October 15, 2000
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One on One with Anders Härfstrand

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I drove myself to the Pharmacia Corporation's new global headquarters to interview the lead author of, among other scholarly papers, "Evidence for an increased biocompatibility of heparin surface modified (HSM) PMMA intraocular lenses" [Implants in Ophthalmol (Eng). 1990;4:35-39].

Anders Härfstrand, MD, PhD, was working in Uppsala, Sweden, at a company called Kabi Pharmacia a decade ago when he wrote that paper. Today he is vice president, global ophthalmology business, at a new Pharmacia Corporation that has, in the meantime, absorbed Carlo Erba, Upjohn and Monsanto.

The company had just dropped "Upjohn" from its name when I visited the Peapack, N.J., headquarters. The campus is more collegiate than big pharma, and there doesn't seem to be enough office space for a global company of this size. But the elevators go down to underground levels where the brown stone buildings are connected by long corridors. At intervals are the doors to offices, laboratories, libraries and a new teaching center.

"Even the parking lot is connected underground," Dr. Härfstrand said as we toured. "That's something we could use in Sweden in the wintertime."

Like many of top executives today, Dr. Härfstrand looks for local innovations that he can turn global. Xalatan, the first prostaglandin-derived glaucoma therapy, has been in a series of launches worldwide ever since its 1996 debut. It was the "little" ophthalmology division's big contribution to the corporate sales figure, which totaled about $16.4 billion for pharmaceuticals and agriculture products in 1999.

His medical degree and PhD in neuropharmacology lend weight to Dr. Härfstrand's assessment of new thinking in glaucoma. He is doubly annoyed at some current claims of neuroprotection – as a businessman who considers his competitors' claims unsubstantiated, but also as a clinical scientist who knows personally how difficult it is to prove efficacy in that area.

Dr. Härfstrand began our interview by presenting an overview (complete with PowerPoint graphics) of the global pharmaceutical market, Pharmacia's place in it and the ophthalmology division's place within Pharmacia.

Joseph Hoffman
Editor in Chief

Anders Härfstrand, MD, PhD---Anders Härfstrand

Anders Härfstrand, MD, PhD: The global pharmaceutical business is quite a big one: about $345 to $350 billion for western-type medicines in the largest countries. That market is dominated by the United States, and that is, of course, the reason why we are located here. You cannot be a major pharmaceutical company today without having a presence in the U.S. That is the reason for many mergers in the past, and it probably will be a reason for many more mergers into the future as well.

Japan has the second largest individual market now, and Europe is indeed also a stronghold in the business.

When you look at the pharmaceutical market as such, not including surgery whatsoever, you see how dominating the family practitioner products are - all the "blockbusters" that are usually targeted for common diseases.

The figures from 1999 show that the merger of Pharmacia and Upjohn took us up to a 3% share of the global pharmaceutical market. We have about 4% of the U.S. market. That put us around the top 10 or 12 companies worldwide, depending upon how you choose your numbers. It's interesting that if you look at the top worldwide market shares, even a very big merger like Glaxo and SmithKline Beecham, or Pfizer and Warner Lambert, would achieve about a 7% worldwide market share. I remember a couple of years ago that, with the creation of Novartis, they reached about a 7% market share.

However, you have a continuous erosion because market share is based on one or a handful of products, and competition continuously eats into this. This is a very segmented business.

What, then, is driving the consolidation within the industry today? I think it's definitely the cost of research and development. The latest estimates are that R&D costs companies around $600 million per drug on average. The critics of the system say, "You have to pay for everything that goes wrong." Yes. That's what we do. We need to have enough successful products to pay for themselves and for everything else that fails.

The challenge for us is to maximize the R&D expenses. That's not so easy with continuously increasing demands for safety documentation on one hand and also that need to come up with innovations. But that's what is driving everything: the patient benefit.

The cornerstone of what we're doing is always the patient benefit. Coming up with a third, fourth or fifth cardiovascular compound in the same category doesn't help. That's why we strongly believe in innovative medicines. And if you can't create innovation, maybe you can find it through a merger.

