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Astellas: Ten years young

Ken Jones and Sef Kurstjens on the company's progress and plans
Ken Jones

As a company Astellas can trace its roots back to the late 19th century and the 1894 foundation by Tomokichi Fujisawa of Fujisawa Shoten, an Osaka-based business whose biggest product was initially a form of camphor used as an insect repellent.

Tomokichi Fujisawa provides one half of Astellas' origins. The other can be found in the form of Kenji Yamanouchi, who founded the company that bears his name - Yamanouchi Yakuhin Shokai - in 1923, also choosing Osaka for its operational base.

Fast-forward to 2005 and the merger of the two companies to form Astellas, and we find ourselves at an ideal vantage point from which to look back over the firm's first decade of operations and hear from two of its senior executives on where Astellas is heading.

First, looking back, the last ten years have been a time of growth for the company, which three years ago moved its European headquarters to a larger site just outside London. In Europe sales rose 18.5% in 2014 and the region has been of increasing importance to Astellas.

“Ten years ago no one knew who Astellas was - they knew who Fujisawa was, and they knew Yamanouchi. Some even thought we were going to be called Fujiyam or Yamafuji,” says Ken Jones, president and chief executive officer of Astellas' EMEA operations. It meant one of the company's first priorities was to get its name known among the healthcare professionals it wanted to talk to about its products. With that hurdle out of the way Astellas has managed an impressive strike rate when it comes to its pipeline.

“In Europe we have been launching a product almost every single year,” notes Ken, pointing to products such as the overactive bladder (OAB) drug Betmiga (mirabegron) - the first of a new class of OAB treatments to emerge in over 30 years, the antifungal Mycamine (micafungin) and the anti-infective Dificlir - the first new treatment in 50 years for clostridium difficile or c. diff.

Alongside these launches the company has been moving into the oncology arena, adding to its legacy interest in urology from Yamanouchi and Fujisawa, and transplantation, where it has Prograf (tacrolimus) as well as a once-daily formulation in development as the brand Advagraf (tracrolimus extended release capsules).

Its efforts to date in oncology have seen it form a prostate cancer franchise on the back of Eligard (leuprolide acetate) and more recently Xtandi (enzalutamide). With Xtandi the company is both following a traditional oncology development route of moving it further and further up the treatment paradigm, while also looking at the drug's application against other androgen receptor-driven tumours. There it is currently conducting a series of investigations in breast cancer to assess Xtandi's potential. Meanwhile, the company has Levact (bendamustine) for chronic lymphocytic leukaemia, non-Hodgkin's lymphomas and multiple myeloma, giving it broader interests in the area. Commenting on Xtandi in prostate cancer, Ken says the drug has “driven our growth and really put us steadfast for the future in terms of being able to continue to grow”. 

It's not all been plain sailing for Astellas in oncology - a couple of candidates, notably rilotumumab, have fallen by the wayside in gastric cancer - but it continues to expand its research interests in a targeted way.

“We're trying to focus on where we know we can compete and where we can make a difference. It's easy to get distracted, and we're trying to stay focused - that's probably why we've done better than the market in overall performance in the last 10 years,” says Ken.

He adds: “We're used to being the new kids on the block and people usually underestimate us, which is okay - we don't go around beating our chests, we just get focused, do what we're supposed to do with humility, and focus on the patient and the unmet need.”

We're used to being the new kids on the block and people usually underestimate us ...which is okay

He says that a lot of other companies have got themselves involved in areas that have proved to be a sideshow to the main event - “now they're dealing with the repercussions”.

In contrast Astellas has, Ken says, deliberately avoided being diverted. “Our strategy has been around being a global category leader, which is really focusing on very discrete areas where we want to be market leader and be competitive and not try to be all things to everybody.”

Astellas Sef Kurstjens

The company also seems to manage to pull off the tightrope act of remaining focused while having a diverse portfolio. Chief medical officer and president of global development Sef Kurstjens explains: “Some of the diversity we get is through one effect - that we have a global portfolio, as well as a regional portfolio. And specifically the competence we had in Japan affords us the ability to do deals with other companies that are still not established in Japan.”

One of those companies keen to tap into Astellas' local knowledge has been Amgen, which signed a co-development and co-commercialisation deal with the Japanese firm in 2013. With the partners gearing up to launch Amgen's PCSK9 therapy for hypercholesterolemia - a class of drugs that is top of many peoples' minds - it's an approach that seems to be paying off. Repatha from Amgen was the first in the class to be approved in Japan in January, although it will likely only be months before Sanofi's rival Praluent will join it on that market.

 “One of our strengths is that we're quite flexible in how we do our deals,” says Ken. “So we've got global deals. We've got single region deals. We've got multiple region deals. So we're a flexible partner depending on what people are looking for. And one of our core strengths is actually our Japanese component being a company in Japan for over 100 years and then having expertise in certain scientific areas as well. So that gives us that flexibility.”

The flexibility is, Ken says, an important point of differentiation for the company, with variety seen in its portfolio on national, regional and global levels. “We're not dependent on one blockbuster to survive, and that's our key strength,” he adds.

We're not dependent on one blockbuster to survive, and that's our key strength

Given the uncertainty often seen in drug development, Sef reaches for a gambling metaphor to further the point, likening the company's approach to 'spreading its bets' across different geographic areas and with a different portfolio. 

It's obviously an approach with more than a few moving parts to it, and it's one that Astellas looked to fine-tune not so long ago with a formal 'research reshaping' effort in 2013. “One component of that was sort of structural and philosophical changes to how we manage things,” says Sef. “Our research organisation, which is primarily based in Tsukuba, outside Tokyo, in Japan, became a lot more therapeutic-area aligned and a lot more empowered in terms of decision making.”

“In other words, just to create an innovative environment that inspires scientists to do things and make decisions, as opposed to being very much beholden to what does each line do and where does it come together, so an important philosophical shift.”

The other part of the strategy was to embrace external innovation. “We had set up what's called an Astellas innovation management group that looks to secure the 'best science, best time, best place'. So not everything has to be done now, and part of that has been collaboration with academic institutions or other small biotechs.” Based in Redwood City, California, this innovation team is actively looking at opportunities and is largely staffed by people with expertise in areas such as research, partnerships and biotech.

In addition to innovation, the project also has a significant element of future-scoping, Sef says. “We have a legacy, an expertise in urology, transplantation and the associated immunology space, and are establishing an oncology portfolio. But where are the future therapeutic areas? Where do we want to play in 10 to 12 years' time?”

The two new areas the company has publicly said it will be focusing on are ophthalmology and muscle disease, along with the further development of some internal compounds in ophthalmology.

But partnerships, as is so often the case, will be key, and it's got a deal with Harvard Medical School looking at gene therapy for retinitis pigmentosa as one potential option, while in muscle disease Astellas is working with Californian clinical-stage biopharmaceutical company Cytokinetics, looking at mechanisms for improving muscle strength.

Ken concludes: “Innovation doesn't have any borders anymore, does it really? You need to go where it is, and it could be anywhere in the world. We don't have to do everything inside the company.”

Article by
Dominic Tyer

is PMGroup’s editorial director

18th February 2016

From: Sales

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