Monogram Provides Update on Trofile(TM) Co-Receptor Tropism Assay
2007年2月13日 - 9:18PM
PRニュース・ワイアー (英語)
Pfizer announces maraviroc NDA filed with priority review by FDA
SOUTH SAN FRANCISCO, Calif., Feb. 13 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc. (NASDAQ:MGRM) announced today that its
collaborator Pfizer, Inc. (NYSE:PFE) has separately announced today
that the U.S. Food and Drug Administration (FDA) has granted
priority review status and the European Medicines Agency (EMEA) has
agreed to the accelerated review procedure for the marketing
authorization applications for maraviroc, potentially the first in
a new class of HIV treatments. Pfizer submitted the U.S. and EU
applications in December 2006 for maraviroc as treatment for
antiretroviral-experienced patients with a specific strain of HIV
(CCR5-tropic HIV-1). Priority Review is granted by FDA to products
that, if approved, would be a significant improvement compared to
existing approved therapies. The goal for reviewing a product with
Priority Review status is six months from the filing date, rather
than the typical review period of up to one year. Monogram's
co-receptor tropism assay, Trofile(TM), 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.
"Throughout the clinical development of maraviroc, physicians and
patients relied on Trofile to predict a patient's likelihood for
response," said Monogram CEO William Young. "We believe this new
model of drug and diagnostic collaborations will create a more
personalized and effective treatment for patients with HIV."
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 expects to present the results
of a phase III study of maraviroc at an upcoming scientific
meeting. 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 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 for an HIV drug that requires a
molecular diagnostic for patient selection, expected protection
provided by patents, 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 or
recommend a molecular diagnostic for patient selection for an HIV
drug, risks related to the implementation of the collaboration with
Pfizer; 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 inhibitors, 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 inhibitors; 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, whether the draft guidance on Multivariate Index Assays
recently issued by FDA applies to our current or planned products;
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; restrictions on the conduct of our
business imposed by the Pfizer and Merrill Lynch debt agreements;
and whether we will be able to raise sufficient capital in the
future, if required. For a discussion of other factors that may
cause 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. 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 ; or Jeremiah Hall
of Feinstein Kean Healthcare, +1-415-677-2700, or Web site:
http://www.monogrambio.com/
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