Af­ter years of short­ages, Mer­ck an­nounces plans for a new fac­to­ry for an old life­sav­ing drug

Four years af­ter Sanofi left them as a pop­u­lar blad­der can­cer drug’s on­ly pro­duc­er, Mer­ck is in­vest­ing in a new fa­cil­i­ty that could help ame­lio­rate the wide­spread short­ages that pa­tients, doc­tors and man­u­fac­tur­ers have faced for near­ly a decade.

Mer­ck said they will build a new plant at their Durham, NC vac­cine man­u­fac­tur­ing cen­ter to pro­duce BCG, an im­munother­a­py that has been used for decades to treat blad­der can­cer. The fa­cil­i­ty won’t be an im­me­di­ate so­lu­tion — Mer­ck said it will take 5 to 6 years to con­struct and even then, the batch­es will on­ly grow grad­u­al­ly — but the com­pa­ny, one of the world’s largest pro­duc­ers of vac­cines, said it will even­tu­al­ly triple their cur­rent pro­duc­tion and meet de­mand.

Julie Ger­berd­ing

“As de­mand for this med­i­cine has in­creased over the last sev­er­al years, we rec­og­nized the need to do more,” Julie Ger­berd­ing, EVP and chief pa­tient of­fi­cer, said in a state­ment. “While this new fa­cil­i­ty will take a num­ber of years to com­plete, we look for­ward to the day when we can meet the needs of all pa­tients whose physi­cians have pre­scribed TICE BCG for them.”

Orig­i­nal­ly de­vel­oped as an in­oc­u­lant for a dead­ly in­fec­tious dis­ease and used since the 1970s to treat blad­der can­cer, the vac­cine is com­prised sole­ly of an at­ten­u­at­ed strain of tu­ber­cu­lo­sis-caus­ing bac­te­ria. But that strain can be dif­fi­cult to man­u­fac­ture and short­ages be­gan in 2011 af­ter an FDA in­spec­tion found 58 in­stances of mold at a Sanofi plant in Toron­to af­ter a flood. The French gi­ant pulled out in 2016, just as Mer­ck en­coun­tered some of its own man­u­fac­tur­ing is­sues. Doc­tors found them­selves ra­tioning sup­ply of a drug that, in pa­tients who have a par­tic­u­lar but com­mon form of the can­cer, can have re­sponse rates above 70%.

Be­cause of how dif­fi­cult it is to man­u­fac­ture and be­cause dos­es sell for on­ly $100 to $200, BCG didn’t rep­re­sent a sig­nif­i­cant com­mer­cial op­por­tu­ni­ty and no oth­er com­pa­ny stepped up to fill the short­age.  It’s a prob­lem that has played out with oth­er gener­ics, lead­ing to ei­ther short­ages or in­flat­ed prices.

Ken Fra­zier

“When the prices of drugs get too low — par­tic­u­lar­ly drugs that are gener­ic drugs — then you don’t have a mar­ket in­cen­tive to put the cap­i­tal up to build fa­cil­i­ties like we need for ad­di­tion­al amounts of this BCG drug,” CEO Ken Fra­zier told CN­BC last year.

Al­though some on­col­o­gists have pushed Mer­ck to pro­duce more of the drug, oth­ers not­ed that BCG is not a sig­nif­i­cant prof­it gen­er­a­tor for them and said they had al­ready done con­sid­er­able work, in­clud­ing by dou­bling pro­duc­tion of the prod­uct pri­or to this week’s news. In ad­di­tion to pre­scrip­tion use, Mer­ck al­so makes BCG for clin­i­cal tri­als. This year that in­clud­ed tri­als for Covid-19, as re­searchers test­ed the the­o­ry that it could boost in­nate im­mu­ni­ty to a new virus.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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Covid-19 roundup: As­traZeneca could soon re­sume US vac­cine tri­als; Pfiz­er's dis­tri­b­u­tion plan in­volves spe­cial ship­ping box­es, no whole­salers 

AstraZeneca’s Covid-19 vaccine trial could resume in the US later this week, according to a Reuters report.

Experimental dosing of the candidate came screeching to a halt in September, when a participant in the UK suffered what’s believed to be the spinal inflammatory condition transverse myelitis. Trials have already resumed in the UK, Brazil, India, Japan and South Africa — and four anonymous sources told Reuters that a green light from the US could come as early as this week.

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Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.

Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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