Ab­b­Vie wins a 5-year free pass on mega-block­buster Hu­mi­ra in biosim set­tle­ment with ri­val Am­gen

It was clear from a re­cent sit-down with Leerink’s Ge­of­frey Porges that Ab­b­Vie was feel­ing good about keep­ing its mega-block­buster Hu­mi­ra fran­chise in the US to it­self through 2022. And this morn­ing we got a peek in­to why they were so bull­ish.

Richard Gon­za­lez

Am­gen, which scored the first ap­proval for a biosim­i­lar of Hu­mi­ra in the US, has signed off on a set­tle­ment agree­ment with Ab­b­Vie that will de­lay its roll­out un­til ear­ly 2023. Am­gen can get start­ed in the EU in the fall of next year, with a mar­ket­ing pact that calls on the com­pa­ny to pay roy­al­ties to Ab­b­Vie.

Ab­b­Vie’s shares $AB­BV shot up 6% this morn­ing.

The de­tails on this deal are be­ing kept un­der wraps, but the set­tle­ment re­moves one of the most liti­gious com­pa­nies in the in­dus­try from Ab­b­Vie’s pact. As Ever­cor­eISI’s Umer Raf­fat said in a quick note this morn­ing, the court dates over the patent fight could well have left any fi­nal ap­peals de­ci­sion un­til 2021.

Ab­b­Vie CEO Rick Gon­za­lez is ea­ger to make Hu­mi­ra in­to a $20 bil­lion a year drug be­fore hav­ing to com­pete against biosim­i­lars, and there are at least 10 oth­ers in the late-stage pipeline now with vir­tu­al­ly every­one in the gener­ic bi­o­log­ics busi­ness tack­ling the king of the mar­ket.

The FDA has be­come quite wel­com­ing to new biosim­i­lar ap­pli­ca­tions over the past year. But get­ting an ap­proval and carv­ing up mar­ket share at two com­plete­ly dif­fer­ent things, as Pfiz­er found out when it went af­ter J&J’s Rem­i­cade. Pfiz­er’s knock­off bare­ly made a dent in the mar­ket, and the phar­ma gi­ant re­cent­ly ac­cused J&J of us­ing im­prop­er meth­ods in bar­ring com­pe­ti­tion — a po­si­tion that J&J says was dri­ven by an em­bar­rass­ing in­abil­i­ty to mar­ket the ther­a­py prop­er­ly.

Ab­b­Vie, which has now de­layed the lead threat to its biggest cash cow for an­oth­er five years, was care­ful not to gloat this morn­ing.

Lau­ra Schu­mach­er, ex­ec­u­tive vice pres­i­dent, ex­ter­nal af­fairs, gen­er­al coun­sel and cor­po­rate sec­re­tary, Ab­b­Vie, had this to say:

In reach­ing this agree­ment, we have achieved the bal­ance be­tween pro­tect­ing in­vest­ment in in­no­va­tion and pro­vid­ing ac­cess to biosim­i­lars, which will play an im­por­tant role in our health care sys­tem. We will con­tin­ue to de­fend our in­tel­lec­tu­al prop­er­ty and to rein­vest in fur­ther ad­vance­ments in med­i­cine to bring choic­es to pa­tients in need.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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