Dempsey on Building the Shire Brand in Ophthalmology

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 087″]

Robert Dempsey, vice president of ophthalmics at Shire, was charged with building a brand in ophthalmology with no new drugs. Two years later, Shire has – in the words of one physician – one of “the best kept secrets” in eye care. Dempsey explains how Shire came to build something from nothing.

Podcast Guest

Podcast Transcript
Tom Salemi: Hi, everybody, welcome back to the OIS Podcast. I’m Tom Salemi, your host. One of the great things about OIS is just the opportunity to have all the leaders of the sector in one place. It’s great for obviously companies looking to do deals, great for KOLs looking to meet with the sector’s commercial leaders. And it’s great for me as a content guy just to sit down and talk with some of these folks, just somewhat informally, chair to chair, mic to mic. And you hear what’s going on in their companies. One of the folks I had a chance to speak with in New Orleans was Bob Dempsey. Bob of course is the Vice President and head of the Ophthalmic Business Unit at Shire. And Bob had perhaps one of the more unique jobs in ophthalmology in that he had to build a brand, build an ophthalmology company with no products to speak of at the start. Shire really went looking for earlier stage companies, or at least non-commercial – sorry, earlier stage products or non-commercial products. And their big product, their lead product of course is Lifitegrast, and they’re hoping to get approval for that this summer. So I really enjoyed sitting down with Bob. He’s a good guy, a Boston guy. Shire is about 30 miles or so from your OIS Podcast studio. So please sit back and enjoy this conversation with Bob Dempsey of Shire.

TS: Hi, this is Tom Salemi at OIS TV. Very pleased to be joined by Bob Dempsey, Vice President and Business Unite Head of Shire Ophthalmics.

Bob Dempsey: Thank you.

TS: Great to have you here. Two Boston guys hanging in New Orleans.

BD: Yes, yes.

TS: I was going to ask for an update on your pipeline, but just kind of zoom out and go picture. You were given a great task of basically building a brand, building a business in ophthalmology with no products. I mean basically you had to build the brand and then you were getting the products and bringing them in. What was that process like of getting the Shire name out there in ophthalmology and building the awareness that you need to be a leader?

BD: Well, it was a tremendous opportunity. So when I joined in February of 2013, I was charged with really building Shire’s presence in the ophthalmic space. So we took a very systematic approach to doing that. And one of the ways was through engagement of KOLs and key opinion leaders and obtaining their advice and feedback on our development program for our various programs in development. It also was to establish collaborations with all the eye care organizations, whether it’s the Academy of Ophthalmology, the Cornea Society, on the optometrics side the Academies of Optometry and the American Optometric Association. By doing so, we built up our presence by attending the various conferences and conventions, really working to get the name of Shire out there. And we were very specific about how we did it and the narrative and the message that we wanted to use. And that would be really focused on Shire as a company that’s focused on innovation, that’s focused on unmet needs. And to really build our pipeline to show our commitment to the ophthalmic space. So it’s a very systematic approach, and something we’re very proud of.

TS: Now the name Shire, obviously, you’re not starting from scratch. You’ve got a little bit to work with.

BD: Yes.

TS: Take us back a little more. What was it that caused Shire to stick the tack in ophthalmology and say we want to be there, we want to build a business around there?

BD: Yeah, it really goes to our Chief Executive Officer, Dr. Flemming Ørnskov, who has extensive experience in the ophthalmic space. He was formerly the head of Novartis Ophthalmics as well as President of Bausch and Lomb Pharmaceuticals. And when he joined Shire, it was really his vision to really pursue the ophthalmic space, thought there was a significant need for innovation, that there was significant unmet needs, and with the research and development powerhouse that Shire has, that we could really address some of these opportunities. And really, with the acquisition of Sarcode, and with that acquisition we obtained the molecule Lifitegrast, really was the beginning, the foundation of our build-out of the ophthalmic space. And when you look at our strategic plan, our strategic plan has been built upon acquiring opportunities, in particular in anterior segment as well as looking at opportunities in the posterior segment. But we don’t want to stop there, Tom. I think it’s very important from Shire’s perspective, as being a company focused on rare diseases, to take that rare disease mentality and apply it to the ophthalmic space as well. So as we’ve built our pipeline, we have looked at as I mentioned, anterior segment and posterior segment, but also areas of unmet need and rare ophthalmic diseases. It’s clearly where Shire is going to stand out in this very exciting space.

TS: Was there a temptation to buy approved products in the space to really get that immediate entry into the doctors’ offices?

BD: Yeah, I think that’s a great question. And our approach actually was not to buy existing products. We really wanted to build through our pipeline and really look at products that were innovative in the stages, and that we could literally invest in and put forward with our development team and bring these products to market. So it would have been a lot easier to buy an existing organization, but we think the return in the investment on going our approach will pay dividends. And to give you some context with regards to that, so since I joined two and a half years ago, the investment that Shire has had in the space is right now about $750 million. Now you take all the work we’ll do this year in preparing the market for the pending approval of Lifitegrast. We will probably be looking at well over 8 to $850 million before a script is generated for our programs in development. That’s a significant investment, and it really is the commitment of our CEO, a commitment of board of directors, the commitment of our executive management to invest in this space. So give you a little bit more of the details, but it really shows that Shire, we’re not dipping our toes in the water. We are all in and believe that we have potential best in class pipeline and products that really will address unmet needs.

