Eisai: current focus and pipelines – interview with Gary Hendler

Rebecca Aris interviews Gary Hendler

Eisai

pharmaphorum’s Managing Editor, Rebecca Aris, speaks with Gary Hendler of Eisai on Eisai’s current pipeline, what disease areas it will be focussing on and how its latest epilepsy drug, Fycompa, will be impacting on the lives of those with epilepsy.

Eisai recently announced that it would be transferring the global solid dose manufacturing of its new epilepsy medicine, Fycompa, to its Hatfield site in the UK. This move provides an excellent example of the current positive environment within the life science industry.

To gain a better insight into Eisai’s current pipeline, its disease areas of importance and what Eisai are conducting beyond therapy development to tackle diseases we spoke with Gary Hendler. Gary is President and CEO, Eisai EMEA and Russia. Here he shares insights into the therapy areas that Eisai is focusing on and how Fycompa will impact on those with epilepsy.

Interview summary

RA: What disease areas do you see as important for Eisai moving forwards?

GH: We have always focused in two disease areas predominantly.

The first compound for dementia was Aricept, so we’ve been in the neurodegenerative space for decades. Following that, within the CNS space we have a strong presence in epilepsy, and with the launch of Fycompa we’re going to continue and enhance that presence.

In addition, the company globally, recently entered the oncology market, and we’ve launched our own in-house developed oncology drug for the treatment of metastatic breast cancer. That’s on the market now in America, Europe as well as in Japan. We have a very rich pipeline in oncology.

We’re targeting ovarian cancer with an antibody that we are developing, which is in late stage phase III clinical development. In addition, we’re targeting thyroid cancer with a TKI, also in late phase development.

So the two pillars going forward will be neuroscience, and oncology, as well as potentially immunology in the future.

RA: What activities is Eisai conducting to tackle diseases beyond development of new medicines?

GH: My boss, Mr Naito, always says to us that Eisai doesn’t do corporate social responsibility like other companies. By which he means that rather than give big grants or donations what we like to do is partner with organisations and do drug development for certain diseases.

For example, we’re one of the companies taking part in the London declaration, which was launched in January. In which we are partnering with various stakeholders, including governments, the Bill and Melinda Gates Foundation, as well as other pharmaceutical companies for the development of drugs for neglected tropical diseases.

We have a drug called DEC (diethylcarbamazine) with which we will try to treat lymphatic filariasis, aka elephantiasis. We are partnering with many stakeholders trying to eradicate these diseases by 2020.

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“…previously important markets for us such as Spain really are a problem for pharma at the moment.”

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RA: What do you think Europe can learn from Russia, the ME markets and vice versa?

GH: If you look at the latest published IMS figures for the 12 month period up until June 2012, the European pharmaceutical market is in decline by 1%. Within Europe we have markets in decline at different rates, and previously important markets for us such as Spain really are a problem for pharma at the moment.

This is because of healthcare reform, and different kinds of measures and instruments they’re using to drive down the drug bill.

Part of the reason why we are using the UK as a hub is not only for Europe, but also to expand into the Middle East, into Africa, and into Russia is to try and compensate for the declining market that we’re facing in Europe.

Russia is a very rapidly growing market – it’s growing by about 8%. The UK is growing at 0%. We are lucky to be able to be in a position to be entering the Russian market very soon with our new portfolio. We also will be entering Saudi Arabia, which is another good example of a Middle Eastern market, which we believe has a lot of growth potential.

Strategically having Europe, the Middle East, Africa and Russia, under our responsibility we think that we can ride the storm of austerity through Europe, but at the same time balance our business model by also investing in those new markets.

RA: What difference do you think Fycompa will have on those affected with epilepsy?

GH: Unfortunately, 30-40% of epilepsy patients have symptoms that are not controlled on their current treatment.

The beauty of Fycompa is that it’s a totally new mode of action. All the epilepsy drugs work presynaptically, this drug works postsynaptically.

It gives hope to those patients whose symptoms are not controlled, whose lives are totally dependent on the control of their seizures. These patients are very symptomatic, they can lose their drivers licences and can lose the ability to have employment.

