Godspeed Xiidra. Shire’s Robert Dempsey Introduces the Newest FDA-Approved Treatment for Dry Eye

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Robert Dempsey joined Shire to build a new ophthalmology unit. Until now, the division had been mostly theoretical with no products to sell. Now, the brand building is over. Shire officially has entered the ophthalmology sector with the launch of its potential blockbuster, Xiidra. Hear what’s next for the Dry Eye treatment and what else we can expect to see from Shire’s pipeline.

Podcast Guest

Transcript

Tom Salemi: Everyone, hi, this is Tom Salemi. Welcome back to the OIS Podcast. There are times in the Podcast business when fate just smiles at you, and we are very happy to have the news from Shire that the FDA approved Xiidra, its new treatment for dry eye. This is the flagship product for Shire’s new ophthalmology business. We’ve talked with Robert Dempsey who heads up and created that division on the Podcast just recently. Met up with him at OIS@ASCRS, and very happy that Bob was able to take just a few minutes with us yesterday to discuss the approval of Xiidra, what it means for Shire, what they’ll be doing, when they’ll be launching, and what else we can look forward to in the pipeline. So let’s not take any time. Going to speak with Bob Dempsey from Shire about the approval of Xiidra.

TS: Bob Dempsey, welcome back to the Podcast. How are you?

Robert Dempsey: Doing very well, Tom, thanks for this terrific opportunity to share with you the news.

TS: I bet. I was debating whether or not you didn’t sleep last night or if you slept like a baby last night. Which was it?

RD: Didn’t sleep much last night as we got the news late yesterday, and we had to activate all of our day zero activities. And that kept us well to late in the office. And then we had a little bit of a celebration, as you can imagine.

TS: That’s terrific. So we’re obviously talking about the FDA’s approval of Xiidra, and that is the name of what we had been calling lifitegrast. This obviously had some bumps along the way. What was the communication like with the FDA at this point? They actually came in about a week or so before the PDUFA date.

RD: Yeah. So as you know, our PDUFA date was July 22, and we were very fortunate on 7/11, July 11 to obtain the approval. And like any development programs, you have some trials and tribulations, but ultimately, and working closely with the agency, we were able to obtain the indication for the treatment of signs and symptoms of dry eye disease. So very excited about that. And with the significant unmet need out there, we believe that with this indication and the opportunity that we have, we can address this situation.

TS: Yeah. It’s been a decade or so, or more maybe since the last treatment was approved. So what is the market like? You’ve obviously been having some communications, I would guess, with clinicians. What are your expectations in terms of launching this? How will you get it into their hands, and what kind of reception are you anticipating?

RD: Well, obviously, we’re looking to launch in the third quarter of this year. And over the last 2 and a half years since I joined the company and built out the team, we’ve done a tremendous amount of research, Tom, and trying to identify what the triggers are for both the eye care professions and the consumers. And we’ve studied close to 1500 eye care professionals and had conversations with them to find out what they’re looking for, and close to 2500 consumers. And listening to the patients, we really have been trying to identify what will drive them into the eye care professional’s office. And I think we’re really in a good situation to understand the market, understand the thought process of the eye care professionals, and how we can address this significant unmet need that’s out there.

TS: And what else will your sales team be carrying in its bag? Who will be selling this? Is this a new sales team that you’ve created strictly for ophthalmology? Or how is Shire approaching the sales of this?

RD: Yeah, it’s a great question. So obviously we have been in the process of building out our sales organization. And we have hired, trained, and recently deployed our sales organization out in the field. And now we’ll be bringing them back in and then training them on the label associated with Xiidra. And our plan is to activate them in the third quarter of this year and start actively selling and promoting the product to both ophthalmology and optometry.

TS: And do you anticipate giving them more products to sell? Obviously this is a great foot in the door. But what’s next for the pipe – well, what’s next on the horizon on the commercial front that you hope to get to your salespeople as well?

RD: Yeah, Tom. So as you know, over the last two and a half years, obviously the lifitegrast or now Xiidra was our anchor program. But we don’t want to stop there. We do not want to have just one product into the ophthalmic space. So we have been busy building our infrastructure from an R&D perspective, and from a commercial development perspective to bolt on other opportunities. So over the course of the time I’m with the organization, we’ve made numerous strategic acquisitions, one of which we’re very excited about that’s entering phase 3 is a program for infectious conjunctivitis. And when you look at the call point of both ophthalmology and optometry, and the overlap between dry eye disease and infectious conjunctivitis, we believe we could become a major factor in the treatment of all ocular surface diseases. So with our program for infectious conjunctivitis, we believe that’s a great compliment to a program for dry eye disease. But we don’t want to stop there, so we also have programs for the posterior segment, a program in development for the prevention of retinopathy prematurity, a program for autosomal dominant retinitis pigmentosa, and an early stage program for glaucoma. So when you look at our portfolio and our commitment as an organization to build out our portfolio, we believe we’re really situated quite well to address the significant unmet needs in this space.

TS: Hi, this is Tom. Going to take a quick break from this quick podcast to remind you to go to OIS.net, check out our agenda for OIS@ASRS. It is happening on August eighth in San Francisco. You need to be there. Go to OIS.net, check it all out. Now back to Bob Dempsey.

