Charles Riv­er bags an­ti­body dis­cov­ery-fo­cused Dis­tri­b­u­tion Bio for $104M, sig­nal­ing re­turn to pre-pan­dem­ic buy­out spree

Charles Riv­er Labs, one of the biggest CROs that spe­cial­izes in pre­clin­i­cal re­search pro­grams, has inked a new dis­cov­ery pact as part of a string of deals over the last few years. And af­ter the Covid-19 pan­dem­ic proved less of a fi­nan­cial bur­den than ex­pect­ed, the com­pa­ny could be ready to make even more moves.

Charles Riv­er $CRL pur­chased an­ti­body dis­cov­ery com­pa­ny Dis­trib­uted Bio for up to $104 mil­lion, the com­pa­nies an­nounced Mon­day, a fig­ure that in­cludes $83 mil­lion in up­front cash. The oth­er $21 mil­lion in the deal is re­served for fu­ture “per­for­mance” pay­ments.

With the ac­qui­si­tion, Charles Riv­er hopes to “meet our goal of elim­i­nat­ing an ad­di­tion­al year from our clients’ ear­ly-stage de­vel­op­ment time­lines,” Charles Riv­er CEO James Fos­ter said in a state­ment. Shares ticked up­ward rough­ly 1% in ear­ly Mon­day trad­ing.

The goal of the deal is to give more clients ac­cess to Dis­tri­b­u­tion Bio’s pro­pri­etary plat­form, which is called Su­per­Hu­man. By com­bin­ing an­ti­body li­braries and data­bas­es with a ma­chine learn­ing de­sign, the plat­form can cut the dis­cov­ery process by sev­er­al months, the com­pa­nies said.

Mon­day’s deal al­so marks the for­mal­iza­tion of an ex­clu­sive part­ner­ship the two com­pa­nies struck in Oc­to­ber 2018. Back then, the com­pa­nies had aimed to cre­ate a new plat­form for an­ti­body dis­cov­ery, mar­ry­ing Charles Riv­er’s re­sources with Su­per­Hu­man.

Charles Riv­er has been on an ac­qui­si­tion spree in re­cent years, drop­ping $800 mil­lion for ri­val CRO MPI Re­search in Feb­ru­ary 2018, one of its biggest com­peti­tors in the pre­clin­i­cal sphere. The fol­low­ing Feb­ru­ary, the com­pa­ny paid north of half a bil­lion dol­lars to buy out Citoxlab and its slate of non-clin­i­cal ex­perts, beef­ing up tox­i­col­o­gy, dis­cov­ery, ge­nomics and med­ical de­vice test­ing ser­vices while ex­pand­ing its foot­print in Eu­rope.

The CRO had al­so been part­ner­ing with Ei­sai for years in pre­clin­i­cal work, ex­tend­ing a two-year col­lab­o­ra­tion in 2017 for an­oth­er year to work on pre­clin­i­cal med­i­cines for malar­ia.

But the Covid-19 pan­dem­ic halt­ed much of Charles Riv­er’s mo­men­tum, as well as the mo­men­tum of the en­tire CRO in­dus­try, when it forced more than 1,000 clin­i­cal tri­als to hit the pause but­ton in the ear­ly stages of the out­break. Back in May, the CRO re­port­ed that it need­ed to adopt a va­ri­ety of cost-cut­ting mea­sures due to the pan­dem­ic, and ex­pect­ed to chop away $55 mil­lion to $90 mil­lion in 2020 costs.

In sec­ond quar­ter and third quar­ter earn­ings re­ports, how­ev­er, Fos­ter not­ed that the Covid-19 head­winds end­ed up be­ing more mod­er­ate than they’d orig­i­nal­ly an­tic­i­pat­ed. For 2020’s third quar­ter, the com­pa­ny’s rev­enue was up 11.3% over the same time pe­ri­od in 2019.

Charles Riv­er op­er­ates more than 90 fa­cil­i­ties in at least 20 coun­tries and notes it sup­port­ed de­vel­op­ment for about 85% of FDA ap­proved drugs in 2019.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Troy Wilson, Kura CEO

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.

A Sen­ate bill wants to even an 'un­lev­el play­ing field' for do­mes­tic, for­eign in­spec­tion drop-ins amid back­log

Amid geopolitical tensions between the US and China, two Republican senators are calling for a bill that would aim to strike a balance on domestic and foreign inspection requirements from the FDA.

Sens. Mike Braun (R-IN) and Joni Ernst (R-IA) have penned a bill called the Creating Efficiency in Foreign Inspections Act. It contains a bit of rhetoric, highlighting “communist China” not once, but twice in the release, but states that the goal is to even the playing field between foreign and American manufacturers.

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