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.”

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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John Houston, Arvinas CEO

Pfiz­er bets $1B cash on the orig­i­nal pro­tein de­graders as tech­nol­o­gy nears prime time

As one of the largest multinational corporations in the world, Pfizer has its tendrils in everything. The Big Pharma has potentially hundreds of billions of dollars to play with, and when it decides to go big, it can go as big as it wants.

And did Pfizer ever on Thursday.

Returning to one of its partners in protein degradation, Pfizer is teaming up again with Arvinas to advance and vastly expand a program for breast cancer. As part of the deal, Pfizer is handing over $1 billion immediately — $650 million in upfront cash and $350 million in an equity investment — and promising up to another $1.4 billion in regulatory and commercial milestones.

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.

Mod­er­na es­tab­lish­es pub­lic health-fo­cused char­i­ty; FDA ap­proves As­traZeneca di­a­betes drug for pe­di­atric use

To help promote public health and healthcare in underserved areas of the world, Moderna will establish a charity with a $50 million endowment.

The Cambridge, MA-based company announced the board of directors’ approval Thursday. The foundation will focus on “charitable, scientific and educational endeavors” with an emphasis on promoting public health and the access to healthcare, the press release said. The foundation will start operations once its status as a 501(c)(3) is approved.