This year has proved to be a busy one for Ipsen, with the first three months of 2016 alone encompassing a key licensing agreement and the not inconsequential matter of a management reshuffle.
In February deputy CEO Christel Bories was ousted, with the company highlighting disagreements over strategy between her and its board of directors. At the same time the French speciality pharma company went on the hunt for a new chief executive in February after deciding to separate the CEO and chairman roles held by Marc de Garidel.
Commenting at the time on the decision to split the two senior roles, he said it “meets the need for our group to accelerate its international development in an increasingly complex environment”.
Its CEO search ended in July with the appointment of David Meek, whose US, regional and global experience ticked the boxes for Ipsen, as did his oncology background - the latter was particularly important because cancer drugs account for more than half of its sales.
David was until recently the head of Baxalta's oncology division, whose formation he led, guiding it through a series of acquisitions and partnering deals. But Baxalta's own acquisition by Shire, a $32bn deal that was completed in June, prompted David to cross the Atlantic to Paris in July to take the helm at Ipsen. Doing so was the latest move in a 25-year pharma career that has also encompassed stints at Johnson & Johnson, Novartis - including a spell as its oncology head for northern, central and eastern Europe - and US biotech Endocyte.
When I met him at the annual European Society for Medical Oncology (ESMO) meeting in Copenhagen last month he explained how international expansion and oncology were key to Ipsen's plans.
US rising, China transforming
“This is the first year that the US has been the number one affiliate for us in revenue, and that's very important for us because it really shows our global presence,” David said.
The firm now employs more than 300 people in the US. Last year it achieved sales of nearly €158m, thanks to year-on-year growth of more than 65%, allowing it to achieve profitability 18 months ahead of plan. “Now we can declare a success in the US,” David noted, adding that it's also Ipsen's fastest-growing affiliate.
2015 also saw the opening of Ipsen's first US R&D centre in Cambridge, Massachusetts, adding to research bases in Les Ulis in France and Slough in the UK.
Overall, Ipsen's global presence spans 115 countries, from Algeria to Vietnam, and among those China is one of David's focus territories. Ipsen has had offices in the country since 1992, subsequently adding manufacturing and production facilities and then an Asian clinical and scientific affairs development hub in Beijing.
Having recently returned from a trip to China, David ran through the big changes Ipsen has been making in the Middle Kingdom, a market that has proved challenging of late.
“We've transformed our primary care business model there into a primary care and over-the-counter model, so we've transformed the way that business operates and the way they commercialise our products.”
The company's flagship product in primary care in China is Smecta, a treatment for diarrhoea in children and adults that's available over-the-counter, and the pharmacy sector is key to the company's plans.
David noted that the transformation of Ipsen's commercialisation model is “less physician-facing and more retail-facing now, because a lot of the responsibility has been transferred to the retail pharmacist in China“.
The move is also an acknowledgement of the way the Chinese healthcare is becoming more dynamic, he said, adding: “We needed to shift in light of that so that's one of the things that we've done - shift our go-to-market model in China.”
Another avenue on Ipsen's roadmap is to continue to develop the leading lights in its portfolio, starting with its biggest product Somatuline. The drug treats the hormonal disorder acromegaly and neuroendocrine tumours (NETs), a rare form of cancer. It's currently seeing strong growth in the US and performing generally well in Europe, driving third-quarter sales of €137m, up 34%.
Behind that as a focus product is Dysport, a botulinum toxin that was approved in the US by the FDA in August for a new indication to treat paediatric lower limb spasticity. This, David says, will be “a big launch event for the US team”. Dysport is part of Ipsen's partnership with Galderma that sees Nestlé's skin care business manage its aesthetics business while Ipsen has the therapeutics side.
This is the first year the US has been the number one affiliate for us and that's very important
Earlier this year Ipsen signed another deal to bolster its pipeline by harnessing external innovation, licensing promising cancer drug Cabometyx (cabozantinib) from Californian biotech Exelixis. The February deal, which gives Ipsen commercialisation and development rights outside the US, has seen Cabometyx take off rapidly. Its first US approval came in April for second-line treatment of renal cell carcinoma (RCC), a prevalent and difficult-to-diagnose cancer, with European regulators giving it the green light in September. Along the way it also received a Promising Innovative Medicine (PIM) designation from the UK's MHRA in just five days, which Ipsen believes is a record-breaking timescale.
But, for David and his company, the focus and excitement is all about the product's trial results. “We're really thrilled about that, and why are we excited? It's because of the data - the overall objective response rates, the progression-free survival and gold standard of overall survival. This makes a difference to patients - so we're excited about it in the second-line setting and in the first-line setting, [where it's] beating the standard of care pretty solidly. We're excited about that and we're hearing from patients and physicians that they're excited about that. I think these is some really game-changing data for first-line and second-line RCC patients.”
In Copenhagen, Ipsen's ESMO focus was on the CABOSUN study, whose findings will be used to pursue new first-line indications in RCC. It showed that Cabometyx can decrease the rate of disease progression or death by 31% in advanced renal cell carcinoma (RCC). In addition to meeting the primary endpoint of the study, the trial also showed median progression-free survival of 8.2 months versus Sutent's 5.6 months.
Work is already underway to prepare the data for submission to the FDA for a supplementary new drug application, and discussions with the EMA have begun about the next steps for updating its EU licence.
Before that happens, Ipsen's focus is on steering Cabometyx through the market access process - with HTA conversations “happening as we speak”, David tells me. “Germany and the UK are first, Austria, Denmark and the Netherlands are right there with us - it's really their timing that determines it, not just ours. So we're following the typical wave one markets, then wave two and so on. The dossiers are going in and the conversations with NICE and the SMC are happening and we're cautiously optimistic.”
Those discussions help Ipsen progress in putting managed access plans in place across Europe that will see Cabometyx made available to healthcare systems free of charge until it wins reimbursement or until December 2017, whichever comes first. But the company said that even if it doesn't win reimbursement it won't start charging patients for access to the drug if they have already started on the programme.
So, with its lead products expanding, the US playing a big part in the French company's plans and a new strategic direction in China, plus an exciting new cancer treatment, the next 12 months look like they will also be a busy time for Ipsen.