Am­gen may see $3B+ in ad­di­tion­al tax­es; EQRx, Ab­Cellera ink an­ti­body de­vel­op­ment deal

Along­side the re­lease of its Q2 re­sults late Tues­day, Am­gen al­so sig­naled that it’s de­fend­ing what could be a size­able chunk of cash that it owes the IRS.

Last month, the com­pa­ny said it filed a pe­ti­tion in the US Tax Court to con­test no­tices of de­fi­cien­cies re­ceived from the IRS over three years in the ear­ly 2010s.

“These no­tices seek to in­crease our U.S. tax­able in­come by an amount that would re­sult in ad­di­tion­al fed­er­al tax of ap­prox­i­mate­ly $3.6 bil­lion, plus in­ter­est. Any ad­di­tion­al tax that could be im­posed would be re­duced by up to ap­prox­i­mate­ly $900 mil­lion of repa­tri­a­tion tax pre­vi­ous­ly ac­crued on our for­eign earn­ings,” the com­pa­ny said, adding, “We firm­ly be­lieve that the IRS’s po­si­tions in the no­tices are with­out mer­it and we will vig­or­ous­ly con­test the no­tices through the ju­di­cial process.”

SVB Leerink an­a­lyst Ge­of­frey Porges did not men­tion that po­ten­tial tax bill in a note on the earn­ings Wednes­day, but called it a “lack­lus­ter quar­ter” for the Cal­i­for­nia-based com­pa­ny. He al­so ex­plained how Am­gen is in re­build­ing mode, as it’s re­stock­ing its ear­ly-stage pipeline with a string of ac­qui­si­tions. “The com­pa­ny could be well po­si­tioned by 2023 or 2024 when the fruits of those ac­qui­si­tions and col­lab­o­ra­tions, and of their long stand­ing in­vest­ment in bis­pecifics and nov­el im­muno­log­i­cal med­i­cines, ap­proach­es fruition,” he wrote.

Shares of Be­yond­Spring sky­rock­et on new, pos­i­tive can­cer drug tri­al re­sults

About five years since it filed for an IPO, phar­ma com­pa­ny Be­yond­Spring is hit­ting the big time. The New York-based com­pa­ny saw shares of its stock spike by more than 320% at one point on Wednes­day morn­ing as it re­port­ed pos­i­tive Phase III re­sults for its first-in-class se­lec­tive im­munomod­u­lat­ing mi­cro­tubule-bind­ing agent plinab­u­lin in com­bi­na­tion with do­c­etax­el to treat 2nd and 3rd line NSCLC (EGFR wild type) com­pared to do­c­etax­el alone.

The com­pa­ny said that in a tri­al of 559 pa­tients, the drug com­bi­na­tion met the pri­ma­ry end­point of in­creas­ing over­all sur­vival (p = 0.03) and met key sec­ondary end­points, in­clud­ing sig­nif­i­cant­ly im­prov­ing ORR, PFS and 24- and 36-month OS rates, and sig­nif­i­cant re­duc­tion in the in­ci­dence of Grade 4 neu­trope­nia.

Josh Schim­mer at Ever­core ISI not­ed that the pos­i­tive da­ta was very un­ex­pect­ed and moved his peak sales pro­jec­tion on the drug up to $2 bil­lion.

Trevor Fe­in­stein of the Pied­mont Can­cer In­sti­tute and a prin­ci­pal in­ves­ti­ga­tor of the tri­al said in a state­ment: “The treat­ment of 2nd and 3rd line NSCLC, es­pe­cial­ly with EGFR wild type where ty­ro­sine ki­nase in­hibitors do not work, is an area of se­vere un­met med­ical needs. Now that check­point in­hibitor im­munother­a­py has moved in­to first line, there is a vac­u­um in this in­di­ca­tion, where treat­ment is heav­i­ly cen­tered around do­c­etax­el.”

EQRx and Ab­Cellera ink an­ti­body de­vel­op­ment deal

Drug pric­ing dis­rup­tor EQRx, which has made clear its mis­sion to ag­gres­sive­ly dis­count mar­kets dom­i­nat­ed by ex­pen­sive drugs, on Wednes­day an­nounced an­oth­er AI-pow­ered part­ner­ship, this time with ther­a­peu­tic an­ti­body de­vel­op­er Ab­Cellera.

