Cel­gene bags CAR-T play­er Juno in $9B buy­out as biotech M&A sud­den­ly ex­plodes

The buy­out buzz was ac­cu­rate.

Cel­gene $CELG has struck a deal to buy Juno Ther­a­peu­tics $JUNO for $87 a share, or about $9 bil­lion, in­stant­ly vault­ing in­to the front ranks of the CAR-T com­pa­nies. And they plan to stay there, vow­ing to be­come the pre­em­i­nent play­er in one of the most com­pet­i­tive R&D ri­val­ries in the in­dus­try.

Mark Alles

Cel­gene stamped the deal with its own bull­ish fore­cast that the buy­out will quick­ly de­liv­er a new CAR-T that will hit peak sales of $3 bil­lion a year.

The buy­out gives Cel­gene JCAR017, which has pro­duced some stel­lar ef­fi­ca­cy and safe­ty da­ta. The ther­a­py al­so val­i­dates Juno’s bet that it can make a come­back in a field where it was blight­ed by the lethal fail­ure of its lead pro­gram, which killed pa­tients both be­fore and af­ter an FDA hold.

Tak­ing the lessons it had learned along the way, Juno had won back in­vestors with proof that it could over­come the safe­ty is­sues that scut­tled JCAR015. And Cel­gene is now pay­ing a hefty pre­mi­um be­cause of it.

For Cel­gene, the $9 bil­lion deal al­so helps put some of its own set­backs in the rear view mir­ror, as well as some shaky fi­nan­cials that spooked in­vestors late last year. In a call with in­vestors Mon­day morn­ing, Cel­gene CEO Mark Alles al­so un­der­scored that their BC­MA CAR-T part­ner­ship with blue­bird bio $BLUE re­mains a top pri­or­i­ty, even though they are al­so buy­ing a ri­val BC­MA pro­gram at Juno.

The ex­ec­u­tive team al­so hit hard on how the ac­qui­si­tion will fit in­to its ex­ist­ing I/O pipeline plans, which in­cludes a new­ly ac­quired PD-1 as it plans to grad­u­al­ly move past its re­liance on Revlim­id for its rev­enue per­for­mance. And the com­pa­ny plans to keep the op­er­a­tions Juno has built up in the Seat­tle area, mak­ing it a new cen­ter of ex­cel­lence in the com­pa­ny.

Some top an­a­lysts may al­so be dis­ap­point­ed by the fi­nal val­ue num­ber. Leerink in par­tic­u­lar was look­ing for Cel­gene to fork over $93 a share, which is what Cel­gene pegged the price at when it bought a mi­nor­i­ty share in the biotech.

CAR-T has been one of the big suc­cess sto­ries for biotech, of­fer­ing a new ap­proach to en­gi­neer­ing T cells in­to at­tack weapons fo­cused on can­cer cells. No­var­tis and Kite led the way, and Gilead re­cent­ly jumped in with a $12 bil­lion deal to buy Kite just ahead of its pi­o­neer­ing first ap­proval. Juno sits well be­hind the two lead­ers, but Cel­gene is bet­ting that it can still jump in just as the mar­ket­ing op­er­a­tions be­gin to ma­ture, leav­ing plen­ty of fran­chise val­ue to carve out for it­self. And the race for next-gen tech is al­ready well un­der­way as the lead­ers look to ex­pand from blood can­cers in­to sol­id tu­mors.

The deal, com­ing right on the heels of Sanofi’s $11.6 bil­lion buy­out of Biover­a­tiv in a play for the he­mo­phil­ia mar­ket, will al­so stoke hopes in the bank­ing com­mu­ni­ty for a burst of new M&A deals in biotech, which will rain cash and fees in the in­dus­try af­ter a long dry spell.

It will take awhile be­fore it be­gins to pay off for Cel­gene, though. In their state­ment to­day, the com­pa­ny notes:

The ac­qui­si­tion is ex­pect­ed to be di­lu­tive to ad­just­ed EPS (earn­ings per share) in 2018 by ap­prox­i­mate­ly $0.50 and is ex­pect­ed to be in­cre­men­tal­ly ad­di­tive to net prod­uct sales in 2020. There is no change to the pre­vi­ous­ly dis­closed 2020 fi­nan­cial tar­gets of to­tal net prod­uct sales of $19 bil­lion to $20 bil­lion and ad­just­ed EPS greater than $12.50.

Notes Alles:

Juno’s ad­vanced cel­lu­lar im­munother­a­py port­fo­lio and re­search ca­pa­bil­i­ties strength­en Cel­gene’s glob­al lead­er­ship in hema­tol­ogy and adds new dri­vers for growth be­yond 2020.

https://twit­ter.com/brad­lon­car/sta­tus/955414778276732930

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.

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