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1 February, 2022
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1. New buyers lining up bids for Novartis' giant generics arm
2. BREAKING: Pfizer raids Roche executive committee for new drug development chief — and Schwan plucks his replacement from the board
3. Baker's dozen: Pfizer joins 12 peers in restricting sales of discounted drugs under a federal program
4. Biogen leaps into a showdown between Roche and Regeneron, betting on a potential new franchise player
5. Hologic plans Super Bowl ad with Mary J. Blige to show women ‘Real Love’ means health checkups
6. Controversial opioid Zohydro ER pulled from the market
7. After deal shielding Sacklers from further litigation overturned, family members to pour more money into settlement
8. Weight loss spinout Gelesis ditches promotional staff after SPAC fail — report
9. Recipharm's global deal spree continues with acquisition of Portuguese CDMO
10. How UCB beat 2 other bidders to land $1.9B buyout of Zogenix and its epilepsy drug
more stories
 
John Carroll
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The last few days have made it completely clear that we're in for a painful retrenchment on the biotech side. And it's also clear — to me at least — that we're entering a new cycle on M&A and deals. Except that now we're in a buyers market. Stay tuned — this is just getting started.

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John Carroll
Editor & Founder, Endpoints News
@JohnCendpts
Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)
1
by Nicole DeFeudis

—With the fate of No­var­tis’ gener­ics unit up in the air, more po­ten­tial buy­ers are re­port­ed­ly lin­ing up for what could be one of the largest M&A deals the in­dus­try has seen in the last year or so.

Black­stone and the Car­lyle Group are con­sid­er­ing a joint of­fer for San­doz that could val­ue that unit at up to $25 bil­lion, Bloomberg and the Fi­nan­cial Times re­port­ed on Tues­day. Some­one with knowl­edge of the mat­ter has con­firmed to End­points News that Car­lyle is in talks with Black­stone re­gard­ing a po­ten­tial of­fer.

When asked about the re­ports, a No­var­tis spokesper­son sim­ply said: “We don’t com­ment on mar­ket ru­mor and spec­u­la­tion.”

The news comes about a month and a half af­ter re­ports emerged from Ger­many that EQT and the bil­lion­aire Strüng­mann broth­ers were in talks over a $21 bil­lion bid. This wouldn’t be the Strüng­manns’ first rodeo, as they sold Hexal to No­var­tis in 2005.

No­var­tis’ Vas Narasimhan con­firmed back in De­cem­ber that he's seen some un­spec­i­fied M&A in­ter­est, though no hard of­fers were on the ta­ble. In Oc­to­ber, the chief ex­ec­u­tive flagged a plan to un­der­take a strate­gic re­view of San­doz to see whether the gener­ics group should stay in­side No­var­tis, or be sold or spun off in­to an in­de­pen­dent com­pa­ny. Gener­ic drug prices have re­mained un­der in­tense pres­sure — and now, Narasimhan could fol­low in the foot­steps of Mer­ck, J&J and oth­ers and split off from the gener­ics unit en­tire­ly.

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William Pao (L) and Hans Clevers
2
by John Carroll

Pfiz­er has found its new chief of drug de­vel­op­ment, and they’ve dis­patched a raid­ing par­ty to Basel to pluck him off the ex­ec­u­tive com­mit­tee at Roche.

William Pao, who took over as head of pRED af­ter John Reed ex­it­ed to take the R&D chief post at Sanofi in 2018, is head­ed to the ex­ec­u­tive com­mit­tee at Pfiz­er now, where he’ll re­port to Al­bert Bourla in New York. And he has a big re­mit that in­cludes "in­flam­ma­tion and im­munol­o­gy, in­ter­nal med­i­cine, hos­pi­tal, on­col­o­gy and rare dis­ease, as well as reg­u­la­to­ry af­fairs in sup­port of Pfiz­er’s R&D pipeline and port­fo­lio of mar­ket­ed ther­a­pies."

Pao is re­plac­ing Rod MacKen­zie, who re­cent­ly opt­ed to re­tire af­ter a 35-year stint at the phar­ma gi­ant. And he's com­ing in at a time Pfiz­er is dou­bling down on in­no­va­tion for its fu­ture, with drug de­vel­op­ment in the cen­ter ring.

Roche in the mean­time has opt­ed to bring in Hans Clevers for Pao’s job, mak­ing the switch from the board to top R&D ex­ec on March 18 as Pao heads to the US for his new job. Clevers is a not­ed pro­fes­sor in mol­e­c­u­lar ge­net­ics at the Uni­ver­si­ty of Utrecht and will now step off the board in a move rem­i­nis­cent of Tom Lynch's brief move from Bris­tol My­ers Squib­b's board to run R&D. He's now in charge of Fred Hutch.

