Bio­Haven hopes to soothe Chi­nese headaches with Shang­hai sub­sidiary

Cap­i­tal­iz­ing on the bur­geon­ing bio­phar­ma in­ter­est in Chi­na, neu­ro-fo­cused drug de­vel­op­er Bio­Haven $BHVN is set­ting up shop in Shang­hai with a sub­sidiary called BioShin that will be tasked with shep­herd­ing the Con­necti­cut-based com­pa­ny’s ar­se­nal of late-stage mi­graine and neu­rol­o­gy prod­ucts in mar­kets across the Asia-pa­cif­ic re­gion.

Vlad Coric

Bio­Haven, which ear­li­er this week said it had sub­mit­ted a US ap­pli­ca­tion to mar­ket a sub­lin­gual for­mu­la­tion of the ALS drug rilu­zole, is gear­ing up to re­port key da­ta from a piv­otal late-stage tri­al test­ing its acute mi­graine drug, rimegepant, be­fore the end of the year in the Unit­ed States. The com­pa­ny’s in­ter­est is Chi­na is not un­ex­pect­ed, giv­en that large swathes of the re­gion’s im­mense pop­u­la­tion suf­fer from mi­graine and oth­er cen­tral ner­vous sys­tem dis­or­ders, al­though pa­tients have not ben­e­fit­ed from the heady pace of med­ical in­no­va­tion their US coun­ter­parts have en­joyed.

“Al­most 90 mil­lion in­di­vid­u­als in Chi­na alone suf­fer from mi­graine and could ul­ti­mate­ly ben­e­fit from our late-stage mi­graine de­vel­op­ment plat­form,” said Bio­Haven chief Vlad Coric.

Once a breed­ing ground for sci­en­tists that em­i­grat­ed to the Unit­ed States, Chi­na is now at­tract­ing top re­searchers and en­tre­pre­neur­ial tal­ent back to its shores as fi­nan­cial in­cen­tives, gov­ern­men­tal sup­port, in­dus­tri­al in­fra­struc­ture, reg­u­la­to­ry re­forms and a large, age­ing pop­u­la­tion pro­vide the ide­al back­drop for rapid drug dis­cov­ery and de­vel­op­ment.

Don­nie Mc­Grath

BioShin will be led by Don­nie Mc­Grath, a for­mer Bris­tol-My­ers $BMY ex­ec who has served as Bio­Haven’s chief of cor­po­rate strat­e­gy and busi­ness de­vel­op­ment since 2017, along with fel­low ex-Bris­tol-My­ers ex­ec Karl Lin­tel who has been ap­point­ed COO. With the sup­port of Bio­Haven, BioShin can fur­ther build its team and “raise cap­i­tal from both the pri­vate and pub­lic mar­kets in main­land Chi­na and Hong Kong,” Mc­Grath said in a state­ment on Wednes­day.

BioShin is ex­pect­ed to sub­mit an ap­pli­ca­tion to eval­u­ate rimegepant in hu­man tri­als in Chi­na next quar­ter, and ad­di­tion­al INDs for oth­er in­ves­ti­ga­tion­al drugs are al­so planned for sub­mis­sion in 2019. Mean­while, in the Unit­ed States, pos­i­tive Phase III rimegepant da­ta will al­low Bio­Haven to sub­mit an ap­pli­ca­tion to mar­ket the as-need­ed oral CGRP treat­ment for mi­graine in mid-2019, trail­ing be­hind Al­ler­gan $AGN that has re­cent­ly re­it­er­at­ed it is on track to sub­mit its ap­pli­ca­tion for a ri­val oral CGRP by the first quar­ter of next year.

