Philip Mor­ris nabs over 20% of Vec­tura's shares; On­copep­tides drug may be head­ed for ad­comm, CEO says

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

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms.

“While no clear trend in the adverse reactions or new safety signal has been identified by Gilead at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine (Vidaza) combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA,” the big biotech said in a statement.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

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.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

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.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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