Gilead locks in Daniel O'­Day as CEO, tap­ping the Roche vet to re­ju­ve­nate growth

The sus­pense over who will suc­ceed John Mil­li­gan at Gilead has fi­nal­ly end­ed.

Daniel O’Day, cur­rent CEO of Roche’s Phar­ma di­vi­sion, has been tapped for the top job, Gilead an­nounced days be­fore Mil­li­gan is set to de­part from his cor­ner of­fice.

John Mil­li­gan

O’Day’s ap­point­ment ush­ers in a new era for the Fos­ter City, CA-based big biotech, which Mil­li­gan and his pre­de­ces­sor, John Mar­tin, ran for near­ly three decades, cre­at­ing an HIV pow­er­house and an in­dus­try-dom­i­nat­ing he­pati­tis C fran­chise. In re­cent years, how­ev­er, it’s seen its rev­enue shrink as com­pe­ti­tion heats up and the pain­less cure ef­fec­tive­ly down­sized the mar­ket.

Mar­tin has pre­vi­ous­ly an­nounced his de­par­ture as board chair­man, amid an ex­ec­u­tive ex­o­dus that al­so claimed R&D head Nor­bert Bischoberg­er, CMO An­drew Cheng and com­mer­cial chief James Mey­ers (who is re­tir­ing).

Be­fore O’Day as­sumes his role on March 1, 2019, Gregg Al­ton — a 20-year vet­er­an of the com­pa­ny who’s served as gen­er­al coun­sel and, most re­cent­ly, chief pa­tient of­fi­cer — will man the fort as in­ter­im CEO.

In­vestors wel­comed the news, send­ing Gilead shares $GILD up 2.5%.

O’Day, who Jef­feries’ Michael Yee de­scribes as “pret­ty straight down the road” in terms of risk tak­ing with­out a his­to­ry of big M&A deal­ing, grad­u­ates from Roche as a 30-year vet­er­an of the Swiss phar­ma gi­ant, hav­ing start­ed with com­mer­cial and sales roles in 1987. Since tak­ing con­trol of the phar­ma unit in 2012, he’s over­seen the launch of sev­er­al po­ten­tial block­buster drugs in­clud­ing Hem­li­bra and Tecen­triq.

Baird’s Bri­an Sko­r­ney, mean­while, of­fers a de­cid­ed­ly glow­ing re­view of the new CEO:

(I)n his role at Roche, we think he has done a phe­nom­e­nal job at nav­i­gat­ing the com­pa­ny in­to a next gen­er­a­tion of prod­ucts (Ocre­vus, Hem­li­bra, po­latuzum­ab are just a cou­ple of prod­ucts we see as new, im­pact­ful block­buster drugs). Most im­por­tant­ly, we be­lieve the long his­to­ry at Roche makes him a choice that isn’t like­ly to break an al­ready good com­pa­ny. While we ex­pect that re­plac­ing the head of one of the strongest man­age­ment teams ever seen in biotech to be a chal­leng­ing role, we think that O’Day is high­ly qual­i­fied and should ease in­vestor con­cerns lead­ing in­to Mil­li­gan’s re­tire­ment.

While in­vestors keen­ly await a strate­gic plan and vi­sion from O’Day, an­a­lysts at Jef­feries laid out a pos­si­ble sce­nario:

We be­lieve O’Day will look to de­vel­op a strat­e­gy over the course of 2019 and it will in­clude a view on de­ploy­ing GILD’s cur­rent cash of ~$32B to­wards more on­col­o­gy as­sets and oth­er key ar­eas, such as in­flam­ma­tion and liv­er dis­eases. Note’s GILD’s cur­rent debt-to-EBIT­DA ra­tio stands at rough­ly ~2.6x so the com­pa­ny could still lever up to do more deals. (…) we can as­sume his plan-of-ac­tion for 2019 is to en­sure that: (1) HCV sta­bi­lizes and be­comes more “pre­dictable”, (2) HIV grows as Bik­tarvy con­tin­ues to reach record rev­enues, and (3) Yescar­ta grows each quar­ter as the com­pa­ny con­tin­ues to ex­pand its pres­ence in hema­tol­ogy (e.g. al­lo­gene­ic CAR-T) and sol­id tu­mors (neo-anti­gens).

Faced with a wan­ing hep C fran­chise, Gilead has swal­lowed Kite Phar­ma in a bid to be­come a leader in CAR-T, snap­ping up new tech­nolo­gies along the way. It is now up to O’Day to gal­va­nize the sales of Kite’s CAR-T ther­a­py Yescar­ta, which de­spite im­pres­sive sur­vival rates gen­er­at­ed a pal­try $183 mil­lion for the first nine months of 2018.

Mean­while in Basel, Genen­tech CEO Bill An­der­son will fill O’Day’s shoes.


Im­age: Daniel O’Day. ROCHE

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

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Alk­er­mes adds bipo­lar de­pres­sion to its FDA wish­list; Con­go con­firms first Ebo­la case in large city

→ An ever-ambitious Alkermes $ALKS team plans to add bipolar depression to its list of conditions for ALKS-3831, which it plans to pitch to the FDA in Q4. Alkermes says they were persuaded to add bipolar depression after a pre-NDA meeting with the agency, which came about 7 months after the biotech reported positive data for schizophrenia. The drug is a combo using olanzapine/samidorphan, which they hope will be shown to be as effective as olanzapine without the substantial increase in the risk of weight gain.

Pe­ter Kolchin­sky and Raj Shah raise a $300M fund de­vot­ed to biotech star­tups

Peter Kolchinsky and Raj Shah have another $300 million-plus to play with on the biotech venture side of their investment business. 

The two announced Monday morning that they’ve put together their first pure-play venture fund at RA Capital Management, which has been known to bet on just about every angle in healthcare investing — from rounds to follow-on investments at public companies. This new fund of theirs arrives well into a go-go era of new startup financing, with a particular focus on building new biotechs.

Boehringer buys Swiss biotech in its lat­est M&A deal, go­ing the next-gen can­cer vac­cine route

Boehringer Ingelheim has snapped up a Swiss biotech startup and added their group as a new platform for the oncology pipeline. 

The German biopharma company has bagged Geneva-based AMAL Therapeutics, paying out an unspecified upfront in a $358 million deal — cash, milestones and everything else, all in. Plus there’s 100 million euros on the line for commercial milestones.

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Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

Ab­b­Vie beefs up the on­col­o­gy pipeline, bag­ging an up­start STING play­er with its own unique ap­proach

AbbVie isn’t letting its $63 billion buyout of Allergan stop its M&A/deals team from continuing their work.

Monday morning we learned that the pharma giant is snapping up tiny Mavupharma out of Seattle, a Frazier-backed startup that has its own unique take on STING — which is on the threshold of their first clinical trial.

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Billing it­self as the first AI biotech to launch hu­man tri­als, Re­cur­sion adds $121M C round

Billing itself as the first AI biotech with programs in the clinic, Salt Lake City-based Recursion now has a $121 million bankroll to start gathering human data to see if it’s on the right track. 

“We’re trying to build this discovery engine,” Recursion CEO Chris Gibson tells me ahead of the C round news. “We now have the first two programs in the clinic.” And that, he adds, qualifies as a first for any AI establishment “that actually have something in the clinic.”

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.