Patient Centric - Pharmaceutical Executive


Patient Centric
Five years ago, in the race to deliver Gleevec, Novartis leaders glimpsed what a pharma company could be. Today, across the company, theyre putting that experience to work.

Pharmaceutical Executive

The approach is simple and focuses resources on innovative drugs, but it has its own risks, which Fishman discussed in a recent speech. "There are two major concerns expressed about this approach," he said. "The first is that this kind of focus may abandon diseases in which there is a large unmet medical need but for which there is scant understanding of mechanism, for example, clinical depression. Our approach does not rule out these kinds of diseases. Indeed, by refocusing on mechanism we are accelerating the growth in knowledge needed to drive these diseases toward treatment."

A second objection is that the approach will favor "small- market" diseases, such as cystic fibrosis, where sales may not ultimately repay the cost of research and development. "There are two answers to this objection," Fishman said. "The first is that the market likely will tolerate a high price for any truly innovative drug that treats an unmet medical need. But the more compelling answer is scientific. Genes and proteins do not work in and of themselves, but only in the context of a dynamic, four-dimensional environment—physiology. The intricate molecular dances of these elements can be described in terms of a few dozen highly conserved molecular signaling cascades, or 'pathways.'... [T]hese pathways are also used for different purposes in different physiological settings in the same organism. Thus, diseases that would present in the clinic as entirely different entities may be closely related at the level of the molecular pathway."

Whether the theory works as a practical management tool is a question for tomorrow. Today, Novartis finds itself in an enviable position with regard to R&D. It has 79 products in development, 61 of them in Phase II, III, or registration. The number of projects in clinical development grew 44 percent from 2000 to 2003. Average development time has fallen by 25 percent. And the company had 12 novel compounds approved by FDA in the past four years.

"They are unmatched when it comes to developing products," says Michael Muyot, president of Tracer Analytics, a strategic intelligence company. "Their pipeline success ratio and productivity are great. Also, because they didn't fall into the industry consolidation trap, they've been able to focus on organic growth, unlike some other companies that are still getting over big acquisitions or mergers."

Tracer has developed proprietary metrics for comparing pharma companies. One looks at the "momentum" of prescription drug portfolios, tracking such factors as breadth and concentration of product lines and commercial age over a five-year period (ending with estimated figures for 2006). "Novartis was number one in momentum," says Muyot. "It's a very exciting story, and I don't believe they're getting the message out to the investment community enough."

Jörg Reinhardt, head of pharma development, describes Novartis' goal: "We want to keep a balance between specialty care and primary care. We do not want to be a pure primary- care company. We want to be highly innovative, with real first-in-class compounds that will treat significant medical needs."

Reinhardt points to some highlights of the pipeline:

PTK 787 is a VEGF inhibitor that is being developed for colorectal cancer. "It has a method of action different from Roche's Avastin [bevacizumab]," says Reinhardt. "It's a small molecule that is active after oral intake, not a monoclonal antibody that has to be injected like Avastin. And it blocks not just one version of the VEGF receptor but all five." PTK 787 is in Phase III trials for both first- and second-line treatment.

Novartis was first to enter Phase III with a drug in an attractive new class of diabetes drugs that inhibit the enzyme dipeptidyl peptidase IV (DPP-IV). Novartis' compound, LAF 237, is in Phase III; half a dozen other companies are working on compounds in the class, the furthest along being Merck's MK-0431. "The interesting aspect of this class," says Reinhardt, "is that the compounds not only affect blood glucose and insulin release, but they may also have a disease-modifying effect in the cells in the pancreas that produce insulin."


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