Monogram Biosciences Collaborates with Gilead Sciences, Inc. for Elvitegravir
SOUTH SAN FRANCISCO, Calif., June 18 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc., announced today that the Company has signed an agreement with Gilead Sciences, Inc. to provide resistance testing and consultative services for Gilead's Elvitegravir Phase III studies. Monogram assays will be used to screen patients for study enrollment and help select drugs to be given in conjunction with Elvitegravir during the study. Both Monogram's Integrase phenotype and genotype assays were used in Elvitegravir preclinical and Phase II studies, and will be used to evaluate Phase III patient outcomes. The Phase III studies are anticipated to begin enrolling patients later this year.
Elvitegravir is the most recent Gilead drug to enter Phase III and is the latest drug in the promising new class of drugs known as "Integrase inhibitors." Integrase is a viral enzyme that helps HIV integrate its genetic material into a healthy cell's DNA, allowing that cell to begin producing genetic material for new viruses. Integrase inhibitors block the action of this enzyme, interrupting the HIV life cycle before it can begin reproducing.
"Momentum in new ways to combat HIV, such as Integrase inhibitors, is vital to dealing with a virus that is becoming increasingly difficult to treat," said Bill Young, Monogram's chief executive officer. "The Elvitegravir development program shows the importance of strong collaborations between diagnostic and drug makers to more quickly get powerful new treatments into the hands of those who need them most."
Monogram is a biotechnology company 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.
About Monogram's Assays
As recommended by the U.S. FDA Antiviral Drugs Advisory Committee, biopharmaceutical companies use HIV resistance testing technology to support and enhance next-generation HIV drug development. Monogram's proprietary technology is being applied to new HIV drug targets for screening and in subsequent clinical development programs for optimization of background therapy, patient monitoring and, in the case of CCR5 antagonists, for patient selection. Monogram is a leader in providing drug susceptibility and tropism assays for pharmaceutical development. PhenoSense GT(TM) is the only assay combining actual phenotype and genotype drug results in a single report. PhenoSense GT also includes a measure of replication capacity (RC), sometimes called viral fitness, and HIV-1 subtype. PhenoSense Entry(TM) is the only commercially available phenotypic test for measuring susceptibility to entry inhibitors. Similarly, PhenoSense Integrase(TM), which is a phenotypic test for measuring susceptibility to integrase inhibitors, is expected to be introduced commercially soon. Trofile(TM) is a patient selection co-receptor tropism assay that determines whether a patient is infected with a strain of HIV that uses the CCR5 co-receptor, the CXCR4 co-receptor, or a combination of CCR5 and CXCR4 to enter cells. Trofile is the only clinically validated tropism assay and has been used to select patients in all phase II and phase III studies of CCR5 antagonists to date. Together these assays provide the most complete picture of susceptibility to antiretroviral medications. These assays are used by physicians as an aide to guiding therapy selection decisions. They are also frequently used by pharmaceutical companies in phase II and phase III clinical trials for optimization of background therapy.
Forward Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include references to the demand for our resistance and tropism assays, the size and timing of clinical trials utilizing our products and the use of our assays by physicians in guiding patient therapy decisions. 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 CCR5 antagonists or other HIV drugs; the risk that physicians may not use our resistance tests to monitor patients being treated with an integrase inhibitor; 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 integrase 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.
CONTACT: Alfred G. Merriweather, Chief Financial Officer of Monogram
Biosciences, Inc., +1-650-624-4576, firstname.lastname@example.org; or
Jeremiah Hall of Feinstein Kean Healthcare for Monogram Biosciences, Inc.,
Web site: http://www.monogrambio.com/