British CRO wins con­tract for Covid-19 chal­lenge virus; Dutch agency aims to slash Zol­gens­ma prices in half

Ef­forts are un­der­way to de­vel­op a new chal­lenge virus for SARS-CoV-2, and a British CRO is mak­ing its case.

Open Or­phan said Mon­day that its sub­sidiary hVI­VO signed a con­tract with Im­pe­r­i­al Col­lege Lon­don to man­u­fac­ture such a chal­lenge virus. The con­tract is worth £3 mil­lion and hVI­VO will de­vel­op the virus based on new emerg­ing Covid-19 vari­ants of con­cern. The com­pa­ny hopes to then use the virus in fu­ture chal­lenge stud­ies.

Open Or­phan added the project will be­gin im­me­di­ate­ly, and man­u­fac­tur­ing is ex­pect­ed to be com­plete by the end of the year.

The CRO feels hVI­VO is well-suit­ed to the task be­cause of its past ex­pe­ri­ence work­ing on chal­lenge virus­es for the flu, RSV and the com­mon cold, in ad­di­tion to an ear­li­er ver­sion of SARS-CoV-2. That orig­i­nal Covid-19 strain is be­ing used in a chal­lenge study in col­lab­o­ra­tion with the UK gov­ern­ment.

“The avail­abil­i­ty of a vari­ant SARS-CoV-2 virus will great­ly ex­pand the util­i­ty of the SARS-CoV-2 chal­lenge mod­el and al­low us to an­swer a wider range of im­por­tant sci­en­tif­ic ques­tions to aid con­trol of the pan­dem­ic as well as fa­cil­i­tate fur­ther test­ing of vac­cines de­signed against Covid-19,” — hVI­VO CSO An­drew Catch­pole said in a state­ment.

Dutch agency says Zol­gens­ma price should be cut in half

No­var­tis’ Zol­gens­ma drug for spinal mus­cu­lar at­ro­phy is no­to­ri­ous for be­ing the most ex­pen­sive med­i­cine in the world at about $2.1 mil­lion. But the Dutch are try­ing to change that.

The Zor­gin­sti­tu­ut, the na­tion­al health care in­sti­tute of The Nether­lands, is push­ing to slash Zol­gens­ma’s price in half, per a state­ment re­leased Mon­day. The in­sti­tute not­ed that the price point does not re­flect the drug’s ef­fec­tive­ness, say­ing there is too lit­tle ev­i­dence the drug works to cost its cur­rent price.

It has rec­om­mend­ed that the Dutch gov­ern­ment not cov­er the costs of the med­i­cine un­less this price cut is met.

“The Zor­gin­sti­tu­ut en­sures that our care is and re­mains good and af­ford­able, all this to on­ly spend our mon­ey for health­care on valu­able treat­ments that are known to ac­tu­al­ly work,” the agency said in a state­ment. “We ul­ti­mate­ly make these com­pli­cat­ed but nec­es­sary choic­es for and on be­half of 17 mil­lion Dutch peo­ple, so that every­one con­tin­ues to have ac­cess to good and af­ford­able care in the fu­ture.”

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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