Robert Kramer, Emergent BioSolutions CEO

Emer­gent scores a DoD award to eval­u­ate its chikun­gun­ya vac­cine in the field

Emer­gent BioSo­lu­tions is look­ing to make progress with its chikun­gun­ya vac­cine and has re­ceived a $10 mil­lion US gov­ern­ment grant to help it along.

Emer­gent an­nounced that it has been hand­ed a re­search award from the De­part­ment of De­fense’s Con­gres­sion­al Di­rect­ed Med­ical Re­search Pro­grams to eval­u­ate the ef­fi­ca­cy of its sin­gle-dose chikun­gun­ya virus vac­cine can­di­date.

The plan­ning phase will be done in col­lab­o­ra­tion with the Armed Forces Re­search In­sti­tute of Med­ical Sci­ences (AFIRMS) and oth­er aca­d­e­m­ic part­ners to kick off a “post-ap­proval field ef­fi­ca­cy study.” The study is to be done in ar­eas with ac­tive chikun­gun­ya virus trans­mis­sion.

The $10 mil­lion award will fund both the plan­ning and clin­i­cal study phas­es.

Chris Ca­bell

“We look for­ward to com­bin­ing our prod­uct de­vel­op­ment ex­per­tise with the ca­pa­bil­i­ties of AFRIMS in chikun­gun­ya epi­demi­ol­o­gy and field stud­ies, and of our aca­d­e­m­ic part­ners in in­fec­tious dis­ease mod­el­ing and ef­fi­ca­cy tri­al de­sign, to find ways to ad­dress chikun­gun­ya dis­ease, a pub­lic health threat for which no vac­cine or treat­ment ex­ists,” Emer­gent chief med­ical of­fi­cer Chris Ca­bell said in a state­ment.

The study, which is dubbed as a mul­ti-cen­ter Phase II­Ib study, will look to show how ef­fec­tive the vac­cine is in pre­vent­ing the dis­ease, as well as see how the “sur­veil­lance frame­work” will work us­ing chikun­gun­ya as a mod­el of an “emerg­ing pathogen.”

The vac­cine it­self is cur­rent­ly be­ing in­ves­ti­gat­ed in two Phase III tri­als and re­ceived break­through ther­a­py and fast-track des­ig­na­tion from the FDA in 2020 and 2018, re­spec­tive­ly. It al­so re­ceived a pri­or­i­ty med­i­cines des­ig­na­tion from the EMA in 2019.

Emer­gent’s push to fur­ther eval­u­ate the vac­cine comes at a time when oth­er vac­cine mak­ers are giv­ing greater at­ten­tion to the chikun­gun­ya space. Vac­cine pro­duc­er Val­ne­va is gear­ing up for mar­ket en­try of its chikun­gun­ya vac­cine can­di­date, where it ex­pects to com­plete the rolling BLA sub­mis­sion for the vac­cine by the end of the year.

The move al­so comes as Emer­gent is mak­ing fur­ther gains in the small­pox space. Emer­gent grabbed the glob­al rights for Tem­bexa, for $238 mil­lion, from the North Car­oli­na-based biotech Chimerix in Oc­to­ber, along with Chimerix’s 10-year BAR­DA con­tract to pro­duce 1.7 mil­lion dos­es of the drug. The val­ue of the con­tract sits at $680 mil­lion as well as a “prod­uct pro­cure­ment” that is val­ued at $115 mil­lion.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Paul Hudson, Sanofi CEO (ROMUALD MEIGNEUX/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Pfiz­er will in­vest $1.2B+ in Irish man­u­fac­tur­ing site, adding 500 em­ploy­ees

Covid-19 trailblazer Pfizer has confirmed its commitment to a large expansion project on the Emerald Isle.

The New York-based company announced on Thursday that it will make a €1.2 billion ($1.26 billion) capital investment into its manufacturing site at Grange Castle in Dublin.

The expansion of the site marks Pfizer’s largest expansion investment in Ireland to date. The expansion includes the construction of a new facility on the premises as well as adding in more laboratory space and will ultimately double the capacity for “biological drug substance manufacturing” in the oncology and rare disease space as well as inflammation, immunology and internal medicines.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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As the amox­i­cillin short­age drags on, sev­er­al sen­a­tors pres­sure FDA and HHS for so­lu­tions

With the US staring down several drug shortages this year, one in particular is now catching lawmakers’ attention.

A bipartisan group of senators sent a letter to HHS Secretary Xavier Becerra and FDA commissioner Robert Califf expressng “strong concern” about the amoxicillin shortage for patients and general public health. Sens. Amy Klobuchar (D-MN), Sherrod Brown (D-OH), Ed Markey (D-MA) and Bill Cassidy (R-LA) are pushing for FDA and HHS to start working more forcefully to address the amoxicillin shortage along with the other drug shortages.

Man­u­fac­tur­ing roundup: Touch­light nets $2M grant from the Gates Foun­da­tion; Ex­per­ic clos­es $14M Se­ries B

The manufacturer of the “Doggybone DNA” synthetic vector has netted deals with big names, the latest of which is a grant from the Bill & Melinda Gates Foundation to help further Touchlight’s “preclinical development” of its vaccine platform.

The vaccine program aims to build on evidence that the synthetic DNA the company produces can produce strong antibodies and durable T cell responses following vaccine administration.

Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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