San Diego, California and Vancouver, British Columbia, August 16, 2012 — Sophiris Bio Inc. (TSX: SHS) today announced the appointment of Randall E. Woods as Chief Executive Officer effective August 16, 2012. Mr. Woods brings almost 40 years of relevant industry experience to Sophiris, including past roles as CEO at Sequel Pharmaceuticals, NovaCardia Inc., and Corvas International. Mr. Woods takes the helm as Sophiris prepares to initiate a pivotal Phase 3 trial for its lead compound, PRX302, a highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate).
Mr. Woods’ appointment is the final step of an operational realignment that began in 2011, led by Executive Chairman and President Lars Ekman, M.D., Ph.D., to focus on the development of PRX302 for BPH. Since relocating to San Diego, Sophiris has recruited a management team that has achieved more than twenty drug approvals, including blockbuster pharmaceuticals.
“Randy’s blend of executive experience in biotech research and development, pharmaceutical sales and marketing, coupled with successful fundraising and value creation makes him an ideal fit for leading Sophiris into the next phase of growth, beginning with advancing PRX302 into pivotal trials later this year,” said Dr. Lars Ekman, Executive Chairman and President of Sophiris.
“Nearly every man over the age of 60 suffers from BPH, yet current treatments either lack sustained relief of symptoms or come with unwanted side effects,” added Mr. Woods. “Based on the clinical data available to date PRX302 has shown meaningful clinical improvements with an attractive safety profile and presents a very special opportunity for addressing a significant market need for men with BPH.”
Prior to joining Sophiris, Mr. Woods was President and CEO of Sequel Pharmaceuticals, a spin-out of NovaCardia developing a potential treatment for atrial fibrillation. Mr. Woods was previously the President and CEO of NovaCardia, a pharmaceutical company focused on cardiovascular diseases until its acquisition by Merck & Co for $350 million in 2007. Prior to NovaCardia, Mr. Woods was President and CEO of Corvas International, a publicly held biopharmaceutical company focused on cardiovascular disease and cancer until its acquisition by Dendreon in 2003. Before joining Corvas, he served as President of Boehringer Mannheim’s U.S. Pharmaceutical operations, and spent 20 years at Eli Lilly & Company in various sales and marketing positions. Mr. Woods is a past Chairman for the Advisory Board of UC San Diego’s Sulpizio Family Cardiovascular Center and is a past Chairman of the Board of Directors for BIOCOM, a life science industry association in Southern California. Mr. Woods serves on the Board of Arena Pharmaceuticals and is Chairman of the Board for Sorbent Therapeutics. He received his B.S. in Biology and Chemistry from Ball State University and an MBA in Marketing from Western Michigan University.
BPH is a $5 billion market with more than 4 million patients treated each year in the U.S. alone. Despite available medical treatments and surgical options, no single solution provides quick, long-term relief of symptoms without serious unwanted side effects. Pharmaceutical product sales in the U.S. for BPH are $4 billion annually, however they lack sustainable efficacy and are associated with undesirable side effects including sexual dysfunction. More aggressive treatment options include invasive surgical procedures that may be successful at treating BPH but can also result in nerve damage and sexual dysfunction.
PRX302 is designed to be a single treatment for the long-term relief of BPH symptoms, such as restricted urinary flow from enlarged prostate, without causing sexual dysfunction or sacrificing quality of life.
PRX302 is highly targeted to prostate tissue. It is delivered directly to the prostate tissue via localized injection and it is activated selectively by active Prostate Specific Antigen (PSA) found only in prostate tissue. PRX302 has shown meaningful improvements in the International Prostate Symptom Score (IPSS) and urinary flow (Qmax) at 3 and 6 months in a randomized controlled Phase IIb trial (TRIUMPH study). IPSS has been a primary endpoint and Qmax has been a secondary or co-primary endpoint for prior BPH drug approvals. To date 126 patients with BPH have been treated with PRX302, and no drug related sexual adverse events have been reported in the studies completed.
Sophiris Bio Inc. is a urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), an unsatisfied market with blockbuster potential. PRX302, the company’s lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris is planning to begin a pivotal trial by the end of 2012. Sophiris is advised by world-leading urologists, backed by experienced investors, and led by a team that has achieved more than twenty drug approvals including several blockbusters. For more information, please visit www.sophirisbio.com.
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Sophiris’ current beliefs as well as assumptions made by and information currently available to Sophiris and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Sophiris in its public securities filings; actual events may differ materially from current expectations. Sophiris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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