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UNITED STATES
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SECURITIES
AND EXCHANGE COMMISSION
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Washington,
D.C. 20549
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SCHEDULE 14A
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Proxy Statement
Pursuant to Section 14(a) of
the Securities Exchange Act of 1934 (Amendment No. )
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Filed by the Registrant x
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Filed by a Party other than the Registrant o
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Check the appropriate box:
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Preliminary Proxy Statement
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Confidential, for Use of the Commission Only (as
permitted by Rule 14a-6(e)(2))
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Definitive Proxy Statement
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Definitive Additional Materials
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Soliciting Material Pursuant to §240.14a-12
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Sonus
Pharmaceuticals, Inc.
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(Name of Registrant
as Specified In Its Charter)
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(Name of Person(s)
Filing Proxy Statement, if other than the Registrant)
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Payment of Filing Fee (Check the appropriate box):
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x
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No fee required.
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Fee computed on table below per Exchange Act Rules 14a-6(i)(1)
and 0-11.
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(1)
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Title of each class of securities to which transaction applies:
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(2)
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Aggregate number of securities to which transaction applies:
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(3)
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Per unit price or other underlying value of transaction computed
pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing
fee is calculated and state how it was determined):
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(4)
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Proposed maximum aggregate value of transaction:
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(5)
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Total fee paid:
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Fee paid previously with preliminary materials.
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Check box if any part of the fee is offset as provided by
Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting
fee was paid previously. Identify the previous filing by registration
statement number, or the Form or Schedule and the date of its filing.
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(1)
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Amount Previously Paid:
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Form, Schedule or Registration Statement No.:
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Filing Party:
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Date Filed:
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ONCOGENEX RECEIVES COMPLETED SPECIAL PROTOCOL ASSESSMENT FOR
PRIMARY REGISTRATION STUDY OF LEAD DRUG CANDIDATE OGX-011
VANCOUVER, British Columbia, Canada –
July 14, 2008 – OncoGenex Technologies Inc. announced
today that the company has reached an agreement with the U.S. Food and Drug
Administration (FDA) on the design of a Phase 3 registration trial of OGX-011,
its lead product candidate targeting hormone refractory prostate cancer, via
the Special Protocol Assessment (SPA) process. In the letter responding to the OncoGenex submission, the FDA stated
that they agreed with the design and planned analysis proposed by OncoGenex,
and that the study design adequately addresses the objectives necessary to
support a regulatory submission.
The Phase 3 trial has
been designed in collaboration with internationally recognized experts in the
treatment of patients with hormone-refractory prostate cancer (HRPC) including Dr. Celestia
Higano at the University of Washington and Dr. Kim Chi at the University
of British Columbia. This will be a
randomized, controlled, international study in 765 men with metastatic HRPC who
responded to first-line docetaxel therapy, but subsequently progressed and are
in need of second-line chemotherapy. Patients will be randomized to receive
treatment with either OGX-011 and docetaxel/prednisone or docetaxel/prednisone
alone. The primary endpoint of the study will be overall survival. It is
expected that approximately 80 sites in the United States and Canada will
participate in this study.
“Patients who have progressed after receiving
docetaxel as first-line chemotherapy have few options,” said Cindy Jacobs,
M.D., Ph.D., OncoGenex’ Executive Vice-President and Chief Medical Officer. “A
recent survey of 130 oncologists practicing in Canada and the United States
indicates that their primary option for patients who responded to first-line
docetaxel is retreatment with docetaxel. This is not surprising since the only
product shown to increase survival in patients with HRPC is docetaxel.”
Dr. Jacobs added, “Preliminary
data from Phase 2 studies of OGX-011 in combination with docetaxel retreatment
have indicated that OGX-011 may help restore tumor sensitivity to docetaxel and
may improve overall survival for second-line therapy.”
The planned initiation of
this Phase 3 trial is supported by encouraging preliminary Phase 2 data that
were presented at the 2008 annual meeting of the American Society of Clinical
Oncology (ASCO). These preliminary data are derived from a Phase 2 study
evaluating 42 patients with HRPC who had received first-line docetaxel therapy
and required second-line chemotherapy: 22 patients were treated with
mitoxantrone plus OGX-011 and 20 patients with docetaxel retreatment plus
OGX-011. While follow up on surviving patients is still ongoing, the following
preliminary findings were reported:
· Survival continued to be better than
expected based on previously published reports: With a median follow-up of 17.2
months following the start of second-line chemotherapy, median survival has
been estimated at 11.4 months in the mitoxantrone plus OGX-011 group and 14.7
months in the docetaxel retreatment plus OGX-011 group. These data compare
favorably with published results reporting median survivals at approximately 10
months for HRPC patients receiving second-line chemotherapy without OGX-011.
· In addition, average serum clusterin
levels during treatment were predictive of survival, with low-average levels
predicting median survival time of 14.7 months compared to high-average levels
predicting median survival time of 5.5 months. These data suggest that a
reduction in clusterin levels may improve survival.
About
OGX-011
OGX-011 is designed to block production of clusterin,
a cell survival protein that is over-produced in several cancer indications and
in response to many cancer treatments. Increased clusterin production is
observed in many human cancers, including prostate, non-small cell lung,
breast, ovarian, bladder, renal, pancreatic, anaplastic large cell lymphoma and
colon cancers and melanoma. Increased clusterin
production is linked to faster rates of cancer
progression, treatment resistance and shorter survival duration. Clusterin
levels may be further increased in response to standard cancer therapies,
including hormone ablation therapy, chemotherapy and radiation therapy. Clusterin
expression is linked to disease progression, treatment resistance, poor
prognosis and survival in scientific publications. For example, increased
expression of clusterin in prostate cancer is closely correlated with
increasing Gleason score, which is a strong prognostic factor for poor survival
of patients with prostate cancer.
