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.”

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.