Chi­nese biotech Ever­est signs $550M+ li­cens­ing deal for BTK in­hibitors on heels of Covid-19 pact

Ever­est Med­i­cines is on a roll with two li­cens­ing deals in one week.

The Shang­hai-based biotech has paid Sinovent and SinoMab $12 mil­lion up­front for the rights to a BTK in­hibitor for re­nal dis­eases, the com­pa­ny an­nounced Thurs­day. The deal comes just days af­ter Ever­est came away with rights to a Covid-19 vac­cine in Chi­na, Tai­wan, Sin­ga­pore, Thai­land and In­done­sia.

Ever­est will pay Sinovent and SinoMab up to $549 mil­lion in mile­stone pay­ments and roy­al­ties. The agree­ment in­cludes tech trans­fer of Sinovent and SinoMab’s man­u­fac­tur­ing process for the can­di­date, named XNW1011.

The BTK in­hibitor has fin­ished a Phase I study in Chi­na so far. Chron­ic kid­ney dis­ease, Ever­est CEO Ker­ry Blan­chard said in a press re­lease, is a prob­lem world­wide, and B cell ab­nor­mal­i­ties can af­fect a num­ber of dis­eases that have a high preva­lence in Asia.

“We are im­pressed by the da­ta gen­er­at­ed from XNW1011 (or “SN1011″) to date and are com­mit­ted to mov­ing this com­pound quick­ly in­to phase 2 stud­ies to ex­plore a num­ber of re­nal dis­eases, of which rep­re­sent a few glob­al first-in-dis­ease op­por­tu­ni­ties for Ever­est,” he said. “This im­por­tant part­ner­ship with Sinovent and SinoMab not on­ly so­lid­i­fies Ever­est’s lead­er­ship in de­vel­op­ing nov­el ther­a­pies to com­bat re­nal dis­ease, but al­so un­der­scores our tran­si­tion to de­vel­op­ing nov­el ther­a­pies for the glob­al mar­ket by lever­ag­ing the vast pa­tient pop­u­la­tion in Greater Chi­na and Asia.”

This week, the com­pa­ny paid $100 mil­lion up­front to Prov­i­dence Ther­a­peu­tics, and could pay up to $400 mil­lion more for its mR­NA-based Covid-19 vac­cine. Ever­est will al­so gain the rights to any fu­ture Covid-19 vac­cine can­di­dates that are de­signed for a spe­cif­ic vari­ant, which are cur­rent­ly in the pre­clin­i­cal stage.

Aside from XNW1011, Ever­est has two drugs in its pipeline for car­dio-re­nal dis­ease: Ne­fe­con for the treat­ment of IgA nephropa­thy, and Ra­linepag for pul­monary ar­te­r­i­al hy­per­ten­sion. In to­tal, there are nine can­di­dates in the com­pa­ny’s pipeline, sev­en of which are ei­ther in Phase III tri­als or have a bi­o­log­ics li­cense agree­ment sub­mit­ted.

SinoMab’s flag­ship can­di­date SMO3 tar­gets CD22 to treat rheuma­toid arthri­tis, and is cur­rent­ly in Phase III tri­als in Chi­na. Sinovent’s fo­cus area is in on­col­o­gy, and meta­bol­ic and in­fec­tious dis­eases.

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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