Bio­gen, Ab­b­Vie yank MS drug Zin­bry­ta off the mar­ket in the wake of en­cephali­tis cas­es

The mar­ket­ing ef­fort for the MS drug Zin­bry­ta (da­clizum­ab) im­plod­ed to­day af­ter Eu­ro­pean reg­u­la­tors flagged a lethal safe­ty warn­ing over cas­es of in­flam­ma­to­ry en­cephali­tis and menin­goen­cephali­tis. Bio­gen $BI­IB and Ab­b­Vie $AB­BV, which had been look­ing to spend this year build­ing sales of the MS treat­ment, are now yank­ing it off the mar­ket in the EU and the US.

“Giv­en the na­ture and com­plex­i­ty of ad­verse events be­ing re­port­ed, char­ac­ter­iz­ing the evolv­ing ben­e­fit/risk pro­file of Zin­bry­ta will not be pos­si­ble go­ing for­ward giv­en the lim­it­ed num­ber of pa­tients be­ing treat­ed,” the com­pa­nies said in a state­ment. “There­fore, Bio­gen and Ab­b­Vie be­lieve it is in the best in­ter­est of pa­tients to vol­un­tar­i­ly with­draw world­wide mar­ket­ing au­tho­riza­tions for Zin­bry­ta.”

En­cephali­tis is char­ac­ter­ized by brain in­flam­ma­tion, usu­al­ly caused by a vi­ral in­fec­tion, which is rare and po­ten­tial­ly dead­ly.

Al San­drock, Bio­gen

The drug hit the US mar­ket in 2016 with a black box warn­ing over the threat of liv­er tox­i­c­i­ty af­ter the FDA ap­proved it for third-line MS cas­es. Reg­u­la­tors, though, have been will­ing to put up with con­sid­er­able safe­ty prob­lems with MS drugs so long as the dam­age to pa­tients is rare and the ben­e­fits con­sid­er­able. In this case, Bio­gen and Ab­b­Vie have yet to gain much trac­tion for a drug that an­a­lysts had felt would be lim­it­ed to peak sales of $500 mil­lion a year.

The with­draw­al won’t have much im­pact on Ab­b­Vie longterm, where the R&D group is in hot pur­suit of sev­er­al po­ten­tial block­busters to bol­ster its work around Hu­mi­ra. Bio­gen, though, won’t get off so easy. The big biotech made its rep in MS and has a thin pipeline dom­i­nat­ed by a high-risk Alzheimer’s ther­a­py. Bio­gen CMO Al San­drock man­aged to rat­tle the mar­ket re­cent­ly with news that they were adding pa­tients to their piv­otal tri­al for the Alzheimer’s drug to ac­count for some vari­abil­i­ty in the da­ta — which in turn trig­gered fresh jit­ters over its fu­ture.

“Bio­gen be­lieves the vol­un­tary world­wide with­draw­al of ZIN­BRY­TA, a treat­ment for re­laps­ing mul­ti­ple scle­ro­sis, is in the best in­ter­est of pa­tients,” said San­drock in a state­ment. “Bio­gen and Ab­b­Vie con­tin­ue to pri­or­i­tize pa­tient safe­ty and the care of mul­ti­ple scle­ro­sis pa­tients world­wide.”

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

Paul Laikind, ViaCyte CEO

Stem cell play­er Vi­a­Cyte ex­pands col­lab­o­ra­tion with Gore to de­vel­op sub­cu­ta­neous di­a­betes treat­ment

Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.

Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.

My­ovant lands a fresh $200M loan as FDA mar­ket­ing de­ci­sion looms; Amarin goes it alone in Eu­rope

Myovant is getting ready to roll out its commercial operations to back relugolix, now under FDA review for prostate cancer.

The startup has added a fresh $200 million in support from Sumitomo Dainippon Pharma, which controls a majority of the stock $MYOV. Sumitomo is handing the cash over as a loan, bringing its total to $600 million. Myovant — which is gearing up for a showdown with AbbVie — has also filed an NDA to sell relugolix for uterine fibroids and recently posted positive late-stage data for endometriosis.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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