Monogram
Biosciences, Inc. (Nasdaq: MGRM) announced today that its collaborator
Pfizer, Inc. (NYSE: PFE) has separately announced plans to establish a
multi-national Expanded Access Program (EAP) that will make its
investigational CCR5 antagonist maraviroc available to HIV/AIDS patients
who have limited treatment options due to resistance or intolerance.
Monogram's co-receptor tropism assay, Trofile, was 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 on a global basis.
"This investigational therapy represents a potential milestone in the
treatment of HIV," said Monogram CEO William Young. "We applaud Pfizer's
vision to sculpt a new model for drug development that so closely
integrates advanced diagnostics into the clinical program. We are proud to
be a part of this ground-breaking effort."
Pfizer also confirmed plans to submit applications for marketing
approval of maraviroc in both the U.S. and EU following review of the data
from the two currently ongoing Phase 3 clinical trials of the drug. The
company expects to submit these study results for presentation at an
upcoming HIV conference.
Maraviroc is designed to work differently from other available HIV
medications. CCR5 antagonists block the virus from gaining access into
healthy cells via the CCR5 co-receptor, a common pathway for viral entry.
Monogram's Trofile co-receptor tropism assay identifies whether individual
strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co-
receptors to infect healthy cells. This helps clinicians determine whether
a CCR5 antagonist like maraviroc may be a good therapeutic option for
treating individual patients.
Pfizer's EAP is intended to provide access to maraviroc for patients
who, in the opinion of the program investigators, have an urgent need for
novel medicines because of viral resistance or intolerance to currently
available therapies. To be eligible for the program, patients must be
clinically stable with documented CCR5- tropic HIV-1 infection.
In a study presented at the International AIDS Conference in Toronto in
August 2006 by scientists from Pfizer, the negative predictive value of
Monogram's Trofile co-receptor tropism assay was assessed for maraviroc
(Study 1029). Results show that patients identified by the assay as having
virus using both the CXCR4 and CCR5 receptors (dual/mixed tropic) did not
respond virologically to the investigational (CCR5) therapy. These data
suggest that screening patients with the Trofile assay will allow
physicians to optimize treatment regimens for their HIV patients.
Maraviroc and other entry inhibitors currently in development come at a
time when increasing drug resistance makes treating HIV more difficult than
ever. Highly sensitive and precise diagnostic tools are playing an ever
more important role in the development of new therapeutic approaches that
give new hope to physicians and patients running low on options.
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 monogrambio/.
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, the
ability of the Company to advance its opportunities in HIV, and activities
expected to occur in connection with the Pfizer collaboration. 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 an HIV drug, risks related to the implementation
of the collaboration with Pfizer; risks related to progress Pfizer's
clinical trial and any ultimate approval of maraviroc, risks related to our
ability to recognize revenue from activities under the collaboration with
Pfizer; 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 antagonists, entry inhibitors or integrase
inhibitors; the use of our Trofile co-receptor tropism assay for patient
use in the event of approval of any CCR5 antagonists; our ability to
successfully conduct clinical studies and the results obtained from those
studies; whether larger confirmatory clinical studies will confirm the
results of initial studies; 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; the timing and ultimate size of pharmaceutical company
clinical trials; 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; whether we will encounter
problems or delays in automating our processes; 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. 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.
Monogram Biosciences, Inc.
monogrambio/