We now have a substantial sales force of more than 10,000 reps worldwide. In ophthalmology, we have about 650 reps worldwide.

We have absolutely one of the best patent positions in the industry and an R&D pipeline of exceptional strength. We make the substantial investments in R&D that are required. A couple of years ago, $1 billion was the magic number, and now it's $2 billion to have enough power to drive innovation.

I think we have a competitive advantage in ophthalmology. I don't think you can be a stand-alone company and have a long-term future in ophthalmology. If you are strictly surgical, yes, but not in pharmaceuticals. Because of all of the new systems being put in place to "crunch" new molecules, you need a parent company that can generate those new molecules for the future. That is driven by the total amount of revenue being produced.

graph We have grown now to be a company of about $18 billion in annual sales. Additionally, we are one of the fastest growing companies in the pharmaceutical industry. The expected top-line growth rate is about 13% to 15%.

Everyone knows about the explosive growth of Celebrex [celecoxib], and we have other COX-2 inhibitors in development. We also have Detrol [tolterodine] for overactive bladder. We will be introducing Vestra for depression. Zyvox [linezolid] is a totally new antibiotic that just got approved in the U.S. and is pending approval in Europe and in Japan.

Zyvox is an absolutely spectacular drug for gram positives and many organisms that are resistant to the traditional therapies as well as vancomycin. This is the first new anti-infective class in 30 years. After several months on the market it has gotten formulary approvals in over 400 U.S. hospitals. It has taken the market by storm.

Pharmacia also has an oncology franchise about the same size as our ophthalmology business. We have synergies there when it comes to anti-neovascularization compounds.

So we come now to ophthalmology. The first area of our ophthalmology business is cataract surgery. The base that we have built from for 20 years now is of course the Healon family - Healon, Healon GV and now Healon 5, which will be introduced this year in the U.S., pending approval.

The whole idea behind Healon 5 was to put the surgeon in control. We recognized that the control in phaco surgery was not really there and decided that a new viscoelastic could accommodate that need. Healon 5 took about 2 years to develop - a very rapid turnover time.

We have had tremendous success with the Healon family, and also with the Cee-On intraocular lenses. The Cee-On line now includes the new Cee-On Edge (pending Food and Drug Administration approval) that prevents secondary cataract formation.

Surgery is a significant part of our business today. We are continuing to build and continuing to invest, and this will continue for another 10 or 20 years. I don't see any clouds on the horizon regarding cataract surgery because I can't see that we will have any cataract prevention compounds. And talking to patients today, you can see they have no problem going into cataract surgery. There are low complication rates and so on. Outpatient cataract surgery will be refined and further refined into the future, but it will be definitely be there.

Glaucoma surgery will also have its place. Will glaucoma surgery ever replace pharmaceutical treatment? No. Definitely not. What about pharmaceuticals replacing surgery if down the road we have neuroprotective agents? No. Unfortunately, surgery will also still have its place for patients that you just can't treat in other ways for various reasons.

The second big area in ophthalmology for Pharmacia is glaucoma, with Xalatan and the Xalatan line extensions but also the new glaucoma therapies that we're working on. Xalatan is the number one worldwide brand of ophthalmic product, with a 28% market share in glaucoma. These are spectacular figures and are growing at a very nice pace worldwide.

Xalatan was one of Pharmacia Corporation's leading products with sales of $507 million and growing, growing, growing. As I said, we have a corporate growth rate of about 15%. My growth target in ophthalmology is 30%, and so far we've been able to deliver. Xalatan sales grew 47% in the first half of this year compared to the first half of last year.

The July 2000 U.S. data from IMS (see chart) shows the new prescriptions for Xalatan rising; Trusopt going down, Alphagan now flat. Alphagan has been flat for 3 months. The only other glaucoma drug that is still growing, but at a lower rate is Cosopt.

Xalatan is the driver of the ophthalmology business right now, but of course we are putting new things into the marketplace. We are looking at other molecules to combine with Xalatan. We have filed for a combination product in the U.S. in December 1999. [Editor's note: The U.S. Food and Drug Administration issued an "approvable" letter for Xalcom, a combination of latanoprost and timolol, in June.] We filed it in Europe in January.

