Swe­den's Cal­lid­i­tas seeks $75M IPO haul to bring its oral steroid to pa­tients with an or­phan kid­ney dis­ease

As biotech af­ter biotech elic­its en­thu­si­as­tic in­vestor sup­port for this cor­ner of the IPO mar­ket, a Swedish play­er is join­ing the Nas­daq line to fund the last leg of its clin­i­cal jour­ney.

Cal­lid­i­tas Ther­a­peu­tics is eye­ing a $75 mil­lion raise, a mod­est sum com­pared to some of the big­ger pub­lic de­buts we’ve seen in re­cent days — but they could well up­size the of­fer­ing like oth­er small, ob­scure com­pa­nies be­fore them have done.

The pitch cen­ters around the drug that Cal­lid­i­tas was found­ed on: Ne­fe­con, an oral for­mu­la­tion of the cor­ti­cos­teroid budes­onide. Af­ter li­cens­ing it from Bengt Fell­ström and Roger Häll­gren at Up­p­sala Uni­ver­si­ty, the biotech stayed laser-fo­cused on an or­phan au­toim­mune re­nal dis­ease known as IgA nephropa­thy, or IgAN. By sup­press­ing the im­mune re­ac­tion, the hope is that Ne­fe­con can keep pa­tients from pro­gress­ing to end-stage re­nal dis­ease.

Renée Aguiar-Lu­can­der

Hav­ing di­vid­ed the on­go­ing Phase III tri­al in­to two parts, Cal­lid­i­tas is plan­ning to seek ac­cel­er­at­ed ap­proval if the drug hits the pri­ma­ry end­point on pro­tein­uria — a bio­mark­er in­di­cat­ing pro­tein in dis­ease — in Part A. Part B would then con­firm the clin­i­cal ben­e­fit of Ne­fe­con post-ap­proval.

In Phase IIb, the com­pa­ny not­ed, the drug-in­duced sta­bi­liza­tion of kid­ney func­tion com­pared to place­bo among 150 pa­tients.

The first cut of Phase III da­ta, from 19 sites around the world, is ex­pect­ed in the fourth quar­ter of this year, set­ting up an NDA fil­ing for the first half of 2021 and a launch in 2022..

“Al­though re­cruit­ment in the first quar­ter of 2020 for Part B of Ne­fI­gArd ex­ceed­ed our plans, re­cruit­ment rates have slowed and we ex­pect a re­duced re­cruit­ment rate over the next sev­er­al months due to the im­pact of the COVID-19 pan­dem­ic,” an SEC fil­ing read. “How­ev­er, based on ex­ist­ing en­roll­ment in Part B and ex­pect­ed com­ple­men­tary re­cruit­ment ac­tiv­i­ties in Chi­na, we con­tin­ue to ex­pect to re­port da­ta from Part B in 2022.”

An­drew Udell

While Cal­lid­i­tas in­tends to com­mer­cial­ize in the US on its own with an ini­tial sales­force of 40 — An­drew Udell, the VP of North Amer­i­ca com­mer­cial, will be in charge of that — Ever­est Med­i­cines has paid $15 mil­lion up­front to grab the rights in Chi­na and Sin­ga­pore. Re­gion­al deals for Eu­rope will fol­low.

Scan­di­na­vian in­vestors made up most of the syn­di­cate, with Stif­telsen In­dus­tri­fonden (14.91%), Linc AB (12.49%) and In­vesti­nor AS (10.67%) rank­ing as the top share­hold­ers.

CEO Renée Aguiar-Lu­can­der, al­so holds 1.05% of the stock, the break­down of which is clear­ly dis­played in her bi­og­ra­phy on the Cal­lid­i­tas web­site. This marks the for­mer in­vest­ment banker and sea­soned ven­ture cap­i­tal­ist’s first go on the front­lines of biotech.

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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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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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.

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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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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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.