SOUTH SAN FRANCISCO, Calif., Oct. 7 /PRNewswire-FirstCall/ -- Monogram
Biosciences, Inc. (Nasdaq: MGRM) today reaffirmed its guidance for revenue
in excess of $60 million for 2008.
"We continue to make progress in both our HIV and Oncology programs,"
said William Young, Monogram chief executive officer. "Our revenues have
been at record levels in the first half of this year and we reaffirm our
guidance for revenues to be greater than $60 million for the year, growth
of over 40% over 2007. We expect further revenue growth in 2009 from
Trofile(TM), our patient selection assay for the CCR5 antagonist class of
HIV drugs."
"We also expect HERmark(TM), our recently launched breast cancer assay,
to contribute to revenue in 2009," continued Young. "Our oncology sales
team is in place and initial HERmark tests have been performed for patients
determined by existing technologies to be HER2-negative. As our prior
clinical data suggests, these patients include some who have now been
reclassified by HERmark as HER2 positive. We are pleased with the reaction
to date of the oncology community to HERmark. We expect to enhance HERmark
during 2009 with clinical data related to Herceptin response upon
completion of our clinical studies, which are progressing well, and with
the introduction of an additional marker that may provide an indication of
Herceptin(R) resistance, for example in patients where combination therapy
may be appropriate. Development work on VeraTag(TM) assays for heterodimers
of HER1:HER2 and HER2:HER3, the HER1:HER1 homodimer as well as for p95, a
truncated form of HER2, and the HER3/PI3K complex is proceeding well and we
expect to present data on several of these assays later in 2008."
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, including
statements regarding the performance, demand and outlook for our products,
including our Trofile and HERmark assays, our projected revenues, the
potential for enhancements to our HERmark assay, the development of
additional assays based on the VeraTag platform, the results and timing of
clinical studies on our products and the presentation or publication of
data from such studies. 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: risks and uncertainties relating to the
performance and acceptance 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
VeraTag assays, including HERmark, may not predict response to particular
therapeutic agents; the risk that we may not be able to obtain additional
cohorts of patient samples for additional VeraTag studies, the risk that
our VeraTag technology may not accurately measure other proteins or protein
complexes, 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 existing levels of reimbursement will be reviewed and reduced by
third party payers, including Medicare; whether the draft guidance on
Multivariate Index Assays issued by the 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, G.E. and other debt agreements; potential
Nasdaq proceedings to delist our common stock, our ability to regain
compliance with Nasdaq listing requirements, the impact of a possible
reverse split of the shares of our common stock, 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.
HERmark, VeraTag and Trofile are trademarks 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
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
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