We are in phase 2 trials of a very nice project with Insite Vision in the area of glaucoma diagnosis and prognosis. We are working on being able to detect patients who are prone to get ocular hypertension and/or glaucoma, and also to figure out the progress of the disease by looking at their genotypes. A couple of thousand patients are in the system now, and that's something that I think will be a foundation for new treatments into the future.

And the third area that is now a major investment for us is treatment of macular degeneration with SnET2 photodynamic therapy.

Macular degeneration is a very interesting area. I think it might well be as large as the glaucoma field for us. It is estimated that there are about 7.5 million people on glaucoma treatments worldwide today, which may be only about 50% of those with glaucoma. We haven't got a clue about the true numbers in macular degeneration, because there haven't really been any good treatments yet.

Also, with acquisition of Sugen, we have all the Sugen anti-angiogenesis compounds. These include anti-VEGF both for injection and other routes. There are other things from the oncology field that we will introduce to ophthalmology. We actually got into macular degeneration via oncology, so you see the very important synergies that exist within a company like ours.

There are other areas where we have projects like this, especially in anti-infectives and inflammation. It goes without saying that with the patents we have on the COX-2 compounds, we will be including them in our R&D for ophthalmology.

Anti-allergy is an area of importance. There and in dry eye, of course, the market is fairly well served by OTC compounds, especially outside the U.S. We also have projects ongoing in refractive surgery. We will definitely be building substantial franchises in oph.thalmology in the next 3 years to be one of the bigger players - definitely.

So that's a little bit of a Swedish smorgasbord, so to speak, on Pharmacia.

Ocular Surgery News: That was a great overview. Let's dig down into a few of those areas and get some more of the details. But first, some more about you. You've been with Pharmacia how long?

Dr. Härfstrand: I've been with the company since 1988.

OSN: So you were there when the Kabi-Pharmacia merger took place?

Dr. Härfstrand: Yes, I was part of that merger.

OSN: Until I started doing my research on Pharmacia, I didn't realize that that merger took place with the Swedish government as a large stakeholder.

Dr. Härfstrand: Oh, yes, Kabi was state-owned. But there were various transactions involved in that merger. The state owned a food business, for instance, and Volvo had a big stake in Pharmacia. They made some swaps so that the government got Pharmacia shares and Volvo got the food business and so on. Everything was assembled under one umbrella that was called Procordia.

From 1990 to 1994, Kabi-Pharmacia was part of Procordia. On July 1, 1994, we split apart. It was actually one of the largest IPOs ever done. We got 500,000 shareholders overnight. That was the birth of Pharmacia AB.

OSN: It must have been tumultuous to go within the space of a few years from being owned by Procordia to the merger with Upjohn.

Dr. Härfstrand: The Pharmacia way has always been to merge. Some of the big companies in the industry have grown entirely organically, but we are built on acquisitions and mergers. It's in my DNA, I suppose, to restructure, to acquire, to merge and to work in a continuously changing environment.

Of course, it was different to be state-owned for a while. But we had very good management at that time. They looked for what was best for the company, often putting it in some safe haven or a more solid foundation by means of a merger.

So we went from a couple of thousand employees all the way to the Pharmacia and Upjohn merger, where we merged 17,000 employees of one with 17,000 of the other into a company of 34,000. And now we are going from 30,000 to 60,000 [with the Monsanto merger].

It gives you a competitive advantage because you never get fat and slow. You're always hungry. You're always aggressive. You always look for opportunities. And you get new technologies, new talents, new colleagues on board.

The foundation for the Pharmacia-Upjohn merger was really to get global reach. The Upjohn company was extremely strong in the U.S. marketplace but needed help where we were stronger - for instance, in Japan. Pharmacia at that time was quite regional. We didn't really have major access to the U.S. market.

Global reach is absolutely necessary. If you're strong in the U.S., you also need to put your products into the European and Japanese markets. In ophthalmology, I think that's what we have proven and what we have achieved today. We are the strongest company in ophthalmology in terms of the global reach.

