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.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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En­her­tu picks up an­oth­er win for As­traZeneca and Dai­ichi Sankyo, join­ing the pri­or­i­ty re­view lane for gas­tric can­cer

Five months after Enhertu received twin breakthrough therapy designations, AstraZeneca and Daiichi Sankyo are one step closer to nabbing another approval for their potential blockbuster drug.

The companies announced Wednesday morning that their billion-dollar antibody-drug conjugate has received priority review for HER2 positive metastatic gastric cancer. Already approved in the US for third-line metastatic breast cancer patients that are HER2 positive, Enhertu’s gastric cancer PDUFA date is scheduled for the first quarter of 2021.

Sci­en­tists warn Amer­i­cans are ex­pect­ing too much from a coro­n­avirus vac­cine

The White House and many Americans have pinned their hopes for defeating the Covid-19 pandemic on a vaccine being developed at “warp speed.” But some scientific experts warn they’re all expecting too much, too soon.

“Everyone thinks COVID-19 will go away with a vaccine,” said William Haseltine, chair and president of Access Health International, a foundation that advocates for affordable care.

No­var­tis CEO Vas Narasimhan signs off on a $231M deal to try some­thing new in the R&D fight against SARS-CoV-2

Patrick Amstutz was baptized by pandemic fire early on.

He and colleagues attended the notorious Cowen conference in early March that included some of the top Biogen execs who helped trigger a superspreader event in Boston. Heading back to his post as CEO of Molecular Partners in Switzerland, the outbreak was sweeping through Italy, triggering near panic in some quarters and creeping into the voices of people he knew, including one friend on the Italian side of the country.

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Cedric Francois, Apellis CEO (Optum via YouTube)

UP­DAT­ED: So­bi bets $250M cash, about $1B in mile­stones for rights to a C3 ther­a­py be­ing pushed through 5 piv­otal tri­als

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early- and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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