Philip­pine health of­fi­cials or­der Sanofi to halt Deng­vax­ia sales as con­tro­ver­sy over health threat swells

Philip­pine health of­fi­cials have or­dered Sanofi to jerk its dengue vac­cine off the mar­ket as the con­tro­ver­sy over the health threat it pos­es to chil­dren con­tin­ues to roil the coun­try.

The Philip­pines was the first coun­try to launch a ma­jor vac­ci­na­tion cam­paign with Deng­vax­ia, the world’s first dengue vac­cine. But last week Sanofi con­ced­ed some­thing that two ex­pert groups had con­clud­ed in­de­pen­dent­ly just as the coun­try was rolling out its $70 mil­lion ef­fort ear­ly last year. The vac­cine, giv­en to any­one who had not al­ready been in­fect­ed, left peo­ple vul­ner­a­ble to se­vere, life-threat­en­ing dengue in the event they were sub­se­quent­ly in­fect­ed by wild type dengue.

Both in­de­pen­dent stud­ies in Vac­cine and Sci­ence con­clud­ed that Sanofi’s own tri­al da­ta on se­vere in­fec­tions among 2-to-5 year olds of­fered am­ple warn­ing of the health threat Sanofi fi­nal­ly con­ced­ed.

Health of­fi­cials say they vac­ci­nat­ed 730,000 chil­dren in the Philip­pines, 9 and up.

Sanofi’s health warn­ing last week sug­gest­ed on­ly that the vac­cine la­bel be changed to urge health of­fi­cials to de­ter­mine the like­li­hood that some­one had been pre­vi­ous­ly in­fect­ed be­fore vac­ci­nat­ing them.

Sanofi of­fi­cials have down­played the threat, say­ing on­ly a small frac­tion of the chil­dren vac­ci­nat­ed face the threat of he­m­or­rhag­ic fever. This is al­so a vac­cine in­tend­ed for mil­lions of peo­ple around the world, and the safe­ty bar is typ­i­cal­ly set high.

Brazil­ian of­fi­cials, mean­while, say that they’ve re­strict­ed the use of the vac­cine in the wake of the dis­clo­sure by Sanofi. And the EMA, which has the vac­cine un­der re­view now, tells me that reg­u­la­tors will take in­to ac­count “any emerg­ing da­ta” in com­plet­ing its as­sess­ment.

Sanofi spent $1.8 bil­lion over more than 20 years to prep this launch, ex­pect­ing to de­vel­op a new fran­chise worth $1.5 bil­lion a year. But not­ed dengue ex­pert Scott Hal­stead — who has spent decades in the field — says that Sanofi’s re­searchers nev­er ful­ly learned the bi­ol­o­gy of the dis­ease they were try­ing to erad­i­cate, point­ing them straight to the cri­sis they’re in now.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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FDA ap­proves the third NSOMD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

There were no FDA approved treatments for neuromyelitis optica spectrum disorder at the start of 2019. Now, as of Friday, there are three.

The latest entrant to the market is the Roche/Genentech drug satralizumab after US regulators gave it the thumbs up late Friday. An IL-6 inhibitor, the drug joins Alexion’s Soliris and AstraZeneca spinout Viela Bio’s Uplizna. The annual cost of satralizumab — which will hit the market as Enspryng — will be $190,000 for 13 doses, a Genentech spokesperson said, though the first year of treatment requires 15 doses and cost about $220,000.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

Martin Shkreli (Shutterstock)

Mar­tin Shkre­li con­tin­ued to or­ches­trate an­ti-com­pet­i­tive schemes for Dara­prim be­hind bars — FTC

Martin Shkreli didn’t just blog, read up on drug development news and run his biotech business with a contraband cell phone in prison. According to the FTC, he was also coordinating the anticompetitive scheme to shield Daraprim — the drug at the center of a price-gouging controversy that earned him the “Pharma Bro” nickname — from generic rivals.

Back in January the FTC, together with New York’s attorney general, launched a federal lawsuit against Shkreli, who’s now serving a 7-year sentence for defrauding investors in his hedge fund, alleging that he effectively created a drug monopoly. While Shkreli’s notorious move to raise the per tablet price of Daraprim from $17.50 to $750 was perfectly legal, the tactics he allegedly deployed to box out competitors weren’t.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 14. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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