Pharm Exec Q&A: Japanese Wedding - Pharmaceutical Executive


Pharm Exec Q&A: Japanese Wedding

Pharmaceutical Executive

Look at Astellas. Fujisawa was an Osaka-based company, and Yamanouchi is in Tokyo. In the United States, Fujisawa was in Chicago, and Yamanouchi was in New Jersey. When they integrated, they expected that a lot of people from New Jersey would move to Chicago. And that didn't happen. I used to work at Searle in Chicago, and I knew it wouldn't happen because people from New York aren't moving to Chicago, and Chicago people aren't moving to New York. And it's much the same way between Osaka and Tokyo. They lost a lot of people they thought they wouldn't have.

We didn't have that challenge because both companies are based in Tokyo. And both US sites are in New Jersey. Now, we lost some people because the sites were an hour away—and in traffic, that's not easy. But 65 percent of the Daiichi people joined Daiichi Sankyo—and we're pretty happy with that.

As Daiichi and Sankyo integrate, all eyes remain focused on prasugrel. When did you first realize the drug's effectiveness?

Shortly after I joined Sankyo, the research group asked me to review a compound that they were considering for licensing, CS-747. The preclinical development work was truly impressive. The team had completely described the metabolism of CS-747 and also of Plavix (clopidogrel) —which wasn't published—and outlined the potential differences. They also described the results of a Phase I study where they found volunteers that didn't respond to clopidogrel while all of the volunteers responded to CS-747 in terms of platelet aggregation. At this point in time, the variability of response to clopidogrel was not widely recognized in the cardiology community. This study showed the potential.

We're now co-developing prasugrel with Lilly, which is in Phase III in the midst of a 13,000 patient trial. We hope to file that by the end of next year. Plavix is about $6 billion in sales. We certainly believe [prasugrel] will be a strong competitor to Plavix.

What were some of the issues you considered in developing a head-to-head study with prasugrel and Plavix?

We didn't have much choice. It was clear that for the most important indications, Plavix was already approved. We thought that a head-to-head comparison would be the best way to show the potential superiority of prasugrel.

We conducted comparative cross-over studies, which suggested that prasugrel provided higher, faster, and more consistent effects than clopidogrel. Also in a Phase II study that we conducted, there was a trend in the reduction of the incidence of major cardiovascular adverse events in favor of prasugrel.

Daiichi developed Plavix in Japan. Can it be part of prasugrel development?

No. We must maintain a "firewall" so potentially critical information is not exchanged between the companies. Sankyo in Japan is in charge of the prasugrel development.

Looking forward, what are your biggest challenges?

We're now combining the organizations in the United States and Europe. That's all gone extremely well. The R&D integration in Japan will be completed next April and that's where a lot of our focus is now.

Growing Big, Staying Small

For the last decade, Joseph Pieroni has presided over Sankyo's commercial operations. Recently, he was named president of the newly formed entity, Daiichi Sankyo. Here, Pieroni offers his perspective on the merger, and the challenges of managing during an integration.

On Building Scale

Joseph Pieroni, President of Daiichi Sankyo
When Yamanouchi and Fujisawa came together, it was definitely eye-opening. It led to the natural question, "Is this a good thing?"


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