Also this disease has a very negative stigma attached to it. We hope to overcome that negative stigma by trying to offer hope to new patients, through patient education, so that we can help the patient, not only help fight the disease. We think it’s a really important new breakthrough for patients who suffer from epilepsy.

RA: How long has Fycompa been in development, and what challenges has it faced so far?

GH: Fycompa was initially targeted to be developed for multiple sclerosis. For a variety of reasons, in terms of clinical development, Fycompa didn’t make it on to the market for MS. We then moved into Parkinson’s disease with Fycompa, and unfortunately we again did not get the outcomes in the phase III clinical trials that we were hoping for.

This often happens in drug development. With the benefit of hindsight we would have ideally started with epilepsy now that we know the drug works very well in epilepsy.

So it’s been in drug development for a lot of time, it’s cost the company a lot of money, but it’s been worth it, because now we can offer patients who have epilepsy with new hope.

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“…now we can offer patients who have epilepsy with new hope.”

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RA: What plans do you have for further development with Fycompa and the epilepsy disease area?

GH: We’ve started phase III clinical development in primary generalised tonic-clonic seizures. That’s an important group of patients, because no other anti-epileptic has the approval for generalised seizures as its primary indication. That’s going to be a core group of patients who today are primarily getting drugs in the off-label setting to try and control their epilepsy.

The incidence of new epilepsy is low, but when you are diagnosed with epilepsy it’s devastating. So what’s also important for us is to try and get Fycompa to be used as early as possible in the onset of the disease, as a monotherapy.

In addition, in the worst case scenario there are patients who suffer from very severe syndromes of epilepsy. There’s a syndrome called Lennox-Gastout syndrome, which is primarily what happens in young children who have drop attacks. So, when they get a seizure they literally fall to the ground, which is very debilitating and is difficult to treat. That’s another area we would like to develop Fycompa in.

RA: Finally, what else is in the pipeline that can impact on UK facilities?

GH: We have a drug for the treatment of thyroid cancer, it’s a tyrosine kinase inhibitor (TKI), and that’s going to be in the solid dose form, so not an injectable.

Our facility in Hatfield has got the licence for solid dose forms – tableting and capsules, and not for injectables. We’re actually modifying the facility so that the production of the TKI can occur out of this site as well.

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“We’re actually modifying the facility so that the production of the TKI can occur out of this site as well.”

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At the moment we are developing and manufacturing drugs here for neuroscience diseases, and going forward we will expand that into oncology as well. That again comes back to the strategy of the company – to have the two areas of priority for us going forward: neuroscience and oncology, as well as potentally immunology in the future.

If all goes to plan with the phase III clinical trials then our compound known as lenvatinib can also be manufactured here in terms of its solid dose form. That’s in late stage development in clinical trials in phase III already!

RA: Thank you for your time.

GH: Thank you very much for your questions.

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European-CME-Forum-15-16-November-2012

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About the interviewee:

Gary Hendler – President &amp, CEO, EMEA &amp, Russia, Eisai Europe Ltd.

Gary Hendler became President &amp, CEO of Eisai Europe Limited in June 2010. Eisai Europe’s headquarters were expanded to become Eisai Europe, Middle East, Africa and Russia in March 2012. Gary joined Eisai in 2008 as European Commercial Development Director. Before Eisai, Gary spent 18 years at Sanofi Aventis in a series of senior management roles that took him from his native South Africa to the UK, Netherlands and France. He has worked across key pharmaceutical therapeutic areas including oncology and metabolic conditions including diabetes &amp, obesity.

About Eisai:

Eisai recently expanded their UK Hatfield commercial, research and manufacturing facility which now supports the company’s growing EMEA business.

Eisai concentrates its R&amp,D activities in three key areas:

• Neuroscience, including: Alzheimer’s disease, epilepsy, depression

• Oncology including: anticancer therapies, tumour regression, tumour suppression, antibodies, etc

• Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, and inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, Belgium, Luxembourg, the Middle East and Russia.

For further information please visit our web site www.eisai.com.

What next for Eisai?