Pfizer describes 10 years with Xalatan as a ‘decade of innovation’

Neil Levine of Pfizer Ophthalmics discusses recent changes in glaucoma treatment approaches and future delivery methods.

Issue: August 15, 2006

ByMary E. Archer, ELS

Ten years have passed since Pfizer’s glaucoma drug Xalatan was granted approval by the Food and Drug Administration. In that time, it has become one of the company’s leading sellers, with 9% annual worldwide growth in 2005, according to a year-end report from the company.

Data from IMS Health and the National Pharmacy Association show that Xalatan (latanaprost) is the No. 1 prescribed IOP-lowering medication in the United States for patients with open-angle glaucoma or ocular hypertension.

In recognition of this trend-setting drug hitting its 10-year milestone, Ocular Surgery News interviewed Neil Levine, senior director and group leader of Pfizer Ophthalmics, to discuss how the glaucoma market and Pfizer have changed over the past 10 years and what the future holds.

Ocular Surgery News: Xalatan was approved 10 years ago. Talk about the changes that have taken place in the market in that 10 years’ time.

Neil Levine

Neil Levine: The growth has been significant. I think Xalatan opened up an opportunity for more patients to get treated in a much easier fashion with a product that was powerful in terms of its IOP lowering. You’ve got IOP lowering that’s unsurpassed; you’ve got a product that’s incredibly well-tolerated from the patient’s perspective. It’s the best in the prostaglandin class, we believe. Patients stay on it, and it’s helped millions of patients over the course of these 10 years.

OSN: What about changes in the glaucoma field in general?

Mr. Levine: I can speak to the more recent time frame. I’ve been working on the product for about 4 years. In general what we are starting to see now is physicians moving further back in the disease continuum. Whereas we’ve always been treating high IOP in patients who have overt glaucoma, a lot of key opinion leaders in glaucoma are looking at risk factors for glaucoma and trying to identify patients who could be at risk before they get overt glaucoma. Treating those patients could potentially prevent or delay the onset of disease.

Pfizer supported the launch of the Scoring Tool for Assessing Risk (STAR), a glaucoma risk assessment calculator, at the American Academy of Ophthalmology meeting in 2005. The goal of STAR was to assess certain key risk factors and identify patients who are at risk for developing glaucoma. It is modeled on the Framingham study that helped build a predictive model for cardiovascular disease.

Maintaining growth

OSN: Xalatan is one of the most commonly prescribed medications in all categories, not just in ophthalmology. How do you continue to compete with other drugs that are available?

Mr. Levine: Xalatan is a product that’s still fresh. We have a program called Vision Matters, a relationship program to encourage people to stay on the therapy, which we think works quite well. It’s a program designed to help motivate patients to take their drops. Patient persistency has always been a challenge, and it’s Pfizer’s goal to help support physicians and patients in the hopes that they will achieve better clinical outcomes.

OSN: What does the passing of 10 years mean for Pfizer’s patent rights? When will the drug come off patent?

Mr. Levine: Our patent goes on for several more years. We still definitely have more patent life left on the product, and we continue work on how best to enhance it.

One of the things that we’ve done to differentiate our position has been the introduction of a product called Xal-Ease. It’s an administration device, if you will, which helps ensure that patients can get the drops in their eyes. We’re proud to have just received an endorsement from the Arthritis Foundation stating that Xal-Ease is an arthritis-friendly device to help patients in the management of their high IOP.

Changes in the company

OSN: Speaking about Pfizer in general, there have been changes in the company in the past 10 years. Can you talk a little bit about the changes in the company during this time?

Mr. Levine: The most obvious one is that the company overall has gotten bigger, which has allowed us to look at more therapeutic areas in places where there was a high medical need, ophthalmology being the one that we’re interested in here. We’re obviously in glaucoma in a big way.

We launched our anti-VEGF category in retina disease last year, and those drugs are bringing hope to a lot of patients in that category as well. We continue to enhance our focus in some of the research and development efforts that we have ongoing at our facility in La Jolla, Calif., in terms of continuing to focus on ophthalmology as an area of unmet medical need.

Future developments

OSN: Can you talk a little bit about what you are focusing on now for the future? Your first-quarter 2006 financial results mention a collaboration with NicOx “to identify novel drugs to treat ophthalmic disorders.”

Mr. Levine: We continue to work on new compounds that could be the next wave of what we hope will be used eventually in the treatment of glaucoma, in terms of IOP-lowering agents.

We’ve signed an arrangement with a company in the area of age-related macular degeneration. We have home-grown efforts ongoing as well that are more proprietary at this point in time. But hopefully we’ll be able to talk about them in the near future.

OSN: Can you talk more about what might take place in the next 10 years?

Mr. Levine: We are a pharmaceutical company, so we will be focusing on the next wave of medical treatments for ophthalmic conditions and how we can best meet the unmet medical needs, whether it be prostaglandins or the work that we’re doing with third parties on additional ophthalmics projects.

OSN: What about plans for your combination glaucoma drug? There has been attention to combination drugs in the European market, with more attention being paid to getting them approved in that market. What about the status in the U.S. market?

Mr. Levine: We still have work ongoing. We’ve talked with the FDA in terms of what they might be looking for, designed studies, and those are ongoing. When those results are available, we’ll speak to the FDA again and hopefully apply to get them approved, and then it will be up to them. At this point we’re in the middle of getting to the next step with it.

OSN: Would you like to say anything more to the readers of Ocular Surgery News?

Mr. Levine: I’d just like to reiterate that we’re excited about Xalatan’s 10th anniversary. It’s been a decade of innovation for us. The anniversary gives us an opportunity to remind people of what this drug has brought to the market in terms of its powerful IOP lowering and its best-in-class tolerability profile.

A note from the editors:
See the article, “At Issue: Latanoprost and glaucoma management,” page 26.

For more information:

Neil Levine can be reached at Pfizer Inc., 235 East 42nd St., New York, NY 10017; 212-573-3493; fax: 212-672-7926; e-mail: levinn@pfizer.com.

Mary E. Archer, ELS, is Executive Editor of OSN U.S. Edition.

Jared Schultz, OSN Staff Writer, assisted with the compilation of this report.