Novartis ($NVS) has admitted that sales of the vitreomacular adhesion (VMA) drug it licensed from ThromboGenics (EBR:THR) have failed to live up to expectations. And while various theories have been put forward to explain the drug's relative lack of commercial success, Novartis thinks part of the issue dates back to clinical trials.
|ThromboGenics CEO Dr. Patrik De Haes|
ThromboGenics and Novartis have both previously posited that below-par sales of Jetrea were linked to the fact that it takes time to change surgeons' habits. Leuven, Belgium-based ThromboGenics has also admitted it may have underestimated what it would take to market the drug to U.S. surgeons. Both these arguments are still valid, but Novartis has now tied the difficulty the partners have faced with the product to a more fundamental problem: The Phase III data weren't great.
"I think it's just fair to say [Jetrea has] been below expectations. I think part of that's driven by the Phase III clinicals--the patient selection didn't screen out--so the efficacy was on the order of 25% to 30%," Jeff George, global head of Novartis' Alcon unit, told investors on the company's fourth quarter results call. In two Phase III trials, Jetrea resolved 27% of VMAs within 28 days, compared to 10% for the placebo. George said real-world efficacy ranges from 50% to 90%, depending on the surgeon.
Novartis now doubts Jetrea will ever hit the commercial highs that were forecast a few years ago, an admission that caused ThromboGenics' stock to drop by 6.5%. The Belgian biotech is looking to a real-world study that is due to report top-line results this quarter to bolster its case for Jetrea.
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