Approximately 80% of U.S. HIV/AIDS Patients Live in States Now Providing
Medicaid Coverage for Trofile
SOUTH SAN FRANCISCO, Calif., April 8, 2008 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc. (Nasdaq: MGRM) today announced that New York
Medicaid has established coverage and reimbursement for Monogram's Trofile
Assay, a diagnostic used to determine patient candidacy for Pfizer's new
HIV anti-viral medication Selzentry(TM) (maraviroc).
Initiated in 1989 to ensure early identification and access to quality
care for New Yorkers who can't afford medical care, the HIV Primary Care
Medicaid Program revised its reimbursement structure in response to
advances in HIV treatment and testing technology. With the establishment of
coverage by the medicaid program, coverage will also be available from the
New York ADAP program so that comprehensive coverage will now be available
from all public payers in New York.
"New York remains the epicenter of the HIV/AIDS epidemic in the U.S.,"
said Dennis deLeon, President of the Latino Commission on AIDS. "The
state's coverage and reimbursement of Trofile allows greater access to an
advanced treatment option for the most vulnerable of our population living
with HIV."
"We are very pleased that New York Medicaid has established coverage
for Trofile," said Bill Welch, Monogram Chief Commercial Officer. "Now the
medical public assistance programs for the states with the largest numbers
of residents living HIV/AIDS -- namely California, Texas, Florida and New
York -- recognize the need and provide reimbursement for accurate tropism
testing."
Trofile is now a covered benefit among 25 state Medicaid programs,
including California, Florida, Illinois, Maryland, Massachusetts, Michigan,
New Jersey, Ohio, Texas and Wisconsin. In addition, Trofile is a covered
benefit by Medicare, the Veteran's Administration, the Corrections and
Prison Systems and Department of Indian Affairs, as well as with a number
of private payers.
Monogram introduced Trofile in August 2007, upon FDA approval of
Pfizer's Selzentry(TM) (maraviroc), and since then, almost 6,000 tests have
been performed for patients throughout the U.S. In January 2008 DHHS
Guidelines for Use of Antiretroviral Agents in HIV - 1 infected Adults &
Adolescents recommend the use of the Trofile assay whenever the use of a
CCR5 inhibitor is being considered as well as to be considered for patients
who exhibit virologic failure on a CCR5 inhibition.
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 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 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 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; or Jeremiah Hall of Feinstein Kean
Healthcare, +1-415-677-2700, jeremiah.hall@fkhealth.com for
Monogram Biosciences, Inc.
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