Red­Hill's an­tibi­ot­ic Tal­i­cia edges clos­er to ap­proval, af­ter sec­ond suc­cess­ful Phase III study

As one of the few com­pa­nies fo­cus­ing on tack­ling the bur­geon­ing threat of su­per­bugs, Is­rael’s Red­Hill Bio­phar­ma $RDHL is mak­ing strides. On Mon­day, it said its ex­per­i­men­tal drug Tal­i­cia was suc­cess­ful in erad­i­cat­ing the H. py­lori in­fec­tion, meet­ing the main goal of a sec­ond Phase III study.

The da­ta are com­pelling enough for the com­pa­ny to sub­mit an ap­pli­ca­tion to mar­ket the drug in 2019 for the es­ti­mat­ed 2.5 mil­lion pa­tients treat­ed for the in­fec­tion each year in the Unit­ed States.

In the 455-pa­tient tri­al, pa­tients were ei­ther giv­en Tal­i­cia or the ac­tive com­para­tor, an amox­i­cillin and omepra­zole reg­i­men. Da­ta showed an 84% erad­i­ca­tion of H. py­lori in­fec­tion with Tal­i­cia ver­sus 58% in those who got the oth­er reg­i­men.

Tri­al da­ta al­so demon­strat­ed pa­tients ex­pe­ri­enced a high re­sis­tance to the stan­dard-of-care reg­i­men — con­sis­tent with the falling ef­fi­ca­cy of such ther­a­pies, which typ­i­cal­ly con­sist of the an­tibi­otics clar­ithromycin and metron­ida­zole, the com­pa­ny said.

Tal­i­cia is an oral cap­sule com­pris­ing ri­fabutin, amox­i­cillin and a pro­ton pump in­hibitor, omepra­zole.

About two-thirds of the world’s pop­u­la­tion has H. py­lori in their bod­ies. But for most, it doesn’t cause ul­cers or any oth­er symp­toms, though is con­sid­ered the strongest risk fac­tor for the de­vel­op­ment of gas­tric can­cer.

The grow­ing scourge of an­tibi­ot­ic re­sis­tance is a sig­nif­i­cant prob­lem that should ar­guably en­tice a swarm of R&D dol­lars, but these drugs com­mand rel­a­tive­ly cheap prices and don’t last as long as, say, can­cer drugs, which has in­cen­tivized Big Phar­ma to fo­cus their at­ten­tion else­where. How­ev­er, a hand­ful of small and big names are keep­ing the R&D en­gine hot. Tel Aviv’s Red­hill is one of them, and the FDA has re­ward­ed their dogged fo­cus by giv­ing Tal­i­cia all the bells and whis­tles to has­ten its path to­ward ap­proval.

The drug was grant­ed the Qual­i­fied In­fec­tious Dis­ease Prod­uct des­ig­na­tion as well as fast-track sta­tus by the reg­u­la­tor, in­clud­ing el­i­gi­bil­i­ty for six-month pri­or­i­ty re­view and eight years of US mar­ket ex­clu­siv­i­ty. The prod­uct is al­so pro­tect­ed un­til at least 2034, un­der var­i­ous US patents.

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.

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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.

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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.

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.

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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.

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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.