Mikael Dolsten, Pfizer
Global president of worldwide research, development and medical
2018 pay package: $7.07 million
2017 pay package: $7.67 million
$1.30 million in base salary
$1.33 million in bonus
$4.12 million in stock and options
$315,000 in other compensation
Next year, Mikael Dolsten will reach his 10-year anniversary as R&D chief of Pfizer, a period which coincided with a lengthy series of patent expiries that hit revenues while the company struggled to bring enough products through the pipeline to compensate.
There’s more pain to come with the loss of exclusivity for $3.5 billion pain drug Lyrica, and that prompted a major restructuring drive by new CEO Albert Bourla, DVM, Ph.D., just a few months into the job. Part of that revamp is a top management shake-up, and Dolsten isn’t excluded, taking on the oversight of the chief medical officer’s role in addition to his R&D duties.
That puts Dolsten firmly in the driver's seat as Pfizer sets out to meet its "15 in five" objective of bringing 15 new blockbuster medicines to market between 2018 and 2022, and on recent evidence the company’s R&D engine seems to be moving up a gear.
2018 saw several new drug approvals, including four targeted drugs for cancer, which is one of Pfizer’s top research priorities with researchers being added to the headcount at its La Jolla facility and new management from ex-Calico research chief Jeff Settleman.
Leukemia drug Daurismo, Lorbrena and Vizimpro for non-small cell lung cancer, and breast cancer therapy Talzenna made their debuts in the last four months of the year, and Pfizer’s oncology pipeline now includes around 44 programs, with 12 at the phase 3 trial stage.
So far this year there has been another clutch of approvals, mainly for biosimilars and line extensions but also featuring green lights in the U.S. and Japan for tafamidis in ATTR cardiomyopathy, an indication that some analysts think could bring in sales of $1.5 billion or more.
Other late-stage projects being highlighted at Pfizer are its 20-serotype pneumococcal vaccine due to be filed next year, which will extend its $3.4 billion Prevnar franchise, a phase 3 Clostridium difficile vaccine which should read out next year, plus a pair of JAK inhibitors that could slot in alongside blockbuster Xeljanz, currently struggling with cardiovascular safety concerns.
Impressive phase 3 data results in May for JAK1 inhibitor abrocitinib in atopic dermatitis laid out a challenge to Sanofi/Regeneron’s fast-growing antibody Dupixent, while Pfizer also has JAK3 inhibitor PF-06651600 in a phase 2b/3 trial for alopecia areata—a new indication for the JAK class with a readout due in 2021.
The company is guarded about the prospects for Eli Lilly-partnered nerve growth factor inhibitor tanezumab—up against a Sanofi/Regeneron rival for chronic pain—after posting mixed data that haven’t dispelled safety concerns with the class. It says it wants to have all the data in hand from its phase 3 program before discussing filing with regulators and the “paying landscape.”
The inevitable crop of pipeline failures have included a Staphylococcus aureus vaccine candidate and Duchenne muscular dystrophy antibody domagrozumab, which both bombed in midstage testing.
Pfizer has generally relied on acquisitions and license deals to keep its pipeline ticking over, and the last few months have been no exception. Its latest crop of deals is headlined by the $11.4 billion buyout of Array Biopharma that gave it two approved cancer drugs—Mektovi and Braftovi—plus a pipeline of 17 partnered programs in preclinical or clinical studies.
The last few months have also seen a partnership with Novartis on nonalcoholic steatohepatitis combinations, the takeover of Therachon and its dwarfism drug, and a pact with BioNTech on an mRNA-based flu vaccine. It’s not all been incoming deals, however, and Pfizer exited central nervous system R&D by spinning its assets into new company Cerevel.
Under Dolsten, Pfizer has also been making a push into gene therapy, spearheaded by its 2016 acquisition of Bamboo Therapeutics that gave it a pipeline of candidates headed by PF-06939926 for Duchenne muscular dystrophy. The lead therapy has however been undermined by safety data concerns that have some analysts playing down its prospects.
It followed that up with a collaboration with Spark in hemophilia A—signed ahead of Roche’s play to take over the gene therapy specialist—a link-up with Sangamo on amyotrophic lateral sclerosis and frontotemporal lobar degeneration, and a 15% stake in Vivet to add a gene therapy candidate for rare genetic disorder Wilson’s disease.
Finally, it’s worth a mention that Pfizer’s recruitment of former FDA Commissioner Scott Gottlieb to its board will give the company a lead into the FDA’s inner workings that could help it steer the new wave of products through regulatory review, but has reignited debate about the revolving door between the agency and industry.