Pharmaceutical Company (Nasdaq:
LJPC) announced that while it is still evaluating results from a Phase II/III
clinical trial of LJP 394 in lupus, it is restructuring operations to reduce
expenses and will use its resources to accelerate the development of an
experimental drug for the treatment of antibody-mediated thrombosis and to
partner its xenotransplantation drug candidate. The Company will reduce its
workforce from approximately 95 to 54 full-time employees.
"We are restructuring our operations to maintain sufficient cash resources to
conduct our programs through the end of next year," said Steven B. Engle, La
Jolla Pharmaceutical's Chairman and Chief Executive Officer. "Our cash and cash
equivalents at June 30, 1999, end of the second quarter, were $17.8 million."
In a separate press release issued today, La Jolla Pharmaceutical Company and
Abbott Laboratories announced that Abbott has terminated its license and
development agreement for LJP 394. Abbott is returning all rights to the
compound to La Jolla Pharmaceutical.
ANTIBODIES REDUCED BY 45%
"We believe that the results from the double-blind, placebo-controlled Phase
II/III clinical trial involving approximately 200 patients and additional
clinical studies of LJP 394 confirm the ability of the Company's Tolerance
Technology to reduce disease-specific antibodies in lupus, which reinforces our
belief that our technology is applicable to other antibody-mediated diseases,"
stated Mr. Engle. "We are continuing forward with an experienced team, who will
concentrate on the preclinical work necessary to advance a Toleragen(R) drug
candidate into clinical trials next year for antibody-mediated thrombosis.
Furthermore, if additional clinical
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trials in lupus are warranted, we have significant inventories of LJP 394 that
could be used in the next study."
During the first four months of weekly drug treatment with 100 mg of LJP 394,
the mean level of dsDNA antibodies were reduced approximately 45% compared to
placebo, and the difference was statistically significant. The mean level of
antibodies rose during the following two-month "off" period, during which there
was no drug treatment, and were suppressed again in each succeeding three-month
"on" period of 50 mg weekly drug treatment over the 18 month study. The Company
believes that this finding supports the ability of Tolerance Technology(R) to
reduce specific antibodies. Despite the reduction in dsDNA antibodies, no
correlations with clinical endpoints were observed. In a separate double-blind,
placebo-controlled, Phase II dose-ranging study involving 68 participants, those
patients receiving a 100 mg weekly dose of LJP 394 had a statistically
significant mean antibody reduction of approximately 50% compared to placebo.
This is the fifth clinical study in which LJP 394 has reduced mean antibody
levels in lupus patients. La Jolla Pharmaceutical is continuing to analyze
results from the LJP 394 clinical program. The management of La Jolla
Pharmaceutical Company is grateful to the hundreds of patients and the dozens of
clinical investigators who participated in these studies.
TOLERAGEN FOR STROKE, HEART ATTACK, DEEP-VEIN THROMBOSIS ADVANCED
"While we complete the lupus analysis, our goals are to streamline expenses and
to maximize shareholder value by advancing a clinical candidate for
antibody-mediated thrombosis to the point where it is attractive to potential
pharmaceutical partners," explained Mr. Engle. Antibody-mediated thrombosis is a
serious blood-clotting disorder that leads to recurrent stroke, heart attack,
and deep-vein thrombosis and afflicts approximately 500,000 people in the U.S.
and Europe. Company scientists have constructed a thrombosis Toleragen candidate
that is designed to reduce the levels of pathogenic antibodies, confirmed the
biochemical mechanism of action underlying this antibody-mediated defect in
blood clotting, developed an assay to quantify the effects of these antibodies
on clotting, and are conducting preclinical testing in a mouse model.
A second Toleragen for antibody-mediated organ rejection in xenotransplantation
has generated positive results in primate and mouse models - a reduction of
disease-causing antibodies and their related B cells. Based on these preclinical
results, the Company is approaching pharmaceutical companies to create a
strategic alliance for its xenotransplantation program. Additional preclinical
results from both of these research programs are expected in the coming months.
STOCKHOLDER'S SPECIAL MEETING SCHEDULED
The Company also announced that the Board of Directors has set a special meeting
of stockholders to be held on November 8, 1999, the primary purpose of which is
to put forth to stockholders a proposed one-for-five reverse split of the
Company's Common Stock. The Company received notice from The Nasdaq Stock
Market, Inc. that its Common Stock will be delisted from the Nasdaq National
Market unless the Company can comply with the Nasdaq requirement that its Common
Stock maintain a minimum bid price greater than or equal to $1.00
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per share. The Board is proposing the reverse split in response to this notice.
The Company expects to distribute proxy materials on approximately October 8,
1999.
San Diego-based La Jolla Pharmaceutical Company develops disease-specific
therapeutics using its proprietary Tolerance Technology for major diseases and
conditions caused by antibodies such as lupus, antibody-mediated thrombosis, a
clotting disorder associated with stroke, myocardial infarction, deep-vein
thrombosis, and recurrent fetal loss, and organ rejection in
xenotransplantation. Toleragens under development by the Company are designed to
reduce the levels of disease-causing antibodies in patients suffering from these
conditions. The Company's common stock and warrants trade on The Nasdaq Stock
Market under the symbols: LJPC and LJPCW, respectively. For more information
about the Company, visit our web site: http://www.ljpc.com.
Statements regarding the analysis of results from clinical trials, as well as La
Jolla Pharmaceutical's drug candidates and drug development plans, are
forward-looking statements involving risks and uncertainties, and a number of
factors, both foreseen and unforeseen, could cause actual results to differ
materially from those anticipated. Clinical trials of LJP 394 may continue to
have negative or inconclusive results. Further, delays in continued testing of
LJP 394 and/or termination of development by the Company would result in delays
or lack of government approval to market the compound. Tolerance or the specific
inactivation of pathogenic B cells is a new technology that has not been proven,
and the development of LJP 394 involves many risks and uncertainties, including,
without limitation, whether LJP 394 can provide a meaningful clinical benefit,
and any positive results observed to date may not be indicative of future
results. La Jolla Pharmaceutical's other drug candidates, none of which has
progressed to clinical trials, involve comparable risks. Interested parties are
urged to review the risks detailed from time to time in La Jolla Pharmaceutical
Company's Securities and Exchange Commission (SEC) filings, including the report
on Form 10-K for the year ended December 31, 1998 and the report on Form 10-Q
for the quarter ended June 30, 1999.
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