Just a month be­fore hand­ing In­ter­cept Phar­ma­ceu­ti­cals a CRL for Ocali­va in NASH, the FDA be­gan eval­u­at­ing the drug for a po­ten­tial risk of liv­er dis­or­der in pri­ma­ry bil­iary cholan­gi­tis (PBC) pa­tients. The probe, which launched in May, was dis­closed by the com­pa­ny deep down in their lat­est quar­ter­ly re­port filed with the SEC, and had not oth­er­wise been com­mu­ni­cat­ed pub­licly by In­ter­cept un­til re­ports sur­faced this week.

The FDA has no­ti­fied us that in the course of its rou­tine safe­ty sur­veil­lance, in May 2020 the FDA be­gan to eval­u­ate a new­ly iden­ti­fied safe­ty sig­nal re­gard­ing liv­er dis­or­der for Ocali­va which the FDA clas­si­fied as a po­ten­tial risk.

Ocali­va was ap­proved in 2016 to treat PBC, a chron­ic dis­ease that af­fects the liv­er’s bile ducts. In­ter­cept spokesman Christo­pher Frates said the biotech is work­ing with the FDA on what will like­ly be a 12-month eval­u­a­tion.

An FDA spokesper­son de­clined to of­fer any ad­di­tion­al in­for­ma­tion aside from what was post­ed in FAERS, the agency’s ad­verse event re­port­ing sys­tem, which states they are “eval­u­at­ing the need for reg­u­la­to­ry ac­tion.”

The probe is the lat­est blow to In­ter­cept in the last few months. In June, the FDA re­ject­ed its NDA for obeti­cholic acid, the ac­tive in­gre­di­ent in Ocali­va, for the treat­ment of NASH. In­ter­cept said reg­u­la­tors want­ed longer term da­ta from their Phase III tri­al to back the sur­ro­gate end­point, re­duc­tion in liv­er fi­bro­sis. Com­pa­ny ex­ec­u­tives ar­gued then that they were blind­sided.

CEO Mark Pruzan­s­ki had said in a state­ment:

At no point dur­ing the re­view did the FDA com­mu­ni­cate that OCA was not ap­prov­able on an ac­cel­er­at­ed ba­sis, and we strong­ly be­lieve that the to­tal­i­ty of da­ta sub­mit­ted to date both meet the re­quire­ments of the Agency’s own guid­ance and clear­ly sup­port the pos­i­tive ben­e­fit-risk pro­file of OCA.

In a Sep­tem­ber SEC fil­ing, In­ter­cept an­nounced that 170 jobs were on the chop­ping block, equal to rough­ly 25% of its staff, in or­der to save cash for its con­tin­ued pur­suit of NASH ap­proval. In­ter­cept shares were down 8% yes­ter­day when news of the FDA probe be­came wide­ly known. An in­vestor on Twit­ter first no­ticed the buried dis­clo­sure.

Back in 2018, the FDA slapped Ocali­va with a black box warn­ing, due to the drug be­ing “in­cor­rect­ly dosed” dai­ly in­stead of week­ly. “To en­sure cor­rect dos­ing and re­duce the risk of liv­er prob­lems, we are clar­i­fy­ing the cur­rent rec­om­men­da­tions for screen­ing, dos­ing, mon­i­tor­ing, and man­ag­ing PBC pa­tients with mod­er­ate to se­vere liv­er dis­ease tak­ing Ocali­va,” it an­nounced.

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

GSK has landed a new first from UNICEF — the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”