Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Span­ish biotech is beef­ing up its plas­ma ther­a­py op­er­a­tions, and on Fri­day, it an­nounced that it’s do­ing so in a bil­lion-dol­lar deal.

Gri­fols is now the largest share­hold­er of Biotest, a com­pa­ny val­ued at more than $1.8 bil­lion. By team­ing up, the two will try to in­crease the num­ber of plas­ma ther­a­pies avail­able and in­crease pa­tient ac­cess around the world, Gri­fols said in a press re­lease.

The com­pa­ny did so by ac­quir­ing hold­ing com­pa­ny Tiancheng Phar­ma­ceu­ti­cal, the Ger­many-based own­er of near­ly 90% of Biotest shares, for near­ly $1.27 bil­lion. Gri­fols now owns near­ly 90% of Biotest vot­ing rights and al­most 45% of the to­tal share cap­i­tal of Biotest.

The move is ex­pect­ed to dri­ve rev­enue growth by more than $8.2 mil­lion by 2024. It will al­low the ex­ist­ing plas­ma-de­rived ther­a­pies in the port­fo­lio to grow, and fast-track the de­vel­op­ment of new ther­a­pies, co-CEO Rai­mon Gri­fols Roura said in a press re­lease.

It al­so spreads the com­pa­ny out ge­o­graph­i­cal­ly across the globe, as Biotest is based out of Ger­many, and the com­pa­ny is look­ing to branch its rev­enue stream out across Eu­rope, the Mid­dle East and Africa.

“This op­er­a­tion of­fers a sin­gu­lar op­por­tu­ni­ty to pro­mote our Eu­ro­pean in­no­va­tion hub and col­lab­o­rate with an out­stand­ing Ger­man firm renowned for its ex­per­tise in clin­i­cal de­vel­op­ment,” co-CEO Vic­tor Gri­fols Deu said in a press re­lease. “By join­ing forces, we aim to ad­vance in­no­v­a­tive sci­en­tif­ic and plas­ma-de­rived de­vel­op­ments that ul­ti­mate­ly of­fer pa­tients an en­hanced qual­i­ty of life.”

The deal will close by the end of Gri­fols’ first se­mes­ter in 2022. Right now, Biotest is in clin­i­cal tri­als on a plas­ma-de­rived fib­rino­gen dubbed BT-524 that will treat con­gen­i­tal and ac­quired dis­or­ders, in­clud­ing an ad­just­ed fib­rino­gen re­place­ment strat­e­gy study in pa­tients who have high blood loss dur­ing spine surgery, and ab­dom­i­nal surgery for pseudomyx­o­ma peri­tonei. The com­pa­ny is al­so in clin­i­cal tri­als for the treat­ment of pa­tients with com­mu­ni­ty-ac­quired pneu­mo­nia.

Biotest can man­u­fac­ture up to 1.5 mil­lion liters of plas­ma a year, and it has plans to dou­ble that amount in its 26 Eu­ro­pean sites in Ger­many, the Czech Re­pub­lic and Hun­gary.

The move is a part of sev­er­al made to ex­pand Gri­fols’ foot­print across the globe. In Au­gust, the com­pa­ny an­nounced its sec­ond ex­pan­sion in­to Africa in just a year, as it con­structs an in­tra­venous so­lu­tions plant in Nige­ria. In ear­ly March, the com­pa­ny al­so put up $80 mil­lion to buy out the ma­jor­i­ty stake in Gi­ga­Gen that it didn’t al­ready own.

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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