New approach at Novartis Ophthalmics: focus on back of the eye

Flemming Ørnskov, MD, MBA, MPH, global head of Novartis Ophthalmics, discusses goals, products and the future of the company.

In early 2001 we saw the transition of Novartis Ophthalmics from CIBA Vision to become a separate business unit. Novartis Ophthalmics began operating under the pharmaceutical division of its parent company Novartis AG (NYSE: NVS), and that is where the mystery began. What was Novartis Ophthalmics then, and what is it today? These questions are particularly interesting now, as this article was being developed in the same month that Novartis Ophthalmics U.S. moved closer to its parent, Novartis Pharmaceuticals, both physically and strategically, and CIBA Vision announced that it is seeking a “strategic alternative” for its surgical business unit.

In January 2003, Flemming Ørnskov, MD, MBA, MPH, became the global head of the $600-million-in-sales, 1,100-employee business unit based in Basel, Switzerland. In 2001, he was the vice president and head of the U.S. CV Therapeutic Franchise of Novartis. Before that he worked at Merck & Co. Inc. in a variety of therapeutic areas, including urology, neuroscience, osteoporosis and arthritis, most notably launching Merck’s Vioxx. Dr. Ørnskov received his medical degree at the University of Copenhagen and later served as chief resident in its department of pediatrics.

Ocular Surgery News spoke to Dr. Ørnskov about the future of Novartis Ophthalmics and where he sees his new charge fitting into the robust ophthalmic landscape.

Joan-Marie Stiglich, ELS
Editor in Chief

Ocular Surgery News: As the Novartis structure can be confusing, could you explain where Novartis Ophthalmics fits into the company’s structure?

Flemming Ørnskov, MD, MBA, MPH: Novartis is one of the major pharmaceutical companies in the world, with headquarters in Basel, Switzerland. Novartis AG has operations in 140 countries and employs over 77,000 people. It has two main divisions, pharmaceuticals and consumer health.

The pharmaceutical area is split into different parts: primary care, oncology, transplantation, mature products and ophthalmics. The biggest part is primary care, and ophthalmics is one of the smaller businesses within pharmaceuticals.

OSN: And the CIBA Vision arm, your surgical and contact lens arm, is what part of Novartis?

Dr. Ørnskov: CIBA Vision is in the consumer health division, as it is more consumer focused.

OSN: As the newly appointed global head of Ophthalmics, what have you been asked to do?

Dr. Ørnskov: I was given quite clear goals when I took over as head of Ophthalmics.

First, benefit from all the things that have been learned by the other business units and apply it to Ophthalmics, thus increasing the standards of that particular unit.

Second, align the structure of Ophthalmics with the other pharmaceutical units. Thus, we realigned the regional structure of Ophthalmics, which now includes Europe, Latin America, Asia-Pacific, Japan and the Americas, which includes Canada and the United States. We also moved the U.S. headquarters from Duluth, Ga., to New Jersey, where the rest of the Novartis North American pharmaceuticals business units are. Finally, we moved the international headquarters from Zurich to Basel.

My third goal was to develop a strong team with an enterprising spirit, to become a top-tier ophthalmic company. I have had the great fortune to internally and externally add top talent to the team.

Finally, I was to aggressively review our top products, look at our pipeline and supplement with licensing when necessary.

Core therapeutic areas

OSN: Are there core therapeutic areas that you are looking at more closely than others?

Dr. Ørnskov: When we started, we were in a lot of categories. One of my fears was that we were stretched too thin, with too many products in many categories. So I asked the team to do several things.

First, I asked them to prioritize. Identify which categories have the highest growth and where we have the best products to offer the community. Second, look at whether we should have global branding, so that our products look the same whether they’re sold in Turkey, the United States, Germany or Spain.

Third, I asked for a long-term strategy. The strategy for me was that in the short term we should maximize the growth of all our products. In the intermediate term, we should focus on a smaller group of products; then long term, take a few areas of ophthalmics with high growth and focus on those. These areas are basically back-of-the-eye and retinal diseases.

With Visudyne (verteporfin for injection), we’ve had the first innovative product in that category, and with Lucentis (ranibizumab) we’ve in-licensed a follow-up compound. We’re also looking at other opportunities, both through our internal pipeline and through acquisitions, to grow further in that area.

What I want is to have a professional look. Novartis Ophthalmics will be focused with clear innovative products that bring value to patients and physicians.

OSN: What about glaucoma as a core therapeutic area?

Dr. Ørnskov: Glaucoma is a huge market, and we have smaller products like Nyogel (timolol 0.1% gel) and Rescula (unoprostone isopropyl ophthalmic solution). It’s a very competitive market and the prostaglandins, such as latanoprost, are doing well. For us to stay in that market and be a big player, we really would have to bring something innovative to the marketplace, and I’m looking into whether we can do that. We are investigating neuroprotection as a possible area of research in addition to agents that lower intraocular pressure.

