Re­gen­eron, Sanofi, get ready to duke it out with Pfiz­er over a megablock­buster eczema mar­ket

An­drew Blau­velt, Ore­gon Med­ical Re­search Cen­ter

Some­time over the next few days or weeks, the FDA will like­ly hand Re­gen­eron and Sanofi an ap­proval for Dupix­ent (dupilum­ab), their ground­break­ing IL-4/IL-13 in­hibitor for eczema which a num­ber of an­a­lysts have pro­ject­ed will go on to grab $4 bil­lion-plus a year in an­nu­al sales. And they’ll hit the mar­ket with some stel­lar new 16- and 52-week da­ta from an­oth­er Phase III study as they go up against Pfiz­er’s new­ly ap­proved Eu­crisa (crisabo­role, tar­get­ing PDE4).

We knew last year that dupilum­ab had hit its marks in the piv­otal SO­LO tri­als as well as CHRONOS, set­ting it up as pos­si­bly the top drug launch slat­ed for 2017. Over the week­end, in­ves­ti­ga­tors turned out with some new goal post da­ta for CHRONOS that will do noth­ing to take the shine off of its big mar­ket pre­dic­tions.

In CHRONOS, re­searchers re­cruit­ed pa­tients whose eczema wasn’t con­trolled by top­i­cal ther­a­pies in­clud­ing cor­ti­cos­teroids. They were divvied up in­to three groups: week­ly 300 mg dos­es of dupilum­ab with top­i­cal cor­ti­cos­teroids (TCS), once every two weeks dos­es with TCS or TCS alone.

In the new CHRONOS da­ta re­viewed at the an­nu­al meet­ing of the Amer­i­can Acad­e­my of Der­ma­tol­ogy in Or­lan­do over the week­end, in­ves­ti­ga­tors not­ed that the se­vere itch­ing pa­tients are af­flict­ed by was re­duced by 55% and 58% in the two drug arms af­ter 16 weeks, com­pared to 29% of pa­tients on TCS alone. And the dis­ease score rat­ing for pa­tients dropped by 4 or more points among 77% of the pa­tients in the drug arms com­pared to 37% of the place­bo/top­i­cal cor­ti­cos­teroid group.

At 52 weeks the im­prove­ment in the itch­ing score held steady at 54% and 56% in the drug ams and 27% in the place­bo group. And the 4-point-plus im­prove­ment in dis­ease score was main­tained by 65% and 76% of the pa­tients on drug, com­pared to 26% on on­ly top­i­cal cor­ti­cos­teroids.

Com­pare that to the pri­ma­ry goal in the crisabo­role study for mild to mod­er­ate eczema:

More crisabo­role- than ve­hi­cle-treat­ed pa­tients achieved (In­ves­ti­ga­tor’s Sta­t­ic Glob­al As­sess­ment) score suc­cess (clear/al­most clear with ≥2-grade im­prove­ment; AD-301: 32.8% vs 25.4%, P = .038; AD-302: 31.4% vs 18.0%, P < .001), with a greater per­cent­age with clear/al­most clear (51.7% vs 40.6%, P = .005; 48.5% vs 29.7%, P < .001).

That’s what Pfiz­er paid $5.2 bil­lion for when it ac­quired Ana­cor.

To­geth­er, these drugs are ex­pect­ed to make a cru­cial dif­fer­ence for a big group of pa­tients who have lim­it­ed treat­ment op­tions. But Re­gen­eron and Sanofi are clear­ly gun­ning for the li­on’s share of the mar­ket with a much broad­er range of late-stage da­ta to take to pay­ers and physi­cians.

They need a clear win here. Their drug sar­ilum­ab was held up by the FDA last fall over man­u­fac­tur­ing is­sues. And their big PC­SK9 play turned in­to an em­bar­rass­ing de­fen­sive ef­fort to beat back a judge’s rul­ing that their drug should be pulled due to patent vi­o­la­tions.

“These new re­sults build up­on pre­vi­ous pos­i­tive Phase III monother­a­py da­ta. In the CHRONOS study, Dupix­ent used with top­i­cal cor­ti­cos­teroids showed sig­nif­i­cant­ly greater clear­ance of skin le­sions and over­all dis­ease sever­i­ty com­pared to  top­i­cal cor­ti­cos­teroids alone, which are com­mon­ly pre­scribed for mod­er­ate-to-se­vere atopic der­mati­tis,” said An­drew Blau­velt, pres­i­dent of Ore­gon Med­ical Re­search Cen­ter and prin­ci­pal in­ves­ti­ga­tor of the study. “This study pro­vides pos­i­tive long-term da­ta for Dupix­ent, which is im­por­tant giv­en atopic der­mati­tis is a chron­ic in­flam­ma­to­ry dis­ease. Ad­di­tion­al­ly, the pre­sen­ta­tion high­lights the crit­i­cal role of IL-4 and IL-13 as dri­vers of this atopic con­di­tion.”

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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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.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.