Pharma’s Next Big Thing: Personalized Medicine

By Lisa LaMotta  DEC 08, 2009 2:30 PM

Who's who in the world of pharmacogenomics.

 


One size definitely does not fit all, so why should one drug treat every patient with a certain disease?

Frankly, it shouldn’t. And the pharmaceutical industry is waking up to that fact.

Some pharma companies are beginning to make headway in tailoring medicines to the individual -- a smart move considering the industry stands to benefit by the billions of dollars.

According to a report released Tuesday by PricewaterhouseCoopers, pharmacogenomics -- or personalized medicine -- is already a $232 billion industry with the potential to grow by 11% annually, into a $450 billion business by 2015. Companies that make pharmaceuticals, medical devices, and diagnostics currently represent about $24 billion of the overall industry and can expect a rate of growth of 10% annually. The rest of the market is comprised of companies in telemedicine, health information technology, disease management services, as well as nutrition and wellness.

Pharmacogenomics determines the differences in every individual through the identification of certain proteins, genes, and metabolic indicators, and then uses those specific markers to customize drugs, determine specific courses of treatment, identify diseases in the early stages, and better modify drug dosages.

Personalized medicine is a great scientific achievement that could change the way the world receives health care, but it also means a major shift in the way the pharmaceutical industry does business. Big Pharma has already recognized that the days of blockbuster drugs that make a few billion dollars annually are over, and many of those drugs will lose patent protection in the next couple of years. Now, the sector is focusing on smaller niche drugs that will be more effective for the patient populations they treat instead of appealing to a mass market.

“Instead of getting a relatively small share of a really large pie -- the traditional blockbuster model -- a tailored therapy could expect to claim a relatively large share of a more segmented pie,” said Eli Lilly (LLY) chairman John Lechleiter. “Repeat prescribing and patient compliance almost certainly would occur at a higher rate -- further supporting the economic case. The net results, in terms of sales, actually look quite favorable.”

Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY), the makers of the blockbuster blood thinner Plavix, had to face the reality that one of the best-selling drugs in the world (it brought in $4.5 billion in the first nine months of 2009) may not be effective in 30% of patients due to an abnormally functioning CYP2C19 gene that doesn’t metabolize the drug properly. The Plavix label was revised in May 2009 to reflect this and help doctors who are prescribing the drug to patients. Plavix isn’t the only blood thinner that's been affected by the personal touch. Warfarin, a widely used blood thinner, also isn’t responsive in certain patient populations that expressed certain genes, causing some patients to be at severe risk of bleeding. But ineffectiveness or adverse drug reactions could become a thing of the past if more patients were required to take genetic tests -- often a one-time deal that would cost between $300 to $800.

But the area that could stand to get the biggest boost from personalized medicine is oncology. Cancer drugs and chemotherapy are often only effective in 50% of the patients they're prescribed to, according to ScientiaAdvisors. "Certainly we can do better than 50/50," said former Eli Lilly chairman Sidney Taurel at Arizona State University luncheon in 2008. Taurel, who stepped down from Eli Lilly late last year, has been one of the major proponents of the personalized medicine movement.

And some companies are already trying to bridge that gap: In 1998 Genentech (now part of Roche) got approval for the cancer treatment Herceptin. The drug is only given to people whose genetic test show that they have an over-expression of the protein HER2, which is an indicator of an aggressive form of breast cancer.

Novartis (NVS) now tests for a protein mutation called BCR-ABL to determine if its chronic myeloid leukemia drug Gleevec will be effective in patients. Those patients that have a prevalence of the protein will respond better to the drug.

The PWC report says that the reason oncology drugs are at the forefront of personal medicine is because “the diagnosis of cancer is almost always based on a biopsy” and “subsequent examination of cells or tumor tissue is also common.”
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