Ab­b­Vie and Roche tout a pos­i­tive PhI­II com­bo study of Ven­clex­ta, Rit­ux­an in CLL — ahead of FDA pitch

Ab­b­Vie and Roche are get­ting a boost out of the news that their com­bi­na­tion of Ven­clex­ta and Rit­ux­an met their pri­ma­ry end­point on pro­gres­sion-free sur­vival, beat­ing out a com­bi­na­tion of chemother­a­py and Rit­ux­an for treat­ment-re­sis­tant cas­es of chron­ic lym­pho­cyt­ic leukemia.

Ab­b­Vie says they’ll be hus­tling along the da­ta — none of which was on dis­play to­day — to reg­u­la­tors af­ter pick­ing up a break­through drug des­ig­na­tion on the com­bo for CLL, which has at­tract­ed a num­ber of drugs.

Michael Sev­eri­no

The re­sults from the MU­RA­NO study have been await­ed by a cou­ple of the an­a­lysts cov­er­ing Ab­b­Vie to see how the com­pa­ny can fare this year in ex­pand­ing its prospects in on­col­o­gy. Its big can­cer drug dri­ver is Im­bru­vi­ca, with Hu­mi­ra pro­vid­ing the bulk of its rev­enue.

Leerink’s Ge­of­frey Porges counts him­self as a hap­py camper on the news. He not­ed:

 We an­tic­i­pate an ex­pe­dit­ed reg­u­la­to­ry fil­ing and ap­proval based on these da­ta, which will ex­pand the la­beled in­di­ca­tion for Ven­clex­ta from a nar­row sub­set of CLL pa­tients (17p dele­tion) to the broad­er R/R CLL pop­u­la­tion and will ac­cel­er­ate the Ven­clex­ta rev­enue op­por­tu­ni­ty by H2 2018. Ven­clex­ta’s cur­rent quar­ter­ly rev­enue run rate of $20-30mm (our es­ti­mate) should in­crease sig­nif­i­cant­ly with the la­bel ex­pan­sion that is like­ly to fol­low this re­sult.

Ex­pand­ing the num­ber of FDA OKs for this drug is cru­cial to Ab­b­Vie’s plan to ex­pand rev­enue from about $125 mil­lion this year to as much as $1.5 bil­lion to $2 bil­lion a year by the end of the decade. The drug was orig­i­nal­ly ap­proved for pa­tients with CLL with 17p dele­tion back in April of 2016.

Re­searchers are al­so stay­ing mum about the safe­ty re­sults from the study, say­ing they’re ex­am­in­ing ad­verse events reg­is­tered in the study.

CLL ac­counts for about a quar­ter of all the new leukemia cas­es di­ag­nosed every year.

“Ab­b­Vie is com­mit­ted to re­search­ing the full po­ten­tial of Ven­clex­ta both as monother­a­py and com­bi­na­tion ther­a­py in pa­tients with CLL and oth­er hema­to­log­ic ma­lig­nan­cies. The analy­sis of the MU­RA­NO tri­al showed that Ven­clex­ta in com­bi­na­tion with Rit­ux­an may of­fer an­oth­er op­tion for pa­tients with R/R CLL, po­ten­tial­ly pro­vid­ing them with a chemother­a­py-free ther­a­py,” said Michael Sev­eri­no, Ab­b­Vie’s chief sci­en­tif­ic of­fi­cer. “We are look­ing for­ward to work­ing with reg­u­la­to­ry au­thor­i­ties around the world to bring this ad­di­tion­al treat­ment reg­i­men to R/R CLL pa­tients.”

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

Endpoints Premium

Premium subscription required

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

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.