About a week af­ter Vec­tura’s board of di­rec­tors said they would unan­i­mous­ly back a Philip Mor­ris takeover, the to­bac­co gi­ant now has con­trol of more than a fifth of the res­pi­ra­to­ry drug­mak­er’s shares.

Share­hold­ers with 22.61% of Vec­tura’s shares have ten­dered their stock to Philip Mor­ris, Reuters re­port­ed on Wednes­day. The move is part of the cig­a­rette com­pa­ny’s $1.5 bil­lion bid to buy Vec­tura. Philip Mor­ris, best known for its Marl­boro prod­ucts, of­fered 165 pence per share, beat­ing out a 155 pence per share of­fer by the pri­vate eq­ui­ty firm The Car­lyle Group.

Though the deal has drawn skep­ti­cism from con­sumer ad­vo­cates, char­i­ties, an­ti-smok­ing groups and the UK’s busi­ness sec­re­tary, Vec­tura’s board is­sued a state­ment last week that it con­sid­ers Philip Mor­ris’ of­fer “fair and rea­son­able.”

“To­bac­co com­pa­nies should not prof­it from the ill­ness­es their prod­ucts cause,” a group of rep­re­sen­ta­tives from more than 20 an­ti-smok­ing and lung health or­ga­ni­za­tions wrote to Vec­tura’s board.

CEO Jacek Ol­czak says the deal is in line with his “be­yond nico­tine” strat­e­gy, which would po­si­tion the com­pa­ny to gen­er­ate more than half its rev­enue from smoke-free prod­ucts by 2025. — Nicole De­Feud­is 

On­copep­tides drug may be head­ed for ad­comm, CEO says

Fol­low­ing the FDA plac­ing a par­tial hold on its con­fir­ma­to­ry tri­al for Pepax­to, On­copep­tides said Thurs­day that the agency may call for an ad­comm to dis­cuss the study.

In its sec­ond quar­ter re­port, CEO Mar­ty Du­vall wrote in a let­ter to in­vestors that reg­u­la­tors “in­di­cat­ed that a pub­lic meet­ing may be held lat­er this year to dis­cuss the safe­ty find­ings and the con­tin­ued mar­ket­ing of the drug in the US.” The FDA placed the hold on all tri­als in­volv­ing Pepax­to on Ju­ly 8 af­ter the drug flopped the over­all sur­vival mea­sure.

Three weeks lat­er, the agency alert­ed pa­tients and health­care providers with more spe­cif­ic in­for­ma­tion, ex­plic­it­ly not­ing the drug re­sult­ed in an in­creased risk of death. Some cost-cut­ting “mea­sures” may be tak­en due to all the un­cer­tain­ty sur­round­ing the drug, Du­vall added in this let­ter.

Pepax­to won ac­cel­er­at­ed ap­proval in Feb­ru­ary, com­par­ing the drug in com­bi­na­tion with dex­am­etha­sone to a Bris­tol My­ers Squibb/steroid com­bo in pa­tients with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma. — Max Gel­man

Bris­tol My­ers nets EU ap­proval for Abec­ma

About five months af­ter get­ting FDA ap­proval for its BC­MA CAR-T ther­a­py Abec­ma, Bris­tol My­ers Squibb has now won an OK in Eu­rope.

The Eu­ro­pean Com­mis­sion ap­proved the drug for adults with re­lapsed and re­frac­to­ry mul­ti­ple myelo­ma who had pre­vi­ous­ly failed at least three ear­li­er lines of ther­a­py, Bris­tol My­ers an­nounced Thurs­day. The pri­or ther­a­py lines must have in­clud­ed an im­munomod­u­la­to­ry agent, a pro­tea­some in­hibitor and an an­ti-CD38 an­ti­body, and pa­tients had to have demon­strat­ed dis­ease pro­gres­sion on the last ther­a­py, the drug­mak­er added.

“The EC ap­proval of Abec­ma is an im­por­tant mile­stone for the treat­ment of mul­ti­ple myelo­ma, and moves us clos­er to of­fer­ing a first-in-class, per­son­al­ized ther­a­py to pa­tients in Eu­rope bat­tling this in­cur­able dis­ease af­ter ex­haust­ing pri­or treat­ment op­tions with the three stan­dards of care,” CMO Samit Hi­rawat said in a state­ment.

Bris­tol My­ers has been push­ing Abec­ma for mul­ti­ple myelo­ma along­side an­oth­er drug, Breyanzi, which was ap­proved for third-line dif­fuse large B cell lym­phoma back in Feb­ru­ary. — Max Gel­man

Third time, like the first and sec­ond, is the charm for Ada­gene, Mer­ck

Ada­gene ap­par­ent­ly loves work­ing with Mer­ck so much they’re go­ing back for thirds.

The San Fran­cis­co biotech an­nounced its third clin­i­cal tri­al col­lab­o­ra­tion on Thurs­day, aim­ing to pair its ex­per­i­men­tal an­ti-CD137 can­di­date with Mer­ck’s Keytru­da in ad­vanced or metasta­t­ic sol­id and/or hema­to­log­i­cal ma­lig­nan­cies. The new clin­i­cal study will build on monother­a­py and com­bi­na­tion ther­a­py da­ta from a Phase I tri­al of the can­di­date, called ADG106.

“While PD-1 drugs have ad­vanced the can­cer treat­ment par­a­digm, there are still a sub­stan­tial num­ber of pa­tients with ad­vanced metasta­t­ic sol­id and hema­to­log­i­cal ma­lig­nan­cies who ei­ther re­lapse or are un­re­spon­sive, high­light­ing the need for new ap­proach­es,” Ada­gene CEO Pe­ter Luo said in a state­ment.

ADG106 is an ag­o­nis­tic an­ti-CD137 IgG4 mon­o­clon­al an­ti­body be­ing eval­u­at­ed in a Phase Ib/II com­bi­na­tion study in ad­vanced sol­id tu­mors and re­lapsed/re­frac­to­ry non-Hodgkin lym­phoma. Ada­gene’s Phase I tri­als have been com­plet­ed with en­roll­ment of near­ly 100 pa­tients in both the US and Chi­na, the biotech said. — Max Gel­man

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.