Leo Phar­ma of­floads a pso­ri­a­sis as­set as their Dupix­ent ri­val heads to the FDA

Leo Phar­ma, a small, cen­tu­ry-old Dan­ish drug­mak­er, has spent the past few years tail­ing Sanofi on their fran­chise drug Dupix­ent, bet­ting that an an­ti­body they li­censed from As­traZeneca cou­pled with a few decades of ex­per­tise in der­ma­tol­ogy could com­pete with one of Big Phar­ma’s biggest drugs. They got a huge boost in that re­gard in De­cem­ber, with pos­i­tive Phase III re­sults in atopic der­mati­tis, and last week, when they an­nounced the FDA had ac­cept­ed their BLA for the drug.

Un­der the di­rec­tion of Thomas Hultsch, a for­mer Sanofi ex­ec who now runs trans­la­tion­al med­i­cine for Leo, the com­pa­ny has been de­vel­op­ing a suite of oth­er ex­per­i­men­tal der­ma­tol­ogy drugs. Now, though, with new part­ner­ships in the mix, they’re of­fload­ing their sec­ond most de­vel­oped com­pound to an­oth­er com­pa­ny.

In an up-to $200 mil­lion deal, Leo has agreed to give glob­al rights to their pso­ri­a­sis and atopic der­mati­tis can­di­date LP0058 to fel­low Dan­ish drug­mak­er Union Ther­a­peu­tics. Leo will al­so re­ceive sin­gle-dig­it roy­al­ties.

LP0058, now re­named UNI500, is an oral PDE4 in­hibitor. That’s a class of drugs that has long been used to treat skin con­di­tions, among oth­er in­flam­ma­to­ry con­di­tions. Most no­tably Ote­zla, the Cel­gene pso­ri­a­sis drug that Bris­tol My­ers Squibb sold off to Am­gen for $13.4 bil­lion last year af­ter the two com­pa­nies merged, is a PDE4 in­hibitor.

Leo can be cir­cum­spect when it comes to tri­al re­sults — the com­pa­ny didn’t an­nounce Phase III re­sults for the Dupix­ent ri­val for about a year af­ter the da­ta were com­plete — and they’ve yet to dis­close the re­sults of Phase II tri­als on the PDE4 in­hibitor. But the com­pa­ny said in a press re­lease that it had “demon­strat­ed su­pe­ri­or ef­fect over place­bo in ran­dom­ized, dou­ble-blind­ed, place­bo-con­trolled clin­i­cal stud­ies.”

For Leo, the out-li­cens­ing deal comes as the com­pa­ny is fo­cus­ing on com­mer­cial­iza­tion for its lead drug and new part­ner­ships that have shored up much of its ear­li­er pipeline with new­er ap­proach­es. In April, the com­pa­ny agreed to an up-to $570 mil­lion deal with One­ness Biotech in Tai­wan and Mi­cro­bio Shang­hai in Chi­na for FB825, a new drug that tries to tack­le eczema and asth­ma by de­plet­ing a kind of B cell called IgE. It’s a sim­i­lar ap­proach to the Roche and No­var­tis drug Xo­lair, which is al­ready ap­proved for asth­ma and now be­ing test­ed for atopic der­mati­tis.

So­cial/tile: News Øre­sund – Jo­han Wess­man (Flickr, Cre­ative Com­mons)

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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Craig Thompson, Cerevance CEO

UP­DAT­ED: Mer­ck makes first big splash for Alzheimer’s drug R&D since 2017 fail, ink­ing re­search pact with Cere­vance

For the first time since discontinuing its late-stage Alzheimer’s program, Merck has found promise on the path forward in the memory-robbing disease.

After a Phase III flop of its drug verubecestat, the New Jersey Big Pharma axed the study in early 2018. More than four years later, the company is ready to sign up for another pact to test the waters of the befuddling disease.

This time, there’s $1.1 billion in biobucks on the line and a target that its partner says no other biopharma is looking at en route to finding the next treatment for Alzheimer’s, a neuroscience field that has hit hurdle after hurdle for decades.

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Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.