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20 for 2020 – Five pharma leaders to watch in 2020

Five individuals we think will have a key role to play in the sector in 2020 and beyond

Five pharma leaders

1. Albert Bourla - Pfizer’s new chief executive

The first entry in our alphabetical list is Albert Bourla, who stepped into the shoes of long-serving Pfizer chief executive Ian Read on 1 January 2019, crowning a 25-year-plus career at the company that saw him rise steadily to the role of chief operating officer.

Like any new CEO, Bourla has moved quickly to set his seal on the third-largest pharma company by revenue and – while 2019 Albert Bourla can be viewed as a transition – 2020 will be the year when the impact of those new strategic moves starts to be felt.

Pfizer is coming off ten years of patent expiries, plus a pipeline that hasn’t yielded as many new products as hoped in that period, and that prompted Bourla to implement a major restructuring drive a few months into the new role.

The checklist of retooling initiatives include a deal to merge Pfizer’s off-patent drug business with generic drugmaker Mylan, combining consumer health assets with GlaxoSmithKline’s equivalent division into a joint venture company that will eventually be hived off, and making worldwide staffing reductions of around 2% of its headcount to allow it to focus on business categories that offer higher returns.

That includes an exit from areas like neurology – which predates Bourla’s appointment as CEO but was set up while he was COO – and a series of bolt-on deals to build its presence in other therapeutic categories like oncology.

The latter includes its $11.4bn deal to buy Array Biopharma – the biggest for the group since its $14.3bn takeover of cancer specialist Medivation – that added two marketed drugs (Mektovi and Braftovi) that Pfizer thinks could become a top industry franchise in colorectal cancer when combined with antibody drug cetuximab.

It would appear that there are more shake- ups to come, given that Bourla told the JP Morgan Healthcare Conference in January that he sees additional space for cutbacks in areas like human resources and finance.

Bourla reckons the changes have resulted in Pfizer’s best-ever pipeline, with a clutch of new product launches in cancer already underway and emerging candidates like a new 20-valent pneumococcal vaccine due to be filed next year that would extend its $3.4bn Prevnar franchise, a Clostridium difficile vaccine in phase 3 and JAK inhibitors for atopic dermatitis and alopecia.

He also thinks Pfizer is heading for a period of industry- leading revenue growth, a view that’s also shared by analysts at RBC Capital Markets who see healthy growth out to 2025 built on the Prevnar franchise, rare disease therapy Vyndaqel (tafamidis), breast cancer therapy Ibrance (palbociclib) and arthritis drug Xeljanz (tofacitinib), among others.

2. Stephen Hahn – FDA’s new commissioner

The FDA Commissioner always has a pivotal role to play in the industry, directing policy in the world’s largest pharma market, and with Stephen Hahn newly appointed to the role all eyes will be on the announcements coming out of the agency in 2020.

A radiation oncologist by training and MD Anderson Cancer Center chief medical executive, Hahn was officially confirmed as the new FDA Commissioner by the Senate in December 2019.

Stephen Hahn He replaced Scott Gottlieb, who was popular with industry but resigned from the post unexpectedly last year, as well as stand-in Ned Sharpless who has now returned to his post as director of the National Cancer Institute.

It’s too early to say what style Hahn will bring to the role and its impact on the pharma sector. However, there are signs of a changing environment at the regulator that may not be welcomed by the sector, such as a proposed new Health and Human Services (HHS) plan announced on 18 December 2019 to allow medicine imports from Canada to help tackle high drug prices.

Hahn has indicated he is open to looking again at the endpoints used in clinical trials and finding new ways to speed up the new drug approval process, which will be welcomed by drugmakers.

His experience in oncology, which is the top investment area for pharma at the moment, will likely also be viewed as a positive, while lawmakers appreciate that he has relatively few links to industry.

Questions have been raised, however, about his perceived lack of government experience, having spent most of his career in academia, although Hahn insists that isn’t an issue.

Hahn is taking over as the FDA is being thrust into the spotlight on a number of issues, including how to deal with medicine prices, the opioid epidemic, hastening access to biosimilars and other lower-cost drugs and health concerns relating to vaping products.

It’s also worth noting that Europe’s EMA is also moving ahead with plans to find a new executive director to replace Guido Rasi, whose current role in the position is due to come to an end in November 2020 after serving two five-year terms. The agency advertised for applications for the role last year.

The new executive director will have the challenge of the continuing fallout affecting the EMA post-Brexit and its forced move from London to Amsterdam, which is still weighing on its work practices.

3. Paul Hudson – taking the helm at Sanofi

Another new chief executive with a lot on his plate in 2020 is Paul Hudson, who took over from Olivier Brandicourt at French drugmaker Sanofi on 1 September last year from a prior role as head of pharma at Novartis.

He was previously also head of pharma for AstraZeneca in North America. Hudson had a distinguished career at Novartis, presiding over the launches and roll-outs of psoriasis blockbuster Cosentyx (secukinumab), spinal muscular atrophy gene therapy Zolgensma (onasemnogene abeparvovec) and heart failure therapy Entresto (valsartan/sacubitril).

Paul Hudson His appointment was welcomed by analysts who suggest appointing a non-French speaking CEO is a positive for Sanofi’s culture, particularly as he has been happy to relocate to Paris. Sanofi’s last non-French CEO, Canadian-German national Chris Viehbacher, parted company with the firm in 2014, reportedly over his decision to relocate to Boston.

Hudson takes over Sanofi at a transitional time for the French group, which like many of its peers has been restructuring
its approach to R&D and trying to turn the group into a ‘lean’ organisation, as well as expanding into new areas like digital.

He has already taken some pretty seismic decisions, such as axing R&D in diabetes – for many years Sanofi’s most important franchise but much reduced following the loss of patent protection for Lantus (insulin glargine) – as well as cardiovascular disease research.

