Allergan continues R&D, expanding indications

With a changing landscape for innovation and research and development strategies for most large companies in ophthalmology and aesthetics, Healio.com interviewed Julian S. Gangolli, corporate vice president and president of North America at Allergan, to find out the latest approaches Allergan is taking in the industry.

Healio: What do you see as Allergan’s biggest successes or wins in 2013 and/or thus far in 2014?

Gangolli: If you look from 2010 to now, which is only a 4-year period, we have had 13 U.S. Food and Drug Administration approvals in that time period. Looking specifically at the last 2 years, I think we have had some remarkable successes in both ophthalmology and aesthetics. The FDA approved Juvéderm Voluma XC, which is a hyaluronic acid volumizing filler made with Allergan’s proprietary Vycross technology, which is used by a number of oculoplastic surgeons in the U.S., as well as in the aesthetic arena.

Most recently, there is the FDA approval of Ozurdex (dexamethasone intravitreal implant) 0.7 mg for the treatment of diabetic macular edema (DME). I think that has added a new dimension to the treatment of DME in the U.S. Up until this time, it has been an anti-VEGF marketplace, and we know that not every DME patient is going to respond to anti-VEGFs and that the retina specialists are going to need an armamentarium of products for the management of DME; to be able to have Ozurdex in our Novadur slow-release system available to retina specialists is certainly a highlight for 2014.

Julian Gangolli

Our research and development organization has also been recognized with three of our products nominated for the Prix Galien USA award this year. This is a prestigious recognition for research and development, and we have been nominated not only for the approval of Botox (onabotulinumtoxinA) in chronic migraine, but also for Ozurdex in uveitis and our Seri surgical scaffold product in the plastics arena for surgical repair.

Healio: With the current products that you have been developing, are you now limited to expanding indications for their use, or will Allergan continue to develop new therapeutic lines?

Gangolli: I think the reason why Allergan, from a developmental R&D perspective, has been so successful is it looks at, first of all, the unmet medical need. Then we say, can that unmet medical need be brought around with enhanced technology for existing products or does it need a new solution?

We have a remarkable example of both of those. Going back 10 years or so, there was no pharmaceutically prescribed treatment for dry eye disease. We took a product, cyclosporine, which was out in an academic setting, we saw the proof of concept, and we applied to that our technology and understanding of how to bring products through to fruition. We were in a position to establish a dry eye treatment modality for a condition that up until that time had never been treated.

If we look at our existing product line and at technologies in the glaucoma arena, for example, and we look at how we bring products that are effective and how do we make them better? I think our bringing out a 0.01% Lumigan (bimatoprost ophthalmic solution) is an example of that. In the future, I think we have the opportunity to look at technology and bimatoprost and a potential paradigm shift in terms of the treatment of glaucoma through slow-release technologies. We have the ability to bring an existing product, a well-characterized product, and provide it in a sustained-release technology, which has major implications in terms of patient compliance. That is an example of repurposing the technology.

In the retina area, we are looking at some exciting novel areas with DARPin, which is a whole new range of retina products that are groundbreaking in terms of first to market and first type of products that talk about a stronger research orientation.

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I think where we have been successful is in being able to blend our existing products with well-characterized efficacy and side effect profiles, looking at technology to improve their utility, and then looking at groundbreaking research-type products, bringing them through proof of concept and into the market. It is a blend in the portfolio that I think is exciting.

Healio: Are you pursuing any other indications for Botox?

Gangolli: Certainly Botox continues to be a product that has multiple indications and utility. It is approved for chronic migraine. It was then approved for neurogenic bladder and overactive bladder, and we continue to look at a number of indications in the dermatological space.

In the facial aesthetics arena, we continue to look at Botox for different aesthetic indications. There is a big initiative in which Scott Whitcup, MD, executive vice president of research and development and chief scientific officer at Allergan, has talked about Botox in the area of depression, which could be a major opportunity and is a major unmet medical need in the U.S.

Outside of Botox, I think it is important to mention Aczone (dapsone) Gel 5% and Tazorac (tazarotene) Gel 0.1%, which are two significant products in the medical dermatology space. Aczone, in particular, has the potential to be the largest acne dermatological product in the United States. It is the No. 1 product for female adult acne in the U.S., so it has been a remarkable success story, as has our entire line of Juvéderm products in the area of facial aesthetics, both filling and volumizing. So there have been a number of technologies in that area that have been significant.

Healio: From a corporate perspective, what changes has Allergan made to fit the changing health care landscape that you are facing right now?

Gangolli: The health care landscape is evolving, it is changing, and it is going to continue to change. I think industry needs to interact with not only the providers, and by providers I mean the physician and the health care community, but the payers as well. We have invested a lot of energy and a lot of what I would call core competencies in understanding how the payer landscape is changing. In many ways, the patient is now a consumer, and we need to understand how they make their decisions around health care. We need to make sure we are aligned with the patient consumerism that is taking place. Now more than ever, and into the future, the patient will have a much greater say in what they are willing to pay for and what they are not willing to pay for. We have a number of initiatives targeted to the patient consumers to help them understand what their choices are and how their health care deductions work over the year. These programs are designed to educate patients about their general condition, whether it is glaucoma, dry eye or ocular surface disease, and the product choices available to them to help support them in making an informed decision. Finally, on the reimbursement side, we focus on how we can help with copay cards or other things to support the cost burden for that individual patient.

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At the payer end of the plans and the employer level, it is all about providing health care economics. What is the tradeoff for our products relative to the cost of treatment and the cost of that condition? We have a dedicated U.S. Health Outcomes Group that is providing payers with informed budget income models that allow those payers to make informed decisions around the value of our products on their formulary.

Healio: What would you most want your physician/customer base to know about Allergan?

Gangolli: Allergan is 64 years old this year, and I think what was true 64 years ago is true now, which is that the specialty orientation of Allergan is the core of its success. The ability for Allergan to understand the ophthalmology and optometry eye care specialty and dedicate resources specifically to that area sets us apart. We are a company that operates across five specialty areas. We focus in neurology, urology, medical dermatology, eye care and medical aesthetics, which includes both facial aesthetics and plastics. We keep each one of those specialty verticals distinct and discrete because each one, particularly now with the changes in health care, has different needs and requirements in terms of the way they need support and partnership.

We are absolutely dedicated to the eye care specialty. We have, from an R&D perspective, a real commitment to bringing innovation to the eye care space. We see the potential for great innovation over the next 3 to 5 years, and we want to be at the forefront of that.

Continuing medical education is also core to what we do, and we have a singular focus on that.

At the physician level, we need a real partnership with our sales organization, which we are proud of and which continues to be recognized in the ophthalmic space as one of the best regarded sales forces in the country.

Allergan has an absolute commitment to the ophthalmic specialty. It has a knowledge base, and on multiple levels, we look to continue to support, partner and bring new innovation and technologies to the physician community, which in turn is going to benefit the patient community. That is what we are all about.

Disclosure: Gangolli is corporate vice president and president of North America at Allergan.