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.

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.”

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.