Taking the U.S. perspective, when we put the headquarters here, that facilitated everything. It really put Pharmacia on the map.

OSN: Managers always talk about companies having to reinvent themselves, and if you keep merging on a regular basis that has to happen. But doesn't a little bit of uncertainty on the part of the personnel come with it?

Dr. Härfstrand: I think we live in that kind of world today. Things are changing so fast, and we are all a part of that. Would I rather be sitting in the company that has been growing only organically maybe for 100 or more years? I would be more nervous there than being in the more changing environment. There, executive management understands that with growth comes a substantial dose of ambiguity about where you go next in the marketplace.

I see us today, in the new millennium, as a very attractive employer. I have people just calling in, via human resources or even straight to me, asking what are the opportunities? Do you have any colleagues in oncology or something that you could refer me to? I think that's a very good sign.

OSN: How about on the manufacturing side? Obviously there's a lot of hard capital infrastructure from each of these mergers. Where is the manufacturing based now, or is it still spread around?

Dr. Härfstrand: In ophthalmology, we have excellent sites in the U.S. and Europe. For the glaucoma products, we have one site in the U.S. and one in Europe. Regarding Healon, the manufacturing is still in Uppsala and the raw material is still made in Sweden. The intraocular lenses are made in Holland in our Groeningen factory.

OSN: So you retained those centers of expertise through the mergers?

Dr. Härfstrand: Oh, yes, and we have added on. One of the reasons we have excellent manufacturing people today is by being part of a big corporation. Say we are looking for the best subcontractors and so on, we can go in with high volume and get absolutely the best service. So I must say we have excellent manufacturing - no back orders. They have done a fantastic job on the Xalatan line. We sell more, they manufacture more.

Healon has been used in 30 million eyes now. Twenty years later, 30 million eyes later, we have not recalled a single batch of Healon that was a risk to patients. I'm very proud of that.

OSN: Your press releases say that as of April 3, "Pharmacia Corporation is established." So you consider the Pharmacia merger is 100% finished?

Dr. Härfstrand: Yes. It is done.

OSN: OK then. Let's take a little look toward the future. In the U.S., the next ophthalmology product you'll be introducing, pending approval, is Healon 5?

Dr. Härfstrand: Healon 5, then Cee-On Edge and then Xalcom. This is the combination product with latanoprost and timolol maleate. As we say, the most power in one drop - when the others are not sufficient.

In glaucoma medical therapy today, we are seeing 38% of patients on Xalatan monotherapy. That should continue to grow, since the conventional habit today is to prescribe the former "gold standard" drug together with the new one.

OSN: Now about the combination drug Xalcom. There aren't too many glaucoma combination drugs out there. And I've always heard that there's some disincentive to do a combination drug for FDA approval.

Dr. Härfstrand: No, this was a straightforward trial. The standard is still millimeters of mercury. What we all need in glaucoma are better clinical models to eventually study visual functions.

For Healon 5, though, I think some of us were surprised to see how much the FDA was requiring. It sounded like they wanted to treat it as a whole new product.

I don't know exactly all the regulatory matters involved. The comments were very valid. We have submitted the file and we have an approvable letter. I don't see anything that should disturb the registration. I'm expecting to get it this year.

We have presented the clinical trial data at the American Society of Cataract and Refractive Surgery meeting in Boston, and they were excellent both figure-wise and safety-wise. There were zero pressure spikes. I would say that the trial we had to do just for the U.S. did one thing, and that's really strengthen the case for using a superior viscoelastic to provide greater control. I think the data supports that. And what better pre-marketing can you do than to have all of the key opinion leaders work with your product in clinical trials and help to answer the questions from the authorities? That's a slam dunk then to get it into the market really.

OSN: I'm familiar with the Cee-On intraocular lens, and I know that clinical work has been done to demonstrate that it inhibits posterior capsule opacification (PCO). Is the Cee-On Edge a new indication for the existing design?

