Monogram Biosciences and Merck to Conduct Erbitux(R) Biomarker Study

/PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq:   MGRM) announced
 today that it has entered into an agreement with Merck KGaA, Darmstadt,
 Germany (Xetra: Merck KGaA) to conduct a cancer biomarker study with
 application to Erbitux(R)(cetuximab), Merck KGaA's IgG1 monoclonal antibody
 specifically targeting the epidermal growth factor receptor (EGFR) found on
 many cancer cells.
     Monogram, utilizing its proprietary eTag(TM) assays, will test
 formalin-fixed, paraffin-embedded (FFPE) tumor samples from patients with
 colorectal cancer before they are treated with Erbitux to evaluate the utility
 of these assays in identifying patients who would most likely benefit from
 Erbitux.  Monogram will test the samples for EGFR-containing receptor dimers,
 which Monogram has identified as potential biomarkers for predicting response
 to Erbitux.  These biomarkers represent activated, functioning targets for the
 drug and control signal transduction pathways involved in tumor cell
 proliferation, survival and angiogenesis.  The parties will then compare
 Monogram's predictions of response based upon eTag assay analysis with actual
 clinical outcomes.  Merck KGaA will make payments to Monogram for the project.
 Other financial details were not disclosed.
     "We are pleased to be working with Merck KGaA on this project.  Merck KGaA
 played a critical role in demonstrating the clinical efficacy of Erbitux and
 gaining its approval, and they have made a strong and broad commitment to
 targeted oncology therapies," stated William D. Young, Monogram's Chairman and
 Chief Executive Officer.  "We believe that predictive diagnostics will play an
 expanding role in clinical testing and clinical practice in this field.  Tests
 like our eTag assays may empower physicians, benefit patients and enhance
 clinical medicine by linking molecular analysis of the individual patient's
 disease to the prescription of critical drugs like Erbitux."
     This is one of nine collaborations that Monogram has had with leading
 pharmaceutical and biotechnology companies in oncology.  These alliances have
 been focused on the ability of eTag assays to identify activated drug targets
 or signaling pathways and their correlation with drug activity in cell line,
 xenograft and human clinical tumor samples.
     "In HIV resistance testing, about a third of our business has historically
 come from collaborations with pharmaceutical companies and we expect a similar
 pattern to develop in oncology," said Young.  "We look forward to establishing
 additional collaborations with these and other companies that have oncology
 drug development programs."
 
     About the eTag System
     Monogram's eTag assays enable detailed analysis of protein drug targets
 and signaling pathways in cancer cells, including FFPE samples, which is the
 standard format in most pathology labs.  The assays can provide information on
 a drug's mechanism of action, selectivity and potency in a biological setting
 in pre-clinical research, and enable enrichment or selection of clinical trial
 populations later in a drug's development.  In addition, Monogram believes
 these assays may ultimately be used to help physicians better determine
 whether certain therapies are more appropriate for individual cancer patients,
 and whether to combine therapies with different mechanisms or properties.  The
 first commercially available activated receptor test panel based on eTag
 technology, focused on the EGFR/HER receptor family, is planned to be
 introduced in 2006.
 
     About Monogram Biosciences, Inc.
     Monogram, formerly ViroLogic, Inc., develops and commercializes innovative
 products to help guide and improve the treatment of infectious diseases,
 cancer and other serious diseases.  The Company's products are designed to
 help doctors optimize treatment regimens for their patients that lead to
 better outcomes and reduced costs.  Monogram'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 can be found at www.monogrambio.com.
 
     About Erbitux
     Erbitux(R) is a first-in-class and highly active IgG1 monoclonal antibody
 targeting the epidermal growth factor receptor (EGFR).  As a monoclonal
 antibody, the mode of action of Erbitux is distinct from standard
 non-selective chemotherapy treatments in that it specifically targets and
 binds to the EGFR.  This binding inhibits the activation of the receptor and
 the subsequent signal-transduction pathway, which results in reducing both the
 invasion of normal tissues by tumor cells and the spread of tumors to new
 sites.  It is also believed to inhibit the ability of tumor cells to repair
 the damage caused by chemotherapy and radiotherapy and to inhibit the
 formation of new blood vessels inside tumors, which appears to lead to an
 overall suppression of tumor growth.  The most commonly reported side effect
 with Erbitux is an acne-like skin rash that seems to be correlated with a good
 response to therapy.  In approximately five percent of patients,
 hypersensitivity reactions may occur during treatment with Erbitux; about half
 of these reactions are severe.
     Erbitux has already obtained market authorization in 45 countries:
 Switzerland, the U.S., Mexico, Argentina, Chile, Iceland, Norway, the European
 Union, Canada, Peru, Australia, Croatia, Israel, Bulgaria, Panama, Guatemela,
 Colombia, Ecuador, Singapore, Hong Kong, and South Korea for the use in
 combination with irinotecan in patients with EGFR-expressing mCRC who have
 failed prior irinotecan therapy.  In the U.S., Canada, Argentina, Chile,
 Mexico, Peru, Singapore, Australia, Panama, Colombia, Guatemala, Ecuador, and
 Hong Kong, Erbitux is also approved for single agent usage.
 
     About Merck KGaA
     Merck KGaA, Darmstadt, Germany is a global pharmaceutical and chemical
 company with sales of EUR 5.9 billion in 2004, a history that began in 1668,
 and a future shaped by 28,600 employees in 54 countries.  Its success is
 characterized by innovations from entrepreneurial employees.  Merck's
 operating activities come under the umbrella of Merck KGaA, in which the Merck
 family holds a 73% interest and free shareholders own the remaining 27%.  The
 former U.S. subsidiary, Merck & Co., has been completely independent of the
 Merck Group since 1917.  Merck KGaA licensed the right to market Erbitux
 outside the U.S. and Canada from ImClone Systems Incorporated of New York in
 1998.  In Japan, Merck KGaA has co-exclusive marketing rights with ImClone
 Systems.
 
     NOTE:  eTag(TM) is a registered trademark of Monogram Biosciences, Inc.
 Erbitux(R) is a registered trademark of ImClone Systems, Incorporated of New
 York.
 
     FORWARD LOOKING STATEMENTS
     Certain statements in this press release are forward-looking. 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 of our products; the
 ability of our eTag assays to predict response to Erbitux or other therapeutic
 agents, 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 timing and ultimate
 size of pharmaceutical company clinical trials; whether payors will authorize
 reimbursement for its products; whether the FDA or any other agency will
 decide to regulate Monogram's products or services; whether the Company will
 encounter problems or delays in automating its processes; whether licenses to
 third party technology will be available; whether Monogram is able to build
 brand loyalty and expand revenues; and whether Monogram will be able to raise
 sufficient capital when required. For a discussion of other factors that may
 cause Monogram's actual events to differ from those projected, please refer to
 the Company's 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.
 
 

SOURCE  Monogram Biosciences, Inc.