US ups fund­ing for Mod­er­na Covid-19 vac­cine as to­tal nears $6B

The US gov­ern­ment poured mon­ey in­to Mod­er­na as it sought to speed its Covid-19 vac­cine to mar­ket. In hind­sight, the in­vest­ments worked, and the US may end up in­vest­ing about $6 bil­lion in Mod­er­na’s vac­cine when all is said and done, ac­cord­ing to a com­pa­ny SEC fil­ing Wednes­day.

The lat­est funds from the Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty, up to $236 mil­lion more, will re­im­burse for Mod­er­na’s costs as­so­ci­at­ed with the vac­cine’s Phase III clin­i­cal tri­al, as well as phar­ma­covig­i­lance ef­forts to track the vac­cine’s safe­ty.

The in­crease in gov­ern­ment re­im­burse­ments come as the com­pa­ny es­ti­mates it’ll col­lect at least $18.4 bil­lion from sales of its Covid-19 vac­cine this year.

That ex­pect­ed wind­fall fol­lows the gov­ern­ment’s in­vest­ments of an­oth­er $5.75 bil­lion in­to the vac­cine’s de­vel­op­ment, clin­i­cal tri­als, man­u­fac­tur­ing and pur­chase of 300 mil­lion dos­es, all since last April. The com­pa­ny has al­ready de­liv­ered 100 mil­lion dos­es to the US gov­ern­ment, and an­oth­er 100 mil­lion are ex­pect­ed be­fore the end of next month, while an­oth­er 100 mil­lion dos­es are slat­ed for the end of Ju­ly.

As of the end of March, Mod­er­na said $317 mil­lion re­mained avail­able un­der the BAR­DA con­tract, pri­or to this ad­di­tion­al $236 mil­lion. The con­tract al­so spells out ex­act­ly what Mod­er­na can re­quest re­im­burse­ments for and all of those re­quests are re­viewed by BAR­DA in de­tail.

The gov­ern­ment’s in­vest­ment and Mod­er­na’s rise have brought in­stant rich­es to its ear­li­est in­vestors, with Flag­ship sell­ing off $1.4 bil­lion in Mod­er­na shares, and the com­pa­ny’s ex­ec­u­tives.

CEO Stéphane Ban­cel is now worth more than $5.5 bil­lion, and he sold $161 mil­lion in shares of Mod­er­na, while out­go­ing CMO Tal Zaks cashed in $101 mil­lion in shares.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.

Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er tees up 500M vac­cine dos­es for do­na­tion in ex­pand­ed US pact; Ear­ly remde­sivir helps stave off hos­pi­tal­iza­tions — study

Pfizer and BioNTech will sell 500 million doses of their Comirnaty Covid-19 vaccine to the US at cost as part of an expanded agreement to drive donations to low- and middle-income nations, the drugmaker said Wednesday.

The expanded pact doubles Pfizer/BioNTech’s commitment to the US effort, which will ship donations to COVAX, a global clearinghouse for up to 92 target nations, as well as the 55 member states of the African Union, Pfizer said. Deliveries started in August and are expected to run through September 2022.