Durect out-licenses analgesic Posimir to Irish biotech in $136M deal; Arcutis gets 9-figure loan to push for OK for psoriasis cream

Cal­i­for­nia’s Durect has made a deal with a biotech lo­cat­ed all the way across the pond — in Ire­land.

The two biotechs an­nounced a li­cens­ing deal yes­ter­day: Durect is out-li­cens­ing Posimir, an FDA-ap­proved lo­cal anal­gesic for post-sur­gi­cal pain, to In­no­coll, a sub­sidiary of Gur­net Point Cap­i­tal. The agree­ment in­cludes giv­ing In­no­coll ex­clu­sive de­vel­op­ment and com­mer­cial­iza­tion rights to the anal­gesic in the Unit­ed States.

The fi­nan­cials are straight­for­ward: In ex­change for the de­vel­op­ment and com­mer­cial­iza­tion rights, In­no­coll will pay Durect $6 mil­lion in the near fu­ture — a $4 mil­lion li­cense fee and $2 mil­lion when the first com­mer­cial sale is made. Mile­stone pay­ments make up the rest of the $136 mil­lion deal, which doesn’t in­clude roy­al­ties.

While In­no­coll has al­so been giv­en the right to con­duct ad­di­tion­al de­vel­op­ment ac­tiv­i­ties to ex­pand the ap­proved in­di­ca­tions for Posimir, and Durect’s con­tract man­u­fac­tur­ing sup­ply agree­ment for Posimir has been as­signed to In­no­coll — Durect re­tains all com­mer­cial rights to Posimir out­side the US.

In­no­coll CEO Louis Pas­carel­la ex­pressed op­ti­mism with the deal, re­fer­ring to Posimir’s po­ten­tial in a pre­pared state­ment. Out­side of that, Pas­carel­la said that In­no­coll plans to launch Posimir in Q2 next year, sub­ject to what he called ‘sup­ply time­lines.’

Ar­cutis nets $225 mil­lion loan; shoots for 2022 FDA ap­proval for plaque pso­ri­a­sis cream

Im­muno-der­ma­tol­ogy biotech Ar­cutis Bio­ther­a­peu­tics has got­ten a cash in­fu­sion — and a gen­er­ous one to boot.

Ar­cutis is­sued a state­ment this morn­ing, say­ing that it ob­tained a $225 mil­lion term loan fa­cil­i­ty from SLR Cap­i­tal-backed funds. The biotech said that the loan — which should last the biotech through 2024 — would strength­en Ar­cutis’s bal­ance sheet go­ing in­to a very busy new year.

In 2022, it plans to pur­sue po­ten­tial FDA ap­proval for top­i­cal rof­lu­mi­last cream in plaque pso­ri­a­sis, plus Ar­cutis is ex­pect­ing three da­ta read­outs from piv­otal tri­als in atopic der­mati­tis, se­b­or­rhe­ic der­mati­tis, and scalp pso­ri­a­sis.

Ar­cutis pres­i­dent and CEO Frank Watan­abe ex­pressed his own op­ti­mism in a pre­pared state­ment — de­light, as he put it — to be part­nered with SLR for this next year.

Af­ter the deal was done, Ar­cutis got $75 mil­lion to start with. The biotech gets an­oth­er $125 mil­lion once the FDA ap­proves rof­lu­mi­last cream for the treat­ment of plaque pso­ri­a­sis, and the last $25 mil­lion is on­ly avail­able if cer­tain rev­enue mile­stones are achieved.

CALQUENCE is a registered trademark of the AstraZeneca group of companies.

At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.

The FDA on Thursday authorized another new pill to treat the Omicron variant, this time from Merck.

While Pfizer’s antiviral may prove to be more effective, and Merck’s pill has left some scientists questioning the dangers behind its mechanism of action, molnupiravir will be another weapon in the armamentarium of Covid-19 treatments for the US in a time of need, as two mAb treatments from Regeneron and Eli Lilly are no longer effective against Omicron, and as supplies of a third mAb from Vir/GlaxoSmithKline are very limited.

Khurem Farooq, Gyroscope CEO

Christmas is coming early for Gyroscope.

In its latest gene therapy gambit, Novartis is paying $800 million upfront to acquire the Syncona-backed biotech, with another $700 million reserved for milestones.

Novartis has been diving deep into retinal disorders, and Gyroscope’s lead candidate adds a potential one-time treatment for geographic atrophy — a leading cause of blindness — to the pipeline.

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It’s time for our holiday break here at Endpoints News, and like a lot of you, we’ve been prepping for 2022.

Anyone who’s spent some time in industry can tell you the past decade has shoved the drug-hunting field into the forefront of the world’s view of things, garnering tens of billions in investment as new technologies look to change the landscape of R&D. And anyone who qualifies for first-in-class and best-in-class can clean up.

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On the heels of a big FDA approval last week for its keystone asthma drug, Amgen is adding on at its Irish manufacturing site.

Amgen’s site in Dún Laoghaire is about to get a $100 million upgrade to improve its formulation, aseptic drug product filling, lyophilisation and packaging operations as the company celebrates its 10th year in Ireland. The addition will add another 150 jobs for construction workers in the Dublin suburb. The project is set to be the company’s largest outside of North America.

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Amid fears that millions of migrants may not have access to Covid-19 vaccines from Covax following liability fears, the Serum Institute of India has announced that it will waive its protection from legal liabilities for any AstraZeneca-Oxford doses it provides to the program, Reuters reported Wednesday.

Covishield can now be allocated to the Covax Humanitarian Buffer, a program designed to ensure that the most vulnerable portions of populations, such as conflict zones or humanitarian settings that are not able to be reached by government vaccination campaigns, are not left behind. Gavi sees it most effective in areas that have been impacted by state failure or areas controlled by groups that are not the government. Asylum seekers, refugees, detainees, and people who are stateless are all eligible.

Thomas Schmidt, 21st.BIO CEO (via 21st.BIO website)

A Danish bio industrial scale-up company has landed an $86 million investment from Novo Holdings, and it’s hoping to build on a technology base from Novozymes. And with that investment will come a new manufacturing site.

21st.BIO was founded in 2020, and is focused on supporting the upscaling of companies across the world, with the intention of helping those companies meet market demand. Its focus are peptides and proteins, and it wants to provide startups access to facilities to develop a molecule production process that can deliver a high-quality product in the most cost-effective way.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

The centerpiece of Novartis’s $9.7 billion buyout of the Medicines Company can finally go to market.

Branded Leqvio, the small interfering RNA therapy long known as inclisiran is the first and only FDA-approved treatment to reduce LDL-C, i.e. bad cholesterol, with just two maintenance doses a year after an initial dose and another one at three months.

Touting a ‘revolutionary approach,’ Novartis CEO Vas Narasimhan noted that the approval ‘creates new possibilities for how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time.’ The label covers both atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia.

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Qinghua Wang, Innogen CEO

A low profile, Chinese biotech has been working on developing drugs for diabetes and metabolic disorders. Now, the company, known as Innogen Pharmaceutical Technology, has nabbed $120 million in venture capital.

Deal Street Asia reported on the financing this morning, listing the lead investors as Youshan Capital and China Growth Capital. Other investors include CICC Qide Fund, V Star Capital and China Everbright Limited.
https://endpts.com/durect-out-licenses-analgesic-posimir-to-irish-biotech-in-136m-deal-arcutis-gets-9-figure-loan-to-push-for-ok-for-psoriasis-cream/