As part of an ef­fort to ex­pand EQRx’s ear­ly-stage pipeline, the new part­ner­ship will seek to iden­ti­fy nov­el an­ti­body drug can­di­dates, be­gin­ning in the fields of on­col­o­gy and im­munol­o­gy. Fi­nan­cial de­tails of the part­ner­ship were not dis­closed.

The deal in­cludes the op­tion for ad­di­tion­al in­vest­ment from Ab­Cellera at pro­gres­sive stages of pre­clin­i­cal de­vel­op­ment, clin­i­cal de­vel­op­ment, and com­mer­cial­iza­tion in ex­change for an in­creased share of prod­uct sales.

Pre­vi­ous­ly in June, EQRx launched a part­ner­ship with UK-based AI spe­cial­ist Ex­sci­en­tia in search of oth­er dis­cov­ery op­por­tu­ni­ties. Mean­while, EQRx’s first tar­get is PD-1, which de­spite sev­en drugs on the mar­ket hasn’t seen pric­ing dis­counts. In May, EQRx and part­ner CStone read out late-stage da­ta show­ing their PD-1 drug sug­e­mal­imab hit its pri­ma­ry end­point of pro­gres­sion-free sur­vival as a con­sol­i­da­tion ther­a­py for pa­tients with stage III non-small cell lung can­cer whose dis­ease hasn’t pro­gressed af­ter con­cur­rent or se­quen­tial chemora­dio­ther­a­py.

Ky­owa Kirin and Synaf­fix sign ADC agree­ment

While fi­nan­cial de­tails were not dis­closed, Synaf­fix will ini­tial­ly pro­vide tar­get-spe­cif­ic rights to its pro­pri­etary ADC tech­nolo­gies in ex­change for a li­cense sig­na­ture fee, en­abling Ky­owa Kirin to eval­u­ate two of its an­ti­bod­ies as po­ten­tial ther­a­peu­tic can­di­dates. The deal builds off an ear­li­er re­search agree­ment be­tween the two com­pa­nies.

Ky­owa Kirin said it may ex­pand the deal with ad­di­tion­al ADC tar­gets, and if it does, Synaf­fix is el­i­gi­ble to re­ceive a li­cense is­suance fee for each ad­di­tion­al tar­get and mile­stone pay­ments plus roy­al­ties on po­ten­tial fu­ture com­mer­cial sales of AD­Cs de­vel­oped against each li­censed tar­get.

The deal is more recog­ni­tion for Synaf­fix, which has es­tab­lished a grow­ing sta­ble of de­vel­op­ment part­ners, in­clud­ing In­novent and Pro­found­Bio.

Pe­ter van de Sande, CEO of Synaf­fix, said in a state­ment, “This col­lab­o­ra­tion is our sixth an­nounced out-li­cens­ing deal, ex­pand­ing the ge­o­graph­ic foot­print of and val­i­da­tion of our ADC tech­nolo­gies. At the same time, this brings the num­ber of AD­Cs in de­vel­op­ment based on Synaf­fix’ tech­nolo­gies be­yond 10, with three of those part­nered pro­grams al­ready in clin­i­cal tri­als.”

Sarep­ta adds new gene ther­a­py to treat ge­net­ic neu­ro­mus­cu­lar dis­ease

Build­ing on its work re­lat­ed to Duchenne mus­cu­lar dy­s­tro­phy, Sarep­ta Ther­a­peu­tics on Wednes­day ex­e­cut­ed an ex­clu­sive li­cense agree­ment for an in­ves­ti­ga­tion­al gene ther­a­py, known as cal­pain 3, to treat a ge­net­ic neu­ro­mus­cu­lar dis­ease known as Limb-gir­dle mus­cu­lar dy­s­tro­phy type 2A.

The gene ther­a­py was ini­tial­ly de­vel­oped by the Abi­gail Wexn­er Re­search In­sti­tute at Na­tion­wide Chil­dren’s Hos­pi­tal, and the part­ner­ship be­tween Sarep­ta and Chil­dren’s dates back to 2019.

LGMD2A is caused by mu­ta­tions in the CAPN-3 gene and is the most com­mon type of LGMD, ac­count­ing for al­most a third of cas­es. Sarep­ta did not dis­close any plans for how it will take cal­pain 3 in­to the clin­ic.

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.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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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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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

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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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.