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After 'Fits and Starts,' Tm Biosciences Buy, Luminex Licenses JHU's Cystic Fibrosis IP

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Luminex last week said that it has non-exclusively licensed rights to patented cystic fibrosis genetic markers from Johns Hopkins University for use in cystic fibrosis diagnostic screening kits sold by its recently established Luminex Molecular Diagnostics division.
 
The license is the latest of several similar biomarker-related tech-transfer agreements negotiated with universities by Tm Biosciences, which Luminex acquired in March in order to expand its presence in the molecular diagnostics arena.
 
A Luminex official said LMD will look for more of these kinds of deals as it continues building its nucleic acid-based testing products for genetic testing, personalized medicine, and infectious disease.
 
“We get approached by tech-transfer offices fairly frequently, but generally speaking, LMD is interested in these kinds of biomarkers, genetic discoveries, SNPs, and those sorts of thing that are shown to be related to disease and have clinical utility, as well as discoveries in infectious diseases,” Jeremy Bridge-Cook, Luminex’s vice president of molecular diagnostics, told BTW.
 
LMD’s deal with Johns Hopkins relates to four mutations – 549N, 551D, 553X, and 559T – found clustered in an exon of the cystic fibrosis transmembrane gene, and protected by US Patent No. 5,407,796, “Cystic fibrosis mutation cluster.”
 
Through the license, users and distributors have access to LMD’s Tag-It CF Kits, which simultaneously screens for the 23 cystic fibrosis transmembrane conductance regulator gene mutations, and will also have access to the four polymorphisms described in the patent.
 
Approved in 2005, Tm Biosciences’ Tag-It CF Kit was the first multiplexed human disease genotyping test to be cleared by the US Food and Drug Administration as an in vitro device, according to Luminex.
 
Tm had been discussing licensing the technology from Johns Hopkins before the kit was approved, “but it kind of went through some fits and starts, and false starts, so it took us some time to get going,” Bridge-Cook said. He declined to elaborate.
 
A little less than a year ago, Bridge-Cook said, Tm Bioscience and JHU were on the verge of an agreement for the cystic fibrosis biomarkers, but the deal was again put on hold because of the company’s discussions with Luminex about a possible acquisition, which was announced last December.
 
In March, Luminex closed the acquisition and changed Tm’s name to Luminex Molecular Diagnostics. Following the acquisition, JHU and LMD were able to revisit the licensing deal, which was “more or less the same as was originally set up between Tm Biosciences and JHU,” Bridge-Cook said.
 
“We were happy to be able to finally sign the agreement,” Bridge-Cook said. “Both Johns Hopkins and Luminex took the approach that the deal was pretty much ready to sign, and we would end up really prolonging things if we both decided to reintroduce new terms. Both parties were happy, I think, to just go with the existing agreement, even though there might have been a different approach to the negotiation if it had been Luminex all along.”
 
Specific financial details of the licensing agreement have not been disclosed. However, because Tm Biosciences had been selling the CF kit before it managed to license JHU’s IP, LMD said it would pay the university retroactive royalties for the entire time it had been selling the product.
 

“Both Johns Hopkins and Luminex took the approach that the deal was pretty much ready to sign, and we would end up really prolonging things if we both decided to reintroduce new terms.”

“That was something we had agreed to during the negotiation that I think made JHU comfortable, that we were acting in good faith,” Bridge-Cook said.
 
In addition to retroactive and future royalties in the “single low-digits” range percentage-wise, Luminex also agreed to give JHU an undisclosed “modest” upfront payment, Bridge-Cook said.
 
It is unclear how much revenue the CF kit generates for Luminex and in turn JHU because Luminex doesn’t disclose sales figures for specific products. In an e-mail to BTW, a JHU Office of Technology Transfer official wrote that the school was bound by confidentiality not to discuss the deal.
 
According to the Cystic Fibrosis Foundation, cystic fibrosis affects around 30,000 children and adults in the US and 70,000 children and adults worldwide. Around 1,000 new cases are diagnosed each year worldwide, according to the CFF.
 
In 2004 the American College of Medical Genetics and the American College of Obstetricians and Gynecologists recommended CF carrier screening for all pregnant women.
 
Since then, “the market has grown quite dramatically,” Bridge-Cook said. “I would say that the growth of CF testing has slowed down somewhat, but it is a market that is still growing fairly significantly.”
 
Bridge-Cook also said that the CF kits are “by a fairly significant margin” LMD’s biggest-selling products. Other offerings from the Luminex division include an Ashkenazi diagnostic assay panel, which tests for eight different disease genes commonly seen in that population; and “a number of products on the market and in development in the area of pharmacogenetics,” Bridge-Cook said.
 
LMD also expects to launch a respiratory viral panel, which detects 19 different respiratory viruses and subtypes, sometime in the near future.
 
For most of these products, LMD has signed licensing agreements with universities or non-profit research institutes for a number of the pertinent biomarkers.
 
“There are very few products that we sell, if any, that don’t have licenses to one or more sets of biomarkers,” Bridge-Cook said. “I would say that the number of biomarkers that are being discovered in companies might have increased over the last five years, but generally speaking, products like these diagnostics based on biomarkers are often licensed from universities.”

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