With No­var­tis and Roche gun­ning to carve up Eylea fran­chise, Re­gen­eron has an­oth­er PhI­II suc­cess sto­ry to tell

Work­ing fu­ri­ous­ly to stay ahead of two pow­er­house ri­vals in No­var­tis and Roche, Re­gen­eron to­day is run­ning out a promis­ing set of fresh top-line da­ta for its fran­chise drug Eylea. And one promi­nent an­a­lyst quick­ly re­ward­ed them with a pro­jec­tion of $700 mil­lion in added sales in 5 years.

Re­searchers led by chief sci­en­tif­ic of­fi­cer George Yan­copou­los say they hit the pri­ma­ry end­point in their Phase III study for se­vere non-pro­lif­er­a­tive di­a­bet­ic retinopa­thy, set­ting up a sup­ple­men­tal ap­pli­ca­tion at the FDA.

The block­buster drug had lit­tle prob­lem over­com­ing a place­bo in the Panora­ma study, with 58% in the drug arms scor­ing at least a two-step im­prove­ment in the di­a­bet­ic retinopa­thy sever­i­ty scale com­pared to on­ly 6% for the sham.

Re­gen­eron shares bumped up 2% in mid-morn­ing trad­ing on Mon­day.

An­a­lysts fo­cused on Re­gen­eron $REGN have been look­ing to the Panora­ma da­ta to give them a fresh set of num­bers they can use to com­pare Eylea with two ex­per­i­men­tal meds mov­ing up the pipeline: No­var­tis’ $NVS brolu­cizum­ab (RTH258) and Roche’s $RHH­BY RG7716.

As ex­pect­ed, Leerink’s Ge­of­frey Porges led the cheer­ing sec­tion for Re­gen­eron, where he’s been an un­abashed sup­port­er.

(T)his re­sult opens up a sig­nif­i­cant new mar­ket for Eylea, which could ex­pand the ad­dress­able pool of pa­tients in the broad­er di­a­bet­ic eye dis­ease in­di­ca­tion by 30-40% com­pared to the cur­rent DME-on­ly in­di­ca­tion. We an­tic­i­pate US ap­proval and launch for this in­di­ca­tion for Eylea in 2019E, and al­ready in­clude US sales es­ti­mates for Re­gen­eron of $200mm in 2019E, grow­ing to $700mm by 2023E. Over­all, our US Eylea sales es­ti­mate in 2019E of $4,397mm is 6% high­er than re­cent con­sen­sus, and our 2023E es­ti­mate of $4,992mm is 19% high­er than re­cent con­sen­sus, which sug­gests that con­sen­sus is not valu­ing this in­cre­men­tal in­di­ca­tion.

Re­gen­eron is field­ing a full slate of new tri­als in a dri­ve to stay out front, in­clud­ing a study of its own quar­ter­ly dos­ing reg­i­men. Late last year, though, Re­gen­eron and Bay­er were forced to halt work on a next-gen com­bo to suc­ceed Eylea af­ter it couldn’t beat the stan­dard bear­er in a mid-stage study.

No­var­tis has been par­tic­u­lar­ly ag­gres­sive with its block­buster fore­cast for brolu­cizum­ab, which it ex­pects will hit the mar­ket next year with an eas­i­er dos­ing sched­ule af­ter post­ing pos­i­tive da­ta com­pared to Eylea. And Roche, no slouch in the com­pe­ti­tion game, is mov­ing through the clin­ic with its own block­buster slay­er.

Di­a­bet­ic retinopa­thy of­ten starts as NPDR, a con­di­tion that af­fects more than a half mil­lion peo­ple in the US, ac­cord­ing to Re­gen­eron. As the ail­ment pro­gress­es in­to di­a­bet­ic retinopa­thy — a con­di­tion that af­flicts mil­lions — leaky blood ves­sels dis­tort vi­sion.

It’s hard to over­es­ti­mate the im­por­tance of this drug to Re­gen­eron. Even as the big biotech brings on new drugs with Sanofi, world­wide sales of Eylea hit close to $6 bil­lion last year, dwarf­ing any in­come it earned from the rest of its port­fo­lio com­bined.

“This is the first time a ther­a­py has demon­strat­ed it can re­verse dis­ease pro­gres­sion in pa­tients with mod­er­ate­ly se­vere to se­vere non-pro­lif­er­a­tive di­a­bet­ic retinopa­thy with­out di­a­bet­ic mac­u­lar ede­ma, in a tri­al specif­i­cal­ly de­signed to study this pop­u­la­tion,” said Yan­copou­los. “Pa­tients in the tri­al con­tin­ue to be eval­u­at­ed to de­ter­mine if Eylea can pre­vent pro­gres­sion to neo­vas­cu­lar vi­sion-threat­en­ing com­pli­ca­tions or di­a­bet­ic mac­u­lar ede­ma. We look for­ward to shar­ing one-year re­sults lat­er this year.”

George Yan­copou­los, Re­gen­eron R&D chief.

Fangliang Zhang, AP Images

Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom

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.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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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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.

Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

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.