Roche fields first ap­proval for Ro­z­lytrek in the run-up to a show­down with Bay­er, Pfiz­er

While it’s wait­ing to hear back from FDA reg­u­la­tors, Roche is be­gin­ning the vic­to­ry lap for en­trec­tinib in Japan.

Roche is giv­ing Bay­er a run for their mon­ey with this tu­mor-ag­nos­tic drug, which tar­gets NTRK gene fu­sions. Now dubbed Ro­z­lytrek, it’s sanc­tioned to treat adult and pe­di­atric pa­tients in Japan with neu­rotroph­ic ty­ro­sine re­cep­tor ki­nase fu­sion-pos­i­tive, ad­vanced re­cur­rent sol­id tu­mors.

The Swiss phar­ma gi­ant got its hands on en­trec­tinib back in De­cem­ber 2017, when Bay­er was the big part­ner to Loxo On­col­o­gy, via a $1.7 bil­lion ac­qui­si­tion of Igny­ta. It paid 74% pre­mi­um on the stock for a biotech that’s dis­tin­guished it­self on the fore­front of pre­ci­sion med­i­cine.

Loxo has since been ac­quired by Eli Lil­ly in a $8 bil­lion deal and trans­ferred the re­main­ing rights to its drug, Vi­t­rakvi, to Bay­er, to­geth­er with a next-gen TRK in­hibitor con­ceived for po­ten­tial re­sis­tance. As Eli Lil­ly fo­cus­es on Loxo’s whol­ly owned RET as­set, it al­so stands to earn roy­al­ties from prod­uct sales.

While NTRK in­di­ca­tions could run from breast, cholan­gio­car­ci­no­ma, col­orec­tal, gy­nae­co­log­i­cal, neu­roen­docrine, non-small cell lung, sali­vary gland, pan­cre­at­ic, sar­co­ma to thy­roid can­cers, they weren’t all that Roche was eye­ing. En­trec­tinib was al­so de­signed to tar­get ROS1 fu­sion genes, which is be­lieved to dri­ve a thin slice of all NSCLC cas­es.

In the lat­est da­ta cut pre­sent­ed at AS­CO, Roche’s Genen­tech not­ed that their drug scored 11 re­spons­es out of 11 chil­dren and ado­les­cents with “sol­id tu­mors with and with­out neu­rotroph­ic ty­ro­sine re­cep­tor ki­nase (NTRK), ROS1 or anaplas­tic lym­phoma ki­nase (ALK) gene fu­sions.” Two of the pa­tients had a com­plete re­sponse.

With­in that niche, it will be fac­ing off an­oth­er ri­val in Pfiz­er, whose Xalko­ri is the stan­dard treat­ment in ROS1 pos­i­tive pa­tients and who boasts of a re­cent ap­proval for Lorvi­qua, al­so a small mol­e­cule in­hibitor of ROS1 and ALK.

The FDA has grant­ed a break­through ther­a­py des­ig­na­tion to the drug as well as pri­or­i­ty re­views for both the NTRK and ROS1 la­bels, with a de­ci­sion ex­pect­ed by Au­gust 18.

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?

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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From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

Novotech CRO sees 26% growth in Asia tri­al ac­tiv­i­ty from biotechs, but still plen­ty of ca­pac­i­ty

As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.

China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.

The $102B club: The top 15 R&D spenders in the glob­al bio­phar­ma busi­ness -- 2019 edi­tion

