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MethylGene Gets Beta-Lactamase Inhibitor Program Back From Merck

This article was originally published in The Pink Sheet Daily

Executive Summary

Other companies have expressed interest in the antibiotic resistance program, MethylGene CEO tells “The Pink Sheet” DAILY.

Merck notified MethylGene Aug. 1 that it intends to terminate an exclusive license and research collaboration entered into in 2003 for development of the Canadian firm's beta-lactamase inhibitor program, MethylGene said in a same-day announcement.

MethylGene, in Montreal, will regain exclusive rights to the program in 90 days, the company said. The termination has no near-term financial effect on MethylGene, and the company has not included anticipated milestone payments from Merck in its cash projections.

"Our understanding [was that] there was an optimized lead compound that we expected that Merck was testing in advanced preclinical studies to advance it to a clinical candidate," MethylGene CEO Donald F. Corcoran told "The Pink Sheet" DAILY. "Obviously ... they have decided not to move any compound forward."

"We know that there are people who have told us in the past that if [the program] became available they'd like to talk to us," he said.

Basically, the program involves small molecule "broad-spectrum beta-lactamase inhibitors to overcome beta-lactamase-mediated resistance to all the three beta-lactam antibiotics: penicillins, carbapenems and cephalosporins," Corcoran explained.

The compounds are potentially paired with existing antibiotics of those classes to increase their effectiveness against resistance by bacteria that have evolved with an enzyme called beta-lactamase that allows them to survive when attacked by those antibiotics.

Currently, three penicillins/ampicillins are marketed in combination with a beta-lactamase inhibitor, but no combinations have been developed with a carbapenem or a cephalosporin. "Industry's been trying to do this for many, many years," Corcoran said.

While the beta-lactamase inhibitor program was developed by MethylGene enzymologists and chemists, the company's main focus is oncology, Corcoran said.

MethylGene is testing its lead candidate, an isotype-specific histone deacetylase inhibitor (MGD0103) in combination with Boulder, Colo.-based Pharmion's demethylation agent Vidaza (azacitidine for injection). Pharmion reported positive overall survival results today from a Phase III study of Vidaza in myelodysplastic syndromes (1 (Also see "Pharmion Vidaza Phase III Shows First Survival Advantage In Patients With High-Risk Myelodysplastic Syndromes" - Pink Sheet, 2 Aug, 2007.)).

"That's actually good news for us, because that's something we've been running in clinical trials together," Corcoran said. "We had about a 30 percent response rate in our trial that we reported at" the American Society of Clinical Oncology meeting in June, he said. MethylGene is studying the combination therapy in MDS and acute myeloid leukemia.

- Shirley Haley ([email protected])

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