All California public payers now cover Monogram's Trofile assay
SOUTH SAN FRANCISCO, Calif., March 17 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc. (Nasdaq: MGRM) today announced that the
California Medicaid program (Medi-Cal) has established coverage and
reimbursement for Monogram's Trofile Assay.
Medi-Cal is the state medical assistance program in California
established to provide essential medical care and services to individuals
or families on public assistance, or whose income is not sufficient to meet
their individual needs.
"We are delighted that Medi-Cal has established coverage for Trofile,"
said Bill Welch, Monogram chief commercial officer. "California has the
second largest population of HIV/AIDS patients in the U.S. and now all
public payers in the state provide coverage for Trofile. With coverage now
clarified, we expect that testing activity for Medi-Cal beneficiaries may
increase."
Previously, the California ADAP Program (in November 2007), and the
federal Medicare Program (in September 2007) established coverage for
Trofile. 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 without other coverage.
Throughout the U.S. 33 state ADAP/Ryan White entitlement state programs now
have coverage established for Trofile.
Trofile is now a covered benefit with 24 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 5,000 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 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 Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624 4576 Tel: 415 677 2700
amerriweather@monogrambio.com 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, Feinstein Kean
Healthcare, +1-415-677-2700, jeremiah.hall@fkhealth.com
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