Kim Kjøller, Union Therapeutics CEO

In­novent bets $250M+ on Union's PDE4 in­hibitor ahead of a PhII read­out

A year af­ter pluck­ing oris­mi­last from Leo Phar­ma­ceu­ti­cals’ pipeline — and with­out pub­lish­ing any mid-stage da­ta — Union Ther­a­peu­tics is al­ready mak­ing a pret­ty pen­ny on the oral PDE4 in­hibitor.

In­novent Bi­o­log­ics is shelling out $20 mil­lion up­front for de­vel­op­ment and com­mer­cial­iza­tion rights to Union’s “Phase III-ready” oral for­mu­la­tion of oris­mi­last in Chi­na, the com­pa­nies said ear­ly Tues­day morn­ing. Hop­ing to one-up Am­gen’s block­buster PDE4 in­hibitor Ote­zla in terms of po­ten­cy, Union’s been push­ing the can­di­date through Phase II tri­als in skin con­di­tions like pso­ri­a­sis, atopic der­mati­tis and hidradeni­tis sup­pu­ra­ti­va.

If all goes well in Chi­na, the biotech is set to earn an­oth­er $247 mil­lion in mile­stones, plus tiered roy­al­ties on sales. Mean­while, In­novent says the mid-stage can­di­date will bol­ster its au­toim­mune port­fo­lio.

“I think the Chi­nese mar­ket is un­der­go­ing tremen­dous changes,” Union CEO Kim Kjøller said. “We see big in­di­ca­tions like pso­ri­a­sis and atopic der­mati­tis re­al­ly tak­ing off in Chi­na.”

Union snagged oris­mi­last from its fel­low Dan­ish drug­mak­er last sum­mer in an up to $200 mil­lion deal. PDE4s have long been used to treat skin con­di­tions and oth­er in­flam­ma­to­ry con­di­tions. Among the most no­table is Ote­zla, the for­mer Cel­gene drug that Bris­tol My­ers Squibb sold off to Am­gen for $13.4 bil­lion last year af­ter the two com­pa­nies merged. The drug raked in $2.2 bil­lion last year.

Kjøller says oris­mi­last is de­signed to be more se­lec­tive for PDE4 sub­types B and D, which are key for an­ti-in­flam­ma­to­ry prop­er­ties. And while the CEO hasn’t yet re­leased any Phase II da­ta, he says the drug has shown “good ef­fi­ca­cy” and im­proved po­ten­cy over oth­er PDE4s.

While of­fload­ing the drug last year, Leo said it “demon­strat­ed su­pe­ri­or ef­fect over place­bo in ran­dom­ized, dou­ble-blind­ed, place­bo-con­trolled clin­i­cal stud­ies.”

That’s about all that we’ll get for now in terms of re­sults. But Kjøller says Phase IIa da­ta in pso­ri­a­sis and atopic der­mati­tis are com­ing “fair­ly soon,” and Phase IIb tri­als in those in­di­ca­tions are “im­mi­nent.” Af­ter those tri­als get un­der­way, it should be an­oth­er 15 to 18 months un­til a full read­out. There’s al­so a top­i­cal for­mu­la­tion of oris­mi­last in the works for atopic der­mati­tis, which has com­plet­ed a Phase IIa study.

While Kjøller has big plans for Union’s fu­ture, he al­so re­al­izes that he’ll need some mus­cle to be com­pet­i­tive in big in­di­ca­tions like pso­ri­a­sis. Af­ter the Phase IIb stud­ies, or per­haps dur­ing Phase III, Union will be­gin look­ing for an­oth­er glob­al part­ner to mar­ket oris­mi­last in atopic der­mati­tis and pso­ri­a­sis, while han­dling the more niche in­di­ca­tions, like hidradeni­tis sup­pu­ra­ti­va, it­self.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Atomwise CEO and co-founder Abraham Heifets (left) and co-founder Izhar Wallach

A cou­ple bil­lion for Ex­sci­en­tia was on­ly part of Sanofi's AI am­bi­tions, as the Big Phar­ma adds Atom­wise to the ta­ble

Sanofi made clear its AI ambitions were real at the beginning of this year when the Big Pharma took its drug discovery collaboration with Exscientia to the next level, inking a pact that could birth 15 drugs and deliver $5.3 billion to the UK partner.

Seven months later, the AI blueprint is far from over at the French Big Pharma, as another of the much-hyped drug discovery startups is coming to the table in a five-drug deal. Sanofi will pay Atomwise $20 million to kick off the hunt for up to five targets, which are aimed at leading to the creation of new small molecules. Another $1 billion is on the line — as are royalties — and the companies kept mum on the specific diseases or broader therapeutic areas of interest.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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