FDA, late Friday, approved Daiichi Sankyo and Eli Lillyâ€™s Effient (prasugrel), a blood thinner designed to lower the chance of blood clots in patients undergoing angioplasty. The drug received a black box warning from the get go, warning doctors of an increased risk of bleeding. However, the fact that the two companies now have a competitor against Bristol-Myers Squibb and Sanofi Aventisâ€™s blockbuster Plavix (clopidogrel bisulfate) is a huge boon, even if it is geared towards only a small share of Plavix users.
Pharm Exec talked to Daiichi Sankyo President and CEO Joseph P. Pieroni on Monday to learn more about the drug.
Why was this drug necessary?
If you look at antiplatelet therapies, there has been an evolutionâ€”starting from nothing, to aspirin, to Plavix. The feeling is that antiplatelet therapy can be improved upon and that was the intent of the very large 13,000 patient study, which showed an incremental benefit in preventing future heart attacks, strokes, and death in patients undergoing PCI. The feeling was that there was room for improvement.
In what situations is it best used?
People who undergo surgery for a stentâ€”whether itâ€™s a bare metal stent or a drug eluting stentâ€”face the very good chance that without an antiplatelet therapy (APT), they are going to get restenosis, which means that the stent closes up or there is a heart attack, death, or stroke. Virtually everyone going for a PCI is on aspirin and Plavix and they usually continue on it for up to a year. Otherwise they run the risk of having blood clots again.
This was an attempt to measure the difference between our product versus Plavix on top of aspirin.
How does Effient differ from Plavix?
Itâ€™s not that different. They are both antiplatelet therapies. Plavix is a very good product, but these drugs need to be metabolized into an active form. So when you take both Plavix and Effient, then arenâ€™t active until they are metabolized in the body. There are certain geno types, which prevent Plavix from being metabolized and that ranges from 30 percent in Caucasians to up to 60 percent in Asiansâ€”they are non-responders. In the case of Effient, that phenomenon does not existâ€”virtually every patient is able to metabolize the drug into its active form.
Is that something you were looking to do from the start?
Early on, we looked at platelet aggregation. From the first study that we didâ€”before we embarked on the large phase III studyâ€”we saw that there were certain poor metabolizers. We did a crossover study and treated them with Effient and noticed that 100 percent of patients had achieved platelet aggregation. That gave us the encouragement to go into the very large phase III study.
How did the partnership with Lilly come about?
It goes back 8 years. At the time, Plavix hadnâ€™t even demonstrated advantages over aspirin. In this field, there were a couple of failures in other categories that were expensive clinical programs costing hundreds of millions dollars. We just felt that to partner with a company like Lilly was a smart move to do to share the risk and embark upon the partnership. Daiichi Sankyo discovered the treatment in partnership with our research partner UBE Industries.
Speaking about risk, the drug has come under fire from FDA and is receiving strong labeling from the get go. Do you think the warnings are fair?
I think every antiplatelet product, including Plavix, has its fair share of warnings. Whenever you introduce a more potent antiplatelet, you are going to reduce the risk of future heart attacks and stroke but there is a chance in certain patient subtypes that you could get excessive bleeding. It doesnâ€™t come as a great surprise. There are two major subsetsâ€”the elderly and people with low bodyweightâ€”which we need to be careful about, and it is reflected in the labeling.
Are you continuing with any studies?
When a person goes to the hospital with crushing chest pain or acute coronary syndromeâ€”about half the time they get a stent and the other half of the time they are sent home without the stent, but they still have the condition. Thatâ€™s what we call ACS treatment. We have embarked upon a study called Trilogy, which studies people who go home from the hospital but yet need antiplatelet therapy because they are at great risk of heart attack, stroke, and death.
Have you started your marketing plan for Effient?
DTC probably will come later if we decide to do that, but we wonâ€™t do that initially. We want to make sure that physicians have the first shot at understanding the drug and be exposed to the drug. We do think that it lends itself to DTC. I think there is some sense to it, because people need to be aware that long â€“term antiplatelet therapy is really necessary for people with ACS.
Which physician population are you trying to reach?
There are three very important audiences we are trying to reach, because this is a stent procedure. The first is the interventional cardiologistâ€”the hospital based cardiologists that actually do the stents. Then when the patient leaves the hospital, they either go back to their office based cardiologist or their primary care physician, so the sales forces from DS and Lilly will be targeting all three of these audiences. You just have to make sure that patients stay on therapy for the extended period of time otherwise they are at risk.
What are the risks of not taking an APT?
The risk is that you get restenosis, which means that the stent becomes blocked again and you have the problem all over again. Even though that happens in a relatively small percentage, itâ€™s generally fatalâ€”50 percent of time people die. People can also go on to have heart attacks, death, and stroke. The study we ran showed that over a one-year period, we were able to reduce by 19 percent, the incidents of stroke, death, and heart attack.
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