Here's Decode Genetics, a pioneer in the field of personalized medicine, foundering on the rocks of manufacturing...Seems as though if the drug doesn't dissolve at a certain rate, it won't work. The good news is that Decode was able -- before bringing the drug into later trials -- to pinpoint the problem because of the link between genetics and metabolism. It's an excellent example of why more money and time -- not less -- should be spent on the Critical Path to address drug safety issues.
deCode halts trial of heart attack drug
NEW YORK (AFX) - Biotech drug developer deCode Genetics Inc. said Friday it suspended a late-stage clinical trial for a heart attack prevention drug because of a manufacturing issue with tablets supplied for the study.
The company stopped the trial when it found tablets of the drug veliflapon appeared to be dissolving too slowly, which it said would interfere with gauging the drug's effectiveness.
Reykjavik, Iceland-based deCode said it had presented the problem to the U.S. Food and Drug Administration and is exploring alternative manufacturing processes for the drug.
The company may be best known for licensing the genetic information of Iceland's population.
Using the population data, Veliflapon is one of two compounds the company has linked to two genes that encode proteins that could raise the risk of a heart attack. The other compound is in early stage clinical trials.
deCode halts trial of heart attack drug
NEW YORK (AFX) - Biotech drug developer deCode Genetics Inc. said Friday it suspended a late-stage clinical trial for a heart attack prevention drug because of a manufacturing issue with tablets supplied for the study.
The company stopped the trial when it found tablets of the drug veliflapon appeared to be dissolving too slowly, which it said would interfere with gauging the drug's effectiveness.
Reykjavik, Iceland-based deCode said it had presented the problem to the U.S. Food and Drug Administration and is exploring alternative manufacturing processes for the drug.
The company may be best known for licensing the genetic information of Iceland's population.
Using the population data, Veliflapon is one of two compounds the company has linked to two genes that encode proteins that could raise the risk of a heart attack. The other compound is in early stage clinical trials.
