Am­gen tees up a swift ap­proval for a fran­chise de­stroy­er aimed at Ab­b­Vie’s $14B drug Hu­mi­ra

The FDA wast­ed lit­tle time in com­ing to the point in their re­view of Am­gen’s ap­pli­ca­tion for ABP501, their new biosim­i­lar of Ab­b­Vie’s megablock­buster in­flam­ma­to­ry drug Hu­mi­ra: They got it right.

“In con­sid­er­ing the to­tal­i­ty of the ev­i­dence, the da­ta sub­mit­ted by Am­gen sup­port a demon­stra­tion that ABP 501 is high­ly sim­i­lar to US-li­censed Hu­mi­ra, notwith­stand­ing mi­nor dif­fer­ences in clin­i­cal­ly in­ac­tive com­po­nents, and sup­port a demon­stra­tion that there are no clin­i­cal­ly mean­ing­ful dif­fer­ences be­tween ABP 501 and US-li­censed Hu­mi­ra in terms of the safe­ty, pu­ri­ty, and po­ten­cy of the prod­uct to sup­port the demon­stra­tion that ABP 501 is biosim­i­lar to the US-li­censed Hu­mi­ra in the stud­ied in­di­ca­tions of RA and PsO,” the agency notes in their ex­ec­u­tive re­view.

And Am­gen should have a clean shot at all the in­di­ca­tions Hu­mi­ra – the dom­i­nant arthri­tis treat­ment on the mar­ket – is ap­proved for.

“The Ap­pli­cant has al­so pro­vid­ed an ex­ten­sive da­ta pack­age to ad­dress the sci­en­tif­ic con­sid­er­a­tions for ex­trap­o­la­tion of da­ta to sup­port biosim­i­lar­i­ty to oth­er con­di­tions of use and po­ten­tial li­cen­sure of ABP 501 for each of the in­di­ca­tions for which US-li­censed Hu­mi­ra is cur­rent­ly li­censed and for which Am­gen is seek­ing li­cen­sure.”

The re­view comes just ahead of a pan­el re­view for ABP 501 next week, the lat­est in a wave of ap­pli­ca­tions aimed at some of the biggest block­busters on the mar­ket.

No­var­tis CEO Joe Jimenez

Ab­b­Vie and Am­gen have been squared off in a fight over the huge Hu­mi­ra fran­chise, but it seems clear that copy­cat ver­sions of Hu­mi­ra are loom­ing that will slice and dice the mar­ket for the $14 bil­lion drug, which ac­counts for more than half of Ab­b­Vie’s rev­enue. Now that the FDA has es­tab­lished a clear path­way for ap­provals, a num­ber of big com­pa­nies have tar­get­ed Hu­mi­ra and oth­er ag­ing bi­o­log­ics.

Sur­veys of physi­cians are find­ing a ready will­ing­ness to adopt cheap­er copies of the orig­i­nal. And some com­pa­ny ex­ecs, like No­var­tis CEO Joe Jimenez, are pre­dict­ing that a round of ap­provals in each cat­e­go­ry could trig­ger dis­counts of up to 75%. That’s much deep­er than the ini­tial 25% to 30% dis­count fore­cast. And it bodes ill for Ab­b­Vie, which still re­lies pre­dom­i­nant­ly on Hu­mi­ra – though it has been wheel­ing and deal­ing on new drugs that can take its place.

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

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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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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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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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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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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