In another component of an ongoing agreement with Gen-Probe, BioMérieux has paid the company a $4.5 million license fee for the rights to its ribosomal RNA markers, and has promised as much as $3 million more due to Gen-Probe by the end of 2006, according to a Gen-Probe spokesperson.
However, Gen-Probe will recognize only $1.9 million of the $4.5 million payment in the first quarter of 2005, due to accounting rules linking the number of targets to the payment, said Mike Watts. As for the balance of the license fee, “there’s no way of knowing precisely when that’s going to be, but there’s no implication that it would be in the next quarter, either,” said Watts.
“We will keep expanding this on an ongoing basis, so there will be more exercises of rights,” said Jean Deleforge, the company’s manager of business development. License fees from BioMérieux in 2005 may amount to more than half of Gen-Probe’s total royalty and license revenue for the year, the company said.
The French molecular diagnostics company has two additional options left on Gen-Probe’s technology — one due at the end of 2005, and another by the end of 2006 — including at least a few infectious disease organisms, said Watts.
The license BioMerieux optioned relates to five ribosomal RNA targets from different species, said Deleforge. “What Gen-Probe has been doing is mapping a vast number of patents,” he said. Some of these are “basic co-patents” using common rRNA sequences as an RNA analysis marker, but others are directed “toward narrow targets, down to, in some instances one bacterial species,” said Deleforge.
The property on which BioMerieux has options is somewhat fluid. “If you look at it from the wide perspective, the same patent route has resulted in somewhat different claims in different parts of the world, so it’s really difficult to characterize this as a fixed set of claims,” said Deleforge.
The license payment was part of three agreements that the companies originally announced in early October 2004. According to these deals, Gen-Probe agreed to pay BioMérieux to access its blood-clot related property — sequences of genetic mutations in the genes for Factor V Leiden and Factor II Prothrombin. “We think the technology has application in infectious disease, blood screening, oncology, and down the road, in predictive medicine, which is where BioMérieux fits in,” said Watts.
Terms of the agreements also included negotiation rights for Gen-Probe to “develop TMA amplified assays complementary to BioMérieux product lines” for further distribution by BioMérieux, according to the companies.
Also complementary to the BioMérieux markers may be tumor-cell detection technology Gen-Probe licensed from AdnaGen, which isolates cancer cells from healthy tissue using an immunoassay, then subjects the cells to gene-expression analysis. Gen-Probe has exclusive access to conduct molecular diagnostic tests for prostate and bladder cancer using the platform. The company also obtained options to exclusively license AdnaGen’s technology for kidney, ovarian, and cervical cancer, and a three-year right of first refusal for using the technology for breast, colon, and lung cancer tests.
“We’re an infectious disease company, so we have currently at the core of our business bacterial identification, some blood culture bacterial identification, antibiotic susceptibility,” said Deleforge. “That franchise has been growing over the last forty years using traditional culture systems.”
For BioMérieux’s part, the deal seems to follow its trajectory toward becoming a full-fledged clinical molecular diagnostic company. “Our original agreement with Gen-Probe is back in 1997, before we acquired Organon Teknika, and we also signed with Affymetrix at the same time for the same proposals, said Deleforge. “The vision was still to use traditional culture systems, to apply molecular technology to speed up the results, and to grow previously difficult organisms,” he said. The “market shift” has been complete, with the company using molecular technology, and sequences like those owned by Gen-Probe, to identify bacteria Deleforge said.
With the rRNA rights, in conjunction with NASBA methods, BioMerieux plans to expand its infectious disease menu, said Deleforge. “This is our gold standard,” because NASBA uses RNA targets, especially the super-abundant rRNAs, he said.
BioMérieux was founded in 1963 by Alain Mérieux, whose grandfather was a student of Louis Pasteur. The company bills itself as a designer, developer, manufacturer, and marketer of reagents and automated instruments for medical analysis, including pathogen detection.
In 1986, BioMérieux acquired API, a reference in microbe identification and susceptibility testing. Two years later it bought US-based Vitek, which allowed BioMérieux to “complete” its automated microbiological diagnostic range and get a “stronger foothold” in the United States. Finally, in 2001, BioMérieux acquired Organon Teknika, the diagnostics division of Dutch chemical and pharmaceutical giant Azko Nobel.