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Market for Monogram's Trofile Assay Poised for Growth as Pfizer Extends Co-Marketing Deal

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Pfizer's extension of its deal with Monogram Biosciences will allow the diagnostics company to exploit several opportunities for increased sales of its Trofile assay over the next year.

San Francisco-based Monogram announced this week that Pfizer has exercised its right to extend the collaboration agreement, inked four years ago between the two companies, regarding Monogram's Trofile assay.

Pfizer used Trofile to select patients who will respond to its CCR5-antagonist HIV drug Selzentry (maraviroc) in clinical trials. Pfizer and Monogram in May 2005 announced a non-exclusive collaboration to make Monogram’s Trofile assay available for patients worldwide. Pfizer at the time also invested $25 million in Monogram [see PGx Reporter 05-10-05].

This agreement, set to expire on December 31, 2009, is now extended through December 31, 2010. According to the terms of the deal, Pfizer holds five separate options to extend the agreement by one year on each option. This is the first option Pfizer has exercised.

Pfizer's payments to Monogram on the sales of its Trofile assay are a main source of revenue for the Dx firm. In 2008, Monogram recorded revenues of over $16 million from its Trofile assay for selection of patients for Selzentry.

According to investment group Thomas Weisel Partners, Monogram performs between 2,000 tests and 2,500 tests per quarter. "We believe the extension highlights Pfizer's support for the arrangement and its belief that it will continue to grow," Thomas Weisel Partners said in a note.

Several recent developments, including enhancements to the Trofile assay, promise an expanded market for the test in the coming years.

Last year Monogram made improvements to the assay that it claims increased Trofile's sensitivity 30-fold such that the "X4 virus can be detected in quantities as low as 0.3 percent of the virus population with 100 percent sensitivity." Additionally, using this enhanced assay in clinical trials, Trofile could detect best-responders to Selzentry among treatment-naïve CCR5-tropic HIV patients [see PGx Reporter 02-25-2009].

Selzentry is currently indicated only for treatment-experienced patients. Based on promising clinical trial data, Pfizer has submitted a filing with the US Food and Drug Administration to expand Selzentry's indication to include treatment-naïve HIV patients.

An extension of Selzentry's indication to treatment-naïve HIV patients "opens up the entire HIV population," Thomas Weisel Partners said in its note to investors, noting that around 50,000 new HIV infections occur each year in the US.

Under the terms of its agreement with Pfizer, Monogram performs the Trofile test at its CLIA-lab facility and handles commercialization efforts in the US. For markets outside the US, Pfizer leads commercialization, while Monogram continues to perform the tests; Pfizer reimburses Monogram for these costs.

Monogram said in a statement that it has also given its consent to allow Pfizer to transfer their agreement to the new entity that is planned to be established when GlaxoSmithKline and Pfizer merge their HIV businesses.

Monogram's deal with Pfizer is non-exclusive, and the pharmacogenetics test maker has the opportunity to ink a commercialization agreement for the Trofile assay with at least one other major pharmaceutical company.

Schering Plough plans to file an NDA submission later this year for its own CCR5-antagonist, vicriviroc, with approval potentially in 2010. The drug maker is already using Trofile to determine best responders in clinical trials for the drug.

"This would offer a second drug that Trofile could be used with to find appropriate patients, and we would expect a similar arrangement to the Pfizer collaboration," Thomas Weisel Partners said.

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