IN SO MANY WORDS

Shire’s Robert Dempsey, VP & Head, Ophthalmology

In So Many Words is a succinct, timely talk with a need-to-heed KOL.

Robert Dempsey

Even before Robert Dempsey arrived at Shire, hired to build, assemble and lead its new ophthalmic unit, he had conceptual blueprints in hand. With 23 years in the ophthalmic industry — and experience in numerous areas of the industry — Mr. Dempsey didn’t have difficulty envisioning what he wanted. Mr. Dempsey, an MBA, has helped launch numerous well-known products, including Restasis and Prolensa, holding C-level positions not only at Allergan and Bausch + Lomb, but also Inspire, Collagenex and Muro. What do Mr. Dempsey — and Shire — want? A successful build-out of the Ophthalmics Business Unit and a diversified product pipeline to help those with unmet needs.

Ophthalmology Management: Tell us about your first days at Shire.

Robert Dempsey: When I joined Shire, in February 2014, they didn’t even have a business unit. We formed one in May of 2014, with the trigger being a successful NDA (new drug application) meeting for lifitegrast with the FDA.

OM: So you were a team of one?

RD: You could say that, yes. On the commercial side of the business, it was just me. We also had a very small R&D team working in ophthalmics. Today the cross-functional team has grown to be over 100 — in commercial, medical and R&D. I’m proud to report that we have some of the best talent and experience in the industry.

We’ve also recently started to build our field leadership team, so that process is well under way. Additionally, we’re well on our way of building out the medical affairs team. We have a global head of medical affairs and hired, trained and deployed a medical science liaison team. This group is helping from a medical perspective to get the word out about Shire in Ophthalmics. And in addition, we now have a research and development team that is conducting studies on Shire’s comprehensive pipeline portfolio candidates, including lifitegrast.

OM: Is your division totally focused on lifitegrast?

RD: If you look at our portfolio, it is a very comprehensive pipeline that has early-, mid- and late-stage investigational-stage candidates. We have invested more than $700 million to build the business unit and have acquired five programs that are in the public domain, covering both the anterior segment and the posterior segment as well as rare ophthalmic diseases. So, lifitegrast is the foundation, being the flagship, but we have been very aggressive in focusing on other opportunities too. These opportunities are very exciting and innovative and show our commitment to the ophthalmic space.

OM: Let’s talk a little bit about that. The portfolio resembles bookends in that you’re looking at glaucoma and you’re looking at dry eye, but right in the middle, you are sticking to the Shire path of looking at rare diseases in terms of the ophthalmic space. Is that a fair assessment?

RD: 100%. In fact, we are leveraging our expertise in rare diseases for rare ophthalmic diseases including programs for the prevention of retinopathy of prematurity (ROP), which is currently in Phase 2 and was granted fast-track designation from the U.S. FDA in January 2015. While the ROP program is still investigative, we are encouraged by early clinical data. Topline data are expected to be reported in 2016.

In addition, from our acquisition of BIKAM Pharmaceuticals, we acquired a pharmacological chaperone under development to treat autosomal dominant retinitis pigmentosa, a rare ophthalmic condition. We are excited about this program, despite it being early phase, as we know that ROP and adRP (autosomal dominant retinitis pigmentosa) are sight-threatening conditions. Through these programs, we are demonstrating our commitment to rare diseases. It’s very exciting within the ophthalmics franchise. We’re applying the Shire principles of innovation and commitment to address areas of unmet need in specialty conditions and rare disease and doing this across multiple conditions that optometrists and ophthalmologists are interested in.

OM: Tell us a little more about your ROP program?

RD: Let me give you more insight into it. Shire currently has an IGF-1 supplementation therapy in development for the prevention of ROP. This program is currently in Phase 2 development, was recently granted Fast-Tract status by the FDA and the primary endpoint is reduction of maximum severity of ROP stage across all retinal examinations. Currently, no prescription treatments are approved for prevention of ROP, and the current standard of care is laser therapy for severe cases of ROP; the anti-VEGFs are used off-label.

OM: If and when lifitegrast is approved, can we tell physicians when it will be available?

RD: If lifitegrast is approved, we will be ready for distribution in the third quarter of 2016.

OM: Any last thoughts you’d like to offer about Shire in ophthalmics?

RD: In just over two and a half years, Shire has made significant progress in building out our Ophthalmics Business Unit and awareness of Shire in ophthalmics. Most recently, we resubmitted our NDA for lifitegrast to the FDA on January 25, 2016. The FDA responded with a six-month review period, assigning a PDUFA (Prescription Drug User Fee Act) goal date of July 22, 2016. While we wait for a response from the FDA, we are continuing to build out the Ophthalmics Business Unit and seeking new opportunities. OM