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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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Hamza Suria, AnaptysBio CEO

The biotech be­hind Glax­o­SmithK­line's PD-1 just scored a $250M cash deal for roy­al­ties

With Merck and Bristol Myers Squibb still dominating the PD-(L)1 space and the threat of lower-cost options coming from behind, is there still room for GlaxoSmithKline’s checkpoint inhibitor — the seventh to market — to make billions? For Sagard Healthcare Royalty Partners, the answer is yes.

Sagard has plumped down $250 million in cash to buy out the 8% royalty AnaptysBio owns on Jemperli sales below $1 billion.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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