The mul­ti-bil­lion dol­lar US mi­graine mar­ket is al­ready re­plete with in­jectable med­ica­tions from Te­va $TE­VA, Eli Lil­ly $LLY, and one from Am­gen $AMGN and No­var­tis $NVS, which are all de­signed to be used as pre­ven­ta­tive treat­ments and are cu­ri­ous­ly priced iden­ti­cal­ly. For those pa­tients who still ex­pe­ri­ence mi­graine at­tacks de­spite pre­ven­ta­tive an­ti-CGRP ther­a­py, acute, as-need­ed treat­ments will still be re­quired, which is where rimegepant and Al­ler­gen’s ri­val ubro­gepant could come handy. If ap­proved, the two acute drugs could po­ten­tial­ly al­so be used in com­bi­na­tion with their an­ti-CGRP in­jectable ri­vals.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

Sanofi’s big week in­cludes a promis­ing PhI­II for an or­phan dis­ease drug, with plans for a pitch to the FDA

The biopharma R&D food chain is paying off with a plan at Sanofi to pitch regulators on a new drug for an orphan disease called cold agglutinin disease.

The pharma giant ushered out a statement Tuesday morning — after it spelled out plans to radically restructure the company, abandoning cardio and diabetes research altogether — saying that their C1s inhibitor sutimlimab had cleared the pivotal study.

In­scrip­ta push­es fund­ing to $260 mil­lion as they launch genome edit­ing plat­form

Inscripta presentations can begin with the advent of agriculture. Or even further back: The emergence of man.

“We’ve come a long way, starting with natural selection,” Inscripta microbial director Nandini Krishnamurthy told a session this year at SynBioBeta, the new annual conference for the synthetic biology field.

Behind her was a slide that’s recurred in company presentations, showing from left to right across the bottom the classic evolution-of-man chart (the ‘humorous’ kind that ends on an overweight soda-drinker), a picture showing the development of corn from thin strand to bulbous Iowan, and then a squiggly protein close-up of “directed evolution.” Below that runs an arrow and a ticker of how long each takes, from 10^9 years to 1.

Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

This is the second biotech buyout pact today, marking a brisk tempo of M&A deals in the lead-up to the big JP Morgan gathering in mid-January. It’s no surprise the acquisitions are both for cancer drugs, where Sanofi will try to make its mark while Merck beefs up a stellar oncology franchise. And bolt-ons are all the rage at the major pharma players, which you could also see in Novartis’ recent $9.7 billion MedCo buyout.

ArQule — which comes out on top after their original lead drug foundered in Phase III — highlighted early data on ‘531 at EHA from a group of 6 chronic lymphocytic leukemia patients who got the 65 mg dose. Four of them experienced a partial response — a big advance for a company that failed with earlier attempts.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

Re­pub­li­cans un­veil a drug price bill to ri­val the De­moc­rats — promis­ing low­er prices and more cures

Nancy Pelosi unveiled the Democrats’  drug pricing bill back in September and brought the fight straight to the industry with a proposal to empower the US government to negotiate prices for select drugs. Republicans, who decried the bill reeks of heavy-handed government intervention which will stifle innovation, now have a counterproposal they claim will result in cheaper drugs and incentivize R&D — further clouding the prospects of a bipartisan compromise that could land on Donald Trump’s desk.

Chris Garabedian. Perceptive

Per­cep­tive teams up with Chris Garabe­di­an to open up a new, $210M biotech fund fo­cused on A rounds

Perceptive Advisors is one of those prolific biotech investor groups which has traditionally enjoyed zeroing in on clinical-stage investments and crossover rounds, a group that prefers more established drug development players with near-term payoff potential.

But now they’re partnering with Xontogeny chief and longtime biotech entrepreneur Chris Garabedian on a $210 million fund — with money contributed by institutional investors and family funds — to go into the launch space with their first early-stage VC fund. Dubbed the Perceptive Xontogeny Venture Fund, LP, or just PXV Fund, they plan to favor upstarts that Garabedian is fostering in his incubator. But they’ll also plan to reach outside that inner circle for more A rounds to back, with plans to dominate initial funding with $10 million to $20 million per newborn biotech.

Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.