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Astellas VP-Business Development Masaki Doi: An Interview With “The Pink Sheet” DAILY (Part 2 0f 2)

This article was originally published in The Pink Sheet Daily

Executive Summary

Exec talks about emerging markets in Asia, and how Astellas’ culture differs from other Japanese pharmas.

"The Pink Sheet" DAILY visited recently with Astellas Pharma VP-Business Development Masaki Doi at the company's headquarters in Tokyo to talk about the Japanese pharma's global licensing strategy and the changing paradigm of Japanese deal flow. This is the second of a two-part interview. The first part is available 1 (Also see "Astellas VP-Business Development Masaki Doi: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)" - Pink Sheet, 9 Mar, 2007.) .

"The Pink Sheet" DAILY: Another recent deal that has generated interest is the one with Theravance for the antibiotic telavancin. That also was a deal that eventually expanded, this time into a global deal. Can you tell us about how Astellas views the importance of that deal?

Masaki Doi: That's another successful deal we have cut since Astellas [was founded]. That compound is kind of a leftover opportunity for Theravance after they made that famous deal with GSK.

So again, with the first European and the U.S. deals, that team worked very closely and was very successful. And we have now agreed to expand that to a global deal. We believe the compound is a great compound and is very promising in that sector of antibacterials, and we are looking forward to launching that.

[Theravance submitted an NDA for telavancin with FDA in December (2 (Also see "Theravance’s First NDA Is Antibiotic Telavancin" - Pink Sheet, 8 Dec, 2006.)).]

"The Pink Sheet" DAILY: Astellas recently signed a deal with Kirin Brewery to develop and market a fully human anti-CD40 monoclonal antibody for organ rejection associated with organ transplantation. Can you talk a little bit about that deal and what it means to Astellas?

Doi: The meaning of that deal to us at Astellas is a huge one because that is in the transplant/immunology area, which is one of the prime franchise areas of us. We keep seeking compounds which can take over our post- Prograf position. Anti-CD40 is one of the pathways by which we can suppress not the whole rejection, but only immunological reaction selectively to the antigens we have to suppress.

[The Astellas/Kirin partnership is a global deal with undisclosed up-front payments and milestones (3 (Also see "Astellas’ Once-Daily Prograf Receives Mixed Decisions For Three Prophylaxis Claims" - Pink Sheet, 24 Jan, 2007.)).]

"The Pink Sheet" DAILY: If you had to highlight a deal that maybe hasn't gotten the same level of media attention as FibroGen or Theravance, what would it be?

Doi: All of our other deals are very promising deals. For instance, we have an interesting deal with Toyama Chemical. It is only a Japanese deal, but one compound is already filed in Japan and very close to the market. And the Theravance compound, too, is very close to the market in the United States.

Another compound is Amevive , which we purchased from Biogen Idec. It's a protein drug, already launched for psoriasis. It has supplemented well our dermatology franchise in the United States.

[Astellas paid Biogen $60 million, plus royalties, to purchase Amevive (alefacept) (4 (Also see "Astellas Buys Amevive From Biogen Idec" - Pink Sheet, 3 Apr, 2006.)).]

And one unique compound that is not very well recognized is ILY101, licensed from Santa Clara, Calif.-based Ilypsa. It is a second-generation Renagel - a phosphate binder - but it can absorb phosphate far more efficiently than [Genzyme's] Renagel (sevelamer), so that it improves both compliance and the adverse event profile. We are highly excited about that compound.

"The Pink Sheet" DAILY: During your BIO-Asia talk, you noted that it could be challenging to manage relationships with partners who may reside 6,000 miles away. How does Astellas achieve this goal?

Doi: When I raised the point about 6,000 miles, I was trying to send the signal that it doesn't matter. Our colleagues work very closely together, faxing, e-mails or holding conference calls almost every day in all areas of the collaboration - clinical development, protocols, formulations or even commercial aspects.

What is important for alliance management is continuity of the relationship and continuity of a deep understanding of the biotech companies.

And I think we like to understand the agenda of the partner, [for example] what are the concerns of their CEO and where such concerns could impact the deal, who are the key persons on their board, who are the [trickiest] VCs and managers on the board. And that kind of background knowledge has to be taken over completely by the Astellas organization....

