SOUTH SAN FRANCISCO, Calif., March 10 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc., announced today that the Company has signed an agreement with AVEXA Limited to be the exclusive provider of HIV resistance and tropism testing technology in support of Avexa’s drug discovery and development programs.
Avexa plans to use Monogram’s assays across its virology portfolio, including the phase III program for its lead compound, apricitabine (ATC), an anti-HIV drug in the nucleoside reverse transcriptase inhibitor (NRTI) class. ATC has successfully completed the 48 week dosing of its Phase 2b trial and the Phase 3 program has been initiated. Avexa plans to use Monogram’s PhenoSense(TM) GT assay to select patients and optimize background therapy for trials involving approximately 2,000 patients, and to monitor response to drug treatment during the trials. ATC is a new nucleoside analog that is intended for use in patients who have developed viral resistance to existing drugs. Avexa also has HIV drugs in early development in the CCR5- and integrase- inhibitor classes.
“We are pleased to have selected Monogram as the exclusive provider of resistance tests for our development programs,” said Julian Chick, Avexa’s chief executive officer. “Monogram has an impressive portfolio of tests that we believe provide the accuracy and reliability that are necessary for studies that are intended to be submitted to the FDA and other regulatory agencies.”
“Monogram’s phenotypic resistance tests to optimize background therapy helped contribute to successful clinical trials for both new HIV drugs approved by the FDA in 2007,” said Bill Young, Monogram’s chief executive officer. “We are delighted to work with Avexa on their exciting development programs, and to build international partnerships that bring truly global cooperation and innovation to the fight against HIV.”
As recommended by the U.S. FDA Antiviral Drugs Advisory Committee, biopharmaceutical companies are using 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.
About Monogram
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 www.monogrambio.com.
About Avexa
Avexa Limited is a Melbourne, Australia-based biotechnology company with a focus on research and development of drugs for the treatment of infectious diseases. Avexa has dedicated resources and funding for key projects including its HIV integrase program and an antibiotic program for antibiotic-resistant bacterial infections. The Company’s lead program is apricitabine (ATC), an anti-HIV drug which has successfully completed the 48 week dosing of its Phase 2b trial and has initiated Phase 3 trials. Avexa has entered into a collaboration with TargetDrug in China to identify new CCR5 inhibitors for the treatment of HIV. More information about the company and its product candidates can be found on its web site at www.avexa.com.au
Forward Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include references to the demand for our testing products, including our Trofile Assay, the potential use of our Trofile Assay for patient selection for the class of HIV drugs known as CCR5 antagonists, the size and timing of Avexa’s clinical trials utilizing our products, the outlook for Avexa’s investigational drug mentioned in this release and for our testing products, expected protection provided by patents, possible regulation of our products by the FDA. 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; whether larger confirmatory clinical studies will confirm the results of initial studies; 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 HIV drugs, such as Avexa’s drug mentioned in this release; the risk that our Trofile Assay may not be utilized for patient use with CCR5 inhibitors; our ability to successfully conduct clinical studies and the results obtained from those 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.
CONTACT: Alfred G. Merriweather, Chief Financial Officer at 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
Web site: http://www.monogrambio.com/
http://www.avexa.com.au/
