Leaping the hurdles

By Huw Thomas, Editor

As patents expire and pipelines are pressured, Lundbeck's Peter Høngaard Andersen talks to Huw Thomas about working to stay at the front of the R&D race.

“So what we’ve done is made a project system where the empowerment and responsibility is pushed very far out in the organization. The way we do it is that we make a deal with everyone at least once a year on what are they allocated of resources and budget”
-Peter Høngaard Andersen, Lundbeck

Peter Høngaard Andersen has been in the pharmaceutical business for nearly 25 years and has witnessed some major changes in the industry. Perhaps one of the most visible of these has been the shrinking amount of independent pharma companies. “When I started my career there were small companies everywhere,” he says. “The most striking difference is the consolidation you’ve seen taking place, and that’s going to continue.”

There is a new division in the focus areas of many companies, some concentrating on research and innovation while others pursue possibilities in generics. Asked why he thinks such a split has taken place, Andersen’s response is that it comes down to survival. “If you want to survive as a small sized pharmaceutical company you have to be very specialized,” he says. “The only way you can exist in the long run is if you can innovate and deliver specialized product into your focus area. I think the competition these days is so harsh that that’s the only way.”

Andersen started his career in the pharmaceutical industry with Novo Nordisk, where he worked for thirteen years in different positions, the last four of these as a project manager in the metabolic disease area. In 1997 he joined Acadia Pharmaceuticals as Vice President a position he held until he joined Lundbeck. He explains that this diversity of roles has helped prepare him for his current position.

“It’s striking how different the approaches to the issues we’re dealing with can be and the methodologies you have to use. It’s been quite a learning experience to actually work in a different therapeutic area. Also, working as a project manager requires you would say a different set of people skills than in my current role. When you’re a line manager you have the power of hiring and firing people whereas as a project manager you can only make them walk in the same direction by inducing passion in them. That was also a very big learning experience, and an experience that I brought forward and I use a lot in my present job. As innovation is one of our key challenges it’s so important that you really make an environment where people are engaged. Engagement of our scientists is key really for success here.

“So what we’ve done is made a project system where the empowerment and responsibility is pushed very far out in the organization. The way we do it is that we make a deal with everyone at least once a year on what are they allocated of resources and budget and what we expect in return, and then we don’t really interfere with what they’re doing. They can come back to management to use us as coaches and make discussions but we don’t really interfere with what they’re doing but we have a contract what they should deliver. That’s the way it works.

Major changes

Andersen’s time at the company with some big developments. Staff numbers have grown from around 1000 to over 5000 and a series of new product lines have been introduced. Andersen breaks it down into three distinct phases. “The first phase was very much focused on building up the R&D organization to ensure the output we needed for the future,” he continues. “The second phase centred on delivering projects in order to ensure our pipeline for the patent expiring of Ziprolex. The third phase, which we’re in right now, is really to turn the organisation around and meet the challenges of the future. We have called this third phase the 20/20 challenge.”

And make no mistake, this is quite a challenge. The company has suffered some major setbacks in its pipeline, with a number of big projects running into trouble. “We have seen the termination of the Carboxidone sleep medication, we have seen the failure of Dismodiplace in phase three and we have seen Difipronox, which we decided not to file in Europe,” Andersen explains. “Obviously these three products if they had succeeded would have fuelled a very aggressive growth period for Lundbeck in the next year or so and onwards, and that’s obviously not going take place. This has meant that we had to adjust our expectations for the future quite considerably and aggressively look for additional licensing opportunities in the world around us.”

Such a disappointment has obviously had a substantial impact on the research organisation. A lot of effort has already been expended in exploring licensing opportunities and the due diligence process so it is reassuring to hear that the opportunity to salvage some of the work is still possible. Both the Dismodiplace and Difipronox projects are going to continue with adjustment to the development programmes, while even Carboxidone is still being evaluated. “ Everybody in the industry is doing this,” Andersen explains. “If you evaluate carefully and pursue a different focus projects can still continue. In all three cases we have done this very detailed evaluation and are continuing with the projects. We haven’t reached a conclusion yet.”

Regardless of these hurdles, Lundbeck remains committed to pursuing innovation. By the end of 2008 the company will have spent around 20% of its revenue on R&D. “We’re a strong believer that innovative products are the future for us and for any serious pharmaceutical company,” Andersen explains. “It’s also very clear that the requirements to get on the market today both from a safety and efficacy point of view are steadily increasing. In order to meet these challenges we’re seeing a heavy investment in R&D is a prerequisite for really continuing as we want, which is a high growth company. Sometimes the budget is less than 20%, sometimes it’s more.”

Main focus

The central nervous system has long been one of Lundbeck’s main areas of interest, the company developing drugs to counteract depression and schizophrenia as far back as the sixties. More recently, efforts have been stepped up to counteract what Andersen sees as a lack of significant breakthroughs: “The head of the US National Institute for Health has been quoted saying that the biggest reason we aren’t making progress is because psychiatrists and neurologists do not have a sufficient, solid background in biology. Contrary to a lot of other areas where we have been digging into the basic science of the diseases, we really don’t know much biology here.”

