Gilead needs to stop wait­ing and start buy­ing; Let's em­brace Chi­na as a new bio­phar­ma pow­er

End­points as­sess­es the big bio­phar­ma R&D sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.


 Gilead needs to start buy­ing things — pron­to

Gilead once had one of the best rep­u­ta­tions in R&D. Its abil­i­ty to hus­tle through a pack­age of hep C cures was done at a jaw-drop­ping speed and de­liv­ered the goods with first-mover ad­van­tage in rev­o­lu­tion­iz­ing a mar­ket and dis­ease treat­ment. But what have you done for in­vestors late­ly, Gilead? A string of set­backs in the clin­ic has high­light­ed that Gilead isn’t im­mune from the high fail­ure rate in bio­phar­ma. And with­out a big, quick as­sist, its num­bers are go­ing to keep shrink­ing. It’s time to take that big stash of cash and, per­haps with the help of the Trump ad­min­is­tra­tion, get it back in­to cir­cu­la­tion with a cou­ple of ma­jor ac­qui­si­tions that can have an im­me­di­ate im­pact. Any sell­er will see Gilead com­ing from miles away, and will write down a mag­ic num­ber that would of­fend most buy­ers. In this mar­ket, buy­ers can’t be choosers when it comes to su­pe­ri­or deals. Gilead will have to pay top dol­lar. The com­pa­ny wait­ed too long, hop­ing that the pipeline would come to its res­cue. Wrong. Call up the BD team and get mov­ing.


 The Chi­nese are here. Let the com­pe­ti­tion be­gin

The news this week that Chi­nese re­searchers had sur­prised the world with the first use of CRISPR-Cas9 tech in a hu­man study un­der­scores a new re­al­i­ty in the glob­al in­dus­try. Chi­na is mov­ing to chal­lenge the West in drug de­vel­op­ment. And that is go­ing to take some get­ting used to. While the US and Eu­ro­pean bio­phar­ma camps have been op­er­at­ing in clear sight, co­or­di­nat­ing their work with high­ly vis­i­ble reg­u­la­to­ry bod­ies, the R&D at­mos­phere in Chi­na is much more cloudy.  So we’re not al­ways go­ing to get a heads up about R&D firsts like this. While the rest of the world has been fo­cused else­where, Chi­na has been build­ing a mod­ern, au­da­cious R&D in­dus­try of its own. Chi­nese sci­en­tists are among the best in the world, as a large num­ber of com­pa­nies have been find­ing out as they out­source more and more of their work to the Asian su­per pow­er. It’s time we spent more time track­ing the go­ings-on in Chi­nese re­search cir­cles. As one ex­ec re­cent­ly told me, some of these groups are able to work teams on a 24-hour sched­ule when it comes to solv­ing a prob­lem. It’s time we start­ed pay­ing clos­er at­ten­tion. That won’t be easy. But the tech ri­val­ry is re­al, and it’s here. Great!


 Let’s get some clar­i­ty on Trump’s ideas about health­care re­form

Right now, every­body that cov­ers bio­phar­ma is look­ing for clues — sol­id, luke­warm, half-baked, you name it — about where the Trump ad­min­is­tra­tion is head­ed on the in­dus­try. There had been some en­cour­age­ment that Rich Bag­ger, a po­lit­i­cal in­sid­er in the Chris Christie camp and se­nior Cel­gene ex­ec, was like­ly go­ing to be tapped for a se­nior spot in the health­care sec­tor af­ter head­ing up the tran­si­tion as ex­ec­u­tive di­rec­tor. Then seem­ing­ly min­utes lat­er he was re­port­ed to be head­ed back to the pri­vate sec­tor af­ter Christie was clear­ly shoved to the side­lines. We heard sig­nals from Trump dur­ing the cam­paign that he fa­vored the idea that Medicare should ne­go­ti­ate drug prices. And he al­so gave a thumbs-up to reim­por­ta­tion. But such po­lit­i­cal asides mean lit­tle for a new ad­min­is­tra­tion. He fa­vored FDA “re­form,” but we don’t know what that means in prac­tice. And the fu­ture of Oba­macare is still large­ly a mys­tery. We’ll get a much bet­ter idea of what Trump is think­ing when we see his picks for HHS and the rest of the cab­i­net. The soon­er the bet­ter.

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.