Sanofi’s dengue vac­cine slams in­to a safe­ty is­sue, trig­ger­ing a $120M write-off and evis­cer­at­ing old block­buster pro­jec­tions

Sanofi spent $1.5 bil­lion over about 20 long years to de­vel­op its dengue vac­cine, be­liev­ing that it had a block­buster prod­uct head­ed to a mas­sive glob­al mar­ket.

But their in-house de­vel­op­ment team missed some­thing im­por­tant.

On Wednes­day, Sanofi $SNY said that their in­ves­ti­ga­tors had de­ter­mined that Deng­vax­ia pre­sent­ed a re­al threat to pa­tients who were vac­ci­nat­ed against dengue with­out hav­ing first been ex­posed to it. As a re­sult, these sub­jects could ex­pe­ri­ence a sig­nif­i­cant­ly worse re­ac­tion when ex­posed to a new in­fec­tion — with their body re­act­ing to the first ex­po­sure as if it were the sec­ond, due to the vac­ci­na­tion.

Sanofi said in their state­ment:

There are many fac­tors that can lead to se­vere dengue in­fec­tion. How­ev­er, the high­est risk of get­ting more se­vere dis­ease has been ob­served in peo­ple in­fect­ed for the sec­ond time by a dif­fer­ent dengue virus.

And now Sanofi — which has Take­da nip­ping at its heels with a Phase III ri­val — wants to lim­it its use to pro­tect peo­ple who have had a pri­or in­fec­tion.

Sanofi is tak­ing a $120 mil­lion write-off on the set­back, which dwarfs the amount the phar­ma gi­ant has earned in its first ane­mic rounds of rev­enue — which fell far be­hind its own pro­jec­tions as well as the an­a­lysts who had been cheer­ing them on.

The jar­ring re­ver­sal on Deng­vax­ia un­der­scores yet again the deep-seat­ing prob­lems that the phar­ma gi­ant has ex­pe­ri­enced in de­vel­op­ing and field­ing new ther­a­pies out of its own pipeline. While Sanofi has been bull­ish­ly mak­ing ad­vances in hand with its part­ner at Re­gen­eron, its R&D op­er­a­tions in Boston and France haven’t been able to gen­er­ate block­buster new med­i­cines for years.

Deng­vax­ia was sup­posed to help change that rep. Dengue af­fects 390 mil­lion peo­ple glob­al­ly each year, cost­ing bil­lions of dol­lars and claim­ing 20,000 lives. That was sup­posed to ig­nite a ma­jor new mar­ket for Sanofi, but sales start­ed at $60 mil­lion last year and then start­ed to dwin­dle.

Sanofi’s set­back, though, is Take­da’s gain. Just weeks ago Take­da post­ed new da­ta un­der­scor­ing TAK-003’s abil­i­ty to gen­er­ate an­ti­bod­ies to dengue. It’s now in Phase III be­ing test­ed among 20,000 sub­jects.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.