Tuesday March 14, 8:02 am Eastern Time
Company Press Release
SOURCE: SONUS Pharmaceuticals, Inc.
SONUS Pharmaceuticals Receives FDA
Action Letter
BOTHELL, Wash., March 14 /PRNewswire/ -- SONUS Pharmaceuticals, Inc. (Nasdaq: SNUS - news)
announced today receipt of an action letter from the U.S. Food and Drug Administration (FDA) that extended
the approvable status of EchoGen© (perflenapent injectable emulsion), the Company's first ultrasound contrast
agent. SONUS had received an approvable letter for EchoGen in April 1999 indicating that the product could
be approved once certain conditions are satisfied, and the Company submitted a response to the approvable
letter in September 1999. In the new action letter received by SONUS, the FDA is requesting a reanalysis of
certain data that may affect product labeling.
``We are surprised by the FDA's request because we felt that we had addressed all of the FDA's concerns in
our September 1999 submission and in subsequent conversations with agency reviewers. Our next step is to
meet with the FDA to clarify the requests of the action letter and to discuss how we can best respond and the
timeframe for our response. Our objective remains to move as quickly as possible to secure final approval of
EchoGen,' said Michael A. Martino, SONUS President and CEO.
The Company's application to 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. EchoGen has
been administered to more than 2,200 patients and volunteers in worldwide clinical studies, including some
studies of severely ill patients with congestive heart failure and chronic obstructive pulmonary disease. The side
effects of EchoGen observed in clinical trials were mostly mild and transient and most occurred within 30
minutes of administration. The most frequent adverse reactions associated with the use of EchoGen are
vasodilation/flushing (3.1%), headache (1.8%), and taste perversion (1.3%).
The European Commission issued marketing authorization for EchoGen in the 15 countries of the European
Union in 1998 for use in patients with suspected or established cardiovascular disease. In Europe, EchoGen is
approved for use in patients who have had previous inconclusive non-contrast studies to provide opacification
of cardiac chambers and enhance left ventricular border delineation with resulting improvement in wall motion
visualization. In 1999, SONUS received approval of manufacturing variations to the European marketing
license which are required to launch EchoGen in Europe.
EchoGen is a fluorocarbon-based liquid emulsion that is changed into gas microbubbles upon syringe activation
prior to injection into the bloodstream of a patient. EchoGen is highly reflective of ultrasound signals which
enables clinicians to more clearly identify the border between the blood and the surrounding tissue being
imaged. Better ultrasound images can give physicians more diagnostic information, potentially helping them
make more accurate and confident diagnoses.
SONUS Pharmaceuticals, Inc., located in Bothell, Washington, is engaged in the research and development of
proprietary ultrasound contrast agents and drug delivery systems for use in the diagnosis and treatment of heart
disease, cancer and other debilitating conditions.
The Company's news releases and other corporate information are available on SONUS' web site at
www.sonuspharma.com. News releases may also be obtained via fax by calling 800-758-5804, Ext. 108377.
Certain of the statements made in this news release are forward-looking such as those, among others, relating
to the regulatory review process for EchoGen and benefits of ultrasound contrast agents. As discussed in the
Company's annual report on Form 10-K filed February 29, 2000, actual results could differ materially from
those projected in the forward-looking statements as a result of the following factors, among others: there can
be no assurance that SONUS can meet the requirements of the FDA action letter, or any subsequent
conditions, in a timely manner if at all, or that EchoGen will ultimately receive regulatory approval; 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.
SOURCE: SONUS Pharmaceuticals, Inc.
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