Jeremy Levin, Ovid CEO (BIO via YouTube)

Ovid shuf­fles C-suite, lays off staff in wake of PhI­II An­gel­man syn­drome fail

Fol­low­ing a Phase III flop and a culling of its pipeline, Ovid Ther­a­peu­tics is shak­ing things up again — this time at the C-suite lev­el.

Amit Rakhit

Ovid CMO Amit Rakhit will leave his role in Au­gust and tran­si­tion to the sci­en­tif­ic and clin­i­cal ad­vi­so­ry board, the biotech an­nounced Thurs­day af­ter­noon. In ad­di­tion, Ovid has anoint­ed chief com­mer­cial of­fi­cer Ja­son Tar­dio as the new COO and el­e­vat­ed Claude Nicaise to head of R&D. The moves come amidst a larg­er work­force re­struc­tur­ing, as the New York, NY-based biotech has re­duced its staff by about 25% since March.

“It was a priv­i­lege to have Amit as part of the Ovid man­age­ment team,” Ovid CEO Je­re­my Levin said in a state­ment. “He is a friend and col­league and made sig­nif­i­cant con­tri­bu­tions. While his dai­ly pres­ence with­in Ovid will be missed, we look for­ward to his con­tri­bu­tions on the sci­en­tif­ic and clin­i­cal ad­vi­so­ry board.”

In an email to End­points News, an Ovid spokesper­son said the search for a new CMO won’t be­gin right away, with most of the ef­forts cen­tered around find­ing a new chief sci­en­tif­ic of­fi­cer. “As re­gards to CMO, we have all the req­ui­site skills and qual­i­fi­ca­tions al­ready in the com­pa­ny and will make fur­ther moves in this re­gard once Dr. Rakhit leaves in Au­gust,” the spokesper­son said.

Claude Nicaise

On top of the C-suite moves, Ovid is fur­ther ap­point­ing a new board mem­ber in As­traZeneca and Pfiz­er vet­er­an Michael Poole. Levin al­so tapped three new staffers to serve in roles di­rect­ly un­der­neath him and Nicaise — Luke Rosen will re­port to Levin as the se­nior VP of ac­cel­er­at­ed de­vel­op­ment and com­mu­ni­ty en­gage­ment; Todd Baum­gart­ner will be in charge of reg­u­la­to­ry af­fairs un­der Nicaise; and Ju­lia Tsai will head up clin­i­cal de­vel­op­ment and med­ical af­fairs un­der Nicaise.

In its an­nounce­ment, Ovid said the goal of the changes is to re-cen­ter its pipeline ef­forts on ear­ly-stage clin­i­cal as­sets, rather than its pre­vi­ous late-stage fo­cus. The biotech has three pro­grams in an ar­ray of neu­ro­log­i­cal dis­eases, two of which have yet to hit the pre­clin­i­cal phase.

Rakhit joined Ovid back in 2016 and helped over­see much of the brouha­ha over the biotech’s lead An­gel­man syn­drome pro­gram. Af­ter most an­a­lysts agreed the can­di­date flunked a Phase II study in 2018, Levin con­tin­ued in­sist­ing the fi­nal re­sult was pos­i­tive and Ovid had sim­ply mis­com­mu­ni­cat­ed the re­sults to the pub­lic.

Ja­son Tar­dio

Ovid pushed the pro­gram, dubbed OV101, in­to a Phase III study to look at an end­point that had been list­ed 16th out of 17 sec­on­daries in the Phase II, but it came up short again last De­cem­ber. That prompt­ed the biotech to of­fi­cial­ly cut bait in April, in a de­ci­sion Levin said at the time was due to “the to­tal­i­ty of the da­ta” across four clin­i­cal tri­als.

The com­pa­ny is still look­ing to make a mark on An­gel­man syn­drome, as one of its new pipeline can­di­dates aims to tack­le the dis­ease. Where­as OV101 was a delta-se­lec­tive GABAA re­cep­tor ag­o­nist, the new OV882 can­di­date is a short hair­pin RNA ther­a­py tar­get­ing UBE3A gene ex­pres­sion in neu­rons.

In ad­di­tion to the An­gel­man can­di­date, Ovid is re­search­ing a GA­BA amino­trans­ferase in­hibitor to treat seizures as­so­ci­at­ed with tuber­ous scle­ro­sis com­plex and in­fan­tile spasms, as well as an­oth­er pro­gram for KIF1A as­so­ci­at­ed neu­ro­log­i­cal dis­or­der, or KAND. They al­so have soti­cle­stat for de­vel­op­men­tal and epilep­tic en­cephalopathies, which they li­censed to Take­da in March. Ovid net­ted a $196 mil­lion up­front pay­ment for soti­cle­stat and is el­i­gi­ble for up to $660 mil­lion in mile­stones.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

UP­DAT­ED: Am­gen halts some drug dis­counts for safe­ty net hos­pi­tals as SCO­TUS takes on 340B case

Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.

Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.