Dr. Härfstrand: It's a new lens-design - indication, I would say. What we have been able to prove in clinical trials is substantial reduction of PCO by our design. We have a similar outcome with our heparin surface modified Cee-On lenses from the past, where we proved that it reduces PCO in compromised eyes - eyes with hyperpigmentation, exfoliation syndrome. That's been published by independent investigators.

But here in the registration trials for the Cee-On Edge, we just documented that we have lower PCO. Others, like Dr. David Apple, have shown that actually it's the design and not the material that prevents the formation of the opacification.

OSN: I wanted to ask you about the new findings on IOLs and the ruling on the first group of high-technology IOLs. HCFA drew some pretty sharp distinctions on what would be considered "high-technology." Although they said they were going to follow the FDA labeling, it seems that they only considered some of the additional indications to be significant patient benefits. The HSM lens was not on the list.

Dr. Härfstrand: Yes. They selected optical features rather than biological features.

If you look at our HSM lens, it's the most well documented lens ever regarding biocompatibility. Around 1990, we conducted substantial multicenter trials, and one trial that embraced 12 global centers. I think we tested it in almost 600 patients in a masked, truly randomized trial because we had the same lens in a non-HSM model. We have substantial pre-clinical documentation, everything from complement activation to thrombocyte adhesions to prove that, and we proved efficacy in clinical trials.

OSN: That leads right into the New York Times article entitled, "Drug Firms Reap Profits on Tax-Backed Research." [Editor's note: The April 23, page 1 article questioned patients' ability to afford innovative new drugs and used the development and marketing of Xalatan as a case study of "a blockbuster drug." According to the authors, the problem with the $4 million the National Institutes of Health gave to Xalatan researchers over the years is that "the taxpayers have reaped no financial return on their investment."] It was only a few months after that article was published that Reps. Thomas and Wyden suggested a "Return on Investment Fee." Products developed with government-sponsored research would have to pay into a fund to support a Medicare prescription drug benefit. What do you think about all this?

Dr. Härfstrand: We wrote a letter in answer to that article and compared the cost of treatment with our drug for 1 year with something like an 18-month subscription to the New York Times. For many people it's just a choice about what to pay for.

But innovation does do better for the patients. Each individual in the U.S., Europe and Japan should sometimes reflect about the treatments they can get with an anti-hypertensive, anti-depressive, anti-glaucoma and similar compounds. How much is that worth? Will my kids be able to do that in the future? The discussion goes far beyond the individual company, as I said.

OSN: We have been reporting on proposals worldwide called "pharmaceutical reform," but it means very different things in different countries. In Japan it usually means cutting high reimbursements associated with prescription drugs.

Dr. Härfstrand: Yes, they are working on - I wouldn't call them restrictions, but they want to look at what is best for the whole community. The biggest issue is still the demographic shift of the aging population. They are trying to manage that in terms of what drugs are actually going to be needed.

OSN: When Xalatan was launched in Japan, was it done using Pharmacia's own sales force there?

Dr. Härfstrand: Yes. We increased the force from about 50 pre-launch to about 180 at launch, and now we're adding more people. There are about 200 in the force today, all selling Xalatan, Healon and Cee-On in Japan. Healon and Cee-On were the foundation, since in Japan you have more or less the same customer group for cataract surgery and glaucoma.

OSN: According to your numbers, Europe makes about 31% and North America 48% of the world pharmaceutical market. The figure for Europe seems small considering the population.

Dr. Härfstrand: Right. But Europe is growing at a more rapid pace than the U.S. I see it becoming about equal.

OSN: So is the prominence of the U.S. market in those sales figures a result of that one product, Xalatan, becoming so big in America so fast? Was it the Upjohn merger that really fueled that?

Dr. Härfstrand: Yes. At that time in the United States, we had our biotech line, of course, some diagnostics lines and the cataract business.

It was definitely the merger with the Upjohn company that gave us access not only the human resources, but also the infrastructure to really put behind Xalatan. Xalatan was first launched in the United States.

There have been a number of other products that that had the same tremendous success - our human recombinant growth hormone, Genotropin. Now that we have achieved global reach with these products, we just have to fill the pipeline with more.

