Charles Riv­er Lab­o­ra­to­ries has been on an ac­qui­si­tion spree. But Tues­day, it of­floaded two as­sets

Fol­low­ing a sum­mer filled with merg­ers and ac­qui­si­tions, Charles Riv­er Lab­o­ra­to­ries has di­vest­ed its re­search op­er­a­tions in Japan and a CD­MO site in Swe­den, en­gi­neer­ing two sep­a­rate deals ex­pect­ed to cut down $20 mil­lion in rev­enue.

Tues­day, Charles Riv­er sold its gene ther­a­py CD­MO site to a pri­vate in­vestor group for about $52 mil­lion in cash, with the po­ten­tial for con­tin­gent pay­ments up to $25 mil­lion. The site was in the com­pa­ny’s pos­ses­sion for on­ly a few months, as it was ac­quired from Cog­nate BioSer­vices on March 29.

The site pri­mar­i­ly pro­duces plas­mid DNA for gene ther­a­pies. It has about 130 em­ploy­ees and gen­er­at­ed $10 mil­lion in rev­enue in 2020, and the sale re­duces earn­ings per share by about 10 cents in Q4 of this year. Charles Riv­er says it still will pro­duce pDNA in oth­er sites in the UK and US.

The two deals — done sep­a­rate­ly — gen­er­at­ed $98 mil­lion for Charles Riv­er. The sale of the RMS Japan op­er­a­tions to the Jack­son Lab­o­ra­to­ry will pro­vide the buy­er with 260 em­ploy­ees and a busi­ness that gen­er­at­ed $46 mil­lion in rev­enue in 2020. Charles Riv­er and the Jack­son Lab­o­ra­to­ry have had a dis­tri­b­u­tion agree­ment for more than 20 years, and Charles Riv­er will still have the Japan lo­ca­tion make and dis­trib­ute the com­pa­ny’s re­search mod­els in Japan. The site was sold for $63 mil­lion.

James Fos­ter

In mid-May, Charles Riv­er paid $292.5 mil­lion for Vi­gene Bio­sciences and its 52,000 square feet of man­u­fac­tur­ing space in Rockville, MD. In Feb­ru­ary, the com­pa­ny bought Cog­nate and pledged to dou­ble ca­pac­i­ty in Mem­phis and Eu­rope. It teamed up with Va­lence Dis­cov­ery in April, and ex­pand­ed its man­u­fac­tur­ing op­er­a­tions in Ire­land by ex­tend­ing its test­ing ca­pa­bil­i­ties in a deal worth near­ly $10 mil­lion that will add an­oth­er 90 roles to the team in the next three years. The deal will al­so help pro­vide test­ing and de­ploy­ment of As­traZeneca’s Covid-19 jab Vaxzevria and flu vac­cine Fluenz.

About 6% of Charles Riv­er’s Q2 growth was thanks to ac­qui­si­tions, ac­cord­ing to an earn­ings re­port. Year-over-year rev­enue was up 34% this year af­ter Q2, from $682.6 mil­lion in 2020 to $914.6 mil­lion. CEO James Fos­ter said in a press re­lease that the strength of the non-clin­i­cal con­tract re­search and man­u­fac­tur­ing port­fo­lios helped po­si­tion the com­pa­ny to re­spond well to the de­mands that came along with Covid-19.

In a May in­ter­view with End­points News, Bir­git Gir­shick — a 32-year Charles Riv­er vet­er­an and EVP of dis­cov­ery and safe­ty as­sess­ment — said that or­gan­ic in­vest­ment through M&As has helped the com­pa­ny nav­i­gate an area un­der con­stant change.

“Our guid­ing prin­ci­ple for ac­qui­si­tions is to ac­quire com­pa­nies with the best sci­ence and the best peo­ple,” she said. “This is how we en­hance the breadth and qual­i­ty of our ser­vices as we grow.”

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.

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%.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,400+ biopharma pros reading Endpoints daily — and it's free.

Kenneth Galbraith, incoming Zymeworks CEO

Zymeworks re­places half its C-suite, aims to lay off 25% of to­tal work­force as new CEO takes over

New Zymeworks CEO Kenneth Galbraith is aiming to hit the ground running when his tenure officially begins next month, but he’ll be doing so with a much different looking team.

In a lengthy press release outlining the biotech’s 2022 goals, Galbraith said Zymeworks will be laying off at least 25% of its staff over the course of the year. Half of its C-suite will also be replaced immediately as Galbraith looks to remake the company in his image after Ali Tehrani, Zymeworks’ founder and CEO since 2003, stepped down two weeks ago.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,400+ biopharma pros reading Endpoints daily — and it's free.

Flori­da man con­vict­ed of fal­si­fy­ing clin­i­cal tri­al re­sults sen­tenced to over 2 years in prison

A Florida man who falsified medical records in connection to clinical trials was sentenced to 30 months in prison in federal court Thursday.

Daniel Tejeda, 35, of Clewiston, was also ordered to pay $2.1 million in restitution. Tejeda was a project manager and study manager for the CRO Tellus Clinical Research, and made it appear that subjects were participating in trials when they weren’t. Two other research workers from Florida were sentenced in the same case in August for 46 and 30 months, respectively.

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?”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,400+ biopharma pros reading Endpoints daily — and it's free.

Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,400+ biopharma pros reading Endpoints daily — and it's free.