Div­ing deep in­to the he­mo­phil­ia mar­ket, Sanofi strikes an $11.6B Biover­a­tiv buy­out

Olivi­er Brandi­court

Sanofi $SNY has fi­nal­ly bagged a multi­bil­lion-dol­lar biotech buy­out.

In a state­ment ear­ly Mon­day the phar­ma gi­ant said it has closed a deal to ac­quire Bio­gen spin­out Biover­a­tiv $BIVV for al­most $11.6 bil­lion — a 64% pre­mi­um on its $64.11 Fri­day close at $105 a share. The ac­qui­si­tion helps ex­plain a new­ly re­worked pact with Al­ny­lam that put Sanofi on course to build­ing a fran­chise in the he­mo­phil­ia field.

“With Biover­a­tiv, a leader in the grow­ing he­mo­phil­ia mar­ket, Sanofi en­hances its pres­ence in spe­cial­ty care and lead­er­ship in rare dis­eases, in line with its 2020 Roadmap, and cre­ates a plat­form for growth in oth­er rare blood dis­or­ders,” Sanofi CEO Olivi­er Brandi­court said in a state­ment. “To­geth­er, we have a great op­por­tu­ni­ty to bring in­no­v­a­tive med­i­cines to pa­tients world­wide, build­ing on Biover­a­tiv’s suc­cess in dri­ving new stan­dards of care with its ex­tend­ed half-life fac­tor re­place­ment ther­a­pies.”

The deal gives Sanofi a big stake in the fast-chang­ing he­mo­phil­ia mar­ket, where Roche just scored with a new OK for Hem­li­bra — which clear­ly threat­ens Biover­a­tiv’s busi­ness — and a group of de­vel­op­ers like Bio­Marin and Spark/Pfiz­er are look­ing to dis­rupt the busi­ness with new gene ther­a­pies now in late-stage de­vel­op­ment.

Sanofi shares dropped a lit­tle more than 3% Mon­day morn­ing, shed­ding slight­ly more than $3 bil­lion in mar­ket cap.

Biover­a­tiv mar­kets Eloc­tate and Al­pro­lix in part­ner­ship with Stock­holm-based So­bi. Some longterm ob­servers in the field note that while key play­ers in he­mo­phil­ia like Shire and Waltham, MA-based Biover­a­tiv face big changes ahead, this is the kind of mar­ket where physi­cians and pa­tients may be slow to switch from the drugs that have long sta­bi­lized their dis­ease.

Sanofi is bet­ting big on that as­sump­tion, gam­bling bil­lions that it can com­pete as the mar­ket de­vel­ops — de­spite earn­ing a rep for fail­ing at in-house in­no­va­tion over the re­cent past.

Sanofi got in­to rare dis­eases in a big way with the $20 bil­lion ac­qui­si­tion of Gen­zyme in Boston, where it’s been deeply root­ed ever since. Sanofi al­so re­cent­ly re­struc­tured its am­bi­tious RNAi deal with Al­ny­lam to gain glob­al rights on the he­mo­phil­ia ther­a­py fi­tusir­an, per­haps with this deal in mind.

Sanofi’s Brandi­court has been left snubbed in the last cou­ple of buy­out talks, miss­ing out on Medi­va­tion as well as Switzer­land’s Acte­lion af­ter get­ting beat­en out by Pfiz­er and J&J re­spec­tive­ly. In the mean­time, its one re­cent claim to fame, the dengue vac­cine Deng­vax­ia, has im­plod­ed in the wake of a be­lat­ed ac­knowl­edg­ment of some se­vere safe­ty is­sues.

Sanofi has seen rare dis­eases as an al­ter­na­tive to its di­a­betes busi­ness, where it faces grow­ing price com­pe­ti­tion as well as the loss of mar­ket share to gener­ic com­pe­ti­tion. Some an­a­lysts struck a dis­tinct­ly skep­ti­cal tone in re­view­ing the deal Mon­day morn­ing.

Sea­mus Fer­nan­dez at Leerink says the deal makes sense, but added that there could eas­i­ly be trou­ble ahead for Sanofi. He not­ed:

SNY is bolt­ing on the Biover­a­tiv he­mo­phil­ia Busi­ness to its rare dis­ease port­fo­lio for $11.6B, a strate­gi­cal­ly sound move, in our opin­ion, that will bring near-term ac­cre­tion to the busi­ness and where SNY’s re­cent­ly re­struc­tured deal with AL­NY (MP) pro­vides a medi­um-term pipeline oppt’y with­in the Fac­tor VI­II busi­ness with fi­tusir­an. The biggest chal­lenge for SNY mgmt will be con­vinc­ing in­vestors that – much like SH­PG’s ac­qui­si­tion of Bax­al­ta – the cur­rent he­mo­phil­ia mar­ket will not be dis­rupt­ed by new tech­nolo­gies (Gene Ther­a­py) and prod­uct launch­es (Roche’s ACE910). At a min­i­mum, af­ter a num­ber of spec­u­lat­ed un­suc­cess­ful bids, in­clud­ing Medi­va­tion and Acte­lion, SNY in­vestors now have a deal to di­gest that is im­me­di­ate­ly ac­cre­tive to 2018 earn­ings and es­ti­mat­ed to be “up to 5% ac­cre­tive” in 2019. Whether or not this lev­el of ac­cre­tion is achiev­able re­mains to be seen, but on bal­ance, the price tag is not com­plete­ly out­side of that paid for oth­er biotech­nol­o­gy fran­chis­es.

