Zealand Pharma's 'More Commercial' CEO Jensen On Lixisenatide And Beyond

Danish company Zealand Pharma, most noteworthy for developing the thus far commercially disappointing Sanofi-partnered GLP-1 receptor agonist Lyxumia (lixisenatide), appointed its new CEO a year ago, claiming it needed someone with a more commercial focus. Scrip caught up with Britt Meelby Jensen to find out what lessons the company has learned from the Lyxumia episode and how Zealand Pharma is moving beyond diabetes.

Jensen's resume boasts 11 years at Novo Nordisk, followed by a shorter spell as the CEO of diagnostics company Dako, so she was well-suited to replace David Solomon.

Scrip: What attracted you to Zealand Pharma?

Britt Meelby Jensen: I already knew Zealand well before I was approached about the position. I am Danish, and I spent a long time at Novo Nordisk, so it was inevitable. I was excited by the company. There were strategic decisions to be made and my commercial background made me a good fit.

Scrip: What were your immediate priorities?

BMJ: I had to make a lot decisions. What were we good at? Where did we want to go? Did we have the right management team in place to achieve that? Very quickly we put three new board members in place, including a new chair, and together we set up a long-term strategy for the company. And through all of that we had to keep the business running.

Scrip: Have the past 12 months gone to plan?

BMJ: For me it has been a fun year. We've made extremely good progress on our proprietary pipeline. Sanofi has reported good progress with lixisenatide. It laid out a plan at the start of the year for both the products: Lyxumia and LixiLan (lixisenatide plus Lantus), and it has delivered on that. Lyxumia has been filed in the US. The only remaining thing is the US filing of LixiLan, which Sanofi says is on track to happen by the end of this year. Our share price is up 80% over the year. We have built a strong foundation for future growth, and we continue to be innovative.

Scrip: Have there been any significant frustrations?

BMJ: Not everything runs smoothly every day of the week, but there have been no major frustrations. I am an impatient person, and I like things to move fast, so I would say that I am impatiently waiting for certain things that are set to happen in 2016. Obviously a big part of our valuation is related to Sanofi and there were earlier frustrations there. Sanofi has gone through a lot of change this year, but it has continued to demonstrate its commitment to LixiLan through everything that has gone on. Maybe the only single frustration has been the lack of growth in Lyxumia sales outside the US, which is owing to a number of factors: lack of payer interest, coming to the market late, but we always knew that outside the US was never going to be a major market for us. But still, we hoped for more. However, we are confident that LixiLan is going to be a major product.

Scrip: How reliant are you on the potential LixiLan revenue stream to fund operations in 2016 and beyond?

BMJ: We have €61m in cash right now. There is a potential €13m that could be added to this pile in Q4. So we're okay for 2016. We are not dependent on Sanofi filing the LixiLan NDA this year. There is also the potential for things to look very much better quite soon. Sanofi has purchased a priority review voucher. We don't know if it plans to use it for LixiLan, we will probably find out when it files the product, but if it does we could be on the market in August or September next year, if the NDA filing is made as planned by yearend. Whatever happens, from 2017 Zealand will look a very different company.

Scrip: How has Zealand changed following its experience with lixisenatide?

BMJ: We have five fully proprietary products in clinical development. We have learnt that we should try and keep compounds in-house for longer. And with one of these five, the GLP-2 analogue ZP1848 for short bowel syndrome (SBS), we want to keep hold of it all the way to market.

We also want to be more external in our early discovery, more collaborative. We have been looking for a head of R&D that has experience in leading internal programs as well as external ones. We're hoping to close that [search] soon. We recently appointed a new business chief [Carlos de Sousa] to drive our business development agenda. Rather than straight out-licensing, we want a more collaborative structure [to our deals].

We want to continue our focus on research but focus more on specialty diseases rather than broad indications such as diabetes.

Scrip: Tell us about your proprietary pipeline.

BMJ: ZP1848 is currently in Phase II. With an orphan indication [such as SBS] the clinical development program is manageable – unlike with diabetes – and we have a good relationship with the lead investigator [Professor Palle Bekker Jeppesen] who probably knows more about this indication than anyone else in the world. He ran two clinical trials for Shire's (formerly NPS') Gattex (teduglutide) for the same indication. Our product has a longer-acting profile than Gattex, though we need to investigate how that transfers to a clinical benefit. Also, Gattex is a lyophilized powder and there are many [preparation] steps before it can be injected. ZP1848 is a ready-to-inject liquid.

Ahead of ZP1848 is danegaptide, which is in Phase II as a treatment to prevent cardiac tissue damage after an acute myocardial infarction undergoing PCI. We will have that data at the end of the first quarter next year. If all goes well, we will look for a partner.

We have ZP4207, our glucagon analog, where we have Phase I data. We are developing it as a glucagon rescue pen for acute severe hypoglycemia and also as a multiple-dose version for mild to moderate hypoglycemia. Obviously we will need to partner that for the device element.

We also have ZP2929, a dual-acting glucagon/GLP-1 peptide agonist that is currently on clinical hold. It was the subject of a collaboration with Boehringer Ingelheim, but Boehringer is pursuing the backup compound. We are negotiating with the US FDA to get the hold lifted as we believe in its safety and efficacy. The plan is to get it back on track and then look for a partner.