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.”

Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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The FDA will hus­tle up an ex­pe­dit­ed re­view for As­traZeneca’s next shot at a block­buster can­cer drug fran­chise

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

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Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.

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CSL ac­cus­es ri­val Pharm­ing of par­tic­i­pat­ing in a scheme to rip off IP on HAE while re­cruit­ing se­nior R&D staffer

Pharming has landed in the middle of a legal donnybrook after recruiting a senior executive from a rival R&D team at CSL. The Australian pharma giant slapped Pharming with a lawsuit alleging that the Dutch biotech’s new employee, Joseph Chiao, looted a large cache of proprietary documents as he hit the exit. And they want it all back.
Federal Judge Juan Sanchez in the Eastern District Pennsylvania court issued an injunction on Tuesday prohibiting Chiao from doing any work on HAE or primary immune deficiency in his new job and demanding that he return any material from CSL that he may have in his possession. And he wants Pharming to tell its employees not to ask for any information on the forbidden topics.
For its part, Pharming fired off an indignant response this morning denying any involvement in extracting any kind of IP from CSL, adding that it’s cooperating in the internal probe that CSL has underway.

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Eli Lil­ly’s first PhI­II show­down for their $1.6B can­cer drug just flopped — what now?

When Eli Lilly plunked down $1.6 billion in cash to acquire Armo Biosciences a little more than a year ago, the stars seemed aligned in its favor. The jewel in the crown they were buying was pegilodecakin, which had cleared the proof-of-concept stage and was already in a Phase III trial for pancreatic cancer.

And that study just failed.

Lilly reported this morning that their cancer drug flopped on overall survival when added to FOLFOX (folinic acid, 5-FU, oxaliplatin), compared to FOLFOX alone among patients suffering from advanced pancreatic cancer.

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UP­DAT­ED: Alex­ion pays $930M to buy out Achillion and its promis­ing com­pan­ion drug to Soliris

After a series of stock-crunching setbacks over the years, Achillion enjoyed a turn in the sun a few weeks ago as the FDA blessed their lead drug danicopan (ACH-4471) — a complementary therapy for PNH patients taking Alexion’s Soliris — with a breakthrough drug designation after taking a look at some solid supporting Phase II data.

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