Block­buster per­for­mance: Re­gen­eron, Sanofi add stel­lar PhI­II dupilum­ab da­ta on dis­play at EADV

Af­ter a steady drum­beat of praise from Re­gen­eron and its part­ners at Sanofi, in­ves­ti­ga­tors to­day backed up their un­blush­ing op­ti­mism over their late-stage drug prospect dupilum­ab with a batch of stel­lar late-stage tri­al da­ta for atopic der­mati­tis, adding to the pos­i­tive pro­file al­ready sketched out.

The sci­en­tists turned up at the Eu­ro­pean Acad­e­my of Der­ma­tol­ogy and Venere­ol­o­gy in Vi­en­na to re­view the da­ta from SO­LO1 and SO­LO2. And it was worth the wait for a drug they plan to mar­ket as Dupix­ent as they look to start rack­ing up rev­enue against the multi­bil­lion-dol­lar peak sales es­ti­mates that have hov­ered around this drug.

On every ma­jor score, dupilum­ab hand­i­ly out­per­formed the place­bo, un­der­scor­ing the part­ners’ high ex­pec­ta­tions for a ther­a­py that’s al­so in late-stage test­ing for asth­ma. And new da­ta on itch­ing and de­pres­sion should help close the sale.

Gi­an­lu­ca Pirozzi

“I tru­ly be­lieve this is go­ing to be rev­o­lu­tion­ary for many pa­tients,” Gi­an­lu­ca Pirozzi, the glob­al project head for Sanofi, tells me. This is the first mon­o­clon­al an­ti­body that blocks both Il-4 and IL-13 cy­tokines, and there’s noth­ing that looks like a ri­val threat on the near hori­zon, leav­ing these two big play­ers a lot of room to move.

The pa­tients in these sto­ries rep­re­sent a se­vere­ly af­flict­ed group, he adds, with no chance of re­lief. And while a long way from a uni­ver­sal ef­fect, the da­ta in­di­cate that this drug has a tremen­dous amount of com­mer­cial po­ten­tial, with lit­tle in the way of safe­ty is­sues to fret about.

The full re­port card now in­cludes:

On the Pru­ri­tus NRS ranges from 0 (no itch) to 10 (worst itch imag­in­able). At 16 weeks, for SO­LO 1 and SO­LO 2, re­spec­tive­ly, 41 and 36 per­cent of pa­tients who re­ceived Dupix­ent 300 mg every two weeks, and 40 and 39 per­cent of pa­tients who re­ceived Dupix­ent 300 mg week­ly, achieved a four-point or greater re­duc­tion in their NRS score com­pared to 12 and 10 per­cent with place­bo.

Lest any­one for­get, the two big part­ners have al­so post­ed an im­pres­sive amount of pos­i­tive da­ta.

On the pri­ma­ry end­point: 37 and 36 per­cent of adult pa­tients who re­ceived Dupix­ent 300 mg week­ly, and 38 and 36 per­cent of pa­tients who re­ceived Dupix­ent 300 mg every two weeks, achieved clear­ing or near-clear­ing of skin le­sions as mea­sured by the 5-point In­ves­ti­ga­tor’s Glob­al As­sess­ment (IGA) scale. In the place­bo arm, those rates were tracked at 10 and 8 per­cent with place­bo.

On an­oth­er EU pri­ma­ry and US sec­ondary end­point: 52 and 48 per­cent of adult pa­tients who re­ceived Dupix­ent 300 mg week­ly, and 51 and 44 per­cent of pa­tients who re­ceived Dupix­ent 300 mg every two weeks, achieved a 75 per­cent or greater re­duc­tion in their Eczema Area and Sever­i­ty In­dex score (EASI-75). In the place­bo arm that hit 15 and 12 per­cent.

On the per­cent im­prove­ment in EASI from base­line:  The score was 72 and 69 per­cent in pa­tients who re­ceived the 300 mg week­ly dose, and 72 and 67 per­cent for pa­tients who re­ceived Dupix­ent 300 mg every two weeks, com­pared to 38 and 31 per­cent for place­bo.

Based on the da­ta they’ve seen so far, it looks like they will go with a drug dosed once every two weeks. Dupilum­ab was re­cent­ly filed with the FDA and is get­ting a pri­or­i­ty re­view, with a PDU­FA date on March 29. So far, this drug has been sail­ing through a big Phase III with­out a hitch.

An­a­lysts haven’t over­looked the po­ten­tial here, but there has been some fret­ting that pay­ers are al­ready lay­ing in wait for a big new ther­a­py like this. And that could make it hard for these part­ners to re­al­ize the kind of big gains that have been fore­cast. Ge­of­frey Porges notes:

We now look to the part­nered com­mer­cial or­ga­ni­za­tions to ex­plain how they plan to price and pro­mote dupi, at a man­age­able ex­pense in­vest­ment, to avoid the for­mi­da­ble road­blocks that have stalled the re­cent launch­es of oth­er chron­ic use spe­cial­ty ther­a­peu­tics with large com­mer­cial op­por­tu­ni­ties. Oth­er­wise we have con­cerns that the stock is fac­ing launch es­ti­mates that are too high, and launch rev­enue that falls short of po­ten­tial.

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.

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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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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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.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

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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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.