UK an­titrust watch­dog clears Roche/Spark deal — but what is the FTC think­ing?

Roche has gained the bless­ing from the UK an­titrust watch­dog to pro­ceed with its $4.3 bil­lion ac­qui­si­tion of Spark, just in time for the lat­est dead­line the phar­ma gi­ant has set for Spark’s in­vestors to ten­der their shares fol­low­ing 10 de­lays.

The Com­pe­ti­tion and Mar­kets Au­thor­i­ty con­firmed spec­u­la­tion and ru­mors — pret­ty much as­sumed true at this point — that they had been look­ing in­to the com­pet­i­tive land­scape for he­mo­phil­ia A treat­ments. Af­ter con­clud­ing that there will still be an ad­e­quate choice of al­ter­na­tives even af­ter the mak­ers of Hem­li­bra and a po­ten­tial gene ther­a­py are blend­ed in­to one, reg­u­la­tors gave the deal an un­con­di­tion­al clear­ance.

The CMA added that it’s co­op­er­at­ed close­ly with the US Fed­er­al Trade Com­mis­sion, which is still in­ves­ti­gat­ing the buy­out.

By wrap­ping their in­ves­ti­ga­tion at Phase I, the British au­thor­i­ty saved Roche some un­cer­tain­ty and lengthy de­lays that would have en­sued if they had ini­ti­at­ed a Phase II, an ex­tend­ed and scru­ti­niz­ing re­view that can last up to 24 weeks.

From their re­lease:

While gene ther­a­py treat­ments are like­ly to com­pete with Roche’s Hem­li­bra in fu­ture, the CMA found that Spark is not the on­ly sup­pli­er de­vel­op­ing a gene ther­a­py treat­ment and that its prod­ucts are not cur­rent­ly con­sid­ered to hold any par­tic­u­lar clin­i­cal or com­mer­cial ad­van­tages over those be­ing de­vel­oped by oth­er sup­pli­ers.

The CMA’s in­ves­ti­ga­tion al­so found that there are sev­er­al in­no­v­a­tive non-gene ther­a­py prod­ucts un­der de­vel­op­ment that are like­ly to be­come vi­able al­ter­na­tives to Roche and Spark’s treat­ments.

With the of­fer­ing pe­ri­od set to ex­pire by the end of the day, Roche has yet to an­nounce ei­ther an­oth­er de­lay or how it plans to close the deal in such a short time frame. In fact, the Swiss drug­mak­er raised some eye­brows last Mon­day when it ex­tend­ed the dead­line by a mere six days, com­pared to the usu­al one month.

It ap­pears that the FTC re­view re­mains the fi­nal hur­dle ahead of a close. In Oc­to­ber the Capi­tol Fo­rum re­port­ed that the agency’s staff had rec­om­mend­ed the deal from ap­proval, but a spokesper­son lat­er fol­lowed up to End­points News with a clar­i­fi­ca­tion: “The FTC has not filed a com­plaint in this mat­ter, and the agency doesn’t sign off on deals. It ei­ther files a com­plaint or it doesn’t.”

Ear­li­er this year, the FTC re­quest­ed a rare “sec­ond re­quest” — some­thing slapped on on­ly 5% of ac­qui­si­tions. A vote from the chair­man and four com­mis­sion­ers on its Bu­reau of Com­pe­ti­tion would mark the fi­nal step for ap­proval.

Gbo­la Amusa

As the saga un­fold­ed, ob­servers have voiced con­cerns that the holdup would have a chill­ing ef­fect on gene ther­a­py M&A and scare would-be ac­quir­ers away. But Chardan an­a­lyst Gbo­la Amusa, who cov­ers oth­er gene ther­a­py play­ers such as Bio­Marin and uniQure, won­ders if it has more to do with buy­er’s re­morse on Roche’s end.

“It was one that nev­er made sense to us at that val­u­a­tion giv­en our view, and I don’t know why it hasn’t gone through,” he said, “but I don’t think there’s any read-across for the rest of the space.”

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.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Hedge fund jumps in with Avoro ac­tivists in an at­tempt to de­rail Mer­ck­'s $11B Ac­celeron buy­out

Avoro Capital, which made its bones blowing up the Seagen-Immunomedics deal and then selling the smaller biotech for $21 billion, is getting an assist in its quest to derail Merck’s $11 billion buyout of Acceleron $XLRN.

Wednesday morning one of Acceleron’s biggest investors joined the opposition. Darwin Global Management, a hedge fund which owns about 4% of Acceleron, blasted the Merck deal, saying the Big Pharma is getting the company for billions less than what it’s worth. Earlier, Holocene Advisers, reportedly a top-20 investor in Acceleron, said it would not tender its stock after criticizing the $180-per-share deal.

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