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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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 15, 1998
CELL THERAPEUTICS, INC.
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(Exact name of registrant as specified in its charter)
WASHINGTON 0-28386 91-1533912
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
201 ELLIOTT AVENUE WEST, SEATTLE, WASHINGTON 98119
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (206) 282-7100
NOT APPLICABLE
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(Former name or former address, if changed since last report.)
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ITEM 5. OTHER EVENTS.
On July 15, 1998, the Cell Therapeutics, Inc. (the "Registrant") issued a
press release announcing that the Registrant had reached an agreement in
principle to revise its agreement with The R.W. Johnson Pharmaceutical Research
Institute and Ortho Biotech Inc., both subsidiaries of Johnson & Johnson, for
the development and commercialization of lisofylline, a drug intended to prevent
serious and fatal infections and damage to mucous membranes following radiation
and chemotherapy treatment. The text of that press release is being filed as
Exhibit 99.1 to this report.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(a) Financial Statements of Business Acquired. - Not applicable.
(b) Pro Forma Financial Information. - Not applicable.
(c) Exhibits.
99.1 Press release dated July 15, 1998, giving notice of an agreement
in principle to revise the Collaboration Agreement dated November
8, 1996, by and between the Registrant, The R.W. Johnson
Pharmaceutical Research Institute and Ortho Biotech Inc.
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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 hereto duly authorized.
CELL THERAPEUTICS, INC.
Dated: July 20, 1998 By: /s/ JAMES A. BIANCO, M.D.
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James A. Bianco, M.D.
President and Chief Executive
Officer
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EXHIBIT INDEX
Exhibit No. Description Page No.
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99.1 Press release dated July 15, 1998, giving notice of an agreement
in principle to revise the Collaboration Agreement dated November
8, 1996, by and between the Registrant, The R.W. Johnson
Pharmaceutical Research Institute and Ortho Biotech Inc.
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[LETTERHEAD OF CELL THERAPEUTICS]
________________________________________________________________________________
WEDNESDAY JULY 15, 6:51 PM EASTERN TIME
COMPANY PRESS RELEASE
CELL THERAPEUTICS REVISES MARKETING AGREEMENT WITH THE R.W. JOHNSON
PHARMACEUTICAL RESEARCH INSTITUTE AND ORTHO BIOTECH INC.
REFLECTS NEW DRUG APPLICATION FILING TIMETABLE FOR LISOFYLLINE
SEATTLE--(BW Health Wire)--July 15, 1998-- Cell Therapeutics Inc. (NASDAQ:CTIC -
news) today announced that it has reached an agreement in principle to revise
its agreement with The R.W. Johnson Pharmaceutical Research Institute (PRI) and
Ortho Biotech Inc. (OBI), both Johnson & Johnson companies, for the development
and commercialization of lisofylline (LSF), a drug intended to prevent serious
and fatal infections and damage to mucous membranes following radiation and
chemotherapy treatment.
Earlier this year Cell Therapeutics (cti) announced that its first Phase III
trial for LSF did not achieve statistical significance for its primary
endpoints. ``However, the company's analysis of the underlying data from the
trial and the enthusiastic feedback from our clinical trial investigators
continues to provide confidence in the future commercial prospects for
lisofylline, ``said James Bianco, M.D., president and chief executive officer of
cti. The revised agreement, which amends one signed in 1996, reflects the drug's
new regulatory filing timeline.
The company noted that under terms of the initial 1996 agreement, PRI was to pay
60% of U.S. development costs in connection with obtaining regulatory approval
of LSF for use with bone marrow transplants (BMT) and, after exercising its
option in 1997, for use with inductive chemotherapy to treat acute myelogenous
leukemia (AML). The initial anticipated regulatory filing was for late 1998.
Thereafter, PRI was to commence development efforts in Europe and pursue
regulatory filings using U.S. documents. The agreement also provided that PRI
could terminate upon 30 days notice for safety reasons and upon six months
notice for any other reason.
Under the terms of the revised agreement, cti will control development and be
responsible for costs associated with development of lisofylline, and PRI will
continue to pay cti its share of development costs through Dec. 31, 1998.
Thereafter, PRI and OBI may elect to resume responsibility for the development
and commercialization of lisofylline following the successful outcome of a Phase
III trial. In connection with this agreement, PRI has agreed to make certain
additional payments to cti upon resumption of its obligations. If PRI does not
resume development activities, then cti will be free to license lisofylline to
other third parties. ``Since the majority of preclinical, clinical and
precommercial manufacturing development will be completed by year end, the
financial impact on Cell Therapeutics in 1999 should not be material. We
anticipate ending the year with approximately
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$50 million," noted D. Bianco.
"These modifications make sound business sense for our firm and accurately
reflect our current best thinking on filing a new drug application. We look
forward to continuing our relationship with Johnson & Johnson in a mutually
rewarding manner," Dr. Bianco concluded.
Lisofylline is currently in Phase III trials for AML and BMT and under
sponsorship of the National Heart Lung and Blood Institute, for Acute Lung
Injury (ALI). In the third quarter, the company anticipates initiating a Phase
I/II trial of LSF in preventing mucositis among cancer patients receiving
radiation and chemotheraphy for head and neck cancer.
Cell Therapeutics Inc. focuses on the discovery, development and
commercialization of small molecule drugs that selectively regulate the
metabolism of oxidized lipids and phospholipids relevant to the treatment of
cancer and inflammatory and immune diseases.
This announcement includes forward-looking statements that involve a number of
risks and uncertainties, the outcome of which could materially adversely affect
actual future results. Specifically, the risks and uncertainties that could
affect the development of cti's products under development includes risks
associated with preclinical and clinical development in the biotechnology
industry in general and of cti's products under development in particular
(including, without limitation, the potential failure of CT-2584, lisofylline,
and related compounds to prove safe or effective for treatment of disease),
determinations by regulatory, patent, and administrative governmental
authorities, competitive factors, technological developments, costs of
developing, producing, and selling cti's products under development, and the
risk factors listed or described from time to time in the company's filings with
the Securities and Exchange Commission including, without limitation, the
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company's most recent Registrations on Forms 10-K, 8K, and 10-Q.
Contact:
Cell Therapeutics Inc.
Lee M. Parker, 800/664-CTIC
[email protected]
www.cticseattle.com
http://www.businesswire.com/cnn/ctic.htm