TS: And the infectious conjunctivitis product, that was the acquisition of ForSight?

RD: Yeah. And we will be announcing how the team will be built. I just hired a proven eye care professional in Beth Marsh, who comes to us, and having worked with numerous ophthalmic companies, and she’ll be leading that program. We have a tremendous head of marketing, Victoria Nobel, who will be sharing with the eye care community and patients our very exciting and novel campaign. And really excited to have these individuals start to be seen as proven leaders in the ophthalmic space.

TS: And what else do you have in the phase 2, phase 3 area that we might be hearing about in the near future?

RD: Yeah. So in addition to infectious conjunctivitis, we have a program for the prevention of retinopathy prematurity. We have a program for autosomal dominant retinitis pigmentosa, and we also have a novel program that is very exciting, a program for glaucoma that we’ll be meeting with the agency over the next couple months and talking to them about the development program there. And we don’t want to stop there, Tom. I think it’s very important for us to send a signal that Shire now, especially with a product that will be entering the market in the third quarter of this year, will be looking to enhance our portfolio of products, and really develop a best in class ophthalmic company to address the significant unmet needs in the space.

TS: Have we talked about the glaucoma product before? Obviously, it’s a huge area. Is that an area you’re going to be building out? Or is this a large kind of product that you can build a glaucoma franchise around?

RD: Yes. We believe it really is a very important supplement to what we’re trying to do in the ocular surface. If you look at the call point, both within ophthalmology and optometry, both of these specialties treat a large percentage of patients with glaucoma. So if you look years down the road, if we have programs for dry eye for infectious conjunctivitis and for glaucoma, we believe we’ll be a powerhouse organization in this space.

TS: I believe you were told it was one of the best kept secrets in ophthalmology. I guess it’s not a secret anymore.

RD: Yes, yes. And when we’ve had an opportunity to meet with many of our key opinion leaders, and they see our pipeline, they see our commitment, they meet our R&D team, I think they’re very impressed. And obviously, with the news late yesterday about the approval of Xiidra, it’s game on, and we’re obviously very excited. We’ll be activating our sales organization in the third quarter of this year, and obviously we’ll be making big plans for the Academy in Chicago this year.

TS: Terrific. I know you have just a few more minutes. Just two quick questions. Again, going back to your interaction with the FDA, it took a little while to get this done, but you got it done. What has your experience been like with the FDA, and what lessons have you learned that you’re going to be carrying forward to the review of the other products in your pipeline?

RD: Well, I think it’s a collaborative relationship. And to work with them closely, I think the FDA – we feel very fortunate to have been granted this indication for the treatments of signs and symptoms of dry eye disease with Xiidra. And our belief is you work closely with the agency and listen to their advice and take their guidance and act on it.

TS: And now that you have this flagship product, does this sort of accelerate any intentions to acquire new properties? I know you’ve been looking out there before. You’ve got an R&D pipeline, but you’re in the game. Does this sort of increase your appetite for acquisitions?

RD: I think it still shows that we want to demonstrate our commitment and address the unmet needs that exists in the ophthalmic space. So we will continue to evaluate and look for opportunity for both the interior segment and the posterior segment.

TS: Terrific. And just finally, we’ve talked about just building the brand of Shire, how you sort of had to start with nothing and assemble these pieces. This does change everything for you, now. You’re no longer just building a brand, you’re now building a company. So that’s got to be exciting.

RD: It’s very exciting. You know, Shire has made a major commitment to the ophthalmic space over the last 2 and a half years, and it really was to – in preparation for today, and the months to come to have the awareness be where it was and obviously we’ve spent a tremendous amount of resources building the name, building the commitment to the space via education and sponsorships. And now to actually have a product we can transition off of Shire and really focus on marketing the brand. And with the innovative program that we will be announcing very shortly about Xiidra, our awareness, our consumer campaign, our educational campaign, we believe we’re situated quite well. And with this beautiful label we have, the treatment of signs and symptoms of dry eye disease, we believe that the stars are aligned, and we are ready to make some impact.

TS: Great. Well, we’re obviously all about innovation. Can’t spell OIS without innovation, so when you’re talking about any innovation programs coming forward, you’ll remember to come back and visit us on the Podcast.

RD: Absolutely, Tom. Thank you. Greatly appreciate it. And thank you for the opportunity again to talk to you about the approval of Xiidra.

TS: Great. Congratulations again, and good luck.

RD: Thank you, Tom.

TS: Thanks, Bob, for taking the time to share Xiidra’s story, and congratulations again. Great news for Shire, great news for ophthalmology. And we look forward to hearing more of the story at AAO. And of course we’ve got an OIS in between now and then. Go to OIS.net. If you’re involved in the retina space, you should be at OIS@ASRS. It’s our newest member of the OIS family. Going to focus exclusively on the retina. We’ve obviously tackled that at other OIS’s, but this is the first time we’re really focusing 100% of our event time on the retina. And it’s a terrific agenda that our co-chairs have put together again. Go to OIS.net, check out what’s happening and make sure you register for the August eighth conference so we can see you in San Francisco. Take care, everyone.