Leaping the Hurdles

As patents expire and pipelines are pressured, NGP finds out how Lundbeck’s Peter Høngaard Andersen is working to stay at the front of the R&D race.

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 number of independent pharmaceutical companies. "When I started my career there were small pharma companies everywhere," he says. "The most striking difference is the consolidation that has taken place. I think that's going to continue."

There is a new division in the focus areas of many companies, with some concentrating on research and innovation, while others pursue possibilities in generics. This can be due to the fact that these two areas require different skill sets, but it can also come down to survival, as Anderson points out. "If you want to survive as a small pharmaceutical company you have to be very specialized. The only way you can exist in the long run is if you can innovate and deliver specialized products into your focus area, because the competition and demands these days are so harsh."

Andersen started his career in the pharmaceutical industry with Novo Nordisk, where he worked for 13 years in different positions, latterly as a project manager in the metabolic disease area. In 1997 he joined Acadia Pharmaceuticals as Vice President of Drug Discovery, 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 work in a different therapeutic area. Working as a project manager also requires 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 building passion in them.

"That was also a very big learning experience, and an experience that use a lot in my present job. As innovation is one of our key challenges it's so important to make an environment where people are engaged and passionate. The engagement of our scientists is key really for success here.

"What we've done is make a project system where the empowerment and responsibility is pushed very far out in the organization. We make a deal with everyone at least once a year around what they will deliver if they are allocated defined resources and budgets. When this deal has been agreed, we don't interfere with what they're doing, although they can come back to management to use us as coaches and/or discuss relevant issues. "

Major changes

Andersen's time at the company has coincided with some big developments. Staff numbers have grown from around 2500 to over 5000 and a series of new product lines have been introduced. Andersen breaks the changes in research 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 to secure our pipeline for the patent expiries in 2012-2015. The third phase, which we're in right now, is to turn the organization around to meet the challenges of the future. We have called this third phase the 2020 challenge."

And make no mistake, it 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 our sleep medication gaboxadol, we have seen the failure of desmoteplase in phase three, and then there was bifeprunox, 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, and but that's not going to take place. We have had to adjust our expectations for the future quite considerably and aggressively look for additional licensing opportunities."

Such a disappointment has obviously had a substantial impact on the company's research organization. A lot of effort was put into exploring licensing opportunities, so it is reassuring to hear that there is still an opportunity to salvage some of this work. Both the desmoteplase and bifeprunox projects are continuing with adjustments to their development programs, and even gaboxadol is still being evaluated.

Regardless of these hurdles, Lundbeck remains committed to pursuing innovation. By the end of 2008, the company will have spent around 20 percent 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 as a prerequisite for being a high growth company."

Main focus

The central nervous system has long been Lundbeck's main area of interest, with the company developing drugs to counteract depression and schizophrenia as far back as the 1960s. More recently, efforts have been stepped up to counteract what Andersen sees as a lack of significant breakthroughs, "Elias Zerhouni, the former director of the US National Institutes 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," he says, pointing out that the reason Dr. Zerhouni led a major reform of the translational and clinical research system in the US was because there has not always been enough interaction between people working in the clinical and molecular areas.

To remedy this situation, Lundbeck has been moving in fresh directions and is seeking out new sources of knowledge. A key element of this strategy has involved partnering with top academic institutions that have experience in cutting-edge biology and a solid link to the clinic. The ultimate aim is to identify novel targets that could both prove profitable for the company and provide help for patients whose diseases are not currently very well treated.

On one of the biggest partnerships, with the Mayo Clinic in Florida, Andersen comments, "The collaboration is focused on the basic biology in neurodegenerative diseases, and the hope we have with this collaboration 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 in-house challenge coming up from 2012 to 2014, which is the expiring exclusivity for Cipralex/Lexapro and Ebixa," says Andersen. "It's critically important for us that we progress our late-stage pipeline and reach 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, I'm confident that we'll make this, and I'm also confident that the profile will be well accepted in the market," he continues.

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 are a lot of new opportunities coming up, where we can jump in and turn these advances into good drugs. It has taken a few more years than everybody expected from when the genome became public, but it is a really big opportunity for the industry."

Making your mark

Peter Høngaard Andersen outlines the work Lundbeck has been doing in the field of biomarkers.

Using biomarkers is utilizing biological tools to either diagnose the patient and/or see if the patient is going to respond to your treatment. It's an area that 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. We decided initially to focus on mood disorders and we have established collaborations with a number of major academic institutions in the world involved in this area. When we started, my expectations were that it would take 10 or more years before this would ever have an impact on what we were doing and the way we saw the patients.

However, the first data are starting to come out now and we are starting to see a picture appear, which makes me believe that within the next five to 10 years we may begin to be able to diagnose certain types of mood disorders from a biological perspective. If we can do that it will be much easier to give them a rational treatment resulting in a better response for the individual

Strength in numbers

Peter Høngaard Andersen explains Lundbeck's alliance with Takeda

I had previously been involved in a collaboration with Takeda in 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 expected, the collaboration has panned out very positively. They're extremely efficient, very aggressive, and the projects are moving forward at a very high speed.

The reason why we decided to go into this collaboration was that we could see that our mood disorder disease area would also have a major part of their market share via GPs. 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. Details on the commercial part of the agreement have been published earlier 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

2002 - Cipralex/Lexapro is introduced on the market for treatment of depression

2005 - Azilect is launched for the treatment of Parkinson's disease

BIO

Peter Høngaard Andersen is Executive Vice President of Lundbeck's research organization. He is responsible for the company'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 Vice President 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.