Personalized Care - The Next Pharmaceuticals Growth Area
Personalized Medicine Prepared By Edmund L. Valentine September 2, 2009
We are now at the beginning of the emergence of personalized care as the next growth wave of pharmaceutical care -- much the same way that we were entering the growth area of biotechnology in the late 1970s and early 1980s. Personalized medicine has been discussed since at least the early 1980s. MMC’s observation is that it generally takes about 30 years for an idea to move to the first commercial product; an additional ten years for the development of an industry comprised of a number of new products; and ten more years to move towards commoditization of the industry.
We are seeing major advances in biomarkers, gene therapy and regenerative medicine. Technologies, government, industry and philanthropic group funding, formation of various associations, changes in reimbursement, expected changes in regulatory reviews, changes in clinical development (Model Trials), investments by select industry players, and a move to pay-for-performance are all coming together to herald personalized medicine. The transition will initially be slow; but the pace will increase exponentially. The transition will be product and disease specific. The industry will not change overnight. However, it is a trend that must be understood, and where appropriate, invested in.
Drug approval agencies, including the FDA and EMEA, are encouraging greater use of biomarkers and diagnostics in drug development and prescribing decisions, thus promoting the concept of companion diagnostics for drugs. More conclusively, both the FDA and EMEA now require that biomarker testing be performed prior to prescribing certain drugs. In addition, the FDA recently started reporting a table of genomic biomarkers, which will be updated quarterly, which it considers “valid” to guide the appropriate clinical use of approved drugs. We are at the start of the process. Of the 28 biomarkers listed on the FDA website in March 2009, only four are “required” to be tested prior to deciding on the use of a companion drug: CCR5-Chemokine C-C motif receptor for Selzentry (Pfizer’s anti-infective); Epidermal growth factor receptor (EGFR) expression for Erbitux (Bristol-Myers Squibb’s Colorectal cancer drug); Her2/neu over-expression for Herceptin (Genentech’s breast cancer drug); and Philadelphia chromosome-positive responders for Sprycel (Bristol-Myers Squibb’s leukemia drug).
Roche is developing new tests designed to improve disease management, with a focus on tests for risk stratification and prediction of treatment response. Genentech has marketed several targeted therapeutics, including Herceptin, Avastin and Tarceva, for which a number of diagnostic tests are used to support prescribing decisions. The EMEA played a key role in requiring biomarker testing for Amgen’s Vectibix, following the FDA’s accelerated approval without specific testing requirements. The EMEA has a larger number of drugs, versus the FDA, for which biomarker testing is required.
Roche, Pfizer and Merck were the most active companion diagnostics deal makers between 2004 and 2008. Personalized medicine played a key role in at least three of the top ten diagnostic deals in 2008: 1) the purchase of Innogenetics by Solvay (Werner Cautreels, the CEO of Solvay Pharmaceuticals spent most of his career in research and development), 2) Cypress and Proprius (Cypress, whose lead pharmaceutical candidate is being developed for fibromyalgia, plans to use its pharma sales force to promote both therapeutics and personalized medicine laboratory services to rheumatologists and other pain specialists.), and 3) AviaraDx was acquired by bioMerieux as an investment to promote its vision of personalized, predictive medicine for the treatment of cancer. Twenty-one of the 45 companion diagnostic deals announced between 2004 and 2008 were for cancer diagnostics.