An­no­vis Bio claims wins in Alzheimer's and Parkin­son's, shares sky­rock­et; FDA de­lays de­ci­sion for Omeros' nar­so­plimab

A Berwyn, PA-based biotech is claim­ing a huge win in both Alzheimer’s and Parkin­son’s dis­eases, and it’s send­ing their shares sky­rock­et­ing.

An­no­vis Bio re­port­ed re­sults from a small co­hort of a Phase II study, con­tain­ing 14 Alzheimer’s pa­tients and 14 Parkin­son’s pa­tients in a tri­al for a pro­gram called AN­VS401. Mea­sur­ing cog­ni­tive im­prove­ment with an as­sess­ment scale known as ADAS-Cog11, An­no­vis said pa­tients’ scores im­proved by about 30% over their base­lines af­ter 25 days.

That amount­ed to a p-val­ue of p=0.04, with an av­er­age nu­mer­i­cal gain of 4.4 points. The biotech al­so com­pared the 4.4 gain to pa­tients in the place­bo group of the co­hort, not­ing the treat­ment arm saw a 22% im­prove­ment (3.3 av­er­age gain) ver­sus the con­trol. An­no­vis’ p-val­ue here was p=0.13.

Sep­a­rate­ly, An­no­vis re­port­ed Thurs­day af­ter­noon that the Parkin­son’s pa­tients saw sig­nif­i­cant re­duc­tions across sev­er­al in­flam­ma­to­ry mark­ers re­lat­ed to that dis­ease. The da­ta built up­on re­sults An­no­vis re­leased in March, which the com­pa­ny said showed pos­i­tive ef­fi­ca­cy in “speed of ex­e­cu­tion.”

An­no­vis says it’s the first dou­ble-blind­ed, place­bo-con­trolled da­ta show­ing im­prove­ment in the Alzheimer’s scale as well as func­tion­al im­prove­ment in Parkin­son’s. News of the re­sults sent An­no­vis shares $AN­VS soar­ing near­ly 140% in ear­ly Fri­day trad­ing.

“While we do not know how AN­VS401 will af­fect cog­ni­tion af­ter more than one month of treat­ment, the present re­sults show promise that the drug may im­prove or stop the course of AD,” the com­pa­ny said in a re­lease.

FDA de­lays de­ci­sion for Omeros’ nar­so­plimab

Omeros will have to wait a lit­tle longer for a po­ten­tial ap­proval re­gard­ing its nar­so­plimab pro­gram.

The Seat­tle biotech had sought an OK hematopoi­et­ic stem cell trans­plant-as­so­ci­at­ed throm­bot­ic mi­croan­giopa­thy, but the FDA said it needs more time to re­view its BLA pack­age. The re­view has been clas­si­fied as a “ma­jor amend­ment,” re­sult­ing in a new PDU­FA date of Oct. 17, Omeros said.

“Omeros views the in­for­ma­tion pro­vid­ed in re­sponse to FDA’s in­for­ma­tion re­quest as fur­ther sup­port­ing the ap­pli­ca­tion, and we look for­ward to mak­ing nar­so­plimab avail­able to HSCT-TMA pa­tients and their physi­cians as soon as pos­si­ble,” CEO Gre­go­ry De­mop­u­los said in a state­ment.

Omeros had pre­vi­ous­ly won a pri­or­i­ty re­view for the can­di­date, with the FDA ac­cept­ing its BLA pitch back in Jan­u­ary.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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