Millipore last week said that it has licensed and plans to further develop an enzyme-linked immunosorbent assay kit that measures biomarkers linked to axonal injury in tissue, serum, and other bodily fluids in basic research applications from a University of Florida spin-out company.
Although Millipore officially licensed the technology from the spin-out, EnCor Biotechnology, the university will receive half of the undisclosed licensing fee and 8 percent of future royalties because the technology was invented by EnCor’s founder while he was a full-time professor at the school.
In addition, the university may receive a significantly larger royalty if Millipore and EnCor develop the technology into a biomarker-based diagnostic assay that can determine the extent of spinal cord and brain injury and detect axonal degeneration in diseases such as amyotrophic lateral sclerosis and multiple sclerosis.
The ELISA assay was developed by Gerry Shaw, the founder and CSO of EnCor and a professor of neuroscience at the University of Florida College of Medicine; and Brian Pike, a former EnCor employee who now works at the National Institutes of Health.
Before Millipore got involved, Shaw was successfully selling various antibody-related technologies to other shops, including Millipore unit Chemicon, with which Shaw has collaborated for 15 years.
Shaw told BTW last week that EnCor “wasn’t founded to do this particular biomarker stuff. It started with me making antibodies for research purposes in my [UF] research lab, and then gradually getting sick of putting them in boxes and sending them to people and dealing with [companies] like Chemicon.
“That was generating more and more income, but these were just antibodies for cell-type markers – [for example] looking at axons in tissue sections, and neurons and glial cells in tissue culture,” he said.
Because of his lab’s increasing commercial activities, Shaw set up shop in UF’s Sid Martin Biotechnology Development Incubator. “When I went out there, probably the first thing I did there was to develop the [neurofilament] ELISA,” he said.
The assay measures levels of an axonal structural protein component called phosphorylated neurofilament H, or pNF-H, which is upregulated in the blood, cerebrospinal, and other bodily fluids following a traumatic brain or spinal cord injury. It is also upregulated in the presence of a neurological disease characterized by neuronal degeneration, such as ALS and MS.
In December 2004, Shaw and Pike filed a patent application, US No. 20040241762, for the assay, which is still pending.
Although developing the neurofilament ELISA “wasn’t the intention of moving out [to the incubator], it worked out pretty well because I developed it completely outside the university,” Shaw said.
Despite this, the university managed to retain claims to the technology for various reasons, including the fact that Shaw was employed full-time by the University of Florida and EnCor was part of the UF incubator when the assay was invented. EnCor has since moved out of the incubator, set up shop in the Gainesville area, and exclusively licensed back the assay from the university.
According to Shaw, the terms of that license call for the university to get half of the licensing fees EnCor might receive when it licenses the technology to another entity. In addition, the agreement requires UF to receive 8 percent of royalties from sales of any future products based on the assay. Shaw also pointed out that the 8-percent royalty payment will be skimmed off of product revenue generated by Millipore, not from EnCor’s royalties.
David Day, director of University of Florida’s Office of Technology Licensing, confirmed the licensing fee arrangement and royalty rate. The amount of money UF will receive from the deal is unclear; as all parties declined to elaborate on specifics of the deal.
According to UF’s Day, the university retained all rights to the ELISA because Shaw developed it while he was still employed as a full-time professor at the school and only worked at EnCor part time. “The incubator itself does not retain any share of anybody’s intellectual property,” Day said.
“[UF] does benefit pretty well off of it,” Shaw said. “From my point of view, it would be great if I could exploit my stuff completely and independently, and not have the university involved at all. But the university clearly has some kind of claim. Even though the bioassay thing was developed outside the university, they still own the incubator.
“There has to be some kind of accommodation between [UF’s] interests and my interests, and the accommodation isn’t too bad,” he added. “Obviously I have to pay them something. Just ask me again in five years’ time whether it was a good deal or not.”