Roche and Pfiz­er main­tain two of the largest R&D or­ga­ni­za­tions on the plan­et. In 2020 they spent a com­bined $24 bil­lion on drug re­search and de­vel­op­ment, with huge glob­al or­ga­ni­za­tions to back large pipelines.

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3
by Zachary Brennan

Be­gin­ning in March, Pfiz­er will be­come the 13th phar­ma com­pa­ny to re­strict sales of its drugs through a fed­er­al pro­gram that of­fers steep dis­counts for low-in­come in­di­vid­u­als.

The 340B pro­gram has come un­der fire as, ac­cord­ing to the phar­ma com­pa­nies, it has bal­looned in re­cent years to in­clude nu­mer­ous con­tract phar­ma­cies work­ing with cer­tain qual­i­fied hos­pi­tals. The hos­pi­tals, mean­while, have crit­i­cized the uni­lat­er­al moves by the phar­ma in­dus­try and have lost mil­lions in rev­enue from the changes.

Like its fel­low peers, Pfiz­er said in a let­ter to stake­hold­ers last week that it's cut­ting back on its par­tic­i­pa­tion in the fed­er­al 340B pro­gram af­ter re­view­ing ex­am­ples, and eval­u­at­ing the wider risk, of "du­pli­cate dis­counts and di­ver­sion that oc­cur through con­tract phar­ma­cy trans­ac­tions."

Oth­er com­pa­nies like No­var­tis and Eli Lil­ly pre­vi­ous­ly raised sim­i­lar con­cerns, ex­plain­ing how the 340B pro­gram had grown be­yond what it was ini­tial­ly tasked to do and how it was lin­ing the pock­ets of hos­pi­tals.

HHS, mean­while, has sought to crack down on these phar­ma com­pa­nies, al­though mixed court de­ci­sions have com­pli­cat­ed the sit­u­a­tion.

Pfiz­er's in­sti­tu­tion of its new "De­fined Dis­tri­b­u­tion sys­tem" will be for its JAK in­hibitor Xel­janz and oral on­col­o­gy drugs, as part of plans "to more ef­fec­tive­ly de­tect du­pli­cate dis­counts and di­ver­sion that would oth­er­wise go un­de­tect­ed."

The com­pa­ny al­so makes clear that any 340B hos­pi­tal-cov­ered en­ti­ty that "de­clines to pro­vide the re­quest­ed lim­it­ed claims da­ta" and "does not have an in-house phar­ma­cy ca­pa­ble of dis­pens­ing 340B priced drugs to its pa­tients," may des­ig­nate a con­tract phar­ma­cy lo­ca­tion on­line via Pfiz­er's new 340B ESP plat­form.

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4
by John Carroll

Plagued by a woe­ful launch for its Alzheimer’s fran­chise, Bio­gen is bet­ting $30 mil­lion on some re­li­able part­ners at Genen­tech to come up with a fast new fran­chise drug — out­side of its CNS spe­cial­ty.

The ther­a­py is mo­sune­tuzum­ab, a "break­through" des­ig­nate at the FDA which looks per­fect­ly po­si­tioned for a shot at an ac­cel­er­at­ed ap­proval. Work­ing on their long­time col­lab­o­ra­tion on CD20, Bio­gen will chip in on some of last year’s R&D work and add a $30 mil­lion pay­ment to step in to co-com­mer­cial­ize the drug.

The drug is one of a line­up of CD20xCD3 T-cell en­gag­ing bis­pecifics in play for B cell non-Hodgkin’s lym­phoma, which in­cludes fol­lic­u­lar lym­phoma (FL) and dif­fuse large B-cell lym­phoma (DL­B­CL). Genen­tech has al­ready flagged for a quick fil­ing on FL as a third-line treat­ment, re­ly­ing on a re­cent pre­sen­ta­tion of the stel­lar da­ta it’s gath­ered so far to set the stage.

Bio­gen picks up joint de­ci­sion-mak­ing rights on de­vel­op­ment and com­mer­cial­iza­tion, with a hefty take in the low to mid 30% range on prof­its (or loss­es) in the US, along with dibs on low sin­gle-dig­it roy­al­ties on sales out­side the Unit­ed States.