Roche: The pharma giant delivered the blockbusters it had to have, here’s the second wave
AbbVie: A Phase III derailment costs AbbVie, but a big buyout and recent successes at the FDA help salve the wound
Merck: Can a single drug be too successful? Analysts urge a broader vision as new checkpoints come along to challenge a dominant Keytruda
Novartis: Scooping up a slate of big wins in the R&D group, the pharma giant careens straight into another major scandal  
J&J Pharma: There’s always a ton of noise around J&J, but focus in on late-stage work and you get a clear picture of what’s important 
Pfizer: After years of talk, company execs are getting down to the basics — and R&D has never been more important to its future
Sanofi: After a series of in-house misfires, they’re once again getting back to fixing R&D. Can they succeed this time? 
Bristol-Myers Squibb: The pharma giant loses its mojo in R&D. Can a megamerger possibly get things back on track?
AstraZeneca: The long-awaited turnaround has arrived. And CEO Pascal Soriot and his reorganized R&D group are fixed on a brighter future 
Celgene: This top 10 player has been a vital source of R&D deals over the years, but it’s being swallowed by Bristol-Myers. We won’t see its like again 
Eli Lilly: Give them an A for effort. But the Indianapolis-based team can’t ever really seem to find the groove in R&D   
GlaxoSmithKline: A new management team has been shaking up the pharma R&D ops. Can a new culture finally deliver for GSK?
Gilead: Here’s another behemoth looking to create a new culture and a new future. Dan O’Day is moving fast  
Amgen: These guys play for keeps. If you cross them, or maybe even if you don’t, they’ll sue you. And they have some hot prospects in the pipeline you can’t ignore
Takeda: A big buyout put Takeda into the trajectory of the top players by market cap. Staying there will take some real success in R&D

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Andrew Dickinson, Gilead

Gilead­'s chief strat­e­gy ex­ec gets a big pro­mo­tion af­ter or­ches­trat­ing multi­bil­lion-dol­lar deals

After gaining credit as the architect of Gilead’s $12 billion Kite buyout as well as the recent $5 billion partnership with Galapagos, chief strategy officer Andrew Dickinson is being promoted to the prestigious CFO post at the big biotech. And new CEO Daniel O’Day says the latest move completes his makeover of the top team.
Dickinson will remain in charge of strategy in his new post.
A 3-year veteran at Gilead, Dickinson joined the bellwether biotech after a lengthy stint at Lazard Frères & Co, where he was global co-head of healthcare investing. Before that, ironically enough, he had been at Myogen, which was bought out by Gilead in 2006. Now he’ll be primarily responsible for building confidence in the numbers at a company that has a strong foundation in HIV, a disappearing franchise in hep C and a CAR-T subsidiary in Kite that has a long way to go in establishing a new business.

That big neu­ro­sciences R&D group Eli Lil­ly built is be­ing dis­man­tled, with lay­offs and parts shipped home

Seven years after Eli Lilly bulked up its neurosciences research group in Surrey and heralded the move as an indication of its commitment to the field, the pharma giant is shutting down and locking up labs.

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Cyteir nets $40M for rad syn­thet­ic lethal­i­ty plat­form — throw­ing an­oth­er mon­key wrench at cell re­pair

A cell is like a speedboat, says Cyteir Therapeutics founder Markus Renschler. When all parts are sound — the hull fortified, the engine steady — it’s smooth sailing. But you could go faster. You could drill a hole in the front, and sure you’d be in greater danger but you’d be gliding. At that point, though, a hole in the back would be deadly.

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Neil Woodford. Woodford Investment Management via YouTube

Wood­ford fired from flag­ship fund — which won't re­open af­ter all

The debacle around Neil Woodford’s suspended flagship fund is coming to an abrupt end.

Link Fund Solutions, the authorized corporate director of the Woodford Equity Income Fund, is sacking the disgraced stockpicker from his namesake fund and winding it down. Beginning in January, the firm’s designated brokers will gradually sell off all assets in the portfolio to pay back the trapped investors — with the first installment due by the end of that month.

A preda­tor's world? Top an­a­lyst sees the 'haves' and the 'haven't­s' di­verge as biotech bub­bles form — and col­lapse

Josh Schimmer

We’ve all seen the deluge of cash that’s been pouring into biotech from every angle: VCs, IPOs and follow-ons have generated billions in capital for new and emerging drug developers with ready access to some powerful new tech. But Evercore ISI’s Josh Schimmer is asking where we’re headed from here.

His answer is neither apocalyptic nor universally blissful, but if he’s right — and this is a discussion we’re hearing much, much more about at a time of growing economic and industry uncertainty — we may well be at a crossroads that could affect valuations, M&A and the entire global industry that has formed over the past 5 years.

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