QUEBEC CITY, May 1, 2012 /CNW Telbec/ - DiagnoCure, Inc. (TSX: CUR), a Quebec life sciences company that develops and commercializes high‐value cancer diagnostic tests, issued a statement today commenting on the proposed acquisition of its commercial partner Gen-Probe (Nasdaq: GPRO) by Hologic Inc. (Nasdaq: HOLX). The acquisition, announced yesterday, is being viewed favorably by DiagnoCure management who see an opportunity for the combined companies to put additional resources behind the marketing of the PROGENSA® PCA3 prostate cancer test.
"Our expectation is that the combined entity, with an expanded footprint within cancer diagnostics, will be in an even stronger position to bring PROGENSA PCA3 to physicians and patients" stated Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure. "Hologic has already demonstrated a commitment to commercializing high value tests and has an established marketing presence in this space. Importantly, we do not foresee any changes in the strategy to maximize the commercial potential of PROGENSA PCA3."
Under the terms of this transaction, announced on April 30, Gen-Probe will become a wholly-owned subsidiary of Hologic. Hologic intends to market Gen-Probe's products on a global basis, focusing on both developed and emerging markets around the world. The combined companies will have direct sales and marketing infrastructure in the U.S. and Europe as well as distribution capabilities in China and other emerging markets. The Gen-Probe brand is to be maintained and it is expected that the growth trajectory of Gen-Probe's products will be significantly enhanced. The transaction is expected to close in the second half of 2012 and is subject to the satisfaction of certain closing conditions, including approval of Gen-Probe's shareholders.
Gen-Probe received FDA approval for the PROGENSA PCA3 assay on February 15, 2012. The urine-based test is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on the current standard of care, before consideration of PROGENSA PCA3 assay results. A negative PROGENSA PCA3 assay result is associated with a decreased likelihood of a positive biopsy. A prostate biopsy is required to diagnose cancer.
DiagnoCure licensed the PROGENSA PCA3 technology to Gen-Probe on an exclusive worldwide basis in November 2003. As part of the licensing agreement, DiagnoCure receives 8% royalties on cumulative sales up to $62.5 million and 16% thereafter. Approximately half of the $62.5 million sales goal has been reached.
About Prostate Cancer and the PROGENSA PCA3 Assay
According to the American Cancer Society (ACS), prostate cancer is the second most common type of cancer found in American men (behind skin cancer), and the second-leading cause of cancer death in men (after lung cancer). One in six American men will get prostate cancer during his lifetime, and one in 36 will die from it. The ACS estimates that about 241,000 Americans were newly diagnosed with prostate cancer in 2011, and that approximately 34,000 men died from the disease.
PCA3 is a gene that is highly over-expressed in prostate cancers. Following a digital rectal examination, the PCA3 gene can be quantified in urine specimens together with the prostate-specific antigen (PSA) gene to generate a PCA3 score. Studies have shown that because the PCA3 gene is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional serum PSA testing in patients who have had one or more previous negative prostate biopsies.
Data from more than 80 peer-reviewed publications suggest that PCA3 gene testing, when used with other patient information, may help address some of the well-known challenges urologists face, such as identifying prostate cancers while reducing unnecessary repeat biopsies.
Gen-Probe's PROGENSA PCA3 assay is the first urine-based molecular diagnostic assay to aid in the decision for repeat biopsy. The test has received regulatory approval and is available for sale in the United States, Canada and the European Union.
DiagnoCure (TSX: CUR) is a life sciences company that develops and commercializes high-value cancer diagnostic tests that increase clinician and patient confidence in making critical treatment decisions. In 2008, the Company launched the PrevistageTM GCC Colorectal Cancer Staging Test through its U.S. CLIA laboratory, and granted the worldwide exclusive rights to this test to Signal Genetics in June 2011. The Company also has a strategic alliance with Gen-Probe (NASDAQ: GPRO) for the development and commercialization of a second-generation prostate cancer test using PCA3, DiagnoCure's proprietary molecular biomarker. The PROGENSA® PCA3 test is commercialized in Europe under CE mark and is now approved for commercialization in Canada and the United States. For more information, visit www.diagnocure.com.
This release contains forward‐looking statements that involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expected. By their very nature, forward‐looking statements are based on expectations and hypotheses and also involve risks and uncertainties, known and unknown, many of which are beyond DiagnoCure's control. As a result, investors are cautioned not to place undue reliance on these forward‐looking statements. The forward-looking statements regarding the outcome of research and development projects, clinical studies and future revenues are based on management expectations. In addition, the reader is referred to the applicable general risks and uncertainties described in DiagnoCure's most recent Annual Information Form under the heading "Risk Factors". DiagnoCure undertakes no obligation to publicly update or revise any forward‐looking statements contained herein unless required by the applicable securities laws and regulations.
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