Roche just her­ald­ed a great set of place­bo com­par­isons for their new flu drug — too bad it flopped against gener­ic Tam­i­flu

Genen­tech just rolled out some of the hard da­ta around its Phase III CAP­STONE-2 tri­al for their new flu med­i­cine balox­avir mar­box­il, and it doesn’t look good.

Once you dig through the bon­ny re­marks and keep go­ing on to the sta­tis­ti­cal­ly sig­nif­i­cant place­bo com­par­isons, the phar­ma gi­ant throws in a ma­jor sna­fu. Their flu drug failed to prove sig­nif­i­cant­ly bet­ter than Tam­i­flu in a head-to-head com­par­i­son on the time it took to re­duce symp­toms of the flu. And that’s the mon­ey shot.

The me­di­an time to im­prove­ment of symp­toms for balox­avir was 73.2 hours. The Tam­i­flu com­para­tor arm: 81 hours for an aw­ful p val­ue of 0.8347. Roche op­ti­misti­cal­ly called this out­come “nu­mer­i­cal­ly su­pe­ri­or,” but a pay­er would say the rel­a­tive­ly mod­est dif­fer­ence could have been due en­tire­ly to chance.

That’s not the sort of thing pay­ers like to pay for, es­pe­cial­ly as cheap copies of Tam­i­flu abound, eras­ing a fran­chise Roche had hoped to keep. Dur­ing epi­demics, Tam­i­flu had achieved multi­bil­lion dol­lar sales fig­ures. Now it looks to re­main an oc­ca­sion­al best­seller, at a frac­tion of the cost.

The fly in the flu da­ta helps ex­plain why peak sales fore­casts for this drug have tend­ed to vary dra­mat­i­cal­ly. 

There is a wide range of da­ta to il­lus­trate how this drug does bet­ter than a place­bo, but balox­avir won’t be com­pet­ing against a sug­ar pill. In the mean­time, Roche has a Christ­mas eve PDU­FA date with the FDA and strong odds they’ll get an OK for a record-break­ing year at the agency.

Roche got rights to this drug from Sh­iono­gi, which sells it in Japan.

On the bright side, Roche did have some good news for a sub­pop­u­la­tion, with their drug beat­ing Tam­i­flu in the in­fluen­za sub­type B cat­e­go­ry, with a me­di­an time to im­prove­ment of 74.6 hours com­pared to Tam­i­flu’s 101.6 hours (p<0.05). Their drug al­so re­duced “the time that the virus con­tin­ued to be re­leased from the body (vi­ral shed­ding; me­di­an time of 48.0 hours for balox­avir mar­box­il ver­sus 96.0 hours for both place­bo and os­eltamivir; p<0.0001).”

How about ad­verse re­ac­tions? There again, there was no sig­nif­i­cant dif­fer­ence, with balox­avir at 25.1% and Tam­i­flu at 28%. That too is weak, with the phar­ma gi­ant falling back to its ar­gu­ment of nu­mer­i­cal su­pe­ri­or­i­ty.

Roche’s Genen­tech had re­peat­ed­ly boast­ed that balox­avir was the biggest new thing to come along in the flu-fight­ing are­na in 20 years. And they’re still say­ing it.

“This study adds to the grow­ing body of ev­i­dence sup­port­ing balox­avir mar­box­il as a po­ten­tial first-in-class an­tivi­ral flu treat­ment, and we plan to dis­cuss these da­ta with health au­thor­i­ties around the world,” San­dra Horn­ing, Genen­tech’s chief med­ical of­fi­cer and head of Glob­al Prod­uct De­vel­op­ment.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: Searching the Pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).