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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) April 19, 1999
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., 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 6
Exhibit Index on Page 4
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ITEMS 1 THROUGH 4, 6, 8 AND 9 ARE NOT APPLICABLE.
ITEM 5 OTHER EVENTS.
Reference is made to the press release issued to the public by the
registrant on April 19, 1999, the text of which is attached hereto as Exhibit
99.1, for a description of the events reported pursuant to this Form 8-K.
ITEM 7 FINANCIAL STATEMENTS AND EXHIBITS
(a) Financial Statements
Not Applicable
(b) Pro Forma Financial Information
Not Applicable
(c) Exhibits
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EXHIBIT NO. DESCRIPTION
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99.1 Press Release dated April 19, 1999.
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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: April 22, 1999 By: /s/ Gregory Sessler
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Gregory Sessler
Chief Financial Officer
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EXHIBIT INDEX
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EXHIBIT NO. DESCRIPTION
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99.1 Press Release dated April 19, 1999.
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Exhibit 99.1
NEWS RELEASE
SONUS PHARMACEUTICALS RECEIVES "APPROVABLE LETTER"
FROM FDA FOR ECHOGEN
BOTHELL, WASHINGTON, APRIL 19, 1999 - SONUS Pharmaceuticals, Inc. (Nasdaq:SNUS)
announced today that it has received an "approvable letter" from the U.S. Food
and Drug Administration (FDA) for its first ultrasound contrast agent,
EchoGen(R)(perflenapent injectable emulsion). While certain conditions remain
to be satisfied before final approval, the FDA has indicated that EchoGen can be
approved once those conditions have been satisfied.
"We are pleased at receiving our first approvable letter from the FDA, and we
believe it marks an important milestone for the Company and reflects the
tremendous hard work of our employees and consultants," said Michael A. Martino,
President and COO of SONUS. "At the same time, our ultimate goal is final
approval of EchoGen, and we will continue to work closely with the FDA in our
efforts to achieve that goal as soon as practicable."
The pending application with the FDA is for the use of EchoGen in the
echocardiographic evaluation of left ventricular endocardial border delineation
and left ventricular chamber opacification. Echocardiography is a diagnostic
ultrasound test of the heart used to identify abnormal cardiac function and
structure. Contrast agents used in ultrasound imaging amplify ultrasound signals
returning from the blood, providing enhanced images. Better quality ultrasound
images give more diagnostic information helping physicians to make more
confident diagnoses.
Through agreements signed in 1996, Abbott Laboratories, one of the world's
leading health care companies, has rights to the marketing and distribution of
EchoGen in the U.S., Europe, Latin America, Canada, the Middle East, Africa and
certain Asia Pacific countries.
SONUS Pharmaceuticals, Inc., based in Bothell, Washington, is engaged in the
research and development of proprietary ultrasound contrast agents and drug
delivery systems. The Company's products are being developed for use in the
diagnosis and treatment of heart disease, cancer and other debilitating
conditions.
Contact: Gregory Sessler or Pamela Dull, (425) 487-9500
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The Company's news releases and other corporate information are available on
SONUS' web site at www.sonuspharma.com. News releases may be obtained via fax by
calling PR Newswire's Company News on Call at 800-758-5804, Ext. 108377 and are
also available on PR Newswire's web site at www.prnewswire.com.
Certain of the statements made in this news release are forward looking such as
those relating to the approval of EchoGen, and the benefits of ultrasound
contrast agents. As discussed in SONUS' annual report on Form 10-K filed March
25, 1999, actual results could differ materially from those projected in the
forward-looking statements as a result of the following factors, among others:
EchoGen will require final regulatory approval by the FDA, which approval may
never occur, or may be subject to certain regulatory requirements which can be
lengthy; market acceptance of the Company's products will depend upon a number
of factors, including safety, efficacy, ease of administration, the presence of
competitive imaging products or technologies and the availability of
reimbursement by third party payors. There can be no assurance that the Company
can meet the conditions set forth by the FDA in its "approvable letter" or any
subsequent conditions in a timely manner, if at all, or that EchoGen will
ultimately receive regulatory approval.
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