About the Special Protocol
Assessment and Agreement Process
Under
a Special Protocol Assessment (SPA),
a company and the FDA can reach an agreement on the design and size of a clinical
trial to support a regulatory submission. This agreement can be in writing and
cannot be changed after the clinical trial begins except: (i) with written
agreement of the company and the FDA; or (ii) if the director of the FDA
reviewing division determines that “a substantial scientific issue essential to
determining the safety or effectiveness of the drug” was identified after
testing began.
About OncoGenex
OncoGenex is a private biopharmaceutical company
committed to the development and commercialization of new cancer therapies that
address treatment resistance in cancer patients. The company’s three product
candidates are designed to inhibit the production of specific proteins
associated with treatment resistance and which are over-produced in response to
a variety of cancer treatments. OGX-011 is completing evaluation in five Phase
2 clinical studies in prostate, lung, and breast cancers. OGX-427 has begun
evaluation in Phase 1 clinical studies, while the third product candidate,
OGX-225, has completed preclinical pharmacology studies. More information is
available at www.oncogenex.ca.
Definitive Agreement to Merge
On May 28, 2008, Sonus Pharmaceuticals, Inc.
(NASDAQ: SNUS) and OncoGenex Technologies Inc., jointly announced the signing
of a definitive agreement to merge the two companies. The combined company will
operate as OncoGenex Pharmaceuticals, Inc. The proposed transaction
received unanimous approval from the Boards of Directors of Sonus and
OncoGenex, and is expected to be completed in the third quarter of 2008,
subject to the satisfaction of certain conditions, including the approval of
Sonus’ and OncoGenex’ shareholders and, in the case of OncoGenex, court
approval under the arrangement provisions of the Canada Business Corporations
Act. OncoGenex management believes that
the completion of this SPA for OGX-011 will
result in the release of 25% of the escrowed shares that will be issued
to OncoGenex shareholders at the completion of the merger pursuant to the
Escrow Agreement described in the Proxy Statement and related materials filed
by Sonus with the SEC. A final
determination of the satisfaction of the release conditions under the Escrow
Agreement must be made by the Board of Directors of Sonus immediately following
the merger.
Safe Harbor
This press release contains forward-looking
statements, including statements concerning clinical trial results and the
proposed merger between Sonus and OncoGenex. These statements are based on
management’s current expectations and beliefs and are subject to a number of
risks, uncertainties and assumptions that could cause actual results to differ
materially from those described in the forward-looking statements. All
statements other than statements of historical fact are statements that could be
deemed forward-looking statements. For example, statements of the results of
clinical studies, the timing of clinical trials and development efforts and the
timing of closing the proposed merger are all forward-looking statements. The
potential risks and uncertainties include, among others, that clinical results
will not be maintained in final data analysis, that current or future clinical
trials will not be successful or confirm the results of earlier studies, risks
related to the timing and costs of clinical trials and regulatory approvals,
risks associated with obtaining funding from third parties or completing a
financing necessary to support the costs and expenses of clinical studies,
risks relating to the development, safety and efficacy of therapeutic drugs and
potential applications for these products and the possibility that the merger
with Sonus does not close or that the closing may be delayed. No assurances can
be given that any of the events anticipated by the forward-looking statements
will transpire or occur, or if any of them do so, what impact they will have on
the results of operations or financial condition of OncoGenex. The Company
undertakes no obligation to update the forward-looking statements contained
herein or to reflect events or circumstances occurring after the date hereof.
Proxy Solicitation
In connection with the proposed merger, Sonus filed
with the SEC a Proxy Statement and related materials on July 3, 2008
containing information about Sonus, OncoGenex and the proposed merger. Sonus
mailed the Proxy Statement to its stockholders on or about July 9,
2008. INVESTORS AND SECURITY HOLDERS ARE
URGED TO READ THE PROXY STATEMENT AND THE OTHER RELEVANT MATERIALS, CAREFULLY
AND IN THEIR ENTIRETY, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT SONUS,
ONCOGENEX AND THE PROPOSED MERGER.
Sonus and OncoGenex, and certain of their directors,
executive officers and other members of management and employees may be deemed
to be participants in the solicitation of proxies in connection with the
proposed transaction. Information about the directors and executive officers of
Sonus, including their respective security holdings, is set forth in Sonus’
Amendment No. 1 to Form 10-K for the fiscal year ended December 31,
2007, filed with the Securities and Exchange Commission on April 29, 2008,
and the Proxy Statement filed with the SEC on July 3, 2008. As of June 30,
2008, OncoGenex’ directors and executive officers beneficially owned
approximately 1,755,000 shares, or 14.5%, of OncoGenex’ capital stock.
Investors may obtain additional information regarding the interests of
OncoGenex, Sonus and their respective executive officers and directors in the
merger by reading the Proxy Statement for such proposed transaction.
The Proxy Statement and
other relevant materials, and any other documents filed by Sonus with the SEC,
may be obtained free of charge at the SEC’s web site at www.sec.gov. In
addition, investors and security holders may obtain free copies of the
documents filed with the SEC by Sonus by
directing a request to: Sonus Pharmaceuticals, Inc., 1522 217th
Place SE, Suite 100, Bothell, WA 98021, Phone (425) 686-1500, Fax (425)
686-1600, Attention: Investor Relations.
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OncoGenex Media and Investor Contact:
Jason I. Spark
Porter Novelli Life Sciences
619-849-6005
jspark@pnlifesciences.com