IN SO MANY WORDS

Sun Ophthalmics’ Jerry St. Peter

In So Many Words is a timely talk with an ophthalmic industry thought leader.

Jerry St. Peter

Jerry St. Peter, vice president and head of Sun Ophthalmics, has a thing for risks. Not one to work from somebody else’s game plan, Mr. St. Peter prefers to find a business venture whose fellow C-level members feel like he does: we will start this from scratch, develop our own plan, believe in what we believe can be accomplished… and execute. It’s about looking at what you and your team have accomplished in the past and parlaying them into a new venture, says Mr. St. Peter, who left Nicox prior to joining Sun in 2015. “To see the creation of something that you and your team have invested their sweat equity and passion is very different than walking into a situation that’s already been established, or in somebody else’s footprints. I always want to be the person with the first footsteps.”

Ophthalmology Management: Have you always felt this way?

Jerry St. Peter: I’ve been building specialty pharma companies for 26 years, and I have never not built one from scratch. It was always something you had to think about every element and detail, because nobody else had defined it before. It’s really the defining principles that you learn from your role models and trusted advocates, which for me is my wife and parents. I grew up in a blue-collar family in Lowell, Mass. I was 22 years old, a new college graduate, when I went to work for George Behrakis, the pharmaceutical entrepreneur and founder of Muro Pharmaceutical, Inc. We shared the same ideals. Always treat team members and customers like you want to be treated. Be honest, value trustworthiness and be relentless in all you do. Once you get that appetite for that opportunity, that quenching aspect of fulfilling what you want to do, it’s hard to get away from.

OM: Tell us how you came to be with Sun.

Mr. St. Peter: Sun approached me, as I developed a relationship with them through other business discussions. We talked about their goals to enter into the ophthalmic space. Sun had a strong R&D pipeline but it didn’t have the commercial strategy; however, Sun did have the right attitude to win in this space. They wanted to look at doing in-licensing agreements and identify opportunities for mergers and acquisitions. Sun didn’t have an ophthalmic leadership team, or somebody able to bring on the right management group to develop and foster the strategy, the entrance platform and really start bringing it all together. But now, my team has the support of a successful company that has the resources across the board to feed the business. That is what gets me excited every morning.

OM: Please tell us about the pipeline.

Mr. St. Peter: It’s a great pipeline. It’s been developed through M&A, organically and through in-licensing opportunities with Sun’s R&D incubator called SPARC, or Sun Pharma Advanced Research Center. It began with the acquisition of InSite Vision in late 2015, the subsequent FDA approval for BromSite (bromfenac ophthalmic solution) 0.075% and then a plethora of other early to late-stage products in development. BromSite is approved for the treatment of postoperative inflammation and prevention of pain in patients undergoing cataract surgery — a unique indication. All other NSAIDs have reduction of pain, not prevention in their labels.

Our core focus is on three areas: posterior segment; anterior segment (dry eye, steroids, NSAIDs, blepharitis); and glaucoma (i.e. PGAs, CAI and drug delivery). Dry eye is a major therapeutic category in which we want to participate. It’s a large, growing, robust market with just a few players. We feel that with the resources we have this would be a good market to in which to play. So for the past eight to 12 months, we have evaluated and focused on every late-stage dry eye opportunity in development.

Ocular Technologies, with its lead program of Seciera (cyclosporine A ophthalmic solution) 0.09% and its already patented and proprietary nanomicellar drug delivery technology, offered the best opportunity that aligned with Sun’s portfolio goals.

OM: How close are you to approval?

Mr. St. Peter: Ocular Technologies initiated the confirmatory Phase 3 clinical trial for Seciera, based on FDA guidance, and results are expected in Q1 2017. There will be additional discussions with the FDA on how to move forward with the program.

OM: Summarize the pipeline.

Mr. St. Peter: We have BromSite, launching at the end of November 2016; Xelpros, a BAK-free prostaglandin formulated with a lipid-based, swollen micelle microemulsion we anticipate launching in 2017; a late-stage phase 3-ready program for DexaSite; and in DuraSite drug delivery technology, a twice-a-day ophthalmic dexamethasone; and we’re going after an indication for the treatment of blepharitis.

OM: Posterior therapies?

Mr. St. Peter: Yes. We have a joint venture with Intrexon, a leading gene therapy company. We did the Joint Venture deal with Intrexon in 2013. In addition, whether it’s internal development, in-licensing or M&A – we remain opportunistic.

OM: Lots of interest in this space.

Mr. St. Peter: I agree; however, you have seen a tremendous amount of consolidation in the past 10 years. At one point, there were 14 active companies – by 2014, essentially four remained – Valeant/B&L, Allergan, Novartis/Alcon and Akorn. But two new companies have emerged to participate, Sun and Shire. Hopefully, we will see more that decide to join, because more competition is good for patients, and our customers, the doctors.

OM: But you need serious dollars.

Mr. St. Peter: You do, but it’s not just about the monetary investment, you need superb talent, leadership and fresh thinking

OM: How much has Sun invested?

Mr. St. Peter: We are not disclosing our investment; however, Sun Pharma is fully committed to ophthalmics, as seen through our two acquisitions.

OM: What’s the R&D budget?

Mr. St. Peter: Expected to be approximately 9% of sales in FY ‘17. Overall, Sun’s total posted revenues in 2015 were $4.5 billion, with a market cap of $25 - 30 billion.

OM: Does that negate your risk?

Mr. St. Peter: Not really — there’s always risk. OM