Al­ler­gan dou­bles down on NM­DA de­pres­sion drug de­vel­op­ment ef­forts, bag­ging an op­tion to a small mol­e­cule fol­lowup drug

Close to three years af­ter Al­ler­gan $AGN swooped in to buy Nau­rex and its NM­DA drug for de­pres­sion for $560 mil­lion in cash, help­ing spin out the orig­i­nal team in­to a new biotech dubbed Aptinyx, the two have fol­lowed up with an op­tion deal on a small mol­e­cule fol­low-up pro­gram.

Nor­bert Riedel

Al­ler­gan has so far clear­ly en­joyed its late-stage work on ra­pastinel, an IV drug which the FDA des­ig­nat­ed a break­through ther­a­py for ma­jor de­pres­sion. NM­DA has been a tar­get for years in the R&D crowd fo­cused on de­pres­sion, and Aptinyx CEO Nor­bert Riedel has steered a course to prov­ing that his re­searchers found the ther­a­peu­tic strat­e­gy for get­ting it right.

Just last fall Riedel scored a $70 mil­lion round for his spin­out, which put Bain’s Adam Kop­pel on the board.

There’s no im­me­di­ate word on ex­act­ly how much Al­ler­gan is pay­ing for the small mol­e­cule fol­low-up to the IV ther­a­py, which is called AGN-241751.

David Nichol­son, Al­ler­gan

Al­ler­gan’s ef­forts on de­pres­sion come as a va­ri­ety of biotechs are jock­ey­ing for po­si­tion in search of ap­provals. Alk­er­mes $ALKS was ini­tial­ly stiff-armed on its ap­pli­ca­tion af­ter its lead de­pres­sion drug went 1 for 3 in Phase III, un­der­scor­ing just how hard it is to il­lus­trate suc­cess against high place­bo re­spons­es. And J&J $JNJ is hop­ing to score soon with a pitch on es­ke­t­a­mine, its low dose ver­sion of a horse tran­quil­iz­er that is bet­ter known as Spe­cial K on the par­ty scene. Sage $SAGE, mean­while, has man­aged to at­tract con­sid­er­able at­ten­tion for its work on post­par­tum de­pres­sion, de­spite stick­ing with small study pop­u­la­tions.

Al­ler­gan CEO Brent Saun­ders be­lieves he has good odds in this race.

“Ra­pastinel is a great drug that we have at Phase III,” Saun­ders told Jim Cramer a few weeks ago. “We’ll get the da­ta [in the] ear­ly part of next year. It could be an ab­solute game-chang­er for de­pres­sion.”

“Through our pro­duc­tive re­search col­lab­o­ra­tion with Aptinyx and par­al­lel de­vel­op­ment of ra­pastinel, we have gained im­por­tant in­sights in­to NM­DA re­cep­tor mod­u­la­tion as a po­ten­tial ther­a­peu­tic ap­proach for de­pres­sion,” said David Nichol­son, the chief R&D of­fi­cer at Al­ler­gan. “We plan to ad­vance AGN-241751 for the treat­ment of MDD and be­lieve its phar­ma­co­log­i­cal pro­file will en­able it to be­come an oral com­ple­ment to ra­pastinel, fur­ther bol­ster­ing our pipeline of ther­a­peu­tics ad­dress­ing ar­eas of sig­nif­i­cant un­met med­ical need.”

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Mer­ck scraps their $425M Covid-19 drug in lat­est pan­dem­ic set­back

Seven months after paying $425 million cash to acquire it, Merck is scrapping a Covid-19 drug they hoped could provide one of the only treatments for severe hospitalized patients.

Merck’s decision comes after they faced significant and unexpected regulatory delays in getting the drug, known as MK-7110 or CD24Fc, across the finish line. The Big Pharma licensed the drug under the belief that it had already shown sufficient benefit in severe patients and they could help scale it up far faster than OncoImmune, its former owner, could. But in February, the company reported that the FDA insisted Merck run a new trial before seeking authorization.

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As­traZeneca-Alex­ion merg­er slides through FTC re­view af­ter sup­posed M&A crack­down pos­es no bar­ri­ers

The AstraZeneca-Alexion megamerger received a good sign Friday, despite warning signs of the tides turning against large M&A pharma deals.

US regulators at the FTC have cleared the acquisition for approval, AstraZeneca announced, all but signing off on the deal to go through once it officially closes in the third quarter. AstraZeneca originally said it was planning to buy out Alexion back in December for $39 billion.

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Severin Schwan, Roche CEO (Georgios Kefalas/Keystone via AP Images)

Look­ing to ce­ment its lead in packed MS mar­ket, Roche's Ocre­vus un­corks new da­ta in ear­ly-stage pa­tients

Among a positively jam-packed multiple sclerosis market, Roche’s Ocrevus has managed to stand out for what the Swiss drugmaker is calling the most successful launch in its long history. But in order to press its advantage, Ocrevus is looking to earlier-stage patients, and new interim data should help build its case there.

After 48 weeks on Roche’s Ocrevus, 85% of newly diagnosed primary progressing or relapsing MS patients without a history of disease modifying therapy posted no disease activity, including disease progression or relapse, according to interim data set to be presented this weekend at the virtual American Academy of Neurology meeting.

J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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David Stack, Pacira Biosciences CEO

In high­ly un­usu­al move, Paci­ra sues med­ical jour­nal for li­bel over its non-opi­oid painkiller

A New Jersey biotech whose only approved drug is used as a painkiller after surgeries is suing a scientific journal, its editors and a handful of authors for libel after the publication printed numerous papers and editorials that the company says discredited the drug.

Pacira Biosciences filed the complaint against the American Society of Anesthesiologists in the US District Court for New Jersey on Wednesday afternoon. A February issue of the group’s journal Anesthesiology printed three articles and other content full of “bias” that “seriously disparaged” the drug Exparel, Pacira claimed.

Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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