Monogram establishes European organization for commercialization of Trofile
and partners with Lab21, Ltd. in the U.K.
SOUTH SAN FRANCISCO, Calif., Oct. 1 /PRNewswire-FirstCall/ -- Monogram
Biosciences, Inc. (Nasdaq: MGRM) today announced the establishment of its
European organization to facilitate access to Trofile, its proprietary
tropism test, following the announcement that Pfizer Inc. (NYSE: PFE) has
received European Commission approval of the novel HIV therapy,
Celsentri(R) (maraviroc) tablets (known as Selzentry(TM) in the U.S.).
Trofile was the assay used for patient selection for maraviroc's clinical
development program and the two companies are engaged in a collaboration
agreement to make Monogram's assay available for patient use globally.
Maraviroc has been approved in the European Union for combination
antiretroviral therapy for treatment-experienced adults who are infected
with only CCR5-tropic HIV-1 detectable. Trofile is the only clinically
validated diagnostic that can be used to determine viral tropism. Through
the global collaboration, Pfizer will take the lead in commercializing
Trofile outside of the U.S. Monogram will provide support for Pfizer's
sales, marketing and educational activities.
Monogram also has taken several important steps towards establishing
its European operations including the appointment of Corinne Danan as
European Director. Ms. Danan will lead Monogram's efforts to introduce the
Trofile assay in Europe and will work closely with Pfizer's European
commercial team. Corinne Danan comes to Monogram with over 15 years at Eli
Lilly in Europe and the United States in regional and global roles, serving
as country manager in Israel and Poland as well as in a number of other
marketing positions. Ms. Danan will be based in Paris.
Monogram has been working with Pfizer to develop the appropriate
logistical arrangements for making Trofile available in those countries
targeted for commercial introduction of maraviroc. All samples will be
processed by Monogram in its laboratory in South San Francisco and Monogram
is establishing, with funding from Pfizer, the laboratory and courier
partnerships that are necessary to ensure that samples can be appropriately
managed and delivered to South San Francisco for processing. Monogram
announced that the first such partnership has been established with Lab21
Ltd., of Cambridge, U.K. Lab21 has considerable experience in HIV testing,
as well as strong operations and logistics capabilities, and will provide
access to Trofile in the U.K. and Ireland. Contracts are being finalized
with other labs and logistics groups for the provision of such services in
other European and international markets, coinciding with Pfizer's local
launches of maraviroc and Trofile.
About Trofile
Trofile is a patient selection co-receptor tropism assay that
determines whether a patient is infected with a strain of HIV that uses
either the CCR5 coreceptor, the CXCR4 coreceptor, or a combination of CCR5
and CXCR4 to enter cells. The use of CCR5, CXCR4 or both coreceptors
defines the "tropism" of the virus strain. Trofile amplifies the envelope
gene from a patient's HIV genome (from their blood sample) and then uses it
to make HIV particles containing the patient's virus envelope protein. The
resultant HIV particles are then used to infect cells that contain the CCR5
co-receptor or the CXCR4 co- receptor on the cell surface. Once the virus
infects the cell and it undergoes a single round of replication. Virus
replication results in the production of luciferase from a luciferase gene
that is carried into the cell by the virus The production of luciferase in
either CCR5 cells, CXCR4 cells or both cell types defines the co-receptor
tropism of the patient virus.
About Monogram Biosciences, Inc.
Monogram is advancing individualized medicine by discovering,
developing and marketing innovative products to guide and improve treatment
of serious infectious diseases and cancer. Monogram's products are designed
to help doctors optimize treatment regimens for their patients that lead to
better outcomes and reduced costs. Monogram's technology is also being used
by numerous biopharmaceutical companies to develop new and improved
antiviral therapeutics and vaccines as well as targeted cancer
therapeutics. More information about the company and its technology can be
found on its web site at http://www.MonogramBio.com.
About Lab21 Ltd.
Lab21 is a leading provider of cutting edge diagnostics, supporting
drug discovery, healthcare and environmental monitoring. Its customers
include healthcare providers, pharmaceutical and biotechnology companies.
In addition, the Company supports organizations that need to monitor their
impact on the environment. Lab21 has a rapidly growing portfolio of
diagnostics to support early stage drug development, clinical trials and
regulatory processes in the pharmaceutical industry. A key function is the
support of clinicians and healthcare providers as they treat and monitor
patients. The company's products include diagnostic tests for cancer, liver
disease, respiratory illnesses and infectious diseases such as syphilis
through its subsidiary Newmarket Laboratories. Its pharmaceutical support
services include lead identification and optimization of targets, drug
resistance profiling, mode of action studies, and drug combination studies
as well as clinical trial support. More information about the company and
its technology can be found on its web site at http://www.lab-21.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. These
forward-looking statements include references to the potential for an HIV
drug that requires a molecular diagnostic for patient selection. These
forward- looking statements are subject to risks and uncertainties and
other factors, which may cause actual results to differ materially from the
anticipated results or other expectations expressed in such forward-looking
statements. These risks and uncertainties include, but are not limited to:
risks related to the market acceptance of Selzentry and ongoing and future
clinical trials of Selzentry; whether competitive tropism assays are
developed and commercialized by others; whether third party payers will
provide coverage and reimbursement for the Trofile Assay; the amount of
reimbursement that will be provided by third party payers; risks related to
the implementation of the collaboration with Pfizer; whether we will be
able to effectively build an appropriate organization and establish
appropriate partnerships in Europe and other international markets; risks
and uncertainties relating to the performance of our products; the growth
in revenues; the size, timing and success or failure of any clinical trials
for CCR5 inhibitors or entry inhibitors; the use of our Trofile Assay for
patient use with Selzentry; our ability to establish reliable, high-volume
operations at commercially reasonable costs; expected reliance on a few
customers for the majority of our revenues; the annual renewal of certain
customer agreements; actual market acceptance of our products and adoption
of our technological approach and products by pharmaceutical and
biotechnology companies; our estimate of the size of our markets; our
estimates of the levels of demand for our products; the impact of
competition; whether payors will authorize reimbursement for our products
and services; whether the FDA or any other agency will decide to further
regulate our products or services; the ultimate validity and enforceability
of our patent applications and patents; the possible infringement of the
intellectual property of others; whether licenses to third party technology
will be available; whether we are able to build brand loyalty and expand
revenues; and whether we will be able to raise sufficient capital in the
future, if required. For a discussion of other factors that may cause our
actual events to differ from those projected, please refer to our most
recent annual report on Form 10-K and quarterly reports on Form 10-Q, as
well as other subsequent filings with the Securities and Exchange
Commission. We do not undertake, and specifically disclaim any obligation,
to revise any forward-looking statements to reflect the occurrence of
anticipated or unanticipated events or circumstances after the date of such
statements.
Trofile is a trademark of Monogram Biosciences, Inc. Selzentry is a
trademark and Celsentri is a registered trademark of Pfizer Inc.
contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624-4576 Tel: 415 677-2700
amerriweather@monogrambio.com jeremiah.hall@fkhealth.com
SOURCE Monogram Biosciences, Inc.
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Related links:
http://www.MonogramBio.com
http://www.lab-21.com
CONTACT:
Alfred G. Merriweather, Chief Financial
Officer of Monogram Biosciences, Inc., +1-650-624-4576,
amerriweather@monogrambio.com; Jeremiah Hall of Feinstein Kean
Healthcare, +1-415-677-2700, jeremiah.hall@fkhealth.com
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