Biover­a­tiv had a staff of 350 as of last Feb­ru­ary as well as a small pipeline of its own. There’s a new pro­gram for ST-400, a gene-edit­ed cell ther­a­py can­di­date for peo­ple with trans­fu­sion-de­pen­dent be­ta-tha­lassemia, part­nered with Sang­amo and pre­clin­i­cal gene ther­a­py work in­volv­ing the renowned San Raf­faele In­sti­tute in Italy. CEO John Cox took the op­por­tu­ni­ty to ex­press just how hap­py he was with the ac­qui­si­tion, which was ap­proved unan­i­mous­ly on both sides.

Sanofi brings proven ca­pa­bil­i­ties and a glob­al in­fra­struc­ture, which we be­lieve will help to more rapid­ly ex­pand ac­cess to our med­i­cines glob­al­ly and fur­ther our mis­sion of trans­form­ing the lives of peo­ple with rare blood dis­or­ders.

This deal could mark the long-await­ed start to a burst of M&A ac­tion, with No­vo Nordisk mak­ing a play for Abl­ynx as Cel­gene re­port­ed­ly hunts a deal to ac­quire Juno Ther­a­peu­tics while Bio­gen and UCB re­port­ed­ly joined the hunt for a bad­ly dam­aged Acor­da. Those deals, like this one, were first re­port­ed by the Wall Street Jour­nal.

Andre Kalil, AP Images

A 9/11-era Om­a­ha fa­cil­i­ty, an old Ebo­la drug, and the ubiq­ui­tous Dr. Fau­ci: In­side the first US nov­el coro­n­avirus tri­al

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Olivier Brandicourt (AP Images)

Ex-Sanofi chief Olivi­er Brandi­court, cur­rent Black­stone ad­vi­sor, jumps on Al­ny­lam board

Former Sanofi chief Olivier Brandicourt, who departed his post with an unexpected early retirement last year, has made his move — as most C-suite executives inevitably do — to become a director on the board of a biopharma company.

RNAi player Alnylam is Brandicourt’s destination. Meanwhile, the Cambridge, Massachusetts-based drugmaker — which pioneered the first approval in the field — also disclosed the retirement of Alnylam co-founder Dr. Paul Schimmel from its board.

Jim Wilson's gene ther­a­py start­up Pas­sage Bio bucks mar­ket sen­ti­ments, rais­ing up­sized $216M IPO

A coronavirus fear-induced bloodbath on the Nasdaq has not stopped Passage Bio from making a public debut — and an exuberant one.

By pricing an upsized offering at $18, the top of the range, the gene therapy biotech bagged $216 million from its IPO, 72% more than it’s originally penciled in.

The proceeds likely reflected confidence in Jim Wilson, who gathered all the tools he’s built over decades of gene therapy research to assemble the startup and teamed up with Frazier and OrbiMed to hone its focus on rare, monogenic disorders of the central nervous system. Just before the IPO, Deerfield partner Bruce Goldsmith took over from OrbiMed’s Stephen Squinto as CEO.

Dan O'Day (AP Images)

UP­DAT­ED: A name emerges out of the Gilead M&A ru­mor mill, and it’s a can­cer biotech

After months of questions and speculation about when and if Gilead will make a major acquisition, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

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Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

UP­DAT­ED: Bio­gen makes an­oth­er bold Alzheimer’s bet, drop­ping $350M up­front to part­ner with genome-edit­ing fo­cused Sang­amo

While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

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Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Spark los­es an­oth­er top ex­ec in the wake of $4.3B takeover by Roche — re­port

Days after bidding farewell to co-founder Kathy High, Spark Therapeutics — now operating under Roche — has one more opening on its C-suite.

Kathy Reape

Kathy Reape, who joined the Philadelphia-based biotech in 2016 as head of clinical R&D and became chief medical officer in 2018, is reportedly set to leave.

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'The head­lines are the head­lines, but': Bio­Marin talks up po­ten­tial sav­ings as he­mo­phil­ia gene ther­a­py launch looms

BioMarin execs are still staying tight-lipped about their pricing plans for what is poised to be the world’s first hemophilia gene therapy. But as the company enters the final regulatory stretch and approaches a potential launch this summer, they are also dropping more hints to get investors ready.

First thing to know: They really, really don’t expect an advisory committee to be convened for valrox, which is under priority review, to pop up before its PDUFA date on August 21.

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