Gen-Probe invests US$5 million in DiagnoCure
SAN DIEGO and QUEBEC CITY, April 29 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) and DiagnoCure Inc. (TSX: CUR) today announced that the companies have signed an amendment to their 2003 license agreement, establishing new FDA submission milestones and key distribution arrangements to leverage the full market potential of the PCA3-based test for prostate cancer in the United States, Europe and around the world.
As part of the amendment, Gen-Probe will acquire 4.9 million shares of newly issued DiagnoCure convertible preferred stock for US$5.0 million (C$6.1 million), representing a premium of 19.8% over the average market price of the common shares of DiagnoCure during the 20 trading days from yesterday, subject to DiagnoCure securing the required regulatory approvals from the Toronto Stock Exchange. These convertible preferred shares are non-voting, and may be exchanged for common shares on a one-for-one basis. DiagnoCure has the option to redeem the preferred shares or to require their conversion into common shares in certain circumstances. As part of its investment in DiagnoCure, Gen-Probe will receive a liquidation preference in certain cases and a security interest in some intellectual property. This subscription will take place on or around May 7th 2009 and will be completed pursuant to a statutory prospectus and registration exemptions.
The new milestones for an FDA submission of a PCA3 test can be fulfilled by Gen-Probe with its current end-point TMA assay or its investigational, real-time TMA assay. As part of the contract amendment, Gen-Probe will make annual payments of US$500,000 to DiagnoCure until specific milestones are met. Half the amounts paid will be applied against future royalties payable to DiagnoCure.
Also, in an effort to maximize the global reach for the PCA3 prostate cancer test, DiagnoCure and Gen-Probe have agreed on terms to develop key distributor relationships in countries where it is commercially more effective to do so, such as in Japan, Asia, Israel, South Africa and others.
In a separate press release today, Gen-Probe announced that it intends to initiate in the third quarter of 2009 a pivotal clinical study of its investigational PCA3 assay that could lead to regulatory approval by the U.S. Food and Drug Administration (FDA).
PCA3 is a molecular marker that studies indicate is more specific for prostate cancer than the commonly used diagnostic test, PSA (prostate specific antigen). PCA3 has been the subject of approximately 17 peer-reviewed publications over the past few years. A PCA3-based test, PROGENSA(R) PCA3, is now commercialized by Gen-Probe in Europe under the CE mark. In the United States, the test is not yet approved for commercialization by the FDA.
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has more than 25 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,200 people. For more information, go to www.gen-probe.com.
DiagnoCure (TSX: CUR) is a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services that increase clinician and patient confidence in making critical treatment decisions. DiagnoCure Oncology Laboratories, a subsidiary of DiagnoCure Inc., launched in 2008 the Previstage(TM) GCC Colorectal Cancer Staging Test, the first GCC-based molecular test for the management of colorectal cancer. A major study published in the February 18, 2009, edition of the JAMA ("Journal of the American Medical Association") demonstrated that GCC is the strongest independent predictor of colorectal cancer recurrence in patients considered low risk by current assessment methods. 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 marker. This test is also available through laboratories in the U.S. using PCA3 analyte specific reagents (ASR) manufactured by Gen-Probe, in Europe as the CE-marked PROGENSA(TM) PCA3 in vitro assay, and in Canada. In addition to its own research, the Company intends to acquire or in-license additional promising cancer biomarkers from both academic and commercial institutions. For more information, visit www.diagnocure.com.
Caution Regarding Forward-Looking Statements
Any statements in this press release about Gen-Probe's or DiagnoCure's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning new products, potential regulatory approvals and customer adoption are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by any forward-looking statement. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections contained in the forward-looking statements include but are not limited to: (i) the risk that new prostate cancer products, including those based on PCA3, will not be cleared for marketing in the timeframes we expect, if at all, (ii) the risk that development of these products will not be successful, (iii) the possibility that the market for the sale of these products may not develop as expected, (iv) we may not be able to compete effectively, (v) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, and (vi) we are dependent on third parties for the distribution of some of our products. The foregoing describes some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties the companies face and a discussion of financial statements and footnotes, for Gen-Probe, see documents filed with the SEC, including Gen-Probe's most recent annual report on Form 10-K and all subsequent periodic reports, and for DiagnoCure, see documents filed on SEDAR, including the general risks and uncertainties in the most recent Annual Information Form under the heading "Risk Factors." We assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.
Contacts: Gen-Probe Incorporated Michael Watts Vice President, Investor Relations and Corporate Communications (858) 410-8673 DiagnoCure Inc. J.F. Bureau, CFA Sr Vice President and CFO (418) 527-6100 firstname.lastname@example.org
|SOURCE Gen-Probe Incorporated|
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