Monogram hopes to develop clinical data this year to support commercial launch in oncology

By Jennifer Lanning Drey

Eugene, Ore., July 11 - Monogram Biosciences, Inc. hopes to develop enough clinical data this year to support a commercial launch in oncology, according to Alfred G. Merriweather, chief financial officer of the company.

Monogram is working to expand its diagnostic testing technology into the oncology market by leveraging its experience in HIV, Merriweather said Tuesday at the C.E. Unterberg Emerging Growth Opportunities Conference.

"Looking into the future, we have a growth opportunity in cancer where we're developing products for a market that is 10 times or more the size of our current market," Merriweather.

The company's HIV franchise produces about $50 million a year in revenue, he also said.

Monogram is interested in transitioning into oncology because the company believes cancer therapy is evolving in a similar way to HIV therapy in the past, Merriweather said.

"The complexity of the disease coupled with the complexity of the treatment options available create a need for tests to help sort through all of that complexity for pharmaceutical companies and for physicians, just like we've seen in HIV," said Merriweather.

In November, Monogram announced new clinical data demonstrating the ability of its eTag assays to predict treatment response for patients with lung cancer who receive Iressa (gefitinib).

"We're excited about leveraging all of our experience in HIV into that new exciting opportunity in cancer," said Merriweather.

Growth in HIV with new test

Monogram's HIV franchise also has the opportunity to expand this year through its co-receptor tropism assay, he said.

The HIV co-receptor tropism assay is a diagnostic tool used to show tropism, which is the path taken by the virus to access human CD4 cells. Tropism information is intended to help identify patients who are most likely to respond to a class of investigational drugs known as CCR5 antagonists.

"We have a substantial growth opportunity from the CCR5 compound in particular and multiple drug classes over the long term," Merriweather.

Pfizer used Monogram's diagnostic tool to select and monitor patients in a phase 3 clinical trail of CCR5.

"We believe the use in the phase 3 trial does suggest potential for use of our test in clinical use after the drug is approved," said Merriweather.

Pfizer has indicated that it plans to file a New Drug Application for CCR5 by the end of the year, which means Monogram's co-receptor tropism assay could be used commercially by next year, he said.

In addition, other new classes of drugs in development for treatment of HIV also could help grow the market for Monogram's diagnostic testing, Merriweather said.

"What benefits us from our business perspective is that the complexity of the biology coupled with the increasing complexity of treatment choices that are available creates a need for tests to help guide the decisions the pharma companies make in drug development and the decisions doctors have to make in treatment of patients," Merriweather said.

Monogram, formerly ViroLogi Inc., is based in South San Francisco, Calif., and develops products for the treatment of serious infectious diseases and cancer.

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