OSN: And to round out your cataract products there's a marketing alliance with Paradigm and also Maxxim? How does that work for you?

Dr. Härfstrand: When you want very good customer relations, you have to give surgeons the appropriate products for their patients and the very best service they can get. We are trying to help our customers by bringing in other components from different companies. And I think we will do even more of that kind of business.

That will be something we will see more of in the ophthalmic industry. There are no "sacred cows" anymore. If you can't do it yourself, do it together with your partners and, eventually, your competitors. You can compete in one area and then cooperate in another area. That's the way we must do it into the future to be more effective.

We will look for more partnerships across company borders to serve the customers in the best way. We will find ways of creating a win-win situation, not only with the partners but also with the customers.

OSN: I don't think you expect your cataract business to do anything like your glaucoma business, but how does it fit into the future of Pharmacia?

Dr. Härfstrand: It's a very strong, important platform for us. We are growing the unit volumes day by day. It is very encouraging.

I also see us adding new product lines. The Healon line will always be the basic one that we will supply the customer with. And in the intraocular lens field, we are looking for surgical and optical innovations in the future to address presbyopia and similar problems. We have patents and programs ongoing to introduce new innovations year by year.

We shouldn't neglect the fact that the intraocular lens business is larger than the viscoelastic business. The golden question is, can you expand the total market value? I think that you can continue to grow the total market value by single digit percentages, but to expect substantial price increases on cataract surgery? I think that is history.

OSN: SnET2 is Pharmacia's age-related macular degeneration product, and I understand phase 3 enrollment for the U.S. trial is complete?

Dr. Härfstrand: Yes. Almost 1,000 patients are enrolled, and the results will be collected within a couple of months.

OSN: I noticed a sort of pre-launch, what you might call an "awareness campaign," already underway in Ocular Surgery News and elsewhere. [Editor's note: The advertisement is a large photograph of a row of six glasses ranging from empty to full. The text reads, "When it comes to having enough information about a PDT laser… You are here." Here is the glass filled exactly midway.] What's your thinking behind that?

Dr. Härfstrand: It's preparing the market that we are coming. We are just about to land here with a new range of products in this area, and photodynamic therapy (PDT) will be the first one. It is also saying to reflect upon the alternatives.

We have a close collaboration with Iridex and Miravant. We are running the trials, but we are also thinking internally in Pharmacia about what is the next step. We are very interested in pursuing additional indications with Miravant.

OSN: Back to global pharmaceutical markets. I just saw a press release that the European Union Internal Market Council has reached an agreement regarding the alignment of clinical trials for medicines. How much closer to harmonization is the European Union internally? And then between the FDA and the European Union? And the Japanese Ministry of Health? From your perspective, are these kinds of things coming together?

Dr. Härfstrand: Yes, they are, I must say. I lived 3 years in Japan myself, running the ophthalmic business over there from 1991 to 1994, so I've seen it happen. I see it happen now with the FDA and with the European community.

One must always respect the integrity of individual government authorities like the FDA and the European Medicines Agency. But if a specific question about a common file is arising from an expert panel in a particular country, I think it's absolutely appropriate to put such questions forward.

We had specific questions regarding Healon 5 and intraocular pressure that the U.S. experts want us to answer. And we've answered them now in the clinical trials. The European community didn't ask for such data.

We have been shortening our ophthalmic filing dates in Japan by 2 years. After I came aboard, we really took a close look at filing dates in Japan and had a nice dialogue with the Japanese authorities.

The final proof to see if it all works is of course when we get the license to sell. But we are embarking on that in collaboration with the authorities.

Trials are always being done in quite large numbers in Europe, and Europe also is accepting U.S. data. We are still probably far away from utilizing a substantial amount of Japanese data in the U.S. and Europe. One can discuss the reasons why, but we shouldn't neglect differences in therapy traditions and habits in the U.S. vis a vis northern Europe vis a vis southern Europe vis a vis Japan.

But the short question - do I see harmonization coming through? Yes.

OSN: I hadn't known you spent so much time with Pharmacia in Japan. That would have been around the time of the Xalatan launch. Was that your major focus there?

