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.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.

Mod­er­na es­tab­lish­es pub­lic health-fo­cused char­i­ty; FDA ap­proves As­traZeneca di­a­betes drug for pe­di­atric use

To help promote public health and healthcare in underserved areas of the world, Moderna will establish a charity with a $50 million endowment.

The Cambridge, MA-based company announced the board of directors’ approval Thursday. The foundation will focus on “charitable, scientific and educational endeavors” with an emphasis on promoting public health and the access to healthcare, the press release said. The foundation will start operations once its status as a 501(c)(3) is approved.