Pfizer Receives E.U. Approval of Maraviroc; Monogram Initiates European Operations
2007年10月1日 - 8:00PM
PRニュース・ワイアー (英語)
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
DATASOURCE: Monogram Biosciences, Inc. CONTACT: Alfred G.
Merriweather, Chief Financial Officer of Monogram Biosciences,
Inc., +1-650-624-4576, ; Jeremiah Hall of Feinstein Kean
Healthcare, +1-415-677-2700, Web site: http://www.monogrambio.com/
http://www.lab-21.com/
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