Anx­ious to fill Hu­mi­ra-sized rev­enue hole ahead of US patent cliff, Ab­b­Vie hits the ground run­ning with FDA ap­proval for Skyrizi

With the loom­ing cloud of los­ing US patent pro­tec­tion for its mega-block­buster Hu­mi­ra, Ab­b­Vie needs all the help it can get to fill the gap­ing $20 bil­lion hole the flag­ship au­toim­mune dis­ease drug will leave in its cof­fers. On Tues­day, the com­pa­ny se­cured the FDA ap­proval of an IL-23 in­hibitor, Skyrizi, that is ex­pect­ed to go some way in re­plen­ish­ing that rev­enue stream: $4 bil­lion to $5 bil­lion in peak an­nu­al sales by Ab­b­Vie’s es­ti­mate — al­though that may be dif­fi­cult in the in­tense­ly com­pet­i­tive field it is set to en­ter.

Ab­b­Vie paid Boehringer In­gel­heim $595 mil­lion up­front to li­cense rights to the drug, known chem­i­cal­ly as risankizum­ab, in ear­ly 2016. In the fall of 2017, the in­ject­ed drug was eval­u­at­ed against J&J’s Ste­lara and its own Hu­mi­ra in a pso­ri­a­sis study — and emerged vic­to­ri­ous, hand­some­ly out­pac­ing the ri­val drugs in clear­ing pso­ri­a­sis. Japan be­came the first re­gion to sanc­tion the use of Skyrizi last month.

More than 8 mil­lion Amer­i­cans have pso­ri­a­sis — mak­ing it one of the most preva­lent au­toim­mune dis­eases in the Unit­ed States, ac­cord­ing to the Na­tion­al Pso­ri­a­sis Foun­da­tion. The dis­ease is char­ac­ter­ized by an un­bri­dled im­mune sys­tem and wide­spread in­flam­ma­tion that caus­es painful, itchy plaques any­where on the skin.

Set for US launch in ear­ly May, Skyrizi will en­ter a crowd­ed mar­ket. Hu­mi­ra con­tin­ues to dom­i­nate de­spite the in­tro­duc­tion of new­er bi­o­log­ics, in­clud­ing No­var­tis’ $NVS an­ti-IL17 Cosen­tyx, J&J’s $JNJ an­ti-IL23 Trem­fya and an­ti-IL12/23 Ste­lara, as well as Lil­ly’s $LLY an­ti-IL17 Taltz.

Skyrizi is not the first pure IL-23 in­hibitor to be ap­proved — Trem­fya was ap­proved in 2017 and Ilumya in 2018. But the Ab­b­Vie drug has a dos­ing ad­van­tage over Trem­fya — it is ad­min­is­tered every 12 weeks, ver­sus once every two months for Trem­fya, SVB Leerink’s Ge­of­frey Porges said on Wednes­day, not­ing that oth­er pso­ri­a­sis bi­o­log­ics in ad­di­tion to the oral Ote­zla gen­er­at­ed a com­bined $11.1 bil­lion in 2018 sales.

This does not in­clude sales of an­ti-TN­Fs in pso­ri­a­sis, which should de­crease as pa­tients move to these new, more ef­fi­ca­cious ther­a­pies. These prod­ucts al­so all achieved $500 mil­lion – $1 bil­lion in the sec­ond year of launch, which is like­ly to al­so be achieved by Skyrizi. Over­all bi­o­log­ics are still used in on­ly 30% of the mod­er­ate to se­vere pso­ri­a­sis pop­u­la­tion, (per JNJ in 2017), and Ab­b­Vie’s Skyrizi should ben­e­fit from both best-in-cat­e­go­ry ef­fi­ca­cy (i.e. mar­ket share gains) and the con­tin­ued rapid mar­ket ex­pan­sion.”

The main­te­nance dose for Skyrizi will car­ry a list price of $59,000, which is low­er than the most wide­ly-pre­scribed bi­o­log­ic treat­ments for mod­er­ate-to-se­vere plaque pso­ri­a­sis, an Ab­b­Vie spokesper­son told End­points News.

The drug is ex­pect­ed to win EU ap­proval lat­er this year, and is al­so be­ing eval­u­at­ed for Crohn’s dis­ease, pso­ri­at­ic arthri­tis and ul­cer­a­tive col­i­tis.

“(D)es­pite be­ing po­si­tioned as a best-in-class op­tion, risankizum­ab failed in a proof-of-con­cept anky­los­ing spondyli­tis study, rais­ing ad­di­tion­al ques­tions over its pro­file” Bar­clays an­a­lysts said in March.

Boehringer will re­ceive undis­closed roy­al­ties on sales of the prod­uct, and in ad­di­tion is el­i­gi­ble to get up to $1.6 bil­lion for de­vel­op­ment and reg­u­la­to­ry mile­stones, a por­tion of which has like­ly been paid al­ready, Porges not­ed.

Eval­u­ate has pegged Skyrizi as the num­ber 3 block­buster on its list of heavy­weight drugs launch­ing in 2019, es­ti­mat­ing the drug could earn more than $2 bil­lion in 2024 — a far cry from Ab­b­Vie’s home­grown es­ti­mate of $4 bil­lion to $5 bil­lion in peak sales. Porges has fore­cast ad­just­ed peak an­nu­al sales of $3 bil­lion.

The oth­er can­di­date ex­pect­ed to fill the Hu­mi­ra gap is Ab­b­Vie’s oral JAK1 in­hibitor upadac­i­tinib for rheuma­toid arthri­tis. The com­pa­ny $AB­BV has high hopes for the treat­ment, pro­ject­ing peak sales of $6.5 bil­lion, which was re­ward­ed pri­or­i­ty re­view by the FDA in Feb­ru­ary. The agency is ex­pect­ed to make its de­ci­sion by the third quar­ter of 2019.

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.

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.

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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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.

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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