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.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Ei­sai cut­ting 91 jobs af­ter out-li­cense deal; Mer­ck touts first-line Keytru­da re­sults in en­dome­tri­al can­cer

Eisai will eliminate 91 after it out-licensed a seizure drug.

An Eisai spokesperson told Endpoints News that the change-up is tied to Fycompa, a seizure treatment that Florida rare disease biotech Catalyst Pharmaceuticals agreed to pay $160 million to Eisai in exchange for commercial rights back in December. The job cuts were originally flagged in a New Jersey state WARN notice.

The spokesperson said that Catalyst indicated interest in retaining up to 40 employees who work on Fycompa. Those who qualify will have an opportunity to interview with Catalyst.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.