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Telaprevir Development: Beating the odds (of new drug development)
 
 
 
 
Steven Syre | Boston Capital By Steven Syre Globe Columnist / December 25, 2009
 
Here?s the problem with every promising new drug that pops out of a lab: There are a million ways to fail before any treatment completes the testing and clinical trials required for commercial approval. Hope springs eternal, but the odds stink.
 
As in every other year, in 2009 there were encouraging small developments at Massachusetts life sciences companies looking for new ways to treat serious illnesses. Curis Inc. and Infinity Pharmaceuticals Inc., to highlight just a couple, both seemed to make real progress with difficult problems treating cancer. The two Cambridge companies have big pharmaceutical industry partners, but they are a long way from having anything like an approved cancer-fighting drug.
 
For my money, the year?s most encouraging story about the development of medical products that can really help people isn?t new at all. In fact, it feels like it?s been around forever.
 
Vertex Pharmaceuticals Inc., of Cambridge, is working on lots of things, but everyone is paying keen attention to the company?s Telaprevir treatment for hepatitis C. Telaprevir appears to offer a dramatically better way to treat patients with a serious disease. The promise, in a nutshell: less pain and suffering, much higher success rates, and faster results.
 
A lot of people could benefit - more than 3 million in the United States suffer from hepatitis C, a liver disease spread mainly through contact with the blood of infected patients. Globally, that number balloons to 170 million.
 
Nothing dramatic happened in the development of Telaprevir in 2009, but Vertex pushed forward on clinical and financial fronts to prepare for a new drug application in the year ahead. There were no unexpected setbacks as Telaprevir entered the development home stretch.
 
A series of final clinical trials involving 2,200 patients were launched in 2009. Meanwhile, Vertex produced good new data about the convenience of the drug and its ability to attack the toughest cases.
 
The current treatment for hepatitis C, an antiviral pill combined with alpha interferon, drags on for nearly a year, with side effects that can be debilitating. Success is a 50-50 proposition, at best, and there is little in the way of incremental improvement. You're cured or you're not.
 
Telaprevir is a protease inhibitor, given to patients as a pill along with the conventional treatment. Results from clinical trials so far suggest a treatment timeline of 24 weeks, half the standard duration, cures about 80 percent of patients. That would boost the current success rate by at least half.
 
The progress of Telaprevir has been slow, even by drug development standards. News about its potential has been widely reported for nearly five years. Though Vertex plans to seek approval for Telaprevir next year, it probably won?t be on the market until 2011.
 
The pokey pace has been caused by the length of the current hepatitis C treatment. Each clinical trial of Telaprevir is compared with standard treatment given to some patients. That means waiting 48 weeks, plus another six months to see what happens to patients after treatment.
 
But the news, while slow to develop, has been consistently good. Among the new data this year, Vertex showed that two daily Telaprevir pills instead of the standard three did not hurt the results. The drug also did well among the toughest group of patients - those who did not respond at all to a previous round of standard treatment.
 
Vertex has been gearing up to bring Telaprevir to the medical market for a few years now, and that takes money. Clinical progress helped the company raise more than $750 million in two separate stock sales this year.
 
Vertex shares are up 42 percent in 2009, but the idea shareholders will ride Telaprevir to continued riches is questionable. Other competitors are far along in the development of their own hepatitis C treatments. The big money may have been made by investors whose shares quadrupled to $45 in a year by spring 2006 on the earliest hopeful news about Telaprevir. Nearly four years later, Vertex shares are worth $43 each.
 
I don?t know what is in store for shareholders, but there?s no doubt prospects are improving for so many patients who could benefit from the drug. In 2009, Telaprevir was the most hopeful story to come out of a local industry built on medical hope.
 
Steven Syre is a Globe columnist. He can be reached at syre@globe.com.
 
 
 
 
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