Industry Focus

A Look at Shire

BY JASON J. NICHOLS, OD, MPH, PHD, FAAO

Robert J. Dempsey, MBA
Vice President and Head – Ophthalmics Business Franchise, Shire, plc.

Our focus this month is on Shire, plc., a biotech company based in Boston. I recently had the pleasure to speak with Bob Dempsey, vice president and head of the Ophthalmics Business Franchise.

Q Mr. Dempsey, please tell us a bit about your company in terms of its history and direction.

In 2015, Shire generated more than $2 billion in sales and has a market cap today of about $28 billion. It has 22,000 employees since completing the merger with Baxalta on June 3, 2016. Additionally, five out of the 60 programs in clinical development are dedicated to the ophthalmics space.

Ophthalmics is one of the newest of our seven business franchises and was established in May 2014. We may be a new player to the ophthalmics space, but we’re not new to the pharmaceutical space; Shire is in its 30th year.

We started the ophthalmic business franchise after a successful meeting with the U.S. Food and Drug Administration (FDA) regarding a new drug application (NDA) for our investigational program for dry eye. That was the trigger for us. We started with one individual—me—and have now built out the entire business franchise.

Q Tell us about any new products or new developments in which Shire is involved.

Our flagship program is lifitegrast, an investigational program for the treatment of dry eye that came to be through the acquisition of Sarcode Biotherapeutics. We applied for an indication for the treatment of the signs and symptoms of dry eye disease. Nearly 30 million adults in the United States experience symptoms of dry eye disease, and approximately 16 million are diagnosed with dry eye disease. Those numbers clearly indicate that there’s a tremendous unmet need.

We filed the original NDA in Feb. 2015. In Oct. 2015, we received a complete response letter in which the FDA requested additional clinical data. Shortly thereafter, we had a readout of a pivotal Phase 3 study (the OPUS-3 trial) and announced topline results that were positive for both the primary and secondary endpoints. The R&D team at Shire added the OPUS-3 results to the original NDA and resubmitted it in the first quarter of 2016. The FDA then granted a Prescription Drug User Fee Act (PDUFA) date of July 22, 2016.

We’ve conducted five randomized, placebo-controlled studies to date and have studied more than 2,500 subjects. That is the largest study package to date on the treatment of dry eye.

We also have programs for infectious conjunctivitis, which will be approaching Phase 3; the prevention of retinopathy of prematurity, which is currently in Phase 2; and autosomal dominant retinitis pigmentosa and glaucoma, both in early development. Those five programs build the foundation of the ophthalmics business franchise. We’ve invested about $700 million in those five programs to build up that franchise.

Q Tell us your vision for the dry eye field in the short term (less than 5 years) and in the long term (20 years from now).

There is one prescription product that’s been used for the treatment of dry eye for more than a decade, so there’s a significant unmet need when you look at the numbers we mentioned earlier. I think it’s also fascinating that we’ve seen numerous programs in development that just have not been able to cross the finish line. To get so close to the finish line for us is really exciting.

We’re building our presence and leadership position in ophthalmics, both in optometry and ophthalmology. It is an exciting time, and we look forward to growing our pipeline and expanding innovation in areas of unmet need for both eyecare professionals as well as their patients. CLS

Dr. Nichols is an assistant vice president for industry research development and professor at the University of Alabama-Birmingham as well as editor-in-chief of Contact Lens Spectrum and editor of the weekly email newsletter Contact Lenses Today. He has received research funding from Johnson & Johnson Vision Care.