Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a po­ten­tial­ly pow­er­ful flu sea­son looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss gi­ant just got a small boost in ad­vance of that test as the FDA ex­pand­ed Xofluza’s in­di­ca­tion to in­clude pa­tients at high risk of de­vel­op­ing flu-re­lat­ed com­pli­ca­tions.

Xofluza (balox­avir mar­box­il) was ap­proved last Oc­to­ber in the US, the first land­mark flu drug ap­proval in 20 years and a much-need­ed green light for a com­pa­ny that had watched its lead­ing flu drug Tam­i­flu get eat­en alive by gener­ics. Like its pre­de­ces­sor, the pill of­fered a re­duc­tion in flu symp­toms but not a cure.

Yet ques­tions abound­ed, most no­tably about pay­ers. Be­cause de­spite Phase III tri­als show­ing it was far more ef­fec­tive than a place­bo, Xofluza per­formed  sim­i­lar­ly to Tam­i­flu. For both drugs, symp­toms en­dured for a me­di­an 54 hours af­ter treat­ment in the PhI­II CAP­STONE-1 tri­al. In CAP­STONE-2 Xofluza im­proved symp­toms af­ter 73 hours com­pared to Tam­i­flu’s 81.

Roche tout­ed Xofluza’s con­ve­nience over Tam­i­flu: one dose over one day, rather than 10 dos­es over 5 days.  It hasn’t been clear, though, how pay­ers would weigh the ease of ac­cess when a gener­ic can of­fer the same ef­fi­ca­cy.

Roche tried to get ahead of that prob­lem for last flu sea­son with a spe­cial pric­ing mod­el, of­fer­ing a whole­sale cost of $150, not much high­er than the av­er­age sale price for Tam­i­flu but much high­er than the low­est priced gener­ics, and then of­fer­ing a “coupon.” The coupon would knock $60 off the price for those with­out in­sur­ance and al­low the in­sured to get the drug for as lit­tle as $30.

Genen­tech, which mar­ket­ed the drug in the US for Roche, told End­points News the coupon would be of­fered again this year.

Oth­er prob­lems emerged last year, half a world away, where the drug was ap­proved ear­li­er and em­braced as a “sil­ver bul­let” against the flu. In Japan’s health­care sys­tem, Xofluza’s ease of use quick­ly made it the top flu drug on the mar­ket, WSJ re­port­ed in Feb­ru­ary.  But in the midst of that flu sea­son, Tokyo’s Na­tion­al In­sti­tute of In­fec­tious Dis­eases said it had found that six strains of the virus had be­come drug-re­sis­tant.

This prob­lem had to some de­gree been pre­dict­ed. A New Eng­land Jour­nal of Med­i­cine ed­i­to­r­i­al pub­lished a month be­fore the drug’s US ap­proval re­viewed tri­al da­ta and found  the treat­ment led to “the emer­gence of vi­ral es­cape mu­tants with re­duced sus­cep­ti­bil­i­ty.”

“The is­sue for pub­lic health is whether these in­fluen­za virus­es with re­duced sus­cep­ti­bil­i­ty to balox­avir are trans­mis­si­ble,” wrote Tim­o­thy M. Uye­ki, adding that ear­ly da­ta in­di­cat­ed these strains might be less trans­mis­si­ble be­cause they can’t repli­cate as eas­i­ly.

In re­sponse to Japan­ese con­cerns, Genen­tech not­ed that the six iden­ti­fied strains wouldn’t meet the US stan­dard of “re­sis­tant” be­cause the drug still had some ef­fi­ca­cy on them. At least one Tokyo doc­tor, though, re­port­ed that he stopped pre­scrib­ing Xofluza be­cause pa­tients, mis­un­der­stand­ing the sci­ence, were wor­ried they weren’t ef­fec­tive.

Roche re­port­ed $13 mil­lion in US rev­enue last year from Xofluza, and, as of Sep­tem­ber 10 $9 mil­lion in 2019.

For biotech nerds, the mech­a­nism be­hind the drug may be as ex­cit­ing as the drug it­self. Rather than pre­vent the virus from spread­ing be­tween cells, Xofluza blocks the virus from en­ter­ing cells to be­gin with. It does so by in­hibit­ing the “Cap-de­pen­dent en­donu­cle­ase,” a part of the virus re­spon­si­ble for “cap-snatch­ing” – a process where the virus steals the first 10-20 RNA residues of a host cell as part of a key process for vi­ral in­va­sion.

 

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Glax­o­SmithK­line scraps a LAG3 study, mark­ing an­oth­er fail­ure for the pipeline af­ter a crit­i­cal set­back

Another gap has appeared in GlaxoSmithKline’s pipeline.

Friday morning the Australian biotech Immutep put out word that Hal Barron’s R&D group at GSK had decided to scrap a Phase II proof-of-concept study in ulcerative colitis for their anti-LAG3 therapy GSK2831781. According to the biotech, the program didn’t survive an interim review.

The trial was stopped by GSK based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial’s Data Review Committee. GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.