BioN­Tech part­ners with Bill and Melin­da Gates Foun­da­tion, scor­ing $55M eq­ui­ty in­vest­ment; BeiGene brush­es off short at­tack

→ Less than two months af­ter Ger­man biotech BioN­Tech raised a her­culean $325 mil­lion in an up­sized round of fi­nanc­ing — the Bill and Melin­da Gates Foun­da­tion have signed a pact with the com­pa­ny, mak­ing an ini­tial eq­ui­ty in­vest­ment of $55 mil­lion to de­vel­op vac­cine and im­munother­a­py can­di­dates to pre­vent HIV and tu­ber­cu­lo­sis. To­tal fund­ing un­der the deal could hit $100 mil­lion, via po­ten­tial grant fund­ing from the foun­da­tion, BioN­Tech said on Wednes­day.

→ BeiGene, a pi­o­neer and dar­ling of the grow­ing US-Chi­na biotech crowd, was the sub­ject of a fe­ro­cious short re­port pub­lished by J Cap­i­tal on Thurs­day. Shares fell rough­ly 9% on both the Nas­daq $BGNE and the Hong Kong stock ex­change (06160) on al­le­ga­tions that the com­pa­ny faked sales of the Cel­gene drugs it’s in charge of mar­ket­ing in Chi­na, in­vest­ed in bo­gus man­u­fac­tur­ing sites, and over­spent on wages for R&D staff. Tim Mur­ray, au­thor of the re­port, fur­ther ac­cused ex­ecs of “pump­ing and dump­ing,” talk­ing up BeiGene’s stand­ing with Chi­nese drug reg­u­la­tors and po­ten­tial for its drugs while covert­ly sell­ing off their own stock.

In a state­ment to the HKEX, BeiGene called the al­le­ga­tions “in­ac­cu­rate, un­found­ed and mis­lead­ing” as well as “bla­tant­ly false.”

“From its in­cep­tion, BeiGene has op­er­at­ed with an un­wa­ver­ing com­mit­ment to com­pli­ance, ethics, and in­tegri­ty,” it wrote. “BeiGene re­mains fo­cused on its mis­sion to build a bio­phar­ma­ceu­ti­cal com­pa­ny that will pro­vide the high­est qual­i­ty ther­a­pies to the great­est num­ber of pa­tients around the world.”

No­var­tis $NVS is palm­ing off a Chi­na-based unit for $790 mil­lion yuan (about $110.5 mil­lion), ac­cord­ing to a Wednes­day re­port by Dow Jones. The plant, which was opened a decade ago, was sold to Chi­na’s Zhe­jiang Ji­uzhou, ex­clud­ing the Swiss drug­mak­er’s tech­nol­o­gy and drug-de­vel­op­ment as­sets. The ac­qui­si­tion will help Zhe­jiang Ji­uzhou ce­ment its po­si­tion as a strate­gic sup­pli­er to No­var­tis, not­ed the re­port.

Andre Kalil, AP Images

A 9/11-era Om­a­ha fa­cil­i­ty, an old Ebo­la drug, and the ubiq­ui­tous Dr. Fau­ci: In­side the first US nov­el coro­n­avirus tri­al

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Dan O'Day (AP Images)

A name emerges out of the Gilead M&A ru­mor mill, and it’s a can­cer biotech

After months of questions and speculation about when and if Gilead will make a major acquisitions, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

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Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

UP­DAT­ED: Bio­gen makes an­oth­er bold Alzheimer’s bet, drop­ping $350M up­front to part­ner with genome-edit­ing fo­cused Sang­amo

While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

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Spark los­es an­oth­er top ex­ec in the wake of $4.3B takeover by Roche — re­port

Days after bidding farewell to co-founder Kathy High, Spark Therapeutics — now operating under Roche — has one more opening on its C-suite.

Kathy Reape

Kathy Reape, who joined the Philadelphia-based biotech in 2016 as head of clinical R&D and became chief medical officer in 2018, is reportedly set to leave.

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'The head­lines are the head­lines, but': Bio­Marin talks up po­ten­tial sav­ings as he­mo­phil­ia gene ther­a­py launch looms

BioMarin execs are still staying tight-lipped about their pricing plans for what is poised to be the world’s first hemophilia gene therapy. But as the company enters the final regulatory stretch and approaches a potential launch this summer, they are also dropping more hints to get investors ready.

First thing to know: They really, really don’t expect an advisory committee to be convened for valrox, which is under priority review, to pop up before its PDUFA date on August 21.

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Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Vlad Coric (Photo Credit: Andrew Venditti)

UP­DAT­ED: Bio­haven scores CGRP OK for acute mi­graine — can the com­mer­cial team catch up with Al­ler­gan on its de­but?

Seven years after spinning out of Yale, Biohaven has entered the ranks of commercial-stage biotechs.

The FDA handed down an OK for its CGRP drug, rimegepant, as an acute treatment. Dubbed Nurtec, the orally dissolving pill will join Allergan’s (soon to be AbbVie’s) Ubrelvy and Lilly’s Reyvow on the market amid a new wave of migraine therapies reshaping the disease space.

In a pivotal Phase III trial, Nurtec hit the co-primary endpoints on pain freedom and freedom from most bothersome symptoms at two hours post dose, proving superior to placebo.