Gilead’s New O’Day Regime Has New R&D Structure

After several staff departures, Gilead consolidates its research arm under CEO oversight, while welcoming another Roche/Genentech alum. 

Along with the hiring of former Genentech Inc. exec Merdad Parsey as chief medical officer, Gilead Sciences Inc. has reorganized its research and development organization to report directly to CEO Daniel O’Day.

O’Day has held the lead position at Gilead since March, after serving as CEO for pharmaceuticals at Genentech parent company Roche.  (Also see "Gilead To Let Kite Fly Free; O’Day Says It Will Become Separate Business Unit" - Scrip, 2 May, 2019.) O’Day’s hiring was said to help Gilead along as it shifts attention toward oncology – a specialty that Parsey also brings to the table.

But Gilead is going through a rough transition period, adjusting to the loss of longstanding leadership like John Martin and John Milligan, who had been in place since the mid-90s. R&D chief Norbert Bischofberger, the architect of Gilead’s infectious disease success, left in 2018 after 30 years. (Also see "Gilead's R&D Leadership Change Is End Of Bischofberger Era" - Scrip, 12 Mar, 2018.) 

Throughout this, the company has been under pressure as its mega-blockbuster hepatitis C business slowed down, its core HIV business matures and its first foray into oncology – the CAR-T therapy Yescarta gained through its 2017 acquisition of Kite Therapeutics – gets off to a slow start.  (Also see "Gilead To Let Kite Fly Free; O’Day Says It Will Become Separate Business Unit" - Scrip, 2 May, 2019.)

Continuous personnel changes left the company reeling; John McHutchison and Andrew Cheng were promoted to fill in for Bischofberger, but both have left Gilead. Oncology director Alessandro Riva, hired from Novartis in 2017, was lured away by India-based Glenmark after only two years at Gilead.  (Also see "Glenmark’s Coup: Gilead’s Riva Now CEO Of Spin-Out Innovation Firm" - Scrip, 6 Mar, 2019.) 

Parsey, who had been SVP in charge of early clinical development for Genentech’s Research and Early Development group (gRED), will head up Gilead’s global clinical development. The company said that current research EVP William Lee will remain with Gilead, but will no longer report to a chief scientific officer. Instead, both Lee and Parsey will each report directly to O’Day.

When O’Day came to Gilead in early 2019, Morningstar analyst Karen Andersen suggested that after months of unsteadiness, Gilead could find stability with O’Day, who had previously been with Roche for three decades.  (Also see "Gilead Lures Roche Pharma CEO O'Day As CEO; Genentech's CEO Will Replace Him " - Scrip, 10 Dec, 2018.)

Andersen also expressed concern at the time that Gilead could “lack the scientific expertise needed to guide accretive mergers or acquisitions,” something Parsey’s appointment could help with. Gilead told Scrip that having the research arm report directly to O’Day would provide “a degree of autonomy in following the science.”

Challenges Ahead For New R&D Org

The new organization takes over a relatively young pipeline, and must get past some challenges seen in the past year.

As the HCV market slows, Gilead has turned its attention to other liver diseases. There were setbacks earlier this year when non-alcoholic steatohepatitis (NASH) drug selonsertib, an ASK1 inhibitor, failed in two trials. (Also see "Another NASH Failure: Gilead’s Hits Keep Coming" - Scrip, 25 Apr, 2019.) The company hasn’t given up, however, with the ACC inhibitor firsocostat and FXR agonist cilofexor both in Phase II trials in NASH, which is also being studied for primary biliary cirrhosis and primary sclerosing cholangitis. Gilead is also studying a TLR8 agonist, GS-9688, in Phase II and a PD-1 inhibitor, GS-4224, in Phase I for HBV.

Gilead’s HIV pipeline includes three Phase I drugs: the capsid inhibitor GS-6207, TLR-7 agonist vesatolimod and a broadly neutralizing antibody to HIV, GS-9722. Currently in Phase II is GS-9131, a nucleoside reverse transcriptase inhibitor (NRTI). Gilead has a combination of two NRTIs, tenofovir alafenamide (TAF) and emtricitabine, currently under US Food & Drug Administration review for PrEP, although efficacy concerns dog the new formulation. (Also see "Gilead’s Descovy Nabs Limited HIV Prophylaxis Indication Pending A New Study In Women" - Pink Sheet, 4 Oct, 2019.)

 

With five cancer drugs in Phase I and six in Phase II, Gilead is well on its way to establishing itself in oncology. Studies include cell therapy, immuno-oncology and targeted therapies to treat non-Hodgkin lymphoma and acute lymphoblastic leukemia in adults and children. (See chart below.)

 

Gilead is also looking into treatments for inflammatory, respiratory and autoimmune disorders with a total of eight programs. The syk inhibitor GS-9876 is in Phase II for lupus and Sjogren’s syndrome. The failed NASH drug selonsertib is also in Phase II, for diabetic kidney disease. Gilead’s most advanced inflammatory asset is the JAK1 inhibitor filgotinib, being developed for several diseases, but partner Galapagos has already filed for European approval in rheumatoid arthritis.  (Also see "Europe's Biotechs Gathering Steam With Filgotinib Filing" - Scrip, 16 Aug, 2019.)

 

Gilead's Pipeline
	Phase I	Phase II	Phase III
HIV/AIDS	GS-6207 (Capsid Inhibitor)	GS-9131 (NRTI)	Emtricitabine and tenofovir alafenamide (for PrEP)
	Vesatolimod (TLR-7 agonist)
	GS-9722 (bNab)
Liver Diseases	GS-4224 (PD-L1) for Hep B	Cilofexor (FXR agonist) for NASH	Cilofexor (FXR agonist) for Primary Sclerosing Cholangitis
		Cilofexor (FXR agonist) for Primary Biliary Cirrhosis
		Firsocostat (ACC Inhibitor) for NASH
		GS-9688 (TLR-8 agonist) for Hep B
Hemotology/Oncology	Axicabtagene ciloeucel Trial: ZUMA-11 for DLBCL (41BB)	Axicabtagene ciloleucel Trial: ZUMA-5 for Indolent NHL	Axicabtagene ciloleucel Trial: ZUMA-7 for 2nd line DLBCL
	KTE-X19 Trial: ZUMA-8 for CLL	Axicabtagene ciloleucel Trial: ZUMA-6 for DLBCL (PD-L1 mAb)
	KITE-718 (MAGE A3/A6) for Solid Tumor	Axicabtagene ciloeucel Trial: ZUMA-12 for 1st line DLBCL
	KITE-439 (HPV E7) for Solid Tumor	KTE-X19 Trial: ZUMA-2 for MCL
	GS-1423 (Bi-specific antibody) Solid Tumor	KTE-X19 Trial: ZUMA-3 for Adult ALL
		KTE-X19 Trial: ZUMA-4 for Pediatric ALL
Inflammatory/Respiratory	GS-4875 (TPL2 inhibitor) Potential Indication: for Inflammatory Bowel Disease	Filgotinib (JAK1 inhibitor) for inflammatory diseases	Filgotinib (JAK1 inhibitor) for Rheumatoid Arthritis
		GS-9876 (Syk inhibitor) for Sjogren’s Syndrome	Filgotinib (JAK1 inhibitor) for Ulcerative Colitis
		GS-9876 (Syk inhibitor) for Lupus	Filgotinib (JAK1 inhibitor) for Crohn's Disease
		Selonsertib (ASK-1 inhibitor) for DKD

[Editor's note: This article has been updated with corrections to the pipeline chart.]