You can bet at this stage of the game, they’re cal­cu­lat­ing some prof­its. Roche cer­tain­ly is. And an­a­lysts have tacked a $1 bil­lion block­buster con­sen­sus es­ti­mate for peak sales.

An­a­lysts have been close­ly track­ing this drug, and how it should play as Roche builds up its hema­tol­ogy port­fo­lio with mo­sune­tuzum­ab as well as a very ag­gres­sive glofi­ta­m­ab as well as cevostam­ab fol­low­ing up be­hind Po­livy.

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Hip-Hop/R&B musician and actress Mary J. Blige stars in Hologic\'s first-ever Super Bowl ad (via Hologic)
5
by Beth Snyder Bulik

If Mary J. Blige can make time for health check­ups, so can you. That’s the mes­sage be­hind med­ical de­vice and di­ag­nos­tics com­pa­ny Ho­log­ic's soon-to-be-de­buted Su­per Bowl and Win­ter Olympic ad cam­paign.

The Gram­my-win­ning R&B/hip-hop mu­si­cian and ac­tress trav­els from set to stu­dio to gym to board­room in the up­com­ing TV ads that will de­but dur­ing the high-pro­file – and pricey – ad show­case Su­per Bowl on Feb. 13. The up­shot? Even busy Blige can make time for an­nu­al women’s health­care vis­its.

TV time for the big game – known in the ad world as the biggest US main­stream au­di­ence of the year – is go­ing for as much as $6.5 mil­lion for 30 sec­onds this year. The first-ever Su­per Bowl ad for Ho­log­ic is al­so the com­pa­ny's first di­rect-to-con­sumer TV ad.

Why the Su­per Bowl? Af­ter all, the broad­cast is more typ­i­cal­ly stacked with beer, snack food, car and movie trail­er ad­ver­tis­ing.

"There's a dif­fer­ence be­tween se­ri­ous and im­por­tant," Jane Mazur, Ho­log­ic VP of cor­po­rate com­mu­ni­ca­tions, said. "Your health is ob­vi­ous­ly no laugh­ing mat­ter like a chip com­mer­cial or some in­sur­ance ad, but I do think the stage al­lows us to share a mes­sage that will res­onate with any­body watch­ing. You can't ask for a bet­ter mo­ment in time."

Ho­log­ic, which is the lead­ing mak­er of mam­mog­ra­phy ma­chines along with its women’s health prod­ucts and di­ag­nos­tics, wants to re­mind women that no mat­ter the many re­spon­si­bil­i­ties they deal with dai­ly, find­ing time to pri­or­i­tize health is just as im­por­tant. As Mazur notes, not on­ly did the pan­dem­ic dis­rupt pre­ven­ta­tive health­care vis­its, but women in gen­er­al do tend to put oth­ers ahead of them­selves.

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6
by Zachary Brennan

As the Bel­gian phar­ma UCB re­cent­ly inked a $1.9 bil­lion deal to buy out Zo­genix and its top drug for epilep­sy, the com­pa­ny's for­mer con­tro­ver­sial opi­oid has now been pulled from the mar­ket, ac­cord­ing to a Fed­er­al Reg­is­ter fil­ing by the FDA on Tues­day.

Hy­drocodone-based Zo­hy­dro ER — which ini­tial­ly won FDA ap­proval in 2013 de­spite not hav­ing abuse-de­ter­rent prop­er­ties and de­spite an 11-2 ad­comm vote against ap­proval — is now one of 29 new drug ap­pli­ca­tions from mul­ti­ple spon­sors that have de­cid­ed to pull their drugs from the mar­ket for var­i­ous rea­sons, ac­cord­ing to the fil­ing.

The fil­ing to pull Zo­hy­dro was made by Zo­genix's Geor­gia-based con­tract man­u­fac­tur­er Re­cro Gainesville. In 2015, Zo­genix sold Zo­hy­dro ER to Pernix Ther­a­peu­tics for $100 mil­lion plus reg­u­la­to­ry and sales mile­stones up to $284 mil­lion. In 2019, Pernix was sold to New Jer­sey-based Cur­rax Phar­ma­ceu­ti­cals, which is who most re­cent­ly dis­trib­uted the drug.

Back in 2014, Zo­hy­dro made head­lines as Mass­a­chu­setts banned the pre­scrip­tion, or­der­ing, dis­pens­ing, and ad­min­is­tra­tion of the new opi­oid, but then had that ban over­turned in court, with Zo­genix ar­gu­ing that the ban was pre­empt­ed by fed­er­al law.

