Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that small­pox vac­ci­na­tion pro­duc­tion is weigh­ing on the mind of the US gov­ern­ment. And man­u­fac­tur­er Bavar­i­an Nordic is the lat­est com­pa­ny to ben­e­fit.

Just a few days af­ter Emer­gent, a com­pa­ny that has made gov­ern­ment con­tracts its lifeblood, ac­quired the ex­clu­sive rights to Tem­bexa from Chimerix, with a $225 mil­lion cash pay­ment and an ex­pect­ed BAR­DA con­tract, the agency has of­fered a con­tract for small­pox vac­cine pro­duc­tion.

BAR­DA has inked a deal with the Dan­ish-based vac­cine and im­munother­a­py man­u­fac­tur­er to sup­ply a freeze-dried ver­sion of the Jyn­neos small­pox vac­cine, al­low­ing for the first dos­es of this ver­sion to be man­u­fac­tured and in­voiced in 2023 and 2024. The op­tions have a $119 mil­lion price tag and rep­re­sent the first op­tions ex­er­cised to con­vert bulk vac­cines in­to freeze-dried dos­es of small­pox vac­cine.

Ad­di­tion­al op­tions on the con­tract are val­ued at $180 mil­lion, and, if ex­er­cised, sup­port con­ver­sion of up to a to­tal of ap­prox­i­mate­ly 13 mil­lion freeze-dried dos­es of the small­pox vac­cine that are ex­pect­ed to be man­u­fac­tured in 2024 and 2025.

The trans­fer of the freeze-dry­ing process to the com­pa­ny’s new fill-and-fin­ish plant in Kvist­gård, Den­mark was ini­ti­at­ed last year and fol­low­ing an FDA in­spec­tion in 2022 will lead to com­mer­cial man­u­fac­tur­ing in 2023. The freeze-dry­ing of a vac­cine, which is be­ing done with some Covid-19 vac­cines, is to pre­serve the vac­cine longer and to trans­port it over longer dis­tances.

Jyn­neos has been part of Bavar­i­an Nordic since 2021. BAR­DA ex­er­cised a $12 mil­lion op­tion to pur­chase more dos­es of the vac­cine as part of a $202 mil­lion or­der made last April for up to 1.4 mil­lion liq­uid-frozen dos­es.

But it seems that small­pox is a high pri­or­i­ty for BAR­DA, as the Emer­gent deal is ex­pect­ed to come with a con­tract in the next three to six months fol­low­ing its clos­ing.

This deal comes about al­so as cas­es of mon­key­pox, which Jyn­neos and oth­er small­pox vac­cines can al­so treat, are ap­pear­ing in Spain, Por­tu­gal and the Unit­ed King­dom ac­cord­ing to Stat.

Mean­while, the deal is an ap­pre­ci­at­ed pick-me-up for Bavar­i­an Nordic, as ear­li­er this month J&J end­ed its col­lab­o­ra­tion and li­cens­ing agree­ments with the Dan­ish com­pa­ny con­cern­ing vac­cines for he­pati­tis B virus and hu­man pa­pil­lo­mavirus­es.

This hasn’t turned back the tide on the stock front, how­ev­er, as its price {$BA­VA.CO} is still down 50% from where it was at the be­gin­ning of the year.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

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.

Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; 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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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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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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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).