Team build­ing. Pipeline re­vamp. For­ward thrust. What does a decade of deals at Gilead tell us about Daniel O’Day’s first M&A moves?

Daniel O’Day during Roche’s annual results media conference in Basel, 2018. AP Images

Today marks the start to Daniel O’Day’s first full week as CEO of Gilead. And if the slate of new hires to the helm of large cap companies over the last 2 years helps highlight the path ahead, one of his first major acts will likely be a full pipeline review with a clean out and some new deals put into play, after he puts his top team together.

Team building is job #1, because the founders are all gone. But with biotech buyouts all the rage right now, can O’Day — a longtime Roche veteran — afford to wait out the M&A game now in full swing?

Gilead has made industry history with 2 big buyouts — the Pharmasset deal, which was incredibly successful though short lived for brilliance, and the more recent Kite acquisition in 2017. Kite vaulted Gilead to the front of the CAR-T line, but it’s brand new, with only a trickle of revenue from a leading drug and lots of questions about new and better rivals in the pipeline.

Their recent $820 million write-off related to Kite has raised alarms about more to come.

The company is seeing dwindling hep C revenue, but has a stable fortune coming in from HIV, where they continue to successfully defend the kingdom with new, easier to use therapies.

That’s not really exciting anyone, though, about a bigger, brighter future. Its big NASH drug selonsertib just flunked a Phase III, as investors are wondering who can really make a dent in that field. As for Gilead, it’s completed a slate of NASH deals, likely in search of a new cocktail that can dominate an emerging market. But that’s going to take time. And while some analysts are speculating about a blockbuster future for filgotinib, Pfizer’s safety issues with its JAK inhibitor Xeljanz has raised serious safety issues for the class.

So where does Gilead turn now?

For some insight, we turned to Chris Dokomajilar at DealForma to give us the panoramic view of Gilead’s dealmaking record over the last 10 years, which you can see in detail below.

The summary:

— 71 deals involving Gilead on either side of the deal since Jan. 2008
— 45 of these with Gilead on the buying side

These include:

— 10 acquisitions
— 23 development and commercialization in-licenses
— 4 R&D partnerships
— 2 academic partnerships
— 6 others, service deals, etc. plus its $125 million deal to buy a priority review voucher

Soon after its Kite deal, Gilead followed up with a pact to scoop up Cell Design Labs for $567 million, fitting squarely into former CEO John Milligan’s plan to remain a leader in the cell therapy field. But Gilead is not typically a blue-sky venturer, looking for lots and lots of discovery deals. The company tends to be highly focused on acquisitions and development deals, with an emphasis on commercialization.

Its R&D group under former research chief Norbert Bischofberger has a reputation for moving fast, efficiently and ruthlessly through Phase III. When they are on track, Gilead can be a very effective R&D machine. But that’s a rep that takes years to build and months to lose.

Just ask Celgene.

Seven of its 23 development and commercialization in-licensing pacts were preclinical, with 9 in the platform realm and the rest scattered from Phase I to Phase III.

We know what Gilead has done. Now it’s up to O’Day to tell us what’s next.

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UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

UCB adds on more pos­i­tive PhI­II da­ta for IL-17A/17F in­hibitor bimek­izum­ab, clear­ing a path to the FDA

A month after posting positive top-line data from their first Phase III trial of the IL-17A/17F inhibitor bimekizumab, Belgium’s UCB says they’ve added more upbeat results from their second late-stage test in moderate-to-severe plaque psoriasis.

That leaves the company on track for regulatory submissions in the middle of next year, says CMO Iris Loew-Friedrich.
Their drug beat out a placebo on the co-primaries — a 90% improvement in PASI 90 (the Psoriasis Area and Severity Index) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo. Investigators also boasted of hitting some key secondaries.
UCB is angling to enter an increasingly crowded market space.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.

Social image: UCB