According to UF’s Day, such tech-transfer deals between universities, spin-outs, and larger companies are becoming more common.
“This is pretty typical and people should understand this as being very fundamental,” Day told BTW. “[Federal], state, and foundation money is very useful in creating fundamental discoveries. However, the Millipores of the world are increasingly not coming into universities and taking that basic science and creating products out of it – it’s just too early for them.
“The art and science of creating new spin-off companies and finding funding for them and licensing the early technologies to them … to develop it further to the point where then a larger company wants it, is increasingly becoming the way of life for universities not based in Boston and San Francisco,” he added.
Five years from now, the deal could turn a tidy profit for the University of Florida: As part of their agreement, Millipore and EnCor will continue to work together to further develop the assay for a number of applications, including as a human diagnostic for axonal injury caused by brain trauma, spinal cord trauma, or disease.
Millipore traditionally lacked biomarker experience, but brought it on board when it acquired Chemicon along with Serologicals last July. The recent deal was a natural fit for Millipore and EnCor because Shaw had a long history of collaborating with Chemicon while it was part Serologicals.
“We work very closely together releasing new products,” Carol Birmingham, senior product manager for antibody technologies at Millipore, told BTW last week. “When [Shaw] approached us with the ELISA kit, it fit very nicely into the traditional Chemicon portfolio.”
According to Birmingham, the “first function” of the kit is “to serve in the research area, which hopefully will then move into more of a biomarker diagnostic assay. Obviously we’ve had tools to study these different biomarkers for many years. Once the word ‘biomarker’ starting being the buzzword of the year, everybody started jumping on the bandwagon, but really we’ve been in that market for a very long time,” she said.
“There has to be some kind of accommodation between [UF’s] interests and my interests, and the accommodation isn’t too bad. Obviously I have to pay them something. Just ask me again in five years’ time whether it was a good deal or not.”
“Now, moving things from the research arena to the diagnostic area is a much bigger task,” she added. “Pretty much to date, everything [for us] has [been] focused in the infectious disease area. But that doesn’t mean that down the road we won’t be pursuing clinical tests in the biomarker area.”
The market potential for a biomarker-based diagnostic of axonal injury is unclear. Another University of Florida spin-out company, Banyan Biomarkers, is developing an in vitro biomarker diagnostic specifically for traumatic brain injury.
According to UF TechConnect, a tech-transfer partnership between UF and the US Economic Development Administration, each year 1.4 million people require treatment for traumatic brain injury, translating into a potential US market of $250 million.
In the case of MS and ALS, no single diagnostic test exists for either disease. According to the National Multiple Sclerosis Society, approximately 400,000 Americans have MS, and about 200 people are diagnosed weekly. The ALS Association reports that based on US population studies, more than 5,600 people in the US are diagnosed with ALS each year, and as many as 30,000 Americans have the disease.
“I think even if it turned out to be useful in only ALS … I think the potential is very high” for a diagnostic, Shaw said. “It just depends on how many different kinds of disease states we could use it for. It may turn out that this is one of the blood tests that people do routinely when they do a yearly test with their MD.
“Obviously if you have symptoms of axonal degeneration, you’d better go have an MRI or CAT scan,” he added. “And the animal tests we’ve done with ALS model mice show that you can detect this protein in the blood before the mice become symptomatic. There’s no reason that shouldn’t translate into humans. That would be the best outcome – that it would become part of a standard battery of blood tests, because that would be gigantic.”
University of Florida’s Day summed up the OTL’s feelings on the potential of a diagnostic as “Go, Millipore, go.”
Day said that the current method of diagnosing ALS or MS is invasive and involves surgery, so if it could be done with a blood test it would be a significant advance.
“We hope that the science continues to work, and that [Millipore] is successful and takes it forward,” Day added. “People pay a lot of attention to the amount of money that universities make off this kind of thing. But we all wake up in the morning and say, ‘This is cool stuff that could make the world a better place,’ and that’s what drives everybody.”