Reimbursement Progress for the Only Clinically Validated Tropism Assay
SOUTH SAN FRANCISCO, Calif., Nov. 7 /PRNewswire-FirstCall/ -- Monogram
Biosciences, Inc. (Nasdaq: MGRM) today announced that the California ADAP
program under the California Office of AIDS has established coverage and
reimbursement for Monogram's Trofile Assay. This coverage will be
administered by the "Public Health Service Bureau", the California ADAP
Program's Pharmacy Benefit Manager. The California Office of AIDS has the
lead responsibility for coordinating state programs, services and
activities relating to HIV/AIDS for the State of California. The AIDS Drug
Assistance Program, or "ADAP", is a state and federally funded program,
administered separately in each state to provide healthcare coverage for
HIV/AIDS patients.
Monogram introduced Trofile in August 2007, upon FDA approval of
Pfizer's Selzentry(TM) (maraviroc), and since then, approximately 2,000
tests have been requested. Approximately 1,200 tests have been performed,
of which approximately 400 have been for clients and payers for whom
reimbursement arrangements are in place, and for which revenue is recorded.
"We are pleased with this initial acceptance of Trofile," said William
Young, Monogram chief executive officer. "We believe that the message from
both Pfizer and Monogram that Trofile is the only clinically validated
method of assessing tropism is being well received by physicians." Monogram
and Pfizer Inc have a collaboration to make Trofile available globally.
"We are pleased with this acknowledgement from the California ADAP
program of the value of Trofile," continued Young. "ADAP programs provide a
valuable safety net for patients with no other insurance coverage. We are
working with state Medicaid programs as well as private insurance plans to
add coverage for Trofile to those programs." Coverage by Medicare was
established in September 2007. Monogram is an approved vendor to the
Federal Supply Schedule and in September we gained coverage for Trofile to
service the U.S. Departments of Veterans Affairs and Indian Affairs and the
Federal Bureau of Prisons.
About Monogram
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 anti-viral 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 demand for our Trofile
Assay, the potential use of our Trofile Assay for patient selection for
maraviroc, the size and timing of clinical trials utilizing our products,
the outlook for maraviroc and our Trofile Assay, the number of patients
each year in the U.S. who potentially could be candidates for new classes
of HIV drugs such as maraviroc, expected protection provided by patents,
possible regulation of Trofile and our other products by the FDA, 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 physicians may not use a molecular diagnostic
for patient selection for maraviroc or other HIV drugs; 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 risk that our Trofile Assay may not be utilized for patient
use with maraviroc and other CCR5 inhibitors; 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 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.
Trofile is a trademark of Monogram Biosciences, Inc. Selzentry is a
trademark of Pfizer Inc.
contacts: Alfred G. Merriweather
Chief Financial Officer
Tel: 650 624 4576
amerriweather@monogrambio.com
Jeremiah Hall
Feinstein Kean Healthcare
Tel: 415 677 2700
jeremiah.hall@fkhealth.com
SOURCE Monogram Biosciences, Inc.
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Related links:
http://www.monogrambio.com
CONTACT:
Alfred G. Merriweather, Chief Financial
Officer of Monogram Biosciences, Inc., +1-650-624-4576,
amerriweather@monogrambio.com; Jeremiah Hall of Feinstein Kean
Healthcare, +1-415-677-2700, jeremiah.hall@fkhealth.com, for
Monogram Biosciences, Inc.
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