With the patent cliff, growing research costs and increasing trial timelines, there are plenty of risks associated with pharmaceutical drug research and development. Perhaps there's something to learn from previous missteps with drug launches.
With the patent cliff, growing research costs and increasing trial timelines, there are plenty of risks associated with pharmaceutical drug research and development. And yet, once a company has approval, the risks don’t stop.
Although only a small percentage of experimental therapies actually get approved, these drugs still face the risk of a failed drug launch. There have been plenty of blockbuster drugs with solid hits, but there have also been the Provenges.
Now that the patent cliff has hit, many pharmaceutical companies have large pipelines so they can build up franchises again. They would do well to learn from previous missteps. FiercePharma listed its top 10 drug launch disasters. The majority are pricey cancer drugs that payors balked at paying for.
Here are the top five.
Condition/Disease: restless leg syndrome
Sales: $1.6 million in the third quarter of 2012
Unlike the rest of the top five, Horizant’s trouble didn’t stem from cost. Instead, it was the partnership between GlaxoSmithKline and XenoPort. When sales were much lower than expected the two companies turned on each other before finally going their separate ways.
Company: Human Genome Sciences
Sales: $59 million in 2011
Price: $35,000 for a year of treatment
One problem was that physicians were hesitant to prescribe the drug because of the cost and the feat that they would be on the hook until reimbursement came through.
Condition/Disease: colorectal cancer
Sales: 7 million euros in the third quarter of 2012
Price: $9,600 a month
Sanofi had a second drug in the top 10, so it’s familiar with development risk. The problem with Zaltrap was that it was quite expensive. Providers didn’t like that there were less expensive alternatives that were just as good.
Condition/Disease: prostate cancer
Sales: $228 million in 2011
Price: $93,000 for the treatment
While Provenge's sales weren't bad, they fell far short of Dendreon's forecast of $350 million. Plus, Johnson & Johnson's Zytiga has become a popular alternative. Although, Zytiga is approved for use after chemotherapy fails, physicians have been prescribing it for off-label use in earlier stages of the disease, causing J&J's drug to increase market share, while Provenge's stagnated. Lastly, oncology drugs always have large price tags and physicians were concerned about reimbursements.
Company: K-V Pharmaceuticals
Condition/Disease: preventing premature birth
Sales: $5.1 million in revenue for the final quarter of 2011
Price: $1,500 a dose
Overall the cost for a full course of treatment is $30,000, yet a string of compounding pharmacies were already making this therapy for a lot cheaper — just $10 to $20 a dose.
To see the full list and more about the drugs, click here.