With CRO con­sol­i­da­tion in full swing, Catal­ent inks a $950M deal to ac­quire Cook Pharmi­ca and sig­nals an ap­petite for more

To­day it is Catal­ent’s turn to take a lead role in the con­sol­i­da­tion of the glob­al out­sourc­ing busi­ness.

The big and grow­ing CMO has snapped up Bloom­ing­ton, IN-based Cook Pharmi­ca for $950 mil­lion, adding a group with 750 staffers in­volved in bi­o­log­ics de­vel­op­ment and bio­man­u­fac­tur­ing and flesh­ing out the start-to-fin­ish suite of ser­vices that Catal­ent has on of­fer to the bio­phar­ma world.

Cook is bring­ing their 875,000 square foot fa­cil­i­ty in Bloom­ing­ton to the Catal­ent or­ga­ni­za­tion, along with an­nu­al rev­enue of $179 mil­lion.

John Chimin­s­ki

The deal, which comes with $750 mil­lion in cash and the rest due in an­nu­al in­stall­ments, high­lights the big mon­ey con­sol­i­da­tion game in the con­tract ser­vices busi­ness. As I not­ed in my re­cent look at the top 10 play­ers in clin­i­cal re­search, the name of the game has been build­ing glob­al or­ga­ni­za­tions that can serve as a one-stop shop for the com­pa­nies they work with — at a time bio­phar­ma has been steadi­ly out­sourc­ing more and more of the heavy lift­ing in drug de­vel­op­ment and man­u­fac­tur­ing.

Bar­ry Lit­tle­johns

The com­ple­men­tary bi­o­log­ics de­vel­op­ment, bio­man­u­fac­tur­ing, and fill-fin­ish ca­pa­bil­i­ties of Catal­ent and Cook Pharmi­ca will pro­vide bio­phar­ma­ceu­ti­cal firms with a sin­gle, in­te­grat­ed part­ner sup­port­ing a wide range of clin­i­cal and com­mer­cial needs,” said John Chimin­s­ki, Catal­ent’s chief ex­ec­u­tive. “We are very ex­cit­ed to join forces with the tal­ent­ed Cook Pharmi­ca team in Bloom­ing­ton, In­di­ana and plan to in­vest ag­gres­sive­ly there, in our rapid­ly ex­pand­ing Madi­son, Wis­con­sin fa­cil­i­ty, and in the rest of the Catal­ent Bi­o­log­ics net­work to build a true glob­al leader in the bi­o­log­ics mar­ket, which will help us to im­prove the lives of pa­tients around the world.”

I asked Bar­ry Lit­tle­johns, the com­pa­ny’s pres­i­dent of drug de­liv­ery so­lu­tions, if Catal­ent is look­ing for sim­i­lar deals. His re­sponse: “[We] con­tin­ue to look for ac­qui­si­tions that en­hance our tech­ni­cal dif­fer­en­ti­a­tion,” while adding, “we be­lieve there are nu­mer­ous op­por­tu­ni­ties for us to grow in­or­gan­i­cal­ly and we will con­tin­ue to iden­ti­fy ac­qui­si­tion tar­gets that can en­hance our rate of or­gan­ic growth.”

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.