OSN: What else can you tell us about your pipeline?

Dr. Ørnskov: We have a fairly large group, just under 50 people, who work in discovery. We do both screening of our in-house compounds that are in early stages of development and true developmental work. We have a very strong group who works on many disease platforms that can provide very interesting products for the future, and back of the eye is one of our key areas of research interest.

We could have a better pipeline short term. There’s clearly a lot of interest for us with in-licensing or doing joint ventures with companies. We’ve had a phenomenal collaboration with QLT, and we hope to have a similar great collaboration with Genentech, but we are always looking for partners in this marketplace. We bring a strong sales force and marketing team to the table. QLT can testify to the fact that we are a very good partner.

OSN: Did you have to make adjustments to your sales force when you took over in January?

Dr. Ørnskov: No. I expanded and reorganized the sales force, particularly in the United States. The U.S. sales force consists of 85 people who were split into different groups. I’ve aligned them under one group and one leadership to give them focus.

Treatments

OSN: You’ve mentioned Visudyne and Lucentis several times. How are those two going to work together from a clinical standpoint?

Dr. Ørnskov: Visudyne was launched in 2000 and is the first available drug treatment for wet age-related macular degeneration. It mainly works through a mechanism of action whereby it stops the leakage from vessels. Lucentis has a different mechanism of action. It is an anti-vascular endothelial growth factor (VEGF) antibody. It stops some of the leakage, but it also stops the development of new vessels.

If you look at it from a pure scientific perspective, it is basically two mechanisms of action that are somewhat different and could be complementary to each other. So combination therapy could provide additional benefit. Our upcoming clinical trials will determine whether that is also the case in clinical practice.

We will maximize Visudyne short term for monotherapy and also as combination therapy with some of the newer anti-VEGFs. We will work to make Lucentis the next-generation product and maximize it as both monotherapy and combination therapy.

OSN: I would like to discuss pirenzepine for the treatment for myopia.

Dr. Ørnskov: Pirenzepine is a product we have in-licensed from Valley Forge Pharmaceuticals, a small company based in Pennsylvania. The product is indicated for severe myopia in children. Pirenzepine is a gel that would be applied to children’s eyes for a number of years to decrease myopia or reduce the worsening of the myopia.

The product is in phase 2 clinical trials. We are doing trials in both Europe and Asia-Pacific, where myopia is a more severe issue than it is in the Western world.

It’s quite clear that there’s a huge market for an efficacious product. The early clinical data are very encouraging.

OSN: Obviously, this is a novel approach to the treatment of myopia. How do you think this is going to fit into the market as far as acceptance with clinicians?

Dr. Ørnskov: In any market, we would have to educate both the physician and the consumer about the treatment and the benefit. If the data are good, and if in long-term treatment we see a significant decrease in the progression of myopia, then it will take some market development. We will work with key opinion leaders in this field to disseminate the information.

It’s a new concept, and with all new concepts there’s always a risk in development programs.

The future

OSN: You mentioned that Novartis Ophthalmics will focus on products for the back of the eye. Have you considered divesting some of your product lines?

Dr. Ørnskov: Yes. We have ongoing talks with a number of companies about divesting some of the more mature smaller products that may not fit well into the category.

OSN: In 2002, Novartis had a 7% increase in sales, mainly due to Visudyne. How do you think Novartis will fare as competitors to Visudyne come to market?

Dr. Ørnskov: 2002 was a very good year for us. 2003 will be a year characterized by the costs incurred with the restructuring/reorganization. I see 2003 as an interim year.

If the clinical data for Macugen (pegaptanib sodium, Eyetech Pharmaceuticals/Pfizer) are very promising and the FDA endorses these, we will have a significant competitor in the marketplace. We may see some share loss, but I also think that there will be more noise in the system, more patients will be diagnosed. I am certain that we will continue the strong sales that we’ve had last year and this year for Visudyne.

OSN: In 5 years, where will Novartis Ophthalmics be, from the customer standpoint?

Dr. Ørnskov: I want to say that Novartis is totally committed to this field. We trust that we will have improved significantly in our customer ranking, that ophthalmologists will see us as a trusted partner who brings innovative medicine to the marketplace, that we have good name recognition with the patients who use our products, and that all of our products continue to be seen as high quality. We will be a top-three company in ophthalmics with an interesting range of products and a good pipeline.

We’ve decided this was time to choose the machine and make it ready for the future. We’re coming out of this transition year as a strong company, and I believe that people in this field will see us as a true partner who brings good products to market.

For Your Information:

• Flemming Ørnskov, MD, MBA, MPH, can be reached at Novartis Pharma AG, Business Unit Ophthalmics, CH-4002 Basel; (41) 61-697-9900; fax: (41) 61-697-9501; e-mail: flemming.ornskov@pharma.novartis.com; Web site: www.novartisophthalmics.com.