To remedy this situation, Lundbeck has been moving in fresh directions and seeking out new sources of knowledge. A key spoke in this strategy has involved partnering with top academic institutions that have experience in cutting edge biology areas. The ultimate aim is to access novel compounds which could both prove profitable for the company and provide help for patients whose disease are not currently very well treated. Andersen tells us about one of the biggest partnerships, with Mayo Clinic in Florida: “The collaboration is around looking into very basic biology questions in neurodegenerative diseases and the hope we have with this is to get insight into the diseases and thereby information about new targets we could input into our pipeline. The collaboration started last year and will be running for three years with the possibility for extension.”

So what next for both Lundbeck and the industry? The looming difficulty for everybody in the pharma space is that of patent expiry. “ We have our old in house challenge coming up from 2012 to 2014, which is the expiring exclusivity for Ciprolex and Ibetza,” says Andersen. “Obviously it’s critically important for us that we progress our pipeline and hit the market in due time before this happens.” Despite this tough task, Andersen displays a commendable level of optimism. “With what I’ve seen of data from the pipeline right now I’m confident that we’ll make this, and I’m also confident that the profile will be accepted in the market,” he continues.

But it is not only getting new drugs ready for sale that is a potential stumbling block. There also need to be actual demand for these products. With so many different drugs available, it is essential that companies produce something people really want. “What payers would like to see is new drugs coming out that are offering a major advantage, both clinically but also from a health economics perspective,” Andersen confirms.

But the future still holds much possibility. For Andersen, one of the most exciting areas of research is at the genetic level. “ The human genome came out early this century and what you’re seeing the last couple of years is that the biology around the genome is now starting to flourish,” he says. “If you follow the academic literature there’s a lot of new opportunities coming up these days, where I think we can jump in and really turn these advances into good drugs. It has taken a few more years than everybody expected from when the genome became public, but I think that’s a really big opportunity for the industry.”

Peter Høngaard Andersen is EVP of the Research organization. He is responsible for Lundbeck’s research and for delivering new development candidates for clinical development.

Andersen joined Lundbeck in 1999 as Director of Biological Research. In November 2003 he was appointed VP of Research and Chairman of the Board of Directors of Synaptic Pharmaceuticals (now Lundbeck Research USA, Inc.). He started his career in the pharmaceutical industry with Novo Nordisk A/S where he worked for thirteen years in different positions, the last four of these as a project manager in the metabolic disease area. In 1997 he joined Acadia Pharmaceuticals as VP a position he held until he joined Lundbeck.

He is member of the Scandinavian Society for Psychopharmacology, Collegium Internationale Neuro-Psychopharmacologicum (CINP), American Society for Neuroscience and several other international scientific societies. He is reviewer on a number of international journals. He also serves as Chairman of the Board of Directors of BRIC, and is a member of the Committee on Research Policy of LIF.

Making your mark

Peter Høngaard Andersen outlines the work Lunbeck has been doing in the field of biomarkers.
Using biomarkers is basically utilising biological tools one way or the other to either diagnose the patient or see if the patient is going to respond to your treatment. It’s an area which is pretty advanced in certain cancer areas, but in the central nervous system we’re still in the Dark Ages.

Lundbeck started work in this area a few years ago. As we obviously have some resource limitations with the size we have, we decided to focus primarily on mood disorders and we have established collaborations with all the major institutions in the world involved in this area. When we started, my expectations were that it would take 10 plus years before this would ever have an impact on what we were doing and the way we saw the patients. But the first data is starting to come out now and our best institutions are having a hard time handling the amount of data we’re generating.

We are starting to see a picture appear, which makes me believe that within the next five to 10 years we may start to be able to diagnose certain types of mood disorders from a biological perspective. If we can do that it’ll be much easier to give them a rational treatment resulting in a better response for the individual. That’s our hope at least.

Strength in numbers

Peter Høngaard Andersen explains Lundbeck’s alliance with Takeda
I have previous experience of Takeda collaboration from my old Novo Nordisk days and had very positive experiences. We’re now working with them to develop and commercialize a portfolio of novel compounds for the treatment of mood and anxiety disorders. As I had expected had this collaboration has panned out very positively. They’re extremely efficient, very aggressive, and the good discussions we have are moving forward at a very high speed.

The reason why we decided to go into this collaboration was because we could see that our mood disease area would also have a major part of their market share via GPs. Here Takeda was very strong in the US and had a GP sales force, and that’s been the key driver behind finding a partner for these compounds. So I think the details on the commercial part of the agreement were published but basically the arrangement is that Takeda will have the GP part of the sales in the US and Japan and we’ll have the specialty sales in these areas.

Lundbeck: the edited highlights

1915 – Lundbeck founded as a trading company
1924 – Begins selling medicines and cosmetics
1937 – Lundbeck moves from trading into becoming an organic chemical manufacturer. Introduces Epicutan, the company’s first original medicine
1950 – Begins to focus research on substances that affect the central nervous system
1965 – Fluanxol is introduced for treatment of mild depression, schizophrenia and psychoses
1972 – Citalopram is invented, forming the basis for Lundbeck’s future success and expansion
1996 – Serdolect is launched in 17 European countries
2005 – Azilect is launched for the treatment of Parkinson’s disease