Ot­su­ka puts near­ly $1 bil­lion on the line for four neu­ropsy­chi­atric can­di­dates from Sunovion

It’s been six years since Ot­su­ka got its Lund­beck-part­nered an­tipsy­chot­ic Rex­ul­ti ap­proved to treat schiz­o­phre­nia in the US. Now, the com­pa­ny has its sights set on a new ap­proach for the dif­fi­cult-to-treat dis­ease — and it’s putting down close to $1 bil­lion to snag that can­di­date and three oth­ers from fel­low Japan­ese drug­mak­er Sum­it­o­mo Dainip­pon Phar­ma.

Ot­su­ka is shelling out $270 mil­lion up­front and an­oth­er $620 mil­lion in biobucks for joint de­vel­op­ment and com­mer­cial­iza­tion rights to four neu­ropsy­chi­atric com­pounds from Sum­it­o­mo Dainip­pon’s sub­sidiary Sunovion, the com­pa­nies said on Thurs­day.

Ulotaront (SEP-363856), a schiz­o­phre­nia treat­ment that en­tered Phase III back in 2019, is the fur­thest along. The com­pa­ny’s bipo­lar de­pres­sion can­di­date SEP-4199 isn’t far be­hind, hav­ing en­tered a Phase III tri­al ear­li­er this month. Mean­while, SEP-378614 and SEP-380135, dis­cov­ered in col­lab­o­ra­tion with Psy­choGen­ics, are still in Phase I.

Last April, Sunovion un­corked some pos­i­tive Phase II re­sults for ulotaront, show­ing an av­er­age 17.2-point im­prove­ment on the Pos­i­tive and Neg­a­tive Syn­drome Scale used to as­sess schiz­o­phre­nia, com­pared to a 9.7-point im­prove­ment for the place­bo group.

Schiz­o­phre­nia is as­sessed ac­cord­ing to both “pos­i­tive” symp­toms, such as move­ment is­sues and ab­nor­mal thoughts or per­cep­tions, and “neg­a­tive” ones, such as the loss of mo­ti­va­tion or plea­sure. While re­searchers still have much to learn about the dis­ease, they traced part of those ef­fects to ex­cess dopamine. Cur­rent drugs that block the dopamine re­cep­tor D2 help mit­i­gate the pos­i­tive symp­toms but have had less suc­cess treat­ing the neg­a­tive ones. Rex­ul­ti, on the oth­er hand, is a D2 re­cep­tor par­tial ag­o­nist.

Ulotaront is de­signed to act on two dopamine-af­fect­ing re­cep­tors, called TAAR1 and 5-HT1A, while leav­ing D2 alone. While Phase II study’s sec­ondary end­points weren’t pow­ered to be sta­tis­ti­cal­ly sig­nif­i­cant, re­searchers re­port­ed see­ing promis­ing re­sults on the neg­a­tive symp­toms.

Ken­neth Koblan

Next in line is SEP-4199, which pro­duced some mixed re­sults in bipo­lar I de­pres­sion last sum­mer. A Phase II tri­al en­rolled 344 pa­tients who were ex­pe­ri­enc­ing ma­jor de­pres­sive episodes as­so­ci­at­ed with bipo­lar I dis­or­der. But at the topline read­out, the study failed to meet its pri­ma­ry end­point: a sig­nif­i­cant im­prove­ment on the Mont­gomery-Ås­berg De­pres­sion Rat­ing Scale af­ter six weeks of treat­ment.

CSO Ken­neth Koblan blamed the re­sults on a high place­bo re­sponse, adding: “De­spite the high place­bo re­sponse in this study, which is known to di­min­ish the ef­fect size and the abil­i­ty to de­tect a sig­nal, the topline re­sults sug­gest that SEP-4199 has the po­ten­tial to be an ef­fec­tive ad­vance in treat­ment for peo­ple with bipo­lar de­pres­sion.”

SEP-378614 and SEP-380135 are in Phase I tri­als for treat­ment-re­sis­tant de­pres­sion and ag­i­ta­tion in Alzheimer’s dis­ease, re­spec­tive­ly.

Mako­to In­oue

Ac­cord­ing to the terms of their new deal, Sunovion and Ot­su­ka will share prof­its from the four com­pounds, as well as all ex­pens­es for clin­i­cal stud­ies, reg­u­la­to­ry fil­ings, and com­mer­cial­iza­tion.

“Ot­su­ka has been com­mit­ted to pro­vid­ing new an­tipsy­chotics that con­tribute to pa­tients world­wide in the field of neu­ropsy­chi­a­try by lever­ag­ing in­ter­nal ca­pa­bil­i­ties and ex­ter­nal col­lab­o­ra­tions, start­ing with the launch of an­tipsy­chotics in the U.S. in 2002,” Mako­to In­oue, pres­i­dent and rep­re­sen­ta­tive di­rec­tor of Ot­su­ka, said in a state­ment.

“Through this agree­ment, we are con­fi­dent the com­pa­nies will be able to de­liv­er even more val­ue to pa­tients through the ex­pe­ri­ence and net­works that we have cul­ti­vat­ed over many years world­wide,” he added.

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.

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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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.

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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