Dr. Härfstrand: When I was there my major focus was business and sales. We were driving Healon up very high to 10 billion yen in 1993. But of course, we prepared the market for the introduction of Xalatan.

We did substantial clinical trials in Japan, but also we have had the substantial help of glaucoma experts, from Japan and far beyond, in crafting protocols for the rest of the world and looking at various patient populations. Not least of which is the very interesting phenomenon called normotensive glaucoma, where Japan really has been leading the research.

OSN: You mean that physicians there are more likely to recognize it as a clinical entity that needs to be addressed?

Dr. Härfstrand: Yes. They have done large surveys in the late 1980s and the beginning of the 1990s. Dr. Shiosa conducted epidemiological studies with some 8,000 patients. Combining pressure measurement with visual field testing, they arrived at the conclusion that normotensive glaucoma was quite frequent.

Do they have more cases than we have here? I think we don't know. When young scientists here study it, we may see more of it.

OSN: One of the differences in my research for this interview is that you're the first executive I've in this "One on One" series whose name appears on studies in the peer-review literature, either as the primary author or co-author. You're our first MD, PhD. How different do you think your perspective is as a businessman as a result of your medical training?

Dr. Härfstrand: I think it's a substantial advantage. We have a former executive who left the company and joined IKEA. He said the thing that he appreciated going to IKEA is that he understood the product. When he didn't like the red color of a sofa, he understood and could tell them to change the color. I don't need a subset of advisors to guide me through things. I can use my own judgment in a lot of decisions and ask the experts when I don't understand.

On the academic side, you have a scientific network with not only all the professors in the field of ophthalmology but in all the basic sciences. That's tremendous. You can ask for second opinions in a very discreet way. That's a substantial advantage.

OSN: There was always a close relationship between Pharmacia and the Karolinska Institute. I would imagine that continues to this day.

Dr. Härfstrand: It does. That's where I came from.

We have a very special subsidiary of Pharmacia Corporation with 50 scientists working within the context of the Karolinska Institute genomics department. That's really a stronghold for us.

Scientists in Pharmacia Corporation regard the eye as a spectacular model. You have access to the organ. We have a surrogate marker for glaucoma, for the time being - the IOP. The scientists see a lot of things that they can play with. They have access to the retina, and there are many new, refined methods to study the nerve fiber layer and so on. The have a defined population with the disease. They can get the DNA. Maybe the eye can be a good model for other areas of the body.

There are many other fine universities we are working with. I see only that we will strengthen the university collaborations to find new approaches to eye diseases. This is the philosophy of the whole corporation, not only in ophthalmics. We will see more and more applied research.

Having a medical background - not only the MD but to also the PhD background in the field of the central nervous system - has been very helpful to me in the pharmaceutical industry.

OSN: And your PhD is obviously in the area that glaucoma research is headed today.

Dr. Härfstrand: I understand why. We are certainly aware of the need for neuroprotective agents in glaucoma, since what we really talk about today is glaucoma neuropathy. At Pharmacia, we have a whole CNS product group with more than 20 years of history in the field.

My background includes 9 years in neuropharmacology at the Karolinska Institute. So far, no methods to recover nerve cells have been found. I get very surprised when I hear all of the talk about the conventional IOP-lowering therapies being neuroprotective agents. I don't want to use strong words, but I am very surprised that ethical companies promote such things.

Drugs are designed to do one thing, and you may find useful side effects like with our Rogaine or Viagra. But you put it into clinical trials and you prove it. The way we are talking about neuroprotection in the market today I think is absolutely inappropriate.

Our scientists are trying to find something to help slow down the progression of the neural degeneration not only in glaucoma, but also in macular degeneration. But there is a very long way to go.

Since I've been working with neuropharmacology for 9 years myself with neural regeneration, I also understand the challenges. But with medical training you also get substantial endurance in your backbone. That's important. We know, all of us, that we can make a neuroprotective compound. It would be embarrassing if all the scientists in the pharmaceutical industry, together with all the university professors and their research teams, couldn't do it. But it will take more efforts than we ever can imagine to get there.