In the meantime, Sanofi is stepping up its focus in other areas like immunological and inflammatory diseases, rare blood disorders and vaccines, as well as cancer – an area it had been looking to exit just a few years ago.

That new strategy was thrown into relief by Sanofi’s acquisition of cancer specialist Synthorx, announced in December 2019 and completed in January 2020, the first major deal under Hudson’s stewardship.

There had also been speculation that Hudson may follow the path trodden by AstraZeneca and others by selling off older brands in order to reinvest in its pipeline, and exit non-core business units as it tries to bring through a new generation of blockbuster brands.

Following through on that, Hudson has decided to spin out consumer health as a stand-alone business unit, with its own R&D and manufacturing capabilities.

The changes also mean Sanofi has downgraded some long-standing relationship in R&D – such as a fruitful tie-up with Regeneron that generated some of its top-selling drugs like Dupixent for eczema and asthma – in order to ramp up internal generation of new drug candidates.

That strategy was born under Hudson’s predecessor, however, and it remains to be seen if that in-house focus will be retained
in 2020 and beyond.

4. John Maraganore – Alnylam’s payoff year

2019 was a landmark year for gene-silencing specialist Alnylam and its chief executive John Maraganore.

More than a decade of research into its RNA interference (RNAi) drugs generated the first ever approval of a drug in this category towards the end of 2018, and the company followed that up with a second approval last year to show that wasn’t a fluke.

2020 will be a big year as it continues its transformation into a commercial-stage company while also trying to bring four late-stage RNAi candidates through to approval, one of those before year end.

It’s all part of a plan that Maraganore thinks could catapult Alnylam into a top five position in the biopharma category within five years, according to comments he made at the JP Morgan Healthcare conference in January.

So far, its first launch Onpattro (patisiran) has been growing pretty slowly. Onpattro was approved to treat adults with the John Maraganore destruction of nerves that results from a rare disease, hereditary transthyretin- mediated (hATTR) amyloidosis, and was launched with a $450,000 per year price tag in the US that has come in for some criticism.

Analysts expect sales to peak at $1.5bn by 2023, but sales have been rising slowly – reaching $45m in the third quarter of 2019 – and the turnover needs to accelerate more quickly if it is to reach its lofty predictions.

Standing in its way is a similarly priced antisense rival from Ionis and Akcea – Tegsedi (inotersen) – as well as Pfizer’s fast- growing Vyndaqel/Vyndamax (tafamidis), which is approved for hATTR polyneuropathy in Europe but only cardiomyopathy in the US, where it is cheaper at $225,000 a year.

At the same time, Alnylam is looking to make headway with Givlaari (givosiran) for acute hepatic porphyrias (AHPs), which launched in the US earlier this year following its November 2019 FDA approval with a list price of $575,000 per patient per year.

The company has tried to be creative with its pricing plans for the drugs by offering a money-back guarantee for Onpattro if the therapy doesn’t work and providing rebates to health plans in the US if the number of AHP patients on their books exceed estimates.

2020 is the year that Alnylam will need to show that it can transfer the baton from the scientists to the commercial teams, without losing any momentum in its R&D pipeline.

The company submitted its lumasiran candidate for primary hyperoxaluria to the FDA and has another ATTR amyloidosis candidate – called vutrisiran – in late-stage along with Sanofi-partnered fitusiran for haemophilia A and B.

Meanwhile, there’s considerable excitement about Novartis-partnered cholesterol-lowering therapy inclisiran, which is also up for an FDA decision this year and has been tipped to become a mega-blockbuster if approved.

5. Onno van de Stolpe – Galapagos’ dealmaker

Last on our list is Onno van de Stolpe, the Dutch chief executive of Belgium-based biotech Galapagos.

He signed a landmark deal with Gilead Sciences in 2019 that pulled off a rare trick in the biopharma sector – bringing in billions of dollars in funding from a larger partner without losing the independence and nimbleness that made it an attractive partner in the first place.

The decade-long $5.1bn alliance, announced in July, came on the heels of a long relationship between the two companies that had already yielded a late-stage candidate, JAK inhibitor filgotinib for rheumatoid arthritis.

Onno van de Stolpe The pipeline-building deal is the largest under new Gilead chief executive Daniel O’Day, who took the helm of Gilead in March 2019, and includes a massive $3.95bn upfront, a $1.1bn equity investment to take its stake in Galapagos to 22%, as well as $1.1bn in opt-in payments for two late-stage drug candidates.

For van de Stolpe, who has been at the helm of Galapagos since it was founded 20 years ago, the big question now is what lies in store for the company as it adapts to its new operating environment and tries to prove that Gilead’s faith in its R&D engine is justified.

Analysts think the deal could catapult Galapagos into the top tier of biopharma companies, joining the likes of Regeneron, Biogen and Roche’s Genentech unit, providing its pipeline delivers as hoped and filgotinib’s anticipated launch this year meets expectations in the increasingly competitive market for JAK inhibitors

Gilead’s pipeline is being swelled by six compounds in the clinic and 20 preclinical programmes. The list of new additions is headed by GLPG1690, an oral, once-daily autotaxin inhibitor in phase 3 for idiopathic pulmonary fibrosis (IPF), and GLPG1972, an ADAMTS-5 blocker in phase 2b for osteoarthritis in the US. Servier has rights to the latter elsewhere.

Galapagos gets access to Gilead’s marketing muscle and broader presence in international markets, as well as help as it follows the path towards becoming a fully integrated, commercial-stage company.

Meanwhile, Galapagos looks set to continue adding to its pipeline through licensing deals like its expanded deal with Fibrocor to find new small-molecule drugs for fibrotic diseases of the kidney, liver, lung and other organs.

Five drugs to watch