Potential Stalevo Cancer Link. Last week’s announcement that the U.S. Food & Drug Administration (FDA) was investigating Stalevo for a possible link to prostate cancer has proven to be a drag on the stock price of Finnish drug maker Orion.
According to a Reuters report, last Thursday Orion share were the third most-traded in Helsinki in pre-holiday trade, falling a whopping 10.9 percent.
Orion makes around a third of its total revenues from its key Parkinson’s drugs Stalevo and Comtan, distributed by Swiss-based Novartis (NOVN.VX), with half of the sales coming from the U.S. Last year Novartis reported global sales of $554 million for ‘Stalevo’ and Comtan, Reuters said.
The FDA announced the Stalevo review last Wednesday night.
Data from a long-term clinical trial, known as STRIDE-PD
According to the agency, data from a long-term clinical trial, known as STRIDE-PD, unexpectedly found that a greater number of patients taking ‘Stalevo’ had prostate cancer compared to those taking carbidopa and levodopa (sold as Sinemet), a combination medication used to treat Parkinson’s disease.
Nine out of 245 males had prostate cancer in the study’s Stalevo group compared to two out of 222 males in the carbidopa/levodopa group. The incidence rate of prostate cancer was 14 cases/1,000 patient years for ‘Stalevo’ and 3.2 cases/1,000 patient years for carbidopa/levodopa.
According to Reuters, both Orion and Novartis aid they were working with the FDA as it evaluates the data from STRIDE-PD.