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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) February 26, 1998
SONUS PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
Delaware 0-26866 95-4343413
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No)
22026 20th Avenue, S.E., Suite 102, Bothell, Washington 98021
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (425) 487-9500
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Not Applicable
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(Former name or former address, if changed since last report)
Page 1 of 8
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 releases issued to the public by the
registrant on February 26, 1998 and March 16, 1998, the text of which are
attached hereto as Exhibits 99.1 and 99.2, for a description of the events
reported pursuant to this Form 8-K.
Page 2 of 8
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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: March 18, 1998 By:
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Gregory Sessler
Chief Financial Officer
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EXHIBIT INDEX
SEQUENTIAL
EXHIBIT NO. DESCRIPTION PAGE NO.
- ----------- ----------- ----------
99.1 Press Release dated February 26, 1998. 5
99.2 Press Release dated March 16, 1998. 7
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EXHIBIT 99.1
NEWS RELEASE
SONUS ANNOUNCES THE FDA HAS REQUESTED ADDITIONAL INFORMATION
REGARDING THE ECHOGEN(R) NDA REVIEW
COMPANY EXPECTS RESPONSE TO LEAD TO APPROVABILITY BY THE FDA
BOTHELL, WASH., February 26, 1998 -- SONUS Pharmaceuticals, Inc. (Nasdaq-NNM:
SNUS), today announced that the Company has received notice from the U.S. Food
and Drug Administration (FDA) that approval of the EchoGen(R) New Drug
Application (NDA) requires additional information. The Company expects to be
able to provide completely all of the requested information. EchoGen(R) is the
Company's proprietary fluorocarbon-based ultrasound contrast agent being
investigated to improve ultrasound images for cardiology and radiology.
SONUS received official notice that the FDA has completed its review of the
EchoGen(R) NDA and has asked the Company to provide additional information
relating to the manufacturing processes, including chemistry and analytical
methods validation, and to provide a re-analysis of some of the animal and
clinical data. None of the FDA's questions or requests for data are related to
the clinical safety of the product as reflected in the clinical trials with
EchoGen(R). The Company will be providing these data to the FDA to allow
completion of the review by the FDA. Once the issues are addressed to the FDA's
satisfaction, SONUS anticipates that the FDA's final determination will be
positive.
"Based on substantial additional clinical and pre-clinical work completed since
the NDA was filed, we believe we can complete assembly of the information that
the FDA has requested within a few weeks, although this period could be extended
due to circumstances we cannot directly control," said Steven C. Quay, M.D.,
Ph.D., president and CEO of SONUS. "Some of the data requires re-analysis, which
is underway at this time, and all of our efforts are focused on quickly
responding to all remaining issues."
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) and fluorocarbon technology. The Company's
products are being investigated to improve the diagnosis and treatment of heart
disease, cancer and other debilitating conditions.
-More-
Page 5 of 8
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SONUS PHARMACEUTICALS, INC. - RECEIVES NOTICE FROM FDA
FEBRUARY 26, 1998
PAGE TWO
Contact: Investors Media
Gregory Sessler Kelly Ford
SONUS Pharmaceuticals, Inc. SONUS Pharmaceuticals, Inc.
(425) 487-9500 (425) 487-9500
Certain of the statements made in this news release are forward looking such as
those relating to the regulatory approval of EchoGen(R). As discussed in SONUS'
annual report on Form 10-K filed March 19, 1997, actual results could differ
materially from those projected in the forward-looking statements as a result of
the following factors, among others: EchoGen(R) will require regulatory
approval, which approval is subject to certain regulatory requirements and can
be lengthy and may include additional requests by the FDA; and market acceptance
of EchoGen(R) 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 the FDA will approve EchoGen(R).
NOTE: SONUS Pharmaceuticals' press releases are available via PR Newswires'
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://prnewswire.com. Additional information about SONUS can be
accessed at the SONUS Home Page, http://www.sonuspharma.com.
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EXHIBIT 99.2
NEWS RELEASE
SONUS ANNOUNCES EMEA COMMITTEE WILL REVIEW ECHOGEN(R)
EMULSION MEDICAL MARKETING APPLICATION
COMPANY ALSO ANNOUNCES MEETING WITH FDA TO DISCUSS RECENT REQUEST FOR
MORE INFORMATION REGARDING ECHOGEN(R) NEW DRUG APPLICATION
BOTHELL, WASH., March 16, 1998 --SONUS Pharmaceuticals, Inc. (Nasdaq-NNM: SNUS),
today announced that it has been notified that the Committee for Proprietary
Medicinal Products (CPMP) is scheduled to review the EchoGen(R) Emulsion Medical
Marketing Application (MMA) at its March meeting later this month. The CPMP is
the review arm of the European Medicines Evaluation Agency (EMEA). The committee
makes recommendations to the EMEA which typically accepts and ratifies the
committee's opinions. EchoGen(R) is the Company's proprietary ultrasound
contrast agent being investigated for use in cardiology and radiology
applications.
"We are looking forward to this meeting of the CPMP," said Steven C. Quay, M.D.,
Ph.D, president and CEO of SONUS. "The opinion by the CPMP is the next step
toward a Marketing Authorization by the European Commission (EC) which covers
the 15 nations of the European Union, including the United Kingdom, Ireland,
France, Germany, Italy, Spain, Portugal, Sweden, Finland, Denmark, Belgium,
Luxembourg, the Netherlands, Greece and Austria."
The Company also announced that a meeting has been scheduled with the U.S. Food
and Drug Administration (FDA) on April 27, 1998. The purpose of this meeting is
to discuss the FDA's recent notification requiring additional information
regarding the New Drug Application (NDA) for EchoGen(R). While SONUS continues
to prepare the information to be submitted in response to the FDA's request, the
Company is unable to predict the timing of such a submission until this meeting
has taken place.
EchoGen(R) ultrasound contrast agent is a fluorocarbon-based liquid emulsion
that turns into a gas microbubble upon syringe activation and injection into the
body (a process known as PhaseShift(TM) technology). EchoGen(R) microbubbles
travel in the blood stream and enhance the reflected ultrasound signal of the
blood resulting in improved ultrasound images.
(-More-)
Page 7 of 8
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SONUS PHARMACEUTICALS, INC. - ANNOUNCES CPMP MEETING
MARCH 16, 1998
PAGE 2
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) and fluorocarbon technology. The Company's
products are being investigated to improve the diagnosis and treatment of heart
disease, cancer and other debilitating conditions.
Contact: Investors Media
Gregory Sessler Kelly Ford
SONUS Pharmaceuticals, Inc. SONUS Pharmaceuticals, Inc.
(425) 487-9500 (425) 487-9500
Certain of the statements made in this news release are forward looking such as
those relating to the regulatory approval of EchoGen(R). As discussed in SONUS'
annual report on Form 10-K filed March 19, 1997, actual results could differ
materially from those projected in the forward-looking statements as a result of
the following factors, among others: EchoGen(R) will require final regulatory
approval, which approval is subject to certain regulatory requirements and could
be lengthy; and market acceptance of EchoGen(R) 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 the
EC or FDA will approve EchoGen(R).
NOTE: SONUS Pharmaceuticals' press releases are available via PR Newswires'
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://prnewswire.com. Additional information about SONUS can be
accessed at the SONUS Home Page, http://www.sonuspharma.com.
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