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U.S. 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) November 30, 1998.
SONUS PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
DELAWARE 0-26866 95-4343413
(State of Other (Commission (IRS Employer Identification
Jurisdiction of File Number) Number)
Incorporation)
22026 20TH AVE. SE, BOTHELL, WASHINGTON 98021
(Address of Principal Executive Offices)
(425) 487-9500
(Registrant's Telephone Number, Including Area Code)
NOT APPLICABLE
(Former name or former address, if changed since last report)
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Exhibit Index on Page 4
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ITEMS 1 THROUGH 4 AND 6 THROUGH 9 NOT APPLICABLE.
ITEM 5 OTHER EVENTS.
Reference is made to the press release issued to the public by the registrant on
November 30, 1998 relating to the termination of the Agreement with Daiichi
Pharmaceuticals Co., Ltd., the text of which is attached hereto as Exhibit 99.3
for a description of the events reported pursuant to this Form 8-K.
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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 thereunto duly authorized.
SONUS PHARMACEUTICALS, INC.
Date: December 4, 1998 By: /s/ Gregory Sessler
--------------------
Gregory Sessler
Chief Financial Officer and Assistant
Secretary (Principal Financial and
Accounting Officer)
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EXHIBIT INDEX
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SEQUENTIAL
EXHIBIT NO. DESCRIPTION PAGE. NO.
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99.3 Press Release date November 30, 1998. 5
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EXHIBIT 99.3
SONUS ANNOUNCES TERMINATION OF AGREEMENT WITH
DAIICHI PHARMACEUTICAL CO., LTD. OF JAPAN
COMPANY IN DISCUSSION WITH OTHER PARTIES FOR LICENSING OF ECHOGEN(R) IN
PACIFIC RIM
BOTHELL, WASH., November 30, 1998 - SONUS Pharmaceuticals, Inc. (Nasdaq: SNUS)
today announced that the EchoGen(R) (perflenapent injectable emulsion) licensing
agreement with Daiichi Pharmaceutical Co., Ltd. of Japan has been terminated.
"We appreciate Daiichi's work in taking EchoGen(R) through phase 1 trials in
Japan," said Michael A. Martino, president and COO of SONUS Pharmaceuticals.
"However, we were concerned about the lack of clinical progress following the
completion of the initial trials. We already are talking to other companies that
have expressed an interest in obtaining the licensing rights to EchoGen(R) and
QW7437 (SonoGen(TM)), our next ultrasound contrast agent in development, in the
Pacific Rim."
SONUS and Daiichi signed an agreement in March 1995, giving Daiichi marketing
and distribution rights to EchoGen(R) in Japan and nine other Pacific Rim
nations. Under the agreement, Daiichi was responsible for the timely clinical
development of EchoGen(R) and the management of the agent's registration with
Japanese regulatory authorities.
Daiichi completed the first clinical trial in December 1997, which examined the
safety and efficacy of EchoGen(R) in 64 normal human subjects. Clinical
investigators conducting the study concluded that EchoGen(R) produced sufficient
effect for intravenous myocardial contrast echocardiography without any
significant adverse events. There has been no additional clinical work on
EchoGen(R) in Japan since the completion of the initial study.
The clinical development of EchoGen(R) in Japan is part of an ongoing effort of
global commercialization of the ultrasound contrast agent. In July 1998,
EchoGen(R) was approved in the 15 countries of the European Union. In the U.S.,
the Company recently filed an amendment to the EchoGen(R) New Drug Application
which is currently under FDA review. EchoGen(R) clinical trial experience
exceeds 1,800 patients in various clinical conditions worldwide.
SONUS Pharmaceuticals, Inc., based in Bothell, Wash., is engaged in the research
and development of ultrasound contrast agents and drug delivery systems based on
its proprietary PhaseShift(TM) fluorocarbon technology. The Company's products
are being investigated to improve the diagnosis and treatment of heart disease,
cancer and other debilitating conditions.
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Contact: Investors Media
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Gregory Sessler Kelly Ford
SONUS Pharmaceuticals, Inc. SONUS Pharmaceuticals, Inc.
(425) 487-9500 (425) 487-9500
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Certain of the statements made in this news release are forward looking such as
those relating to licensing discussions for, and global commercialization of
EchoGen(R) and QW7437. As discussed in SONUS' annual report on Form 10-K filed
March 31, 1998, actual results could differ materially from those projected in
the forward-looking statements as a result of the following factors, among
others: the use of EchoGen(R) and QW7437 for certain indications will require
extensive clinical testing, the results of which may be different than
preliminary study results; EchoGen(R) and QW7437 will require regulatory
approval, which approval is subject to certain regulatory requirements and can
be lengthy and ultimately will depend on a number of factors including safety
and efficacy; and market acceptance of EchoGen(R) and QW7437, which will depend
on a number of factors, including safety, efficacy, ease of administration and
the presence of competitive imaging products or technologies. There can be no
assurance that SONUS will find a suitable partner for the commercialization of
EchoGen(R) or QW7437 in the Pacific Rim territories, or that FDA approval or
approval in other countries will be obtained.
NOTE: SONUS Pharmaceuticals' press releases are available via PR Newswire's
Company News on Call service. To receive previous SONUS press releases via fax,
dial 1-800-758-5804, ext. 108377. SONUS releases also can be accessed on the
Internet at http://www.prnewswire.com. Additional information about SONUS can be
accessed at the SONUS Homepage, http://www.sonuspharma.com.
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