Casting about for Profitable Indications

Pharmaceutical companies are in it for the profit, and one of the ways they look to maximize profits from a drug they have patented is to find new indications for a slightly altered and therefore newly-patent-protected variation on an old medication. Sometimes this works. Sometimes it doesn’t.

Consider the case of ISTA Pharmaceuticals, a manufacturer of eye medications, and their flagship product to date had been Xibrom, a twice-daily non-steroidal anti-inflammatory drug (NSAID) solution that is used by cataract surgery patients to reduce inflammation and speed healing. Xibrom’s patent expired in January 2009. However, the company recently capitalized on a reformulated version, Bromday, designed for once-a-day use and capable of providing similarly good results. However, the patent for Bromday expires in 2013, at which point ISTA seems to be out of tricks for this drug.

Or are they? ISTA is trying to find a new indication for a slightly reformulated version to treat the profitable condition du jour, dry eyes. Everyone is trying to get into the dry eyes market, one of the most common eye conditions for which there is not a standard treatment available. The market for dry eye treatments is already $1.7 billion and is expected to grow at least 10% per year until at least 2014, with a potential for reaching $2.4 billion, according to some estimates. That’s some serious scratch, so of course any sensible drug company is going to jump on the opportunity if it has some potentially effective drug under patent.

ISTA moved to third phase clinical trials of its new dry eyes medication Remura in 2010. Positive results from the phase II trials made them hopeful, but when the results came back from the phase III clinical trials, it was found that the drug did not perform better than placebo. Sophisticated statistical analysis showed that the drug actually did give some level of response for “conjunctival staining” (red eyes) when used at the highest dose for women aged 51-70. In other words, the trial is viewed as a total failure.

So ISTA’s stock prices took a dramatic dip (28%), despite a press release that blamed the failure of the study on a “dramatic” placebo response. And the company is looking for some other way to use this drug to make money.

The profit-driven nature of the pharmaceutical industry is another good reason to consult with a doctor about your medications rather than trusting claims or marketing material by the company itself. If you are looking to find the best treatment for your eye condition, please contact a local ophthalmologist today.