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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.