SOUTH SAN FRANCISCO, Calif., June 20 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. today announced that its collaborator Pfizer Inc. separately announced that the U.S. Food and Drug Administration (FDA) issued an approvable letter for maraviroc, a CCR5-antagonist under review as a therapy for treatment-experienced patients infected with CCR5-tropic HIV-1.
According to a statement issued by Pfizer, the company is committed to making maraviroc available and discussions are currently underway with the FDA to resolve any outstanding questions and finalize product labeling as soon as possible.
“Our plans for commercializing Trofile(TM) are well advanced and we will provide details of those plans once maraviroc is approved by the FDA,” said William Young, Monogram CEO.
Monogram’s co-receptor tropism assay, Trofile, was used to select the more than 2,000 patients worldwide who have received treatment with maraviroc through clinical trials. Trofile is currently in use for patient selection in Pfizer’s ongoing expanded access program (EAP). The EAP, which Pfizer is conducting in 30 countries, provides maraviroc to patients with limited treatment options prior to approval.
As the only currently commercially available co-receptor tropism test, Trofile is needed to select patients for treatment with CCR5-antagonists. In order to ensure access for the tens of thousands of HIV patients whose virus has become resistant to current treatments, Monogram plans to make Trofile commercially available after maraviroc is approved.
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. 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.
Forward-Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include references to the potential use of our Trofile Assay as a molecular diagnostic for patient selection for Pfizer’s CCR5 antagonist maraviroc, if approved 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 regulatory authorities may not require a molecular diagnostic for patient selection for maraviroc, the risk that maraviroc will not be approved by the FDA; risks related to the implementation of the collaboration with Pfizer; risks and uncertainties relating to the performance of our products; the growth in revenues and actual market acceptance of our products; the impact of competition; whether payors will authorize reimbursement for our Trofile; whether the FDA or any other agency will decide to further regulate Trofile and our other products; 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; 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. contacts: Alfred G. Merriweather Chief Financial Officer Tel: 650 624 4576 amerriweather@monogrambio.com Jeremiah Hall Feinstein Kean Healthcare Tel: 415 677-2700 jeremiah.hall@fkhealth.com
Monogram Biosciences, Inc.
CONTACT: Alfred G. Merriweather, Chief Financial Officer, +1-650-624-4576, amerriweather@monogrambio.com, or Jeremiah Hall of Feinstein KeanHealthcare, +1-415-677-2700, jeremiah.hall@fkhealth.com
Web site: http://www.monogrambio.com//