TS: Hi, everyone, well, this is Tom just taking a quick break to remind you to go to OIS.net. We will have interviews like this one with Bob up in video format on OIS.net along with all the presentations and panels and other events and content from New Orleans. So go to OIS.net.

TS: And you’ve got a couple of things percolating that will really give you the boost. You’ve got Lifitegrast, which we can hit upon a bit. I know you’re dancing with the FDA and don’t want to step on their toes.

BD: Yes, yes.

TS: But give us a quick update on as much as you can.

BD: Yeah. So since last time we spoke, we announced top line results of our OPUS-3 trial, and used that as the basis of the resubmission of the NDA in February of 2016. And with the resubmission, we heard back from the agency that we now have a PDUFA date of July 22. And from the standpoint of that date, obviously we’re very excited. We’ll be collaborating with the agency and trying to address any questions that they may have.

TS: And the acquisition of Baxalta is sort of working out?

BD: Yeah. So we will be hoping to close that deal, pending approval, at the midpoint of this year. But from the standpoint of the ophthalmics business unit, we’re really focused on what we need to do as an organization to have our best entrance into the ophthalmic space. So whereas the rest of Shire is going through the integration, we’ve been very fortunate to stay focused on our entrance into the ophthalmic space.

TS: So you haven’t been distracted?

BD: Yeah. It’s something that our CEO and our executive committee has really said. The ophthalmics business unit needs to stay focused. And for the most part, my team is as completely ring fenced from that situation with Baxalta.

TS: Are you looking at medtech devices as well?

BD: So right now our focus from a big picture is innovation, unmet needs. And really where we want to stay in the therapeutic space. So whether it’s diagnostics or surgical interventions, right now, those are not strategic priorities for Shire.

TS: And how about on the R&D within ophthalmology? Have you built a unit, a team that’s –

BD: Yeah. It’s just been an incredible build out. Again, when I joined two and a half years ago, it was just me and the business. And when we would go out and look at the opportunities and do due diligences, we really were putting together a small core team that for the most part had very limited experience in the ophthalmic space. Fast forwarding to where we are now, with some of the deals we’ve closed and with some of the due diligences that we have done, we’re in a much, much better situation. I mean I call it the IQ in the ophthalmic space is second to none. And I would say we could challenge any of the larger pharmaceutical companies with not only the programs that we have in development, but the knowledge, insights, and experience that the team has been able to gain in the ophthalmic space.

TS: Is ophthalmology unique in being open to this sort of company creation? Because it’s a specialty where you’re still very much dealing with the doctors, you’re selling directly to the doctors, the whole hospitals’ takeover of – acquisitions of or purchases of new technology hasn’t really hit ophthalmology yet. Would it be more difficult to do this in another specialty?

BD: I think so. I think as Shire has built up this IQ, I think the individuals that we’ve been working with internally have been very, very impressed and excited to work with the ophthalmic community because of the collaboration that the KOLs, the thought leaders, even the academic institutions want to have with industry to move forward these various programs. And when they see a company like Shire, that over 20% of our work force is dedicated to research and development, I really think that stands out. And when you look at our 5 programs in development and some other programs that we haven’t displayed yet to the public, the doctors know that we are committed to this space. And so it’s been a great synergy from what the company wants to achieve, and what the physicians want to achieve. And a quote that – I’ll be honest with you; every time I think back to the discussion I had with Dr. Dick Lindstrom in which one of the times he was in our Lexington office, and I shared with him our pipeline, he leaned back and he said, you know, Bob, that’s probably – no, that is the best kept secret in eye care, looking at the programs that you have in development.

TS: So then project down 3 years or so and some of those secrets will come to light.

BD: Yeah.

TS: What does Shire Ophthalmics look like?

BD: I think it looks like a fully integrated biotech company with a major play in the ophthalmic space, with potentially – if products are approved and go through the regulatory process, products for the front of the eye as well as products for the back of the eye, and having a team in place that is skilled and knowledgeable and able to fully execute on the opportunities that we have.

TS: Great. Final question: we’re at ASCRS. What news have you released this week?

BD: Yeah, so we’re planning to announce the results of the Opus-3 trial. Dr. Edward Holland, who was the principal investigator of this pivotal trial will be announcing results on Monday morning. So we believe obviously this will be a tremendous opportunity and a lot of interest in our development program for our program for dry eye.

TS: Terrific. Well, thanks for joining us today and –

BD: Thank you. Really appreciate it.

TS: Sharing Shire’s story.

BD: Sounds good. Thanks, Tom. Appreciate it.

TS: Bob Dempsey, always a pleasure to talk to you. Thanks for taking a few minutes to share Shire’s story. We wish you the best of luck this summer, and look forward to a follow up Podcast when we can talk about Lifitegrast and how it’s doing in dry eye. Thanks again to our listeners for joining us today, and don’t forget to tune in next week for another tale of innovation. And go to OIS.net, register for our OIS@ASRS, and we will see you in San Francisco.