Roche ex­pands its PhI­II pro­gram for Eylea ri­val as long-act­ing da­ta back its block­buster con­tender faricimab

Roche’s Genen­tech has notched an­oth­er suc­cess on its way to chal­leng­ing Re­gen­eron — as well as the oth­er Big Phar­ma con­tender No­var­tis — for the block­buster crown now worn by Eylea.

Re­searchers at the big sub say that their bis­pe­cif­ic Ang-2/VEGF drug faricimab (you once knew it as RG7716) came up with an im­proved pro­file over their fran­chise play­er Lu­cen­tis as a long-act­ing drug for wet AMD. And they scored on long act­ing 16-week da­ta, while Re­gen­eron $REGN and No­var­tis $NVS have been duk­ing it out over the 12-week niche.

Here’s the lat­est da­ta from their Phase II STAIR­WAY study, which dosed faricimab 6.0 mg every 16 weeks or every 12 weeks, com­pared to ranibizum­ab (Lu­cen­tis) 0.5 mg every four weeks:

At week 24 (three months af­ter the last of four load­ing dos­es), pa­tients ran­dom­ized to faricimab every 16 weeks were switched to 12-week dos­ing if they were shown to have ac­tive dis­ease, per pre-de­fined cri­te­ria. At week 24, 65 per­cent (n=36/55) of peo­ple treat­ed with faricimab had no ac­tive dis­ease, high­light­ing the po­ten­tial of 16-week dos­ing in near­ly two-thirds of pa­tients. Ini­tial vi­sion gains, as mea­sured by Best Cor­rect­ed Vi­su­al Acu­ity (BC­VA), were ful­ly main­tained through to week 52 with 16- and 12-week dos­ing reg­i­mens. Peo­ple treat­ed with faricimab dosed every 16 weeks ex­pe­ri­enced a mean im­prove­ment of 11.4 chart let­ters from base­line, com­pared to 10.1 let­ters in pa­tients treat­ed with faricimab dosed every 12 weeks and 9.6 let­ters in pa­tients treat­ed with ranibizum­ab (Lu­cen­tis) 0.5 mg dosed every four weeks. 

Eylea has been the mas­ter of this mar­ket, giv­ing Re­gen­eron the lu­cra­tive fran­chise mar­ket it needs to build the com­pa­ny’s pipeline and new prod­uct of­fer­ings. No­var­tis, mean­while, has been mak­ing a mark with brolu­cizum­ab (RTH258), which it has pre­sent­ed as a ma­jor late-stage con­tender.

For Re­gen­eron, Eylea re­mains wor­thy of a vig­or­ous de­fense, even though its own next-gen drug failed to make a mark. Re­searchers for the com­pa­ny have been fight­ing back against its ma­jor league ri­vals with their own longterm da­ta aimed at pro­tect­ing its rep and bil­lions of an­nu­al rev­enue.

Roche, mean­while, is push­ing ahead in­to late-stage work — with Phase II­Is that will take con­sid­er­able time for a read­out. They’re al­ready deep in­to di­a­bet­ic mac­u­lar ede­ma and now plan to add wet AMD to the late-stage ros­ter.

Re­gen­eron has plen­ty of sup­port for its ag­gres­sive de­fense strat­e­gy, though. Leerink’s Ge­of­frey Porges, in par­tic­u­lar, has wad­ed in­to the melee, ready to de­fend the ti­tle that Re­gen­eron won ear­ly. But this fight has a ways to go, with ri­vals ready to duke it out in ways that are like­ly to play out in pa­tients’ fa­vor — one way or an­oth­er.

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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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.

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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.