Philip­pines DOJ preps crim­i­nal charges for Sanofi, health of­fi­cials in­volved in the Deng­vax­ia mess

The furor over Sanofi’s Deng­vax­ia con­tin­ues to roil the Philip­pines.

More than a year af­ter Sanofi con­ced­ed that the dengue vac­cine might raise the risk of a se­ri­ous re­ac­tion for the 800,000-plus chil­dren who were vac­ci­nat­ed in 2016, of­fi­cials in the De­part­ment of Jus­tice say they have grounds for in­dict­ing Sanofi ex­ecs along­side for­mer Health Sec­re­tary Janette Garin and 9 more health of­fi­cials in­volved in the vac­ci­na­tion pro­gram on crim­i­nal charges of reck­less im­pru­dence re­sult­ing to homi­cide.

Sanofi has con­sis­tent­ly main­tained it did noth­ing wrong in rolling out Deng­vax­ia, but af­ter tout­ing their long run­ning in-house pro­gram and plans to earn bil­lions on the vac­cine around the world, they have noth­ing but a mess to show for it — along with pend­ing crim­i­nal in­dict­ments.

Their state­ment to­day:

We strong­ly dis­agree with the find­ings made against Sanofi and some of its em­ploy­ees and we will vig­or­ous­ly de­fend them.  As this is an on­go­ing pro­ceed­ing, it would not be ap­pro­pri­ate for us to com­ment fur­ther at this time.

Even be­fore Sanofi spot­light­ed the risk as­so­ci­at­ed with the vac­cine, in­de­pen­dent in­ves­ti­ga­tors had de­ter­mined on their own that the phar­ma gi­ant had the da­ta in hand to un­der­stand that the vac­cine raised the risk of a se­vere re­ac­tion to any­one who had been vac­ci­nat­ed and then ex­posed to the virus for the first time. 

In the first dengue in­fec­tion, peo­ple typ­i­cal­ly get mild flu-like symp­toms as their body gen­er­ates an­ti­bod­ies that fight off the virus, which the vac­cine is al­so de­signed to kick up. Three years ago, Scott Hal­stead and Philip Rus­sell point­ed to those an­ti­bod­ies as a se­vere threat to any­one who then is ex­posed to wild type dengue for the first time. At that point they as­sist the virus in a process called an­ti­body-de­pen­dent en­hance­ment, or ADE. And the most se­vere cas­es can lead to in­ter­nal bleed­ing, a res­pi­ra­to­ry cri­sis, or­gan fail­ure and death.

The threat Deng­vax­ia pos­es was al­so spot­light­ed in a ma­jor study pub­lished in Sci­ence just a few weeks af­ter the Philip­pines got busy vac­ci­nat­ing peo­ple. And the re­searchers, in­clud­ing Neil Fer­gu­son, di­rec­tor of the MRC Cen­ter for Out­break Analy­sis and Mod­el­ing at Im­pe­r­i­al Col­lege Lon­don, of­fered some wide­ly dis­cussed, stark warn­ings of ADE.

“You’d have in­creas­es in hos­pi­tal­ized dengue cas­es,” co-au­thor Derek Cum­mings, a pro­fes­sor at the Uni­ver­si­ty of Flori­da, told CNN at the time. “It would be ex­act­ly the op­po­site of what you in­tend to do.”


Philip­pine Health of­fi­cials and Sanofi Pas­teur ex­ec­u­tives take their oaths be­fore the Philip­pine Sen­ate probe in 2017. ap im­ages

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Up­dat­ed: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales.

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With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

Between 2017 and 2019, Medicare spent more than $220 million on cancer drugs for which the indications were either voluntarily pulled by their applicants or FDA’s oncology adcomm had recommended their withdrawal.

That kind of massive spending on cancer drugs lacking overall survival benefit is wasteful and risks harming people’s health, a research letter published in JAMA Internal Medicine on Monday said. The researchers from Harvard and the London School of Economics called on the FDA to move faster in both requiring timely postmarketing trials and accelerating the speed in pulling these dangling approvals when the confirmatory studies fail.

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Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Raymond Stevens, ShouTi Pharma CEO

A new Schrödinger-backed start­up emerges from the sci­en­tist who mapped the first hu­man GPCR

One of the most popular targets in drug development, representing about a third of existing drugs, are G-protein coupled receptors — the tiny but integral membrane proteins responsible for recognizing things like light, taste, smell, hormones and pain.

But due to challenges in mapping their structure, the protein family remains largely unexplored.

A slate of companies has emerged over the last few years to change that. If one can figure out the structure of these elusive membrane receptors, it might be possible to create small molecule drugs that overcome the limitations of, say, biologic and peptide therapies. That promise is what gets serial entrepreneur Raymond Stevens out of bed in the morning.