Bellde­grun and Chang groom their biotech uni­corn Al­lo­gene for a mon­ster $288M — or so — IPO

Arie Bellde­grun and David Chang are think­ing big again, of course.

To­day the pair run­ning the biotech start­up Al­lo­gene, a CAR-T com­pa­ny $AL­LO look­ing to make his­to­ry pi­o­neer­ing off-the-shelf cell ther­a­peu­tics, out­lined plans to sell 16 mil­lion shares in the com­pa­ny at $16 to $18 a share. That’s $288 mil­lion at the top of the range — though these 2 may not be sat­is­fied with any­thing less than more.


Ac­cord­ing to Re­nais­sance Cap­i­tal, the IPO as­signs Al­lo­gene a ful­ly di­lut­ed mar­ket val­ue of $2.1 bil­lion and an en­ter­prise val­ue of $1.4 bil­lion. Bellde­grun will own 10.9% of that, ac­cord­ing to the S-1, while Chang, the CEO, is in for 3.9%.

Al­lo­gene land­ed with a mighty splash in 2017, ar­riv­ing com­plete with a port­fo­lio of drugs it had in-li­censed from Pfiz­er and a rep that Bellde­grun & Chang had forged at Kite — ac­quired for $12 bil­lion — for build­ing top-per­form­ing teams which knew how to move fast.

In short or­der they raised a $300 mil­lion round in the spring, quick­ly fol­lowed by a $120 mil­lion more and now some­thing on the or­der of $300 mil­lion to add to that. That would be more than $700 mil­lion in 6 months time.

It’s like­ly to set the record for biotech IPOs this year, which is shap­ing up as one of the biggest — of not the biggest — years in the past decade. Ru­bius achieved a to­tal of around $277 mil­lion — a jaw-drop­ping amount for a pre­clin­i­cal com­pa­ny.

Gold­man Sachs, JP Mor­gan, Cowen and Jef­feries are the joint bookrun­ners on the deal, which an­a­lysts ex­pect to price dur­ing the week of Oc­to­ber 8, com­ing up.

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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Covid-19 roundup: Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab; More biotechs dis­close tri­al dis­rup­tions

CRISPR pioneer Jennifer Doudna and her team at UC Berkeley’s Innovative Genomics Institute are pitching in to an industry-wide effort of casting a wide net to diagnose and track Covid-19 within the US.

While the US has rapidly ramped up its testing capacity from an abysmal level — fewer than 100 a day and all conducted by the CDC — in February to tens of thousands daily, governors have warned that they’re still facing shortages. The lack of fast, accurate and widespread testing creates a barrier to building a nationwide surveillance system, which many believe is needed to both understand how the coronavirus is spreading across the country and make key public health decisions.

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Eli Lil­ly antes up $60M gam­ble on a dis­cov­ery deal with GSK-backed biotech

GSK-backed Sitryx has scored another illustrious partner: Eli Lilly.

The Oxford, UK-based company, which is focused on regulating immune cell metabolism to treat cancer and autoimmune diseases, has secured $50 million upfront from the US drugmaker in a deal that will make way for the two companies to collaborate on preclinical autoimmune disease targets identified by Sitryx.

Lilly, which already has its JAK inhibitor Olumiant and IL-17A antagonist Taltz in its immunology portfolio, will also make a $10 million equity investment in Sitryx, and is also on the hook for potential development milestone payments of up to $820 million, as well as commercialization milestones and royalty payments on potential sales.

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Un­de­terred by pan­dem­ic dis­rup­tions, Cowen backs AM-Phar­ma's $176M piv­otal plan around lethal con­di­tion

It may not be the best time to start up a late-stage study unrelated to Covid-19, but AM-Pharma isn’t letting a slight delay derail its overall plan.

The Dutch biotech has been singularly focused on recAP, an anti-inflammatory recombinant human form of an enzyme originally found in cows called alkaline phosphatase.

The one Phase III it believes it needs for approval was scheduled for this summer, funded by a $133 million round last July. Having pushed study initiation to after the summer, AM-Pharma is adding $52 million for the regulatory work needed to prepare for launch, including CMC validation and commercial supply.

John Reed, Sanofi’s global head of R&D (Image: Endpoints News)

IL-6 to the res­cue? Sanofi, Re­gen­eron bar­rel ahead in­to an­oth­er piv­otal ef­fort test­ing Kevzara for Covid-19

Sanofi and Regeneron have hustled up a second pivotal trial for their IL-6 drug Kevzara as a potential therapy for severe cases of Covid-19. The partners swiftly assembled a study drawing patients from Italy, Spain, Germany, France, Canada and Russia, planning to sign up 300 patients in a Phase II to test a low and high dose of Kevzara against placebo, setting the stage for the Phase III followup.

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Covid-19 and weak da­ta force pipeline re­vamp at Rea­ta, but the best tri­als go for­ward — with some cre­ative adap­tions

A confluence of weak clinical results and the rising tide of problems besetting clinical trials in the age of coronavirus has scuttled a significant part of the pipeline effort at Reata Pharmaceuticals.

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