Ab­b­Vie preps fran­chise de­ci­sion af­ter Abl­ynx’s IL-6 drug goes head-to-head against Actem­ra

Ab­b­Vie was will­ing to bet up to $840 mil­lion that Abl­ynx’s nanobody tech could help it pro­tect and ex­pand its $14 bil­lion megafran­chise for Hu­mi­ra. To­day, Ab­b­Vie $AB­BV is get­ting a look at new Phase IIb da­ta for their part­nered IL-6 drug vo­bar­il­izum­ab (ALX-0061) that mea­sures up against Roche’s Actem­ra as it moves clos­er to its de­ci­sion on whether or not it will take it in­to Phase III.

But there’s no clear cut win here. In fact, on key ef­fi­ca­cy mea­sures, a low­er dose failed to mea­sure up to Actem­ra.

A high dose of vo­bar­il­izum­ab pro­vid­ed every two weeks did just man­age to edge out Actem­ra in two out of three stan­dard ef­fi­ca­cy mea­sures, though not by a sig­nif­i­cant amount. But Abl­ynx $ABLX al­so high­light­ed an edge on safe­ty da­ta and dropouts among the pa­tients with mod­er­ate to se­vere rheuma­toid arthri­tis that is re­sis­tant to methotrex­ate. And there’s ev­i­dence of low­er dis­ease ac­tiv­i­ty and an eas­i­er treat­ment reg­i­men to con­sid­er as well, with the most ef­fec­tive high dose pro­vid­ed every two weeks com­pared to Actem­ra’s week­ly sched­ule.

“We’re get­ting re­al­ly stand-out da­ta, which is great, and it is the first step for us in pro­vid­ing a da­ta pack­age to Ab­b­Vie, who will de­cide lat­er in the year whether to take up their op­tion and li­cense the prod­uct,” Abl­ynx CEO Ed­win Moses told Reuters in an in­ter­view. And Moses claims the drug has block­buster po­ten­tial.

But is that go­ing to fly with Ab­b­Vie?

When Ab­b­Vie struck the deal with Abl­ynx in 2013, they were look­ing to see if an IL-6 an­ti­body could pro­vide an al­ter­na­tive to Hu­mi­ra when pa­tients gen­er­at­ed an­ti­bod­ies against their an­ti-TNF drug. But now Ab­b­Vie is fight­ing against a host of biosim­i­lar man­u­fac­tur­ers look­ing to mus­cle in on their big U.S. fran­chise. And in this mar­ket­ing en­vi­ron­ment, any­thing that doesn’t mea­sure up as a big gain for pa­tients can be hard to sell.

There’s al­so a pre­ferred late-stage pro­gram at Ab­b­Vie to con­sid­er. Last fall, Ab­b­Vie axed a col­lab­o­ra­tion it has in place with Gala­pa­gos for their JAK1 in­hibitor fil­go­tinib (GLP0634), say­ing it pre­ferred to take their in-house pro­gram for ABT-494 in­to Phase III for arthri­tis.

“We be­lieve ABT-494 has the po­ten­tial to be­come a best-in-class ther­a­py, par­tic­u­lar­ly in the most chal­leng­ing pa­tient pop­u­la­tion of TNF-in­ad­e­quate re­spon­ders,” Ab­b­Vie CSO Michael Sev­eri­no not­ed af­ter the Phase II da­ta came out in Sep­tem­ber. The Phase III start­ed in Jan­u­ary.

Abl­ynx still has da­ta on a methotrex­ate com­bi­na­tion com­ing up in a mat­ter of weeks.

Ab­b­Vie has shown no re­luc­tance from walk­ing away from any part­nered pro­gram that doesn’t mea­sure up to ex­pec­ta­tions. Ab­b­Vie proved that when it re­cent­ly dropped its col­lab­o­ra­tion with In­fin­i­ty Phar­ma­ceu­ti­cals af­ter their blood can­cer drug du­velis­ib post­ed pos­i­tive but rel­a­tive­ly weak da­ta on in­do­lent non-Hodgkin dis­ease.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Terrie Curran, Phathom CEO (Credit: Arcutis)

Phath­om's old Take­da drug bests Pre­vacid in a PhI­II GI tri­al. Next stop? The FDA

There’s no time for rest in biopharma — at least not at Phathom Pharmaceuticals. Just over a month after submitting two NDAs for its lead acid-fighter vonoprazan, the biotech is already lining up a third, and collecting an extra $50 million to push things along.

Vonoprazan met its primary non-inferiority endpoints in a Phase III study comparing it to standard-of-care Prevacid in a type of gastroesophageal reflux disease (GERD) called erosive esophagitis (EE). It also proved superior to the popular heartburn drug by multiple measures, including healing rate and maintenance of healing.

Thomas Lingelbach, Valneva CEO

Small biotech says its Covid-19 vac­cine spurs more an­ti­bod­ies than As­traZeneca’s. Will sup­ply deals come now?

In a first, a small runner-up vaccine developer says its own Covid-19 jab has induced “superior neutralizing antibody titer levels” over AstraZeneca’s AZD1222 when pitted head-to-head in a Phase III trial.

That and non-inferiority in seroconversion rate were the co-primary endpoints of the trial, which recruited 4,012 adult volunteers across the UK.

But on the exploratory endpoint of Covid-19 case counts, Valneva notes that both treatment groups saw a similar number of infections.