Pfizer Receives E.U. Approval of Maraviroc; Monogram Initiates European Operations
Monday October 1, 7:00 am ET
Monogram establishes European organization for commercialization of Trofile and partners with Lab21, Ltd. in the U.K.
SOUTH SAN FRANCISCO, Calif., Oct. 1 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM - News) today announced the establishment of its European organization to facilitate access to Trofile, its proprietary tropism test, following the announcement that Pfizer Inc. (NYSE: PFE - News) has received European Commission approval of the novel HIV therapy, Celsentri® (maraviroc) tablets (known as Selzentry(TM) in the U.S.). Trofile was the assay used for patient selection for maraviroc's clinical development program and the two companies are engaged in a collaboration agreement to make Monogram's assay available for patient use globally.
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Maraviroc has been approved in the European Union for combination antiretroviral therapy for treatment-experienced adults who are infected with only CCR5-tropic HIV-1 detectable. Trofile is the only clinically validated diagnostic that can be used to determine viral tropism. Through the global collaboration, Pfizer will take the lead in commercializing Trofile outside of the U.S. Monogram will provide support for Pfizer's sales, marketing and educational activities.
Monogram also has taken several important steps towards establishing its European operations including the appointment of Corinne Danan as European Director. Ms. Danan will lead Monogram's efforts to introduce the Trofile assay in Europe and will work closely with Pfizer's European commercial team. Corinne Danan comes to Monogram with over 15 years at Eli Lilly in Europe and the United States in regional and global roles, serving as country manager in Israel and Poland as well as in a number of other marketing positions. Ms. Danan will be based in Paris.
Monogram has been working with Pfizer to develop the appropriate logistical arrangements for making Trofile available in those countries targeted for commercial introduction of maraviroc. All samples will be processed by Monogram in its laboratory in South San Francisco and Monogram is establishing, with funding from Pfizer, the laboratory and courier partnerships that are necessary to ensure that samples can be appropriately managed and delivered to South San Francisco for processing. Monogram announced that the first such partnership has been established with Lab21 Ltd., of Cambridge, U.K. Lab21 has considerable experience in HIV testing, as well as strong operations and logistics capabilities, and will provide access to Trofile in the U.K. and Ireland. Contracts are being finalized with other labs and logistics groups for the provision of such services in other European and international markets, coinciding with Pfizer's local launches of maraviroc and Trofile.
About Trofile
Trofile is a patient selection co-receptor tropism assay that determines whether a patient is infected with a strain of HIV that uses either the CCR5 coreceptor, the CXCR4 coreceptor, or a combination of CCR5 and CXCR4 to enter cells. The use of CCR5, CXCR4 or both coreceptors defines the "tropism" of the virus strain. Trofile amplifies the envelope gene from a patient's HIV genome (from their blood sample) and then uses it to make HIV particles containing the patient's virus envelope protein. The resultant HIV particles are then used to infect cells that contain the CCR5 co-receptor or the CXCR4 co- receptor on the cell surface. Once the virus infects the cell and it undergoes a single round of replication. Virus replication results in the production of luciferase from a luciferase gene that is carried into the cell by the virus The production of luciferase in either CCR5 cells, CXCR4 cells or both cell types defines the co-receptor tropism of the patient virus.
About Monogram Biosciences, Inc.
Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. Monogram'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 about the company and its technology can be found on its web site at www.MonogramBio.com.
About Lab21 Ltd.
Lab21 is a leading provider of cutting edge diagnostics, supporting drug discovery, healthcare and environmental monitoring. Its customers include healthcare providers, pharmaceutical and biotechnology companies. In addition, the Company supports organizations that need to monitor their impact on the environment. Lab21 has a rapidly growing portfolio of diagnostics to support early stage drug development, clinical trials and regulatory processes in the pharmaceutical industry. A key function is the support of clinicians and healthcare providers as they treat and monitor patients. The company's products include diagnostic tests for cancer, liver disease, respiratory illnesses and infectious diseases such as syphilis through its subsidiary Newmarket Laboratories. Its pharmaceutical support services include lead identification and optimization of targets, drug resistance profiling, mode of action studies, and drug combination studies as well as clinical trial support. More information about the company and its technology can be found on its web site at www.lab-21.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include references to the potential for an HIV drug that requires a molecular diagnostic for patient selection. 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 related to the market acceptance of Selzentry and ongoing and future clinical trials of Selzentry; whether competitive tropism assays are developed and commercialized by others; whether third party payers will provide coverage and reimbursement for the Trofile Assay; the amount of reimbursement that will be provided by third party payers; risks related to the implementation of the collaboration with Pfizer; whether we will be able to effectively build an appropriate organization and establish appropriate partnerships in Europe and other international markets; 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 or entry inhibitors; the use of our Trofile Assay for patient use with Selzentry; 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; whether payors will authorize reimbursement for our products and services; whether the FDA or any other agency will decide to further regulate our products or services; 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; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause our 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 and Celsentri is a registered 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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