Monogram Biosciences, Inc. (Nasdaq: MGRM) announced today that its collaborator Pfizer, Inc. (NYSE: PFE) has separately announced today that the U.S. Food and Drug Administration (FDA) has granted priority review status and the European Medicines Agency (EMEA) has agreed to the accelerated review procedure for the marketing authorization applications for maraviroc, potentially the first in a new class of HIV treatments. Pfizer submitted the U.S. and EU applications in December 2006 for maraviroc as treatment for antiretroviral-experienced patients with a specific strain of HIV (CCR5-tropic HIV-1).
Priority Review is granted by FDA to products that, if approved, would be a significant improvement compared to existing approved therapies. The goal for reviewing a product with Priority Review status is six months from the filing date, rather than the typical review period of up to one year.
Monogram's co-receptor tropism assay, Trofile(TM), was 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 on a global basis. "Throughout the clinical development of maraviroc, physicians and patients relied on Trofile to predict a patient's likelihood for response," said Monogram CEO William Young. "We believe this new model of drug and diagnostic collaborations will create a more personalized and effective treatment for patients with HIV."
Maraviroc is designed to work differently from other available HIV medications. CCR5 antagonists block the virus from gaining access into healthy cells via the CCR5 co-receptor, a common pathway for viral entry. Monogram's Trofile co-receptor tropism assay identifies whether individual strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co- receptors to infect healthy cells. This helps clinicians determine whether a CCR5 antagonist like maraviroc may be a good therapeutic option for treating individual patients. Pfizer expects to present the results of a phase III study of maraviroc at an upcoming scientific meeting.
Maraviroc and other entry inhibitors currently in development come at a time when increasing drug resistance makes treating HIV more difficult than ever. Highly sensitive and precise diagnostic tools are playing an ever more important role in the development of new therapeutic approaches that give new hope to physicians and patients running low on options.
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 for an HIV drug that requires a molecular diagnostic for patient selection, expected protection provided by patents, and activities expected to occur in connection with the Pfizer collaboration. 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 or recommend a molecular diagnostic for patient selection for an HIV drug, risks related to the implementation of the collaboration with Pfizer; risks related to our ability to recognize revenue from activities under the collaboration with Pfizer; 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, entry inhibitors or integrase inhibitors; the use of our Trofile co-receptor tropism assay for patient use in the event of approval of any CCR5 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; 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, whether the draft guidance on Multivariate Index Assays recently issued by FDA applies 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 and Merrill Lynch debt agreements; 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.
Trofile is a trademark of Monogram Biosciences, Inc.
Monogram Biosciences, Inc.
http://www.monogrambio.com
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