- Companies Will Work Together to Protect World's Supply of Donated Blood
from Infectious Diseases Until 2025
- Partners Anticipate Continued Expansion into New Global Markets and
Development of Innovative New Products, Including Next-Generation PANTHER
Instrument
- Companies Also Plan Exploratory Collaboration in Pharmacogenomics
- Gen-Probe Provides Preliminary 2009 Financial Guidance Including
Additional Revenue and Profit from Agreement
SAN DIEGO, Jan. 27 /PRNewswire-FirstCall/ -- Gen-Probe (Nasdaq: GPRO)
announced today that it has agreed to extend and expand its blood screening
collaboration with Chiron, a Novartis (NYSE: NVS) business, ensuring the
companies will work together to develop and commercialize molecular
technologies that safeguard the world's donated blood supply until the year
2025.
"Extending and expanding our agreement with Novartis enables us to
continue providing innovative nucleic acid tests that protect the world's
blood supply from dangerous pathogens, while benefiting from our partner's
extensive global commercial presence," said Hank Nordhoff, Gen-Probe's
chairman and chief executive officer. "At the same time, it enables us to
deliver significant additional economic value to our shareholders while
minimizing financial and operational risk and potential disruption to an
outstanding business."
Since 1998, Gen-Probe and Novartis have developed, manufactured and
commercialized nucleic acid tests and instrumentation that have been used by
blood banks to screen more than 125 million blood donations in the United
States alone. These tests have intercepted thousands of units of blood that
were infected with HIV-1, hepatitis C and B, and West Nile virus, thereby
preventing life-threatening diseases from being passed along to transfusion
recipients.
"Together these two companies have discovered and developed innovative
solutions for the screening and prevention of infectious diseases to help
protect the nation's blood supply," said William F. Moore, senior vice
president, biomedical services operations, American Red Cross. "We are pleased
to see this successful collaboration continue to focus on innovations and
reinvestment in technology that will help keep the blood supply as safe as
possible."
Unlike standard serological testing, nucleic acid testing (NAT) detects
viral RNA and DNA during earlier stages of infection, shortening the window
period from infection to detection. Scientific models estimate that NAT
reduces the infectious window period of HIV-1, HCV and HBV from 35% to 91%,
compared with standard serological methods.
About the Revised Agreement
The collaboration between Gen-Probe and Novartis was established in 1998,
and was scheduled to expire in 2013. Under the original terms of the
agreement, the companies shared revenue from the sale of blood screening
assays. Gen-Probe was responsible for manufacturing costs, while Novartis was
responsible for commercial expenses. The companies shared research and
development (R&D) costs.
Under the revised agreement, Gen-Probe will continue to be primarily
responsible for R&D and manufacturing. Novartis will remain responsible for
sales and marketing of the products, but will collaborate more closely with
Gen-Probe on sales, marketing and distribution strategies. In addition to
sharing R&D costs, the companies will share manufacturing expenses. Gen-Probe
also will receive a percentage of end-user revenue that escalates gradually
from 2009 until 2015, and remains constant thereafter.
As part of the expanded agreement, Novartis has agreed to help fund
development of Gen-Probe's PANTHER instrument, a fully automated molecular
testing platform, for the blood screening market. The companies also have
agreed to evaluate, using Gen-Probe's technologies, the development of
companion diagnostics for current or future Novartis medicines.
Gen-Probe Preliminary 2009 Financial Guidance
Gen-Probe expects the new agreement to add to the Company's revenue and
profits in 2009 and future years. Accordingly, Gen-Probe's preliminary
expectation is that its total revenues in 2009 will range from $460 to $490
million, and that its earnings per share will range from $1.80 to $2.05.
These preliminary ranges incorporate foreign exchange rate fluctuations
approximately 10% higher or lower than recent levels, and do not yet include
potential revenue from the new PROCLEIX ULTRIO assay in the United States.
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 1,000 people. For more
information, go to http://www.gen-probe.com.
Caution Regarding Forward-Looking Statements
Any statements in this press release about Gen-Probe's expectations,
beliefs, plans, objectives, assumptions or future events or performance,
including those under the heading "Gen-Probe Preliminary 2009 Financial
Guidance," 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 the future financial effects of the new
agreement, new products, future sales or profits, 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
these risks, uncertainties and assumptions include but are not limited to: (i)
the risk that the revised collaboration will not be maintained, (ii) the risk
that new blood screening products will not be cleared for marketing in the
timeframes we expect, if at all, (iii) the possibility that new markets for
the sale of our blood screening products may not develop as expected, (iv) we
may not be able to compete effectively with other companies currently selling
blood screening products or which launch such products in the future, (v) we
depend on a small number of contract manufacturers and single source suppliers
of raw materials, (vi) changes in third-party reimbursement policies regarding
our products could adversely affect their sales, (vii) changes in government
regulation affecting our products could harm our sales and increase our
development costs, and (viii) litigation involving the assertion of third
party patent rights could be expensive and divert management's attention,
and/or result in damages or injunctive relief. 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 we face and a discussion of our financial statements
and footnotes, see documents we file with the SEC, including our most recent
annual reports on Form 10-K and all subsequent periodic reports. 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.
Contact:
Michael Watts
Sr. director, investor relations and
corporate communications
858-410-8673
SOURCE Gen-Probe Incorporated
01/27/2009
CONTACT: Michael Watts, Sr. director, investor relations and corporate
communications of Gen-Probe Incorporated, +1-858-410-8673
Web Site: http://www.gen-probe.com
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