To do that, we in [business development] have to be kept involved either in the form of alliance management, or the person who negotiated the deal should be kept involved as part of the project team, or called in by the project team whenever an issue pops up.

"The Pink Sheet" DAILY: How focused is Astellas on developing markets in Asia, like China and India, when looking for deals?

Doi: We have a very strong focus on the developing countries in Asia. We have a department that is in charge of those developing territories. And on top of that, of course, we have our subsidiaries in many countries, including China, Taiwan, Korea, the Philippines, Malaysia, Thailand. We do not have any subsidiaries in India yet.

"The Pink Sheet" DAILY: Are these subsidiaries looking for deals with local R&D companies?

Doi: Yes. But, of course there are no local R&D companies in the Philippines and Malaysia. But they are looking for deals in China, for instance.

"The Pink Sheet" DAILY: Have you done deals in China?

Doi: No, not yet.

"The Pink Sheet" DAILY: But are you looking into it?

Doi: Yes. And sometimes an Indian company comes to me with an R&D compound.

"The Pink Sheet" DAILY: What are your priorities for doing deals in the next five years?

Doi: We are looking at the territories [which are a] priority for Astellas, which obviously starts with the United States, where we would like to expand both our platform and pipeline. The reasons for this are obvious. The United States is the fastest growing market in the world.

"The Pink Sheet" DAILY: There have been several mergers of Japanese pharma companies, most recently the merger between Mitsubishi Pharma and Tanabe. Would Astellas consider doing another, bigger merger with another Japanese company?

[Mitsubishi Pharma proposed a merger with Tanabe Seiyaku on Feb. 2 worth a reported $4.3 billion. The deal is expected to close Oct. 1 (5 (Also see "Mitsubishi, Tanabe Merge To Accelerate International Business Development" - Pink Sheet, 2 Feb, 2007.)).]

Doi: My personal bias is that we could be selective. In other words, we might talk to them if they talk to us.

"The Pink Sheet" DAILY: Assuming the Mitsubishi-Tanabe deal closes in October, will the combined company mean additional competition for Astellas on the deal front?

Doi: I don't think so. Our strong point in cutting deals is that we are fast and decisive, serious and diligent.

"The Pink Sheet" DAILY: How are you able to be fast and decisive? Is that something that comes from your management structure?

Doi: This may be part of it. And the other thing is the culture. Even you might see all the Japanese companies as having a [similar] culture. But the culture at Astellas is different.

"The Pink Sheet" DAILY: So Astellas has a culture that fosters quick decisions?

Doi: Yes, we can make quick decisions. I am fortunate to be working in, and to enjoy, that kind of culture.

If you look at the track record, not all Japanese companies can cut 10 deals in 14 months.

"The Pink Sheet" DAILY: Ten deals in 14 months?

Doi: Fourteen months, yes. More precisely, the first deal we announced after the merger was the Theravance deal for the United States and Europe, which occurred in November 2005. In that sense ... it has been 14 months to January 2007 when we made the CD40 deal with Kirin.

The 10 deals include deals with Theravance, Xenoport, Ferring, Toyama Chemical, IBL, Biogen Idec, Illypsa, FibroGen and Kirin. But we count it as two deals with Theravance, because one was the Japanese deal.

- Joshua Berlin ([email protected])

[Editor's note: Recent stories in this series include interviews with Cephalon CEO Frank Baldino (6 (Also see "Cephalon CEO Frank Baldino: An Interview With “The Pink Sheet” DAILY" - Pink Sheet, 9 Jan, 2007.)), Genentech VP-Business Development Joseph McCracken (7 (Also see "Genentech VP-Business Development Joseph McCracken: An Interview With "The Pink Sheet" DAILY (Part 2 of 2)" - Pink Sheet, 20 Oct, 2006.)) and Shire Specialty Pharmaceuticals President Mike Cola (8 (Also see "Shire Specialty Pharmaceuticals President Mike Cola: An Interview With “The Pink Sheet” DAILY (Part 2 of 2)" - Pink Sheet, 17 Jan, 2007.)).]

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