Shire committed to ophthalmic space as dry eye drug emerges on FDA horizon

Editor’s Note: Robert Dempsey, vice president and business unit head at Shire Pharmaceutical’s Ophthalmics Business Unit, recently talked with Ophthalmology Times Group Content Director Mark L. Dlugoss about Shire’s entry into the eye care market. Among the topics discussed are Shire’s attraction to the market, Lifitegrast­–its potential dry eye drug, and other potential ophthalmic compounds.

Update: Shire's FDA-approved drug ends dry eye treatment drought

OPHTHALMOLOGY TIMES: Robert, what is Shire Pharmaceutical’s major focus as a pharmaceutical company?

ROBERT DEMPSEY: Shire is committed to the eye space and is dedicated to specialty pharmaceuticals. Shire is already in the gastrointestinal, internal medicine, and neuroscience spaces. It is committed to working on rare diseases, and now with the emerging Ophthalmic Business Unit, we are excited to focus on the specialty (and) play along with the focus on rare diseases.

OPHTHALMOLOGY TIMES: What attracted Shire to enter the eye care market?

DEMPSEY: There is a significant unmet need across various ophthalmic diseases. We feel that our focus on research and development is a perfect synergy for this space.

OPHTHALMOLOGY TIMES: What initiated Shire’s entry into this space?

DEMPSEY: It began with our acquisition of SARcode Bioscience in 2013. SARcode had a late-stage program in development for dry eye disease, Lifitegrast.

Since then, we have made two more acquisitions–Premacure AB, to gain access to a program for the prevention of retinopathy of prematurity (ROP), and BioChem Pharma, which is developing a program for autosomal dominant retinitis pigmentosa.

We clearly are making a major commitment to the ophthalmic space and intend to be a player for years to come.

OPHTHALMOLOGY TIMES: Where does Shire see the biggest growth areas in ophthalmology?

DEMPSEY: There is a tremendous opportunity for innovation to address unmet needs, such as dry eye disease, posterior segment disease, and more. The venture capital community is investing in many mid- and early-stage companies that have really “cool” technology, and we are very interested in partnering and collaborating with these organizations.

What has Shire accomplished thus far...?

OPHTHALMOLOGY TIMES: What has Shire accomplished thus far to build the organizational structure of the Ophthalmics Business Unit?

DEMPSEY: When I joined in February 2014, I was the only person dedicated to commercialization in Shire’s Ophthalmics Business Unit. I worked to educate internal and external stakeholders on topics, such as what is the difference between an ophthalmologist and optometrist, or what is the difference between the anterior segment and the posterior segment. I did a lot of internal education about our commitment to ophthalmology and the exciting opportunity (Shire has) with Lifitegrast.

I also worked with many professional organizations, such as the American Academy of Ophthalmology and the American Academy of Optometry, to demonstrate our commitment to the space. We have done sponsorships, grants, medical education, and such, and have been fortunate to recruit many friends and former colleagues in business development, research and development, and medical affairs. Recruiting people to join the organization has been very exciting.

OPHTHALMOLOGY TIMES: What is Shire’s strategy moving forward?

DEMPSEY: We have been focused on hiring the marketing leads, the commercial strategy lead, the insight lead, and the consumer lead, and have been fortunate to tap both internal and external people to join the team.

We are very interested, if granted approval, in having Lifitegrast be our first entrant into the market. We believe the dry eye space has significant unmet needs and a product with the potential indication for signs and symptoms will be well received. Flawless execution of Shire’s launch will be critical.  

OPHTHALMOLOGY TIMES: In April 2015, the FDA accepted Shire’s NDA filing for Lifitegrast and granted the agent a priority review designation. Can you review the drug’s path through the clinical trials to the present?

DEMPSEY: It’s a great story. Studies have been completed in close to 1,800 subjects. We have completed two phase III efficacy studies, along with a phase III safety study. In addition, as part of our NDA application, we also submitted a phase II study. We believe that, based on the totality of data, we have an exciting opportunity to bring novel treatment to dry eye disease with Lifitegrast.

What was Shire's rationale for extra OPUS-3 trial?

OPHTHALMOLOGY TIMES: In October 2014, Shire initiated an OPUS-3 trial for Lifitegrast. What was the company’s rationale for the extra study, especially since it is not included in the NDA?

DEMPSEY: OPUS-3 will serve multiple purposes. First, it is a symptom-only study. Second, it will be used to potentially strengthen the label if granted approval for the treatment of signs and symptoms of dry eye in the United States. In addition, OPUS-3 can be used as part of our registration package for global markets.

(Editor’s Note: At press time, the FDA requested an additional clinical study as part of a complete response letter (CRL) to Shire’s new drug application (NDA) for Lifitegrast.