“If the Com­mon­wealth were able to coun­ter­mand the FDA’s de­ter­mi­na­tions and sub­sti­tute its own re­quire­ments, it would un­der­mine the FDA’s abil­i­ty to make drugs avail­able to pro­mote and pro­tect the pub­lic health," the fed­er­al court said in its de­ci­sion.

The FDA al­so came un­der fire for the ap­proval and went to great lengths to try to de­fend the opi­oid, as well as to cor­rect mis­in­for­ma­tion around the drug's strength, which is some­thing the agency rarely does.

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7
by Josh Sullivan

Af­ter more than 500,00 peo­ple have died in con­nec­tion to the fam­i­ly’s drug, and the Hu­lu minis­eries Dopesick cast a broad­er light on the fam­i­ly’s in­volve­ment in the opi­oid cri­sis that has ripped through Amer­i­ca, mem­bers of the Sack­ler fam­i­ly are clos­ing in on an agree­ment to add to the $4 bil­lion of­fer to solve lit­i­ga­tion sur­round­ing the opi­oid cri­sis caused, in part, by the pain re­lief drug Oxy­Con­tin.

A fed­er­al judge over­turned a $4.5 bil­lion set­tle­ment in De­cem­ber that shield­ed mem­bers of the fam­i­ly from fu­ture lit­i­ga­tion from the scan­dal that has led Pur­due Phar­ma in­to a bank­rupt­cy re­or­ga­ni­za­tion. The deal would have dis­solved Pur­due, and re­leased the com­pa­ny’s own­ers — the Sack­lers — from li­a­bil­i­ty in the deal. But judge Colleen McMa­hon, from the US Dis­trict Court’s south­ern dis­trict of New York, said it should not go for­ward. The deal would have called for the Sack­lers to fork over own­er­ship of Pur­due while in­di­vid­u­als get off scot-free.

Judge Robert Drain orig­i­nal­ly ap­proved the plan in Sep­tem­ber, lament­ing that much of the Sack­ler’s mon­ey had been kept in off-shore ac­counts, and call­ing the re­sult “bit­ter,” as fur­ther­ing the de­lay would have tak­en more time, and kept even more mon­ey from the states which have sued.

A me­di­a­tor, for­mer bank­rupt­cy judge Shel­ley Chap­man, said that any fur­ther con­tri­bu­tion from the Sack­lers would be used on­ly for opi­oid abate­ment. Ne­go­ti­a­tions ran from Jan. 25-26, and were more than 12 hours long each day, Reuters re­port­ed.

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8
by Nicole DeFeudis

As biotech stocks con­tin­ue to tum­ble, a Boston-based com­pa­ny strug­gling to gain a foothold in the noisy weight loss mar­ket is the lat­est to bring out the bud­get axe.

Gele­sis has re­port­ed­ly laid off around 140 con­trac­tors hired to pro­mote its weight loss cap­sule Plen­i­ty, ef­fec­tive to­day ac­cord­ing to the Boston Globe, which broke the news. The move comes on the heels of a dis­ap­point­ing SPAC merg­er, which brought in sig­nif­i­cant­ly less cash than the PureTech spin­out was ini­tial­ly count­ing on.

Gele­sis snapped up an ap­proval for Plen­i­ty — which is tech­ni­cal­ly con­sid­ered a med­ical de­vice — back in 2019. Tak­en twice a day be­fore lunch and din­ner, the $98-per-month treat­ment is de­signed to ex­pand in the stom­ach, mak­ing adults feel fuller with small­er por­tions of food. In Ju­ly, Gele­sis struck a deal to merge with Cap­star Spe­cial Pur­pose Ac­qui­si­tion Corp, lin­ing up a po­ten­tial $376 mil­lion in pro­ceeds.

The com­pa­ny called in Sy­neos to build a team of con­trac­tors to pro­mote the treat­ment, which re­quires a pre­scrip­tion, ac­cord­ing to the Globe. Un­til re­cent­ly, mar­ket­ing ef­forts re­lied heav­i­ly on so­cial me­dia ef­forts, as Gele­sis said it was build­ing out a com­mer­cial-scale man­u­fac­tur­ing fa­cil­i­ty.

But when its pub­lic de­but fi­nal­ly came around last month, Gele­sis on­ly reaped about $105 mil­lion in pro­ceeds as more than 98% of in­vestors bailed out, the Globe re­port­ed. Af­ter the merg­er, the com­pa­ny in­formed about 140 mem­bers of the pro­mo­tion­al team they were be­ing laid off.

