While most proteomics companies have their sights on the multi-million dollar drug in the sky, a few firms are making the case that the low-hanging fruit — diagnostic protein markers — might be just as worthwhile a goal. Using proteomics technology, both Matritech of Newton, Mass., and Syn X Pharma of Toronto have discovered disease markers and successfully marketed them to partners, in return for hard cash.
Matritech has chosen to focus on cancer diagnostics, while Syn X, which eventually plans to develop drugs, has been working on stroke, diabetes, Alzheimer’s, and cardiovascular disease.
For Matritech, a diagnostics company, revenues from cancer diagnostic products are just as promising as those for drugs, with less investment required: “What we call it is a pharmaceutical-like market in size,” said president and COO David Corbet. “The upside for us is that our clinical trials cost maybe half a million dollars. A pharmaceutical clinical trial in cardiovascular [disease] costs $150 million.” His company’s discovery and product development costs are a few million, he said, a factor of at least 10 lower than for drugs, and he thinks that the chances for success are much higher.
Syn X Pharma’s COO Rod Wilson echoes the view that the route from proteomics to diagnostics is more straightforward than that to drugs: “The earlier products, I think, are going to be diagnostics because the regulatory hurdles for getting it onto the market are much lower,” he said.
Last month, Matritech announced a partnership with Mitsubishi Kagaku Medical, a division of Mitsubishi Chemical, to develop a mass spectrometry-based breast cancer test for Matritech’s NMP66 serum marker. Although the contract has yet to be finalized, “it is certainly our goal with all of our partners for NMP66…to receive not only upfront and milestone payments, but also a percentage of the revenues associated with offering these tests,” said Corbet. The next step, he said, will be a small-scale validation study, followed by a clinical trial in Japan. After this, Mitsubishi intends to offer the test to women in Japan. Corbet said Matritech is looking for similar agreements with partners in the US and in Germany: “We are working hard with a handful of the top US reference labs, and we are nearing our first US deal.”
Also, in anticipation of a trial this US partner would perform, Matritech has already collected about 1,000 samples from US breast cancer patients, Corbet added.
Two weeks ago, the company also announced an exclusive distribution agreement with Cytogen to market its FDA-approved test for bladder cancer, based on a marker called NMP22, to US physicians. The marketing contract “has the potential to generate $25 million for Matritech in minimum product purchases over five years,” according to a company statement.
These deals are the fruit of Matritech’s long-standing discovery efforts in cancer diagnostics, which started with a technology for isolating nuclear matrix proteins licensed from MIT. Realizing that serum-based markers are more amenable to mass cancer screening than tissue-based assays, Matritech, which has approximately 60 employees to date, switched its technology about four years ago to serum analysis using liquid chromatography followed by Ciphergen’s SELDI mass spectrometry.
Most recently, the company decided to start using Bruker’s mass spectrometers instead, and to develop the actual diagnostic test on a mass spec platform. “We can get it to market quicker, particularly in the United States, by transferring our mass spec method” to a reference lab than by developing an immunoassay, said Corbet. “It chops off a number of years.” While the lab develops the sample preparation method, Matritech focuses on the separation and protein identification steps, and Bruker develops the analysis software, he said.
Like Matritech, Syn X uses proteomics in its discovery — including multi-dimensional chromatography as well as 1D and 2D gels, combined with a variety of mass spectrometers — and focuses on biomarkers in blood for the diseases it targets. But unlike Matritech, Syn X eventually plans to develop drugs. Revenues from diagnostics, it hopes, will keep it afloat to finance these efforts.
So far, this strategy has panned out: Syn X recently announced a licensing agreement with Ortho-Clinical Diagnostics, a Johnson & Johnson company, to exclusively market and distribute an immunoassay based on Syn X’s glutamine synthetase marker for Alzheimer’s disease worldwide. In return, Syn X will receive a “significant” upfront payment, followed by milestones and a “high single-digit royalty on commercialization,” said Wilson. Furthermore, Syn X will make the assay format compatible with Ortho-Clinical’s existing technology, in exchange for a payment of $1 million.
But the company has more in the works. Two weeks ago, it announced that it had received a US patent for a congestive heart failure (CHF) test that combines two markers. Syn X is planning to sell a CHF point-of-care device, which it will launch at a conference in Germany this month, through its European distribution network early next year, and is seeking a distribution partner for the US, according to Wilson. It is also looking for a partner to license the technology for use in central lab equipment, he added.