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.”

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

President Trump (AP Images)

UP­DAT­ED: FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as phar­ma warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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Ab­b­Vie aban­dons a pi­o­neer­ing CRISPR R&D al­liance with Ed­i­tas as Brent Saun­der­s' deal is cast out

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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