European Committee Issues Positive Opinion of Pfizer's Celsentri(R) (Maraviroc) for Treatment-Experienced Patients Infected with
July 20 2007 - 6:00AM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., July 20 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc. (NASDAQ:MGRM) announced today that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMEA) issued a positive opinion
recommending marketing authorization of collaborator Pfizer, Inc.'s
(NYSE:PFE) investigational HIV medication Celsentri (maraviroc) -
the first CCR5 antagonist for use along with other antiretroviral
agents for treatment-experienced adult patients infected with
CCR5-tropic HIV-1. A final decision from the European Commission,
which has the authority to approve medications for the European
Union, is expected within months. Pfizer also noted that 48-week
data from the two MOTIVATE clinical trials confirmed 24-week
findings reported in February 2007 and led to the positive opinion
from the CHMP. If approved, Celsentri would be the first member of
a new class of oral HIV medicines in more than a decade. Monogram's
Trofile(TM) Assay has been used to select patients for the drug's
clinical trials. "Information provided by Pfizer to the April 24,
2007 U.S. FDA advisory committee indicates that "the results in
treatment-experienced patients with CCR5-tropic versus non-CCR5-
tropic HIV-1 provide clinical data validating Monogram's Trofile
Assay as an effective and appropriate means to identify patients
with CCR5-tropic HIV-1 and who are therefore likely to respond to
maraviroc,"" said William Young, Monogram CEO. "We expect to make
our Trofile Assay available commercially in European markets after
Celsentri is approved," continued Young. "Outside the U.S., we are
partnering with Pfizer where Pfizer is taking the lead in marketing
Trofile and we are implementing the necessary logistical
arrangements to make sure the assay can be made available in
concert with Celsentri. We expect to be ready for commercial
availability in as many as eight countries this year, with an
additional forty countries in the planning stages." 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.
The Company's products are designed to help doctors optimize
treatment regimens for their patients that lead to better outcomes
and reduced costs. The Company'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/.
Forward-Looking Statements Certain statements in this press release
are forward-looking. These forward-looking statements include
references to the potential use of our Trofile Assay as a molecular
diagnostic for patient selection for Pfizer's CCR5 antagonist
maraviroc, if approved by the FDA and European authorities. 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: the risk that
regulatory authorities may not require a molecular diagnostic for
patient selection for maraviroc, the risk that maraviroc will not
be approved by the FDA or European authorities; risks related to
the implementation of the collaboration with Pfizer; risks
associated with establishing and maintaining logistics arrangements
in European and other non-U.S. markets for Trofile; risks and
uncertainties relating to the performance of our products; the
growth in revenues and actual market acceptance of our products;
the impact of competition; whether payors will authorize
reimbursement for our Trofile; whether the FDA or any other agency
will decide to further regulate Trofile and our other products; 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; 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.
Celsentri is a registered trademark of Pfizer, Inc. Press Release
contacts: Alfred G. Merriweather Chief Financial Officer Tel: 650
624-4576 Jeremiah Hall Feinstein Kean Healthcare Tel: 415 677-2700
DATASOURCE: Monogram Biosciences, Inc. CONTACT: Alfred G.
Merriweather, Chief Financial Officer of Monogram Biosciences,
Inc., +1-650-624-4576, ; or Jeremiah Hall, of Feinstein Kean
Healthcare, +1-415-677-2700, , for Monogram Biosciences, Inc. Web
site: http://www.monogrambio.com/
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