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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Paul Stoffels, Galapagos CEO (Andrew Harnik/AP Images)

Gala­pa­gos sends some em­ploy­ees — and a re­search unit — off to drug dis­cov­ery CRO as part of re­org

Paul Stoffels has made it clear that he views cutting jobs at Galapagos as difficult but necessary — but he’s getting creative about it.

Galapagos, headquartered in Mechelen, Belgium, has struck an arrangement with French contract research organization NovAliX to transfer its drug discovery and research activities. While NovAliX is based in Strasbourg, it will take over running the site that Galapagos ran in Romainville, France.