Fo­cused on new deals, Bio­gen bags a PhI­II drug for is­chemic stroke with $120M up­front

Bio­gen’s busi­ness de­vel­op­ment team has been on the march.

The big biotech has struck a deal to buy a Phase III drug for is­chemic stroke for $120 mil­lion up front, look­ing to over­see the late-stage pro­gram aimed at ex­pand­ing its port­fo­lio of neu­ro­science drugs.

Michel Vounatsos, Bio­gen

Bio­gen bought the drug from Rem­e­dy Phar­ma­ceu­ti­cals, which com­plet­ed the mid-stage ef­fort and gath­ered or­phan and fast track sta­tus for Cirara. The drug tack­les SUR1-TRPM4 chan­nels, hit­ting a path­way in­volved in brain swelling, or cere­bral ede­ma. And it will now be put along­side na­tal­izum­ab, a Bio­gen ther­a­py now in Phase IIb for in­flam­ma­tion re­lat­ed to is­chemic stroke.

Rem­e­dy isn’t back­ing away, though. It will help fi­nance the pro­gram for large hemi­spher­ic in­farc­tion, a se­vere form of is­chemic stroke and al­so stands to earn a slate of un­spec­i­fied mile­stones if the ef­fort proves suc­cess­ful.

Here’s what Rem­e­dy found in Phase II that at­tract­ed Bio­gen’s at­ten­tion:

Of the 77 pa­tients in the pri­ma­ry analy­sis, there were 19 deaths with­in the first 30-day pe­ri­od, 6 of 41 in the CIRARA group (14%), ver­sus 13 of 36 (36%) in the place­bo group (p=0.03), cor­re­spond­ing to a re­duc­tion in mor­tal­i­ty of 60%. With­in the 90-day fol­low up pe­ri­od, there were a to­tal of 20 deaths, 7 of 41 sub­jects in the CIRARA group (17%), ver­sus 13 of 36 (36%) in the place­bo group (p=0.06), a re­duc­tion in mor­tal­i­ty of 53%.

“In the pre­vi­ous Phase II GAMES-RP study,” not­ed Baird’s Bri­an Sko­r­ney, “CIRARA failed to show a ben­e­fit on the pri­ma­ry end­point of pro­por­tion of pa­tients achiev­ing an mRS score of 0-4 at 90 days. How­ev­er, Bio­gen is more in­ter­est­ed in the po­ten­tial ben­e­fit on mor­tal­i­ty and in­flam­ma­tion, in­di­cat­ing that both ad­ju­di­cat­ed neu­ro­log­i­cal mor­tal­i­ty and death from ede­ma saw sta­tis­ti­cal­ly sig­nif­i­cant re­sults in Phase 2 ver­sus place­bo. Though the cur­rent Phase III de­sign calls for use of im­prove­ment in mRS at 90 days as the pri­ma­ry end­point again, Bio­gen in­tends to meet with the reg­u­la­to­ry au­thor­i­ties and po­ten­tial­ly al­ter the study de­sign, if nec­es­sary, in or­der to ini­ti­ate a Phase 3 study in 2018.”

Dur­ing JP Mor­gan new­ly named Bio­gen CEO Michel Vounatsos sig­naled that he was ready to start do­ing some deals to help re­lieve an­a­lysts’ fret­ting about the com­pa­ny’s pipeline and prospects. Bio­gen scored big with Tec­fidera un­der the old George Scan­gos regime. But the fran­chise drug is com­ing un­der in­creased pres­sure and Bio­gen has been putting a lot of its eggs in the Alzheimer’s bas­ket, where the pay­off is high and the risk of fail­ure even high­er.

This deal with Rem­e­dy isn’t near­ly enough to re­solve wor­ries about the pipeline, but if it can repli­cate the pact with more late-stage ac­qui­si­tions, Vounatsos will be ready for his next JP Mor­gan close­up.

Bio­gen clear­ly has high hopes for its lat­est ad­di­tion to their Phase III pipeline.

“Build­ing on our lead­ing po­si­tion in mul­ti­ple scle­ro­sis, spinal mus­cu­lar at­ro­phy, and Alzheimer’s dis­ease re­search, we see a com­pelling op­por­tu­ni­ty in stroke where we can lever­age our core ex­per­tise in neu­ro­science to make a ma­jor dif­fer­ence in pa­tient care. CIRARA rep­re­sents a po­ten­tial break­through stroke treat­ment that ac­cel­er­ates our ef­forts to build a port­fo­lio of new ther­a­pies for neu­ro­log­ic dis­eases,” re­marked Michael Ehlers, the ex­ec­u­tive vice pres­i­dent of R&D at Bio­gen, in pre­pared text. “We be­lieve the da­ta sup­port­ing the po­ten­tial of CIRARA are com­pelling and that CIRARA can be a first-in-class ther­a­py that gives physi­cians the abil­i­ty to mean­ing­ful­ly im­prove pa­tient out­comes in an area where ef­fec­tive treat­ments have been few and far be­tween.”

Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

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Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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