Gele­sis is the third PureTech en­ti­ty to go pub­lic af­ter Karuna Ther­a­peu­tics hit Nas­daq with a tra­di­tion­al IPO in 2019 and Vor Bio­phar­ma fol­lowed suit in ear­ly 2021.

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9
by Josh Sullivan

Fol­low­ing a mon­ster 2021, in which CD­MO Re­ci­pharm ex­pand­ed its foot­print across the world in places with a small­er man­u­fac­tur­ing pres­ence, it's ex­pand­ing its foot­print in a Eu­ro­pean coun­try where it's al­ready es­tab­lished: Por­tu­gal.

The Swedish com­pa­ny an­nounced its ac­qui­si­tion of GenI­bet, a CD­MO based in Oeiras, Por­tu­gal that was spun out of an iBET - In­sti­tu­to de Bi­olo­gia Ex­per­i­men­tal e Tec­nológ­i­ca - lab in 2016.  The move will help Re­ci­pharm build out its bi­o­log­ics ca­pa­bil­i­ties, and ben­e­fit from GenI­bet’s ex­pe­ri­ence with vi­ral vec­tors and vac­cines, as it looks to fo­cus on the man­u­fac­tur­ing of nov­el ad­vanced ther­a­py med­i­cines. It will in­her­it GenI­bet’s 70 em­ploy­ees at the near­by site just 11 km from Re­ci­phar­m's fa­cil­i­ty in Lis­bon.

GenI­bet made head­lines last year when it re­vealed that it worked with Mod­er­na to pro­duce some of the ear­li­est batch­es of mR­NA for Mod­er­na be­tween 2015 and 2019. It was the on­ly man­u­fac­tur­er in Por­tu­gal to har­ness those brag­ging rights and re­ceived a thank you from Mod­er­na CEO Stéphane Ban­cel.

“Mod­er­na is very thank­ful to GenI­bet Bio­phar­ma­ceu­ti­cals,” he said in 2020. “They part­nered to­geth­er to take the very first Mod­er­na mR­NA vac­cine in the clin­ic at the end of 2015. The GenI­bet team pro­vid­ed Mod­er­na with a high qual­i­ty GMP prod­uct and we are thank­ful for its work.”

Though the work wasn’t di­rect­ly re­lat­ed to Covid-19 re­search, the study of the mR­NA tech­nol­o­gy helped Mod­er­na learn more about the tech­nol­o­gy that was even­tu­al­ly used in the vac­cines.

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10
by Amber Tong

Days be­fore it would nail down the FDA’s ap­proval for its epilep­sy drug Fin­tepla, Zo­genix re­ceived one of the first in­quiries from a phar­ma com­pa­ny about pur­su­ing a po­ten­tial part­ner­ship to mar­ket the drug in the EU and oth­er ge­o­gra­phies out­side the US.

But it wasn’t un­til the OK came through, in late June, that even­tu­al buy­er UCB made ini­tial con­tact, ac­cord­ing to an SEC fil­ing de­tail­ing the back­ground lead­ing up to the deal.

The in­side look doc­u­ments a three-way ne­go­ti­a­tion that last­ed half a year be­fore UCB, the Bel­gian phar­ma, emerged vic­to­ri­ous with a $1.9 bil­lion of­fer.

The nar­ra­tive fea­tures three key play­ers: Par­ty A, a phar­ma com­pa­ny that first ex­pressed its in­ter­est on June 4; UCB, which made con­tact on Ju­ly 19; and Par­ty B, a glob­al phar­ma play­er that touched base on Aug. 3 about a po­ten­tial US deal.

A week af­ter that ini­tial in­tro­duc­tion, Par­ty B be­came the first to bring up a po­ten­tial ac­qui­si­tion, as ex­ecs called Zo­genix CEO Stephen Farr to dis­cuss ei­ther part­ner­ing in the US or buy­ing out the com­pa­ny — to which Farr replied he was not in­ter­est­ed.

Things took a turn in Sep­tem­ber, fol­low­ing a board meet­ing around Zo­genix’s fi­nan­cial needs and the state of the broad­er biotech mar­ket.

When UCB’s EVP of neu­rol­o­gy and head of Eu­rope/in­ter­na­tion­al mar­kets, Charl van Zyl, com­mu­ni­cat­ed its first non-bind­ing of­fer to ac­quire the biotech — lat­er con­firmed in an of­fer at $20.50 per share — it was told that the price was “ma­te­ri­al­ly in­ad­e­quate.”

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John Carroll
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