Monogram Assays to be used by Avexa to select patients and optimize
background therapy in phase III program
SOUTH SAN FRANCISCO, Calif., March 10 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc., (Nasdaq: MGRM) announced today that the Company
has signed an agreement with AVEXA Limited (ASX: AVX) to be the exclusive
provider of HIV resistance and tropism testing technology in support of
Avexa's drug discovery and development programs.
Avexa plans to use Monogram's assays across its virology portfolio,
including the phase III program for its lead compound, apricitabine (ATC),
an anti-HIV drug in the nucleoside reverse transcriptase inhibitor (NRTI)
class. ATC has successfully completed the 48 week dosing of its Phase 2b
trial and the Phase 3 program has been initiated. Avexa plans to use
Monogram's PhenoSense(TM) GT assay to select patients and optimize
background therapy for trials involving approximately 2,000 patients, and
to monitor response to drug treatment during the trials. ATC is a new
nucleoside analog that is intended for use in patients who have developed
viral resistance to existing drugs. Avexa also has HIV drugs in early
development in the CCR5- and integrase- inhibitor classes.
"We are pleased to have selected Monogram as the exclusive provider of
resistance tests for our development programs," said Julian Chick, Avexa's
chief executive officer. "Monogram has an impressive portfolio of tests
that we believe provide the accuracy and reliability that are necessary for
studies that are intended to be submitted to the FDA and other regulatory
agencies."
"Monogram's phenotypic resistance tests to optimize background therapy
helped contribute to successful clinical trials for both new HIV drugs
approved by the FDA in 2007," said Bill Young, Monogram's chief executive
officer. "We are delighted to work with Avexa on their exciting development
programs, and to build international partnerships that bring truly global
cooperation and innovation to the fight against HIV."
As recommended by the U.S. FDA Antiviral Drugs Advisory Committee,
biopharmaceutical companies are using HIV resistance testing technology to
support and enhance next-generation HIV drug development. Monogram's
proprietary technology is being applied to new HIV drug targets for
screening and in subsequent clinical development programs for optimization
of background therapy, patient monitoring and, in the case of CCR5
antagonists, for patient selection.
About Monogram
Monogram is a biotechnology company 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.
About Avexa
Avexa Limited is a Melbourne, Australia-based biotechnology company
with a focus on research and development of drugs for the treatment of
infectious diseases. Avexa has dedicated resources and funding for key
projects including its HIV integrase program and an antibiotic program for
antibiotic-resistant bacterial infections. The Company's lead program is
apricitabine (ATC), an anti-HIV drug which has successfully completed the
48 week dosing of its Phase 2b trial and has initiated Phase 3 trials.
Avexa has entered into a collaboration with TargetDrug in China to identify
new CCR5 inhibitors for the treatment of HIV. More information about the
company and its product candidates can be found on its web site at
http://www.avexa.com.au
Forward Looking Statements
Certain statements in this press release are forward-looking. These
forward-looking statements include references to the demand for our testing
products, including our Trofile Assay, the potential use of our Trofile
Assay for patient selection for the class of HIV drugs known as CCR5
antagonists, the size and timing of Avexa's clinical trials utilizing our
products, the outlook for Avexa's investigational drug mentioned in this
release and for our testing products, expected protection provided by
patents, possible regulation of our products by the FDA. 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 physicians may not use a molecular diagnostic for patient
selection for CCR5 antagonists or other HIV drugs; whether larger
confirmatory clinical studies will confirm the results of initial studies;
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 HIV drugs, such as Avexa's drug mentioned in this release; the
risk that our Trofile Assay may not be utilized for patient use with CCR5
inhibitors; our ability to successfully conduct clinical studies and the
results obtained from those 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 payers will authorize reimbursement for our
products and services and the amount of such reimbursement that may be
allowed; whether the FDA or any other agency will decide to further
regulate our products or services, including Trofile; whether the draft
guidance on Multivariate Index Assays issued by FDA will be subsequently
determined to apply 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, Merrill Lynch and other debt
agreements; the impact of additional dilution if our convertible debt is
converted to equity; 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.
PhenoSense GT is a trademark of Monogram Biosciences, Inc.
Contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624-4576 Tel: 415 677-2700
amerriweather@ jeremiah.hall
monogrambio.com @fkhealth.com
SOURCE Monogram Biosciences, Inc.
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Related links:
http://www.monogrambio.com
http://www.avexa.com.au
CONTACT:
Alfred G. Merriweather, Chief Financial
Officer at Monogram Biosciences, Inc., +1-650-624-4576,
amerriweather@monogrambio.com; or Jeremiah Hall of Feinstein Kean
Healthcare, +1-415-677-2700, jeremiah.hall@fkhealth.com
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