Shire also announced positive topline results from OPUS-3, a phase III efficacy and safety study of Lifitegrast versus placebo. The data showed OPUS-3 met the primary and secondary endpoints of significantly improving patient symptoms of dry eye.

Shire plans to use the data as the basis of company’s response to the CRL when it resubmits the NDA for Lifitegrast in the first quarter of 2016. The FDA also requested additional information related to product quality, which Shire also will address in its CRL response. For more information, go to http://bit.ly/1ReQstW.)

OPHTHALMOLOGY TIMES: Shire has two other candidates in its portfolio from Premacure and Biochem‒SHP607 and SHP630. Please outline these compounds for OT readers.

DEMPSEY: Through the acquisition of Premacure, Shire acquired an exciting product that potentially can prevent retinopathy of prematurity (ROP). It is an insulin-like growth factor 1 (IGF-1) that is administered intravenously to infants in the neonatal intensive care unit.

Shire is in phase II trials and the FDA has granted the company fast-track status. As part of the regulatory process, the primary outcome would be prevention of ROP, but we are looking at numerous other secondary endpoints as well.

With the acquisition of Biochem, Shire acquired SHP630, an early-stage compound for autosomal dominant retinitis pigmentosa. Currently, there are no approved therapies for retinitis pigmentosa.

Shire also is excited to have the opportunity to work with the Foundation Fighting Blindness (FFB) on this. We believe that collaboration will be critical in the development program of this compound for autosomal dominant retinitis pigmentosa.

The collaboration will give us access to their intellectual property and their ability to help us identify clinical endpoints, as well as the opportunity to work with an agency group that has a solid understanding of the condition.

We also believe this collaboration demonstrates Shire’s commitment to eye care professionals and shows we are willing to collaborate with outstanding organizations such FFB.

Building Shire's portfolio

OPHTHALMOLOGY TIMES: Does Shire plan to build its portfolio through acquisition or through internal research and development, or both?

DEMPSEY: Research and development is near and dear to Shire’s strategic focus. We have about 5,000 employees, of which about 1,000 are dedicated to research and development.

We want to send a strong message that Shire is committed to research and development in ophthalmology. However, we also are actively pursuing business development opportunities.

OPHTHALMOLOGY TIMES: What other treatment area is Shire evaluating for future contributions to the eye care market?

DEMPSEY: Shire’s focus is both anterior and posterior segment. We are looking at opportunities that are both early- to mid-stage, along with late-stage, opportunities.

We want to be very opportunistic in evaluating compounds that address unmet needs and that are innovative therapeutics. Our focus is on therapeutics, not diagnostics and devices, at this time.

OPHTHALMOLOGY TIMES: Shire has been making its presence known in the eye care market at a very high level, especially at national meetings. What message is Shire sending to the eye care industry?

DEMPSEY: Fleming Omskov, Shire’s chief executive officer, and Perry Sternberg, head of both the neuroscience and ophthalmic businesses units, have extensive experience in the ophthalmic space through Novartis Ophthalmics and Bausch & Lomb. They have directed me to be very aggressive in getting the word out about Shire. We are allocating a significant amount of resources toward letting people know that Shire intends to be a strong player in this space.

OPHTHALMOLOGY TIMES: Where do you see Shire in five to 10 years? And how is Shire preparing to meet the future needs of this competitive market?

DEMPSEY: Shire clearly wants to be at the forefront of the ophthalmic industry. We want to demonstrate our commitment through research and development and by addressing significant unmet needs. We plan to do that by filling the innovation vacuum that exists. We believe that with the financial resources Shire has, we can do this. We believe the industry will welcome a player with our core competence. We are investing in the ophthalmic space as some other companies are in the process of divesting. We are committed and we are here to becoming a leader in this space.

Dempsey brings strong ophthalmic experience to Shire

Dempsey brings strong ophthalmic experience to Shire

OPHTHALMOLOGY TIMES: How have your experiences prepared you for your role as vice president and business unit head of Shire’s Ophthalmics Business Unit?

DEMPSEY: I have been fortunate to hold numerous positions in the ophthalmic space. I kicked off my career as a sales representative in the Boston area with Allergan. I was promoted into sales management and ultimately to sales leadership.

I was fortunate to join Inspire Pharmaceuticals, a small pharmaceutical company with a dedication to the ophthalmic community, in its infancy stages–as we were building out a commercial infrastructure. Then, I had a unique opportunity to transition into medical affairs with Inspire. I was very fortunate to help initiate our buildup of the medical affairs group.

So, I have expertise in sales, marketing, and medical affairs, which gives me a good background for my current job. I know the key opinion leaders. I know the science. I know the sales component. I know the marketing component.

As Shire builds its (ophthalmic) organization, business development will be very important. I can really foster relationships with eye care professionals and utilize my background to develop opportunities.

Update: Shire's FDA-approved drug ends dry eye treatment drought