No­var­tis to spin off Al­con eye care unit, buy back $5B in stock; Ri­val CAR-Ts from No­var­tis and Gilead get thumbs up in Eu­rope

→ Hav­ing mulled over it for more than a year, No­var­tis $NVS is fi­nal­ly spin­ning off Al­con, the eye care unit that for­mer CEO Daniel Vasel­la pur­chased for a to­tal of $51.6 bil­lion. His tenure marked an era when phar­ma­ceu­ti­cal com­pa­nies were try­ing to di­ver­si­fy their busi­ness in face of gener­ic com­pe­ti­tion to brand­ed drugs. But No­var­tis is a dif­fer­ent com­pa­ny now, led by for­mer R&D chief Vas Narasimhan, who told Bloomberg of the de­ci­sion: “We want to be able to fo­cus our cap­i­tal al­lo­ca­tion to our core, and we be­lieve our core is go­ing to be nov­el plat­forms to de­vel­op in­no­v­a­tive med­i­cines and to in­vest in da­ta and dig­i­tal tech­nolo­gies.” The move, which fol­lows Narasimhan’s de­ci­sion to sell No­var­tis’ stake in a con­sumer health­care joint ven­ture to part­ner GSK for $13 bil­lion, comes at a time Al­con — long con­sid­ered an un­der­per­former — is bounc­ing back on rev­enue. That might help with the val­u­a­tion, which ex-CEO Joe Jimenez said could range from $25 bil­lion to $35 bil­lion. Cur­rent Al­con CEO Mike Ball will be­come chair­man af­ter the spin­off, with COO David En­di­cott slat­ed to be­come the new chief — as­sum­ing the mo­tion goes through at No­var­tis’ an­nu­al gen­er­al meet­ing next year. Af­ter the spin-off wraps up in the first half of 2019, No­var­tis is plan­ning to buy back up to $5 bil­lion in stock.

→ Two ri­val CAR-T drugs both got nods from the Eu­ro­pean Med­i­cines Agency pan­el, a sign that their paths to the Eu­ro­pean mar­ket is clear. The Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) rec­om­mend­ed No­var­tis$NVS Kym­ri­ah for the treat­ment of B cell acute lym­phoblas­tic leukemia and dif­fuse large B cell lym­phoma (DL­B­CL). At the same time, the CHMP rec­om­mend­ed Gilead’s $GILD Yescar­ta for DL­B­CL and pri­ma­ry me­di­asti­nal B cell lym­phoma and trans­formed fol­lic­u­lar lym­phoma. Eu­rope’ reg­u­la­to­ry agency usu­al­ly fol­lows the com­mit­tee’s ad­vice, which means both CAR-Ts could soon go head-to-head in DL­B­CL in Eu­rope.

→ Ul­tragenyx $RARE al­so scored CHMP’s pos­i­tive opin­ion, rec­om­mend­ing the com­pa­ny’s drug Mep­se­vii to treat non-neu­ro­log­i­cal man­i­fes­ta­tions of Mu­copolysac­cari­do­sis VII in Eu­rope. Mep­se­vii is an en­zyme re­place­ment ther­a­py de­signed to re­place the de­fi­cient lyso­so­mal en­zyme be­ta-glu­curonidase in pa­tients with MPS VII, a pro­gres­sive and de­bil­i­tat­ing rare ge­net­ic dis­ease.

→ Pre­ci­sion Ther­a­peu­tics, an Ea­gan, Min­neso­ta-based com­pa­ny ap­ply­ing AI to per­son­al­ized med­i­cine and drug dis­cov­ery, is merg­ing with Pitts­burgh di­ag­nos­tics com­pa­ny Helomics. The merg­er ups Pre­ci­sion’s stake in Helomics from 25% to 100%, and gets Pre­ci­sion ac­cess to Helomics’ suite of AI, pre­ci­sion di­ag­nos­tic, and in­te­grat­ed CRO ca­pa­bil­i­ties, the com­pa­nies said in a state­ment. Carl Schwartz, Pre­ci­sion’s CEO, com­ment­ed, “Up­on com­ple­tion of the merg­er, we will have com­plete own­er­ship of Helomics’ one of a kind tu­mor data­base, which has been de­vel­oped over 15 years of clin­i­cal test­ing and con­tains drug re­sponse pro­files of over 149,000 pa­tient can­cer tu­mors, and its D-CHIP bioin­for­mat­ics en­gine that pro­vides ac­tion­able in­sights in­to this da­ta.”

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

 

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.

Dave Barrett, Brian Chee, Amir Nashat, Amy Schulman. Polaris

Bob Langer's first port of call — Po­laris Part­ners — maps $400M for ninth fund

Health and tech ven­ture group Po­laris Part­ners, which counts Alec­tor, Al­ny­lam and Ed­i­tas Med­i­cine as part of its port­fo­lio, is set­ting up its ninth fund, rough­ly two years af­ter it closed Po­laris VI­II with $435 mil­lion in the bank, sur­pass­ing its tar­get by $35 mil­lion.

The Boston-based firm, in an SEC fil­ing, said it in­tends to raise $400 mil­lion for the fund. Po­laris — which rou­tine­ly backs com­pa­nies mold­ed out of the work done in the lab of pro­lif­ic sci­en­tist Bob Langer of MIT  — typ­i­cal­ly in­vests ear­ly, and sticks around till com­pa­nies are in the green. Like its peers at Flag­ship and Third Rock, Po­laris is all about cham­pi­oning the lo­cal biotech scene with a steady flow of start­up cash.

Partners Innovation Fund

David de Graaf now has his $28.5M launch round in place, build­ing a coen­zyme A plat­form in his lat­est start­up

Long­time biotech ex­ec David de Graaf has the cash he needs to set up the pre­clin­i­cal foun­da­tion for his coen­zyme A me­tab­o­lism com­pa­ny Comet. A few high-pro­file in­vestors joined the ven­ture syn­di­cate to sup­ply Comet with $28.5 mil­lion in launch mon­ey — enough to get it two years in­to the plat­form-build­ing game, with­in knock­ing dis­tance of the clin­ic.

Canaan jumped in along­side ex­ist­ing in­vestor Sofinno­va Part­ners to co-lead the round, with par­tic­i­pa­tion by ex­ist­ing in­vestor INKEF Cap­i­tal and new in­vestor BioIn­no­va­tion Cap­i­tal.

A uni­corn stalks Wall Street in search of IPO cash; CASI Phar­ma in-li­cens­es CD19 ther­a­py from Chi­na’s Ju­ven­tas

→ A herd of up­start biotechs will look to Wall Street for some ma­jor wind­falls this week as a burst of new of­fer­ings con­tin­ues to feed cash in­to the R&D sys­tem. To­day we learned that Bridge­Bio will look to raise in the neigh­bor­hood of $225 mil­lion by of­fer­ing 15 mil­lion shares for $14 to $16 each. And they have a string of joint bookrun­ners: J.P. Mor­gan, Gold­man Sachs, Jef­feries, SVB Leerink, KKR, Piper Jaf­fray, Mizuho Se­cu­ri­ties, BMO Cap­i­tal Mar­kets and Ray­mond James. If suc­cess­ful, Bridge­Bio will emerge with a mar­ket cap of around $1.7 bil­lion. There are 5 biotechs look­ing to IPO this week, in­clud­ing Akero and Pre­vail.

Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.