Exhibit 99.1
CONTACT:
Pamela L. Dull, Sonus Pharmaceuticals, Inc., (425) 487-9500,
Ext. 255
SONUS PHARMACEUTICALS UPDATES CORPORATE PROGRESS AND REPORTS
SECOND QUARTER FINANCIAL RESULTS
Company continuing to advance TOCOSOL®
Paclitaxel toward Phase 3 testing
Quarterly conference call today at 1:30 P.M.
PDT/4:30 P.M. EDT
BOTHELL,
Washington, August 8, 2005—Sonus Pharmaceuticals, Inc. (NASDAQ:SNUS) today reported financial
results for the second quarter ended June 30, 2005 and updated its
progress on 2005 strategic objectives, including the clinical and regulatory
development of TOCOSOL® Paclitaxel, the Company’s lead oncology
candidate.
“We were very pleased to
have met one of our key objectives during the second quarter by reaching
agreement with the FDA on the Special Protocol Assessment (SPA) for the Phase 3
trial of TOCOSOL Paclitaxel,” said Michael A. Martino, President and CEO of
Sonus. “We are continuing to make
excellent progress with TOCOSOL Paclitaxel, and in particular to move the
product into Phase 3 testing this year.
Completing the SPA was one critical step in that process as well as a
key milestone for Sonus.”
Second
Quarter 2005 Highlights:
• Completed Special Protocol Assessment (SPA)
process with the U.S. Food and Drug Administration (FDA) for the pivotal Phase
3 trial of TOCOSOL Paclitaxel. The FDA
has agreed that the planned head-to-head comparison of TOCOSOL Paclitaxel and
Taxol® will be appropriate, if properly conducted and analyzed, for
Sonus to submit a 505(b)(2) New Drug Application based on a single pivotal
Phase 3 trial. The study population will
include women with metastatic breast cancer, and patients will be receiving
paclitaxel as first- or second-line treatment for their disease. Approximately 800 evaluable patients will be
enrolled in the study.
• Presented data from clinical pharmacology
trial of TOCOSOL Paclitaxel at the American Society of Clinical Oncology (ASCO)
annual meeting. Results from the study
showed that TOCOSOL Paclitaxel delivers almost twice the exposure to paclitaxel
that is delivered by
More...
Taxol. The Company believes that the ability to
provide higher exposure to paclitaxel may lead to better anti-tumor activity,
which will need to be validated in the Phase 3 study of TOCOSOL Paclitaxel.
• Submitted an abstract on Phase 2b study of
TOCOSOL Paclitaxel in metastatic breast cancer to the San Antonio Breast Cancer
Symposium that will be held in early December.
As of the end of July 2005, results reported by the investigators
indicate an objective anti-tumor response rate of 53% in the breast cancer
study population, including at least one complete response (no radiographic
evidence of remaining tumor).
Second
Quarter Financial Results
For the second quarter of
2005, the Company reported a net loss of $4.1 million, or $0.19 per share,
compared with a net loss of $3.8 million, or $0.19 per share, for the second
quarter of 2004. For the first six
months of 2005, Sonus reported a net loss of $8.9 million, or $0.41 per share,
compared with a net loss of $7.3 million, or $0.39 per share for the same
period of 2004. The higher net loss for
the year-to-date financial results primarily reflected an increased level of
spending as the Company continues to execute the clinical and regulatory plans
for TOCOSOL Paclitaxel. Cash and
marketable securities totaled $11.4 million at June 30, 2005.
Conference
Call Information
The second quarter
conference call will be web cast live on August 8, 2005 at 1:30 Pacific
Time/4:30 P.M. Eastern Time and can be accessed at
www.sonuspharma.com/events.html. An
archive of the call will be available through the same link. A telephone replay will be available from August 8,
4:30 P.M. Pacific Time/7:30 P.M. Eastern Time, for one week at (800)
642-1687 or (706) 645-9291 for international calls; Conference ID
7868773.
About
TOCOSOL Paclitaxel
TOCOSOL Paclitaxel is a
novel, proprietary formulation of the leading anti-cancer drug paclitaxel. TOCOSOL Paclitaxel has been designed to
overcome the limitations associated with Taxol and generic paclitaxel-based
chemotherapy, including long infusion times, undesirable or treatment-limiting
side effects as well as time consuming and expensive preparation of the
products prior to administration.
TOCOSOL Paclitaxel has generated encouraging data on safety and
anti-tumor activity in Phase 2 trials in breast, ovarian, non-small cell lung
and bladder cancers.
About
Sonus Pharmaceuticals, Inc.
Headquartered near Seattle,
Washington, Sonus Pharmaceuticals, Inc. is focused on the development of
therapeutic drugs that may offer improved administration, safety, tolerability
and effectiveness for the treatment of cancer and related conditions. For additional information on Sonus,
including news releases, please visit www.sonuspharma.com.
2
Safe
Harbor
Certain statements made in
this press release are forward-looking such as those, among others, relating to
the development, safety and efficacy of drug delivery products and potential applications
for these products or the anticipated date of the initiation of the Phase 3
clinical trial for TOCOSOL Paclitaxel.
As discussed in Sonus Pharmaceuticals’ filings with the Securities and
Exchange Commission, including its Annual Report on Form 10-K filed
on March 23, 2005 and Form 10-Qs for the first two quarters of
2005, actual results could differ materially from those projected in the
forward-looking statements as a result of the following factors, among
others: the company’s products will require
extensive clinical testing and approval by regulatory authorities; such
approvals are lengthy and expensive and may never occur; risks that the company
will not be able to initiate the Phase 3 clinical trial for TOCOSOL Paclitaxel;
risks that clinical studies with TOCOSOL Paclitaxel will not be successful;
risks that the FDA may not approve the company’s proposed New Drug Application;
risks of successful development of additional drug delivery products; and risks
that the company may not be successful in obtaining funding from third parties
or completing a financing necessary to support the costs and expenses of
clinical studies as well as research and development activities. The company undertakes no obligation to
update the forward-looking statements contained herein or to reflect events or
circumstances occurring after the date hereof.
###
3