Wednesday, August 3, 2011

The Life Cycle of a Drug: New Indication

Referring back to the bar graph in my earlier post, a second profitable strategy is developing a new indication. In medicine, an indication is defined as a valid reason to use a medicine. There are many examples, and that of Cimzia just happened to catch my eye today. The FDA approved it for people with Crohn's disease, but in 2009 the company also received approval for the treatment of rheumatoid arthritis. One reason UCB Pharma sought approval of Cimzia for this second indication is that the market for drugs to treat rheumatoid arthritis is much larger. "UCB is also developing Cimzia® in other autoimmune disease indications"

 A new indication can also be developed for drugs that are not protected by a patent. Finnish researchers screened 5,000 candidates in a relatively inexpensive manner looking for any that would inhibit the growth of prostate cancer cells in the laboratory. They found that monensin, an antibiotic used in the dairy industry, inhibited the cells. Next they discovered that monensin plus anti-androgens already in use for prostate cancer treatment were even better together in inhibiting cancer cell growth. These are just the first of many steps before monensin can be declared safe and effective for use in humans.



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