Charles Riv­er keeps adding on to its CD­MO arm, snatch­ing up a vi­ral vec­tor play­er for a tidy $350M

Con­tract re­searcher Charles Riv­er Lab­o­ra­to­ries has been on a roll re­cent­ly to flesh out its man­u­fac­tur­ing arm with a spe­cif­ic fo­cus on its ca­pa­bil­i­ties in gene ther­a­py. Now, the firm is putting its name to a big check for a Mary­land-based vi­ral vec­tor firm it thinks will add to its grow­ing ex­per­tise in the field.

Charles Riv­er will dole out $292.5 mil­lion for gene ther­a­py CD­MO Vi­gene Bio­sciences with the pos­si­bil­i­ty for an ad­di­tion­al $57.5 mil­lion in per­for­mance-based pay­ments, the com­pa­nies said Mon­day. The deal will close at the start of Q3, a Charles Riv­er spokesman said.

For Vi­gene, the sale comes right on the heels of a Feb­ru­ary an­nounce­ment that the com­pa­ny would add 52,000 feet of man­u­fac­tur­ing space at its Rockville head­quar­ters fol­low­ing a $1.225 mil­lion loan that Vi­gene se­cured from Mary­land’s com­merce de­part­ment. The ex­pan­sion was set to add 245 new jobs by 2025.

The CD­MO is ex­pect­ed to gen­er­ate be­tween $30 mil­lion and $35 mil­lion in 2021, and Charles Riv­er an­tic­i­pates year-over-year growth of 25% by 2026.

Vi­ral vec­tors are key com­po­nents used in many gene ther­a­pies and re­in­force Charles Riv­er’s grow­ing pres­ence in the field af­ter a spate of re­cent ac­qui­si­tions. In Feb­ru­ary, the com­pa­ny snatched Cog­nate and its 500 em­ploy­ees along with tech for cel­lu­lar im­munother­a­py, im­muno-on­col­o­gy, re­gen­er­a­tive med­i­cine and ad­vanced cell ther­a­py ther­a­peu­tics. Cog­nate had al­so re­cent­ly an­nounced an ex­pan­sion at the time of the buy, pledg­ing to dou­ble man­u­fac­tur­ing ca­pac­i­ty at its Mem­phis head­quar­ters and Eu­ro­pean sites.

James Fos­ter

With the ad­di­tion of Vi­gene, the Charles Riv­er cell and gene ther­a­py port­fo­lio will ex­pand each ma­jor CD­MO plat­form: cell ther­a­py, vi­ral vec­tor and plas­mid DNA pro­duc­tion, CEO James Fos­ter said in the press re­lease.

“In these emerg­ing, high-growth, val­ue-added seg­ments, we in­tend to con­tin­ue to dif­fer­en­ti­ate our­selves by bring­ing our high-sci­ence, cus­tomiz­able ap­proach to sup­port the com­plex needs of cell and gene ther­a­py de­vel­op­ers and in­no­va­tors world­wide,” he said. “Our goal is to be­come our clients’ sci­en­tif­ic part­ner of choice for ad­vanced drug modal­i­ties from dis­cov­ery and non-clin­i­cal de­vel­op­ment to CGMP man­u­fac­tur­ing.”

Vi­gene has a par­tic­u­lar ex­per­tise in AAV pro­duc­tion, as well as lentivirus. That range will com­ple­ment Charles Riv­er’s cur­rent end-to-end, gene-mod­i­fied cell ther­a­py so­lu­tion, the com­pa­ny said.

Mean­while, Charles Riv­er has kept adding on in oth­er ar­eas of its busi­ness amid a busy 2020. In April, the com­pa­ny teamed up with Va­lence Dis­cov­ery to ex­pand its AI plat­form for mol­e­c­u­lar prop­er­ty pre­dic­tion, gen­er­a­tive chem­istry and mul­ti­pa­ra­me­ter op­ti­miza­tion. Va­lence’s plat­form al­lows small mol­e­cule drugs in new re­gions of chem­i­cal space, al­low­ing for rapid op­ti­miza­tion against po­ten­cy, se­lec­tiv­i­ty, safe­ty and phar­ma­col­o­gy, the com­pa­ny says.

In Jan­u­ary, the com­pa­ny bought an­ti­body dis­cov­ery com­pa­ny Dis­trib­uted Bio for up to $104 mil­lion, with the goal of cut­ting down a year from clients’ ear­ly-stage de­vel­op­ment time­lines, the com­pa­ny said.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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James Sabry

'We're in': Roche and Genen­tech join forces on a multi­bil­lion-dol­lar dis­cov­ery pact with a brash AI up­start

Over the past couple of years, the top execs at Roche and Genentech have inked a flurry of deals aligning the global pair with several of the new players that have emerged in the booming AI and machine learning world. That strategy was supercharged in the spring of 2020 by their decision to recruit Aviv Regev out of the computational world she occupied at the Broad. And today they’re taking that computational approach in R&D to a whole new level.

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Brett Monia, Ionis CEO

As­traZeneca grabs PhI­II AT­TR drug from Io­n­is — in­fus­ing $200M cash in­to strug­gling part­ner

AstraZeneca is plucking another antisense drug out of Ionis’ prolific pipeline.

Paying $200 million in cash, AstraZeneca has inked a development and commercialization deal around eplontersen — the Phase III TTR amyloidosis drug formerly known as IONIS-TTR-LRX. On top of the upfront and $485 million worth of conditional payments to follow regulatory approvals, the pharma giant is promising $2.9 billion in sales-related milestones should the drug reach megablockbuster status, plus royalties.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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