Tm Bioscience licenses key P450 pharmacogenetic marker from Epidauros

By E. Janene Geiss

Philadelphia, March 14 - Tm Bioscience Corp. announced Tuesday it has signed an agreement with Epidauros Biotechnologie AG for a co-exclusive commercial license to Epidauros' patents on a specific biomarker related to the P450-CYP2D6 gene.

Only one other company has a license to this genetic marker, and Tm Bioscience and Epidauros have negotiated an agreement whereby no other licenses for this variant will be granted in the future, according to a company news release.

"This licensing agreement puts Tm in the exceptional position of being one of only three companies, including Epidauros, in the world with the right to use this genetic marker," Greg Hines, president and chief executive officer of Tm Bioscience, said in the release.

The company said CYP2D6 is one of the most important markers in pharmacogenetics critical for identifying the second most frequent variation in the CYP2D6 gene in Caucasians.

This marker occurs in 8.4% of the Caucasian population and can lead to changes in the function of the enzyme implicated in the metabolism of 25% of the most commonly prescribed drugs, officials said.

Roche Diagnostics includes this marker in its AmpliChip CYP450 test cleared for in vitro diagnostic use in the United States and European Union, officials said.

Under terms of the agreement, Tm said it will provide an upfront signing fee and royalties on its commercial sales of P450 Tag-It tests that include this biomarker.

The agreement covers the CYP2D6 -1584C greater than G variant which allows the important discrimination between the CYP2D6(x)2 and CYP2D6(x)41 genotypes.

While CYP2D6(x)2 is associated with normal drug metabolism, CYP2D6(x)41 is associated with reduced drug metabolism, which can lead to an increased risk of possible overdose or adverse drug reaction. The (x)41 allele is the second most frequent allele in the CYP2D6 gene in Caucasians, occurring with a frequency of 8.4%, officials said.

Tm Bioscience is a Toronto biotechnology company specializing in pharmacogenetics, which is the application of genetic testing to identify an individual's response to a specific drug. The company is commercializing a suite of drug metabolism tests with initial products focused on the P450 family of enzymes, which affect the metabolism of more than 50% of all drugs.

Epidauros is a Bernried, Germany, pharmacogenetics company that investigates the genetic factors influencing a person's response to a drug in order to make drug development and therapy safer and more efficient.

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