Millennium Predictive's Outcome
Executive Summary
Millennium Pharmaceuticals' new collaboration with Roche Diagnostics to develop prognostic and therapeutic information products in rheumatoid arthritis is notable as being only the second molecular diagnostics discovery deal involving the delivery of targets to a large diagnostics company (the first being Millennium's Becton Dickinson deal in cancer). But the news behind the scenes is that Millennium has also quietly re-integrated two of the three programs in its Predictive Medicine subsidiary, setting the stage for the roll-out of a major, web-based personalized medical information play, most likely by year-end.
The three-year deal between Millennium Pharmaceuticals Inc., together with its wholly owned subsidiary, Millennium Predictive Medicine Inc.(MPMx), and Roche Diagnostics to develop prognostic and therapeutic information products (Diagnomics) in rheumatoid arthritis [See Deal] is notable as being only the second molecular diagnostics discovery deal involving delivery of targets to a large diagnostics company (the first being Millennium's deal with Becton Dickinson & Co. in oncology [See Deal]). But the news behind the scenes is that, without fanfare, Millennium has reabsorbed two of the three programs comprising MPMx, setting the stage for the rollout of a much different platform for Predictive Medicine, most likely by year-end.
According to MPMx president Ken Conway, as of January 1, the Diagnomicsand pharmacogenomics components of MPMx have been reintegrated into the parent company as a department of predictive medicine, including screening, staging, and patient monitoring programs and tests. Going forward, MPMx itself will focus exclusively on developing a broad and deep portfolio of patient management products and services, which Conway says could include web-based tools, information, and diagnostic tests, and will not be limited to programs in which its parent, Millennium, has an interest.
In effect, Conway wants MPMx to be the company that validates other people's information—a high-throughput integrator of knowledge that will offer a Good Housekeeping seal of approval in personalized medicine. And for that he expects to get a piece of the action, when that action is based on the information MPMx supplies. The cut could include a royalty on the drug or diagnostic used, a referral to specialists or labs, even a cut of the long-distance phone call the prescribing physician makes.
Although he says it's too early to discuss the details of what MPMx does and does not want to do, Conway has in the past frequently said that a personalized medicine information play must change a course of action in the practice of medicine in order to succeed. "If a strategy doesn't do that," he states, "it doesn't meet our hurdle." An example of such a change in action could be involving consumers and turning them into payors for their own otherwise uncovered care.
Because he believes patient/consumers will pay for this information, the web will be a big part of MPMx's play. It'll therefore need to bring in software people to integrate information and commercially available expert systems, and "work with the Oracles of the world" to customize data. "A seamless integration," notes Conway, is what will make the concept useable." And consistent with Millennium's long-standing strategy to leverage its resources, MPMx may buy services from the parent company, and fund some internal research.
MPMx will also need the expertise to be able to vet clinical information and products, possibly running independent retrospective clinical trials. For example, when a novel pharmacogenomics test is published in a major medical journal, MPMx may decide to validate the result across thousands of patients. "Now, it may take ten years from the time of such a publication before patients get the benefit. We'll do it much faster" than the drug company, he believes, and in the process educate academics and physicians. In essence, he says, MPMx wants to shift the time it takes clinical information to percolate from drug-company time (decades) to biotech time (years) to web timing—minutes. And Conway expects pharmaceutical companies will gladly pay for the knowledge MPMx will supply for use in discovery, development, and marketing. Some of the earliest programs, he suspects, will be marketing tools, including supplying real-time information on prescription patterns.
To be sure, the MPMx plan has gone beyond the "testing the waters" phase. "This won't be a small company," Conway asserts. "Originally, MPMx was organized to leverage Millennium's capabilities. Then we found it could be a $350 million business. Now, we want to see if it can be a big company." Millennium has already effectively seeded the venture, and MPMx will seek strategic partners for implementing the database component of the business, as well as consider equity investments by companies with differentiated product lines. Labs and diagnostics companies could be collaborators, as could companies that are already involved in educating physicians about the tools of personalized medicine, such as genotyping.
MPMx's first objective is to validate its assumptions about revenue sources with beta tests to see, for example, if a physician, a drug firm, or a consumer will in fact pay for certain information. "We don't need the infrastructure to do that," Conway says; surveys will suffice, including one to measure consumers awareness of the availability of certain tests. "Take women at risk for cardiovascular disease: If you ask 100 wealthy women at risk if they'd pay for a test for Factor V Leiden [a hereditary resistance to activated protein C linked to increased risk of venous thrombosis], I'd be surprised if even two knew that test is currently available. That's the kind of feedback we need."
One of the biggest challenges for MPMx may be establishing who gets what cut of revenues, and deciding who is best suited to run the business in its commercial form, which has yet to be determined. "I anticipate ego issues as well as dollar issues," Conway suggests. "The company that succeeds may be the one that figures out how to share the credit."