Gen-Probe and DiagnoCure Amend Collaboration Agreement Surrounding PCA3-Based Prostate Cancer Tests
April 29 2009 - 4:07PM
PR Newswire (US)
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). About PCA3 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. About Gen-Probe
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 http://www.gen-probe.com/. About
DiagnoCure 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
http://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 DATASOURCE: Gen-Probe Incorporated CONTACT: Michael Watts,
Vice President, Investor Relations and Corporate Communications of
Gen-Probe Incorporated, +1-858-410-8673; or J.F. Bureau, CFA, Sr
Vice President and CFO of DiagnoCure Inc., +1-418-527-6100, Web
Site: http://www.gen-probe.com/ http://www.diagnocure.com/
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