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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The company calls it “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” the Boston Globe reported, quoting a spokesperson.

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Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

John Quisel, Disc Medicine CEO

Disc Med­i­cine goes pub­lic in re­verse merg­er with strug­gling Gem­i­ni Ther­a­peu­tics

After licensing a failed Roche schizophrenia drug last year, Disc Medicine is going public via a reverse merger with Gemini Therapeutics.

The combined company, while still named Disc Medicine, will trade under the stock symbol $IRON, in reference to Disc’s lineup of therapies for blood iron disorders. Alongside the merger, Disc has secured $53.5 million in another financing round, building on the $90 million Series B it raised in September.

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Craig Thompson, Cerevance CEO

UP­DAT­ED: Mer­ck makes first big splash for Alzheimer’s drug R&D since 2017 fail, ink­ing re­search pact with Cere­vance

For the first time since discontinuing its late-stage Alzheimer’s program, Merck has found promise on the path forward in the memory-robbing disease.

After a Phase III flop of its drug verubecestat, the New Jersey Big Pharma axed the study in early 2018. More than four years later, the company is ready to sign up for another pact to test the waters of the befuddling disease.

This time, there’s $1.1 billion in biobucks on the line and a target that its partner says no other biopharma is looking at en route to finding the next treatment for Alzheimer’s, a neuroscience field that has hit hurdle after hurdle for decades.

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