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Gen-Probe has formed collaborations and strategic alliances with a number
of companies to gain access to new technologies, products and markets.
Several of these collaborations/alliances are listed below.
Chiron Corp.: In June 1998, we entered into a strategic
alliance with Chiron to develop and market NAT-based products for
the blood screening and clinical diagnostic markets. The Gen-Probe/
Chiron alliance initially developed and is manufacturing and marketing
the combination HIV-1/ HCV assay for qualitative screening of blood
and blood products under the PROCLEIX name. As well as additional
blood screening assays, such as the PROCLEIX ULTRIO assay and the
WNV assay.
DiagnoCure: In November 2003, Gen-Probe signed a
license and collaboration agreement with DiagnoCure under which the
companies are developing, and Gen-Probe will market, an innovative
urine test to detect a new, highly specific genetic marker for prostate
cancer. The diagnostic test will detect a recently described gene
called PCA3 that has been shown by studies to date to be over-expressed
only in malignant prostate tissue. The test may offer advantages over
prostate specific antigen (PSA) testing, the current standard for
initial prostate cancer screening in conjunction with a digital rectal
exam. Gen-Probe owns exclusive worldwide marketing rights to diagnostic
products resulting from the agreement.
Roche: In February 2005, Gen-Probe signed a supply
and purchase agreement with F. Hoffmann-La Roche Ltd. and its affiliate
Roche Molecular Systems, Inc. under which Gen-Probe will purchase
products for use in molecular diagnostic assays for human papillomavirus
(HPV). Under the agreement, Roche will manufacture DNA probes for
HPV, which Gen-Probe will purchase at agreed-upon transfer prices.
Gen-Probe also has agreed to pay initial manufacturing fees in two
installments. Gen-Probe plans to use HPV probes supplied by Roche
in APTIMA® format HPV test kits to detect high-risk subtypes of
HPV.
Millipore Corporation: In August 2005, Gen-Probe
and Millipore formed an alliance to develop, manufacture and commercialize
on an exclusive basis nucleic acid testing (NAT) products for rapid
microbiological and virus monitoring in the biotech and pharmaceutical
industries. Microbiological monitoring of manufacturing processes
is critical to ensuring patient safety and meeting regulatory requirements.
The companies believe the combination of Gen-Probe's proprietary nucleic
acid amplification and detection technologies with Millipore's technologies
and expertise in microbial process monitoring applications will allow
the creation of the next generation of process monitoring tools for
the biotech and pharmaceutical industries.
Molecular Profiling Institute Inc.: In October 2005,
Gen-Probe formed a non-exclusive collaboration with the Molecular
Profiling Institute Inc. (Molecular Profiling), a private, specialty
reference laboratory, to accelerate market development for Gen-Probe's
pipeline of novel cancer diagnostics. Molecular Profiling is the for-profit
reference laboratory of the Translational Genomics Research Institute
(TGen), a non-profit biomedical research institute whose mission is
to make and translate genomic discoveries into advances in human health.
Under the terms of the agreements, Molecular Profiling has agreed
to validate, commercialize and undertake market development activities
for up to four Gen-Probe products, starting with the Company's investigational
PCA3 assay, which is intended as an aid in the diagnosis of prostate
cancer. As part of the collaboration, Gen-Probe has acquired a minority
interest in Molecular Profiling.
Corixa: In January 2005, Gen-Probe signed an agreement
with Corixa to license rights to develop molecular diagnostic tests
for approximately 50 potential genetic markers in the areas of prostate,
ovarian, cervical, kidney, lung and colon cancer. The agreement is
a significant step forward in our long-term strategy to become a leader
in cancer diagnostics. Gen-Probe gains access to certain Corixa intellectual
property covering multiple genetic sequences related to these potential
markers, which include AMACR for prostate and colon cancers, CA125
for ovarian cancer, and L523S for cervical and lung cancers.
Qualigen: In November 2004, Gen-Probe acquired from
Qualigen® an exclusive option to develop a point-of-use nucleic acid
testing (NAT) instrument based on Qualigen's FDA-approved FastPack
immunoassay system. If development is successful, the portable instrument
would use Gen-Probe's NAT technologies to rapidly detect, at
the point of sample collection, the presence of harmful microorganisms
and genetic mutations. The platform could be used in physicians'
offices, outpatient clinics, blood screening centers and various industrial
settings. Gen-Probe is now evaluating the feasibility of adapting
Qualigen's immunoassay platform to perform NAT using Gen-Probe's
proprietary technologies.
AdnaGen: In January 2005, Gen-Probe signed an agreement
with AdnaGen, a private company based in Germany, to license AdnaGen's
innovative “immunocapture” technology. The technology
may help increase the accuracy of molecular diagnostic tests to detect
prostate and other cancers, help determine the aggressiveness of these
malignancies, and monitor responses to therapy. Under the terms of
the agreement, Gen-Probe gains exclusive access to AdnaGen technology
for molecular diagnostic tests for prostate and bladder cancers. Gen-Probe
also retains options to obtain exclusive licenses to use AdnaGen's
technology in molecular diagnostic tests for certain other cancers.
Tosoh Corporation: In December 2003, we entered
into agreements with Tosoh Corporation to cross-license intellectual
property covering certain NAT technologies. The licenses cover products
in clinical diagnostics and other related fields.
Distribution
bioMérieux: In September 2004, Gen-Probe
entered into non-exclusive licensing agreements with bioMérieux
and its affiliates that provide bioMérieux and its affiliates
options to access our ribosomal RNA technologies for certain uses
to develop diagnostic products for certain disease targets using our
patented ribosomal RNA technologies.
Rebio Gen Inc.: In July 2001, we entered into a
license agreement with Chugai Diagnostics Science Co., Ltd., acquired
by Fujirebio, which re-named the company Rebio Gen, Inc. The agreement
offers a non-exclusive license for Japan in the field of human clinical
diagnostics to various of our proprietary technologies, including
TMA and HPA technology.
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