Look­ing to ex­pand be­yond di­a­betes, No­vo Nordisk en­lists Evotec in CKD pact worth up to $179M per pro­gram

Most of No­vo Nordisk’s kid­ney work has come from di­a­betes, but eye­ing an R&D ex­pan­sion, the Dan­ish gi­ant is putting mon­ey down on a pact to tar­get chron­ic kid­ney dis­ease di­rect­ly.

The new deal comes with an old part­ner: the Ger­man drug dis­cov­ery com­pa­ny Evotec. Un­der the agree­ment, Evotec and No­vo will col­lab­o­rate on dis­cov­er­ing and de­vel­op­ing pre-clin­i­cal can­di­dates across dif­fer­ent modal­i­ties for CKD. No­vo will then be in charge of clin­i­cal and com­mer­cial de­vel­op­ment for any promis­ing ap­proach­es.

The com­pa­nies were loose on specifics, but be­tween up­front pay­ments, re­search fund­ing and mile­stones, Evotec can earn up to €150 mil­lion ($179 mil­lion) per project.

Karin Conde-Knape

“Build­ing on ad­ja­cen­cies with­in car­dio-re­nal and me­tab­o­lism, this col­lab­o­ra­tion will al­low us to strength­en our ef­forts with­in kid­ney dis­ease,” No­vo’s car­dio-re­nal and di­a­betes chief Karin Conde-Knape said in a state­ment, adding the work will be “on the ba­sis of hu­man rel­e­vant bi­ol­o­gy.”

Al­though the over­whelm­ing ma­jor­i­ty of No­vo’s rough­ly $20 bil­lion in an­nu­al sales come from in­sulin and oth­er di­a­betes and obe­si­ty drugs, the com­pa­ny has talked open­ly about its plans to ex­pand in­to oth­er ar­eas over the next five years, in­clud­ing NASH, car­dio­vas­cu­lar dis­ease and CKD.

In 2018, No­vo al­so li­censed a CKD drug from San Diego’s Epi­gen for up to $200 mil­lion, al­though they sig­naled they would al­so de­vel­op the drug in di­a­betes-re­lat­ed con­di­tions.

No­vo and Evotec have col­lab­o­rat­ed since 2017, when No­vo took a €90.3 mil­lion stake in the biotech. It’s proven to be a pru­dent in­vest­ment, in eu­ros and cents alone. Buoyed by a string of big-name part­ner­ships and a few mile­stone pay­ments, Evotec’s rev­enues have near­ly tripled over that time pe­ri­od, from around €150 mil­lion in 2017 to €446 mil­lion last year. And their stock has risen from €6.87 to €22.09 to­day.

In 2018, No­vo turned to Evotec to boost their ear­ly-stage re­search in the Big Phar­ma’s bread-and-but­ter ar­eas: di­a­betes and obe­si­ty. That deal was built sole­ly around small mol­e­cules, but the com­pa­ny has since in­vest­ed heav­i­ly in both bi­o­log­ics and gene ther­a­py, and the new col­lab­o­ra­tion is “modal­i­ty ag­nos­tic.”

With its part­ners, Evotec has worked on a long list of dis­ease ar­eas — in­clud­ing an­ti-in­fec­tive re­search with Bay­er and the Bill & Melin­da Gates Foun­da­tion, neu­ro­science work with Bris­tol My­ers Squibb, and im­munol­o­gy work with Gala­pa­gos and Pfiz­er — and kid­ney dis­ease has been no ex­cep­tion.

The com­pa­ny has worked with Bay­er on drugs for di­a­bet­ics with kid­ney dis­ease since 2016, as part of an up to $300 mil­lion deal. In 2017, Evotec start­ed work­ing with Cam­bridge Uni­ver­si­ty, the Uni­ver­si­ty of Bris­tol, and the Mario Ne­gri In­sti­tute in Italy on what they called the NE­PLEX project. It in­volves us­ing mi­cro-flu­idics and iP­SC stem to cre­ate a “nephron-on-a-chip” that can be used to test pre­clin­i­cal drugs.

Per­haps, most no­tably, the com­pa­ny last year teamed with Vi­for Bio­phar­ma to launch Neph­Thera, a joint ven­ture that us­es da­ta from the mas­sive UK kid­ney biobank study and Evotec’s bioin­for­mat­ics plat­form to find new drugs.

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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