Monogram BioSciences hits new high on drug approval anticipation
Monogram BioSciences Inc.’s (Nasdaq: MGRM) stock hit a new 52-week-high this morning as investors acted in anticipation of potential approval next week of an HIV drug being manufactured by partner Pfizer Inc. (NYSE: PFE).
In 2006, pharmaceutical giant Pfizer agreed to invest $25 million in South San Francisco-based Monogram and enter into a non-exclusive collaboration to make the company’s HIV test, Trofile, available globally.
On April 24, Pfizer’s HIV drug, maraviroc, will be reviewed by a U.S. Food and Drug Administration panel, according to C.E. Unterberg, Towbin analyst Keay Nakae. In early March, Pfizer announced results from phase III clinical trials of the drug.
Monogram's assay, Trofile, was used for patient selection for maraviroc's clinical development program. Trofile is able to determine the pathway the HIV virus takes in a particular patient.
Pfizer is developing the first in a new class of drugs that fight HIV drugs known as CCR5 antagonists.
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 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. Trofile is necessary to determine whether the drug is appropriate for a given patient and also to determine if a patient using the drug grows nonresponsive, according to Monogram.
Maraviroc is currently under accelerated review with U.S., Canadian and European regulatory authorities, and if approved, would be the first new oral class of HIV medicines in more than a decade.
“Our expectation is that Pfizer’s drug will be approved and that will allow Monogram to commence sales of Trofile,” said Nakae. “If the FDA approves Pfizer’s drug, we expect they will stipulate that only patients that have first been screened using Mongram’s Trofile assay will be appropriate candidates to receive Pfizer’s drug.”
Shares of Monogram BioScience climbed by $0.45, or nearly 24%, to $2.35 this morning after trading as high as $2.48 – a new 52-week-high – earlier in the day. Volume was extremely heavy -- 16 million shares had changed hands as of 11:48 ET compared with a three-month average daily volume of 1.2 million shares. The stock has traded as low as $1.30 – on Aug. 11, 2006 – in the past year.
