Ex-Bax­al­ta CEO Lud­wig Hantson gets the top job at a trou­bled Alex­ion


So Lud­wig Hantson will get his chance to run a biotech com­pa­ny af­ter all.

A lit­tle less than nine months af­ter Shire closed on its deal to buy Bax­al­ta, a new spin­out out of Bax­ter, for $32 bil­lion, the for­mer CEO at Bax­al­ta now has the top job at Alex­ion.

Hantson had run Bax­ter Bio­Science be­fore they gave him the reins at Bax­al­ta, giv­ing him a run at op­er­at­ing a $6 bil­lion group re­spon­si­ble for launch­ing 13 prod­ucts. Shire, though, leaped on the buy­out short­ly af­ter it was spun out. Now he’ll be step­ping in­to a va­can­cy cre­at­ed by a mar­ket­ing scan­dal that took down both the CEO and the CFO, who were en­tan­gled in a scheme to push ear­ly sales of Soliris in or­der to meet Wall Street’s rev­enue ex­pec­ta­tions.

Alex­ion $ALXN has a mar­ket cap of close to $27 bil­lion.

Leerink’s Ge­of­frey Porges ques­tioned why a biotech like Alex­ion would want a Big Phar­ma ex­ec like Hantson at the helm.

(C)om­pared to oth­er CEO pos­si­bil­i­ties, in­vestors are like­ly to pre­sume a will­ing­ness by Hantson to sell Alex­ion, should the right of­fer be made, rather than any hubris­tic com­mit­ment to in­de­pen­dence at all costs. Neg­a­tive re­ac­tions to the ap­point­ment could be the lack of biotech ex­pe­ri­ence for Hantson and the re­in­force­ment of Alex­ion’s “big phar­ma” makeover. The ap­point­ment al­so means that oth­er can­di­dates with more di­rect­ly rel­e­vant rare dis­ease and biotech ex­pe­ri­ence have been passed over by Alex­ion’s board of di­rec­tors. Last­ly, some in­vestors will be­lieve that this an­nounce­ment takes the prospects for ac­qui­si­tion of Alex­ion off the ta­ble, for at least the im­me­di­ate fu­ture, al­though we doubt that this an­nounce­ment re­al­ly im­plies such a change in re­cep­tiv­i­ty (for the right of­fer).

Hantson will have his work cut out for him. Just days ago the com­pa­ny — run on an in­ter­im ba­sis by board mem­ber David Bren­nan, who was axed by the board at As­traZeneca af­ter sad­dling the com­pa­ny with the worst pipeline in Big Phar­ma — trig­gered a re­or­ga­ni­za­tion, cut­ting 7% of the com­pa­ny’s work­force. That’s more than 200 em­ploy­ees.

An­a­lysts have been com­plain­ing for months now that Alex­ion has be­come a chron­ic un­der­per­former, with the com­plaints grow­ing af­ter Soliris failed a piv­otal tri­al re­cent­ly. None of that was helped af­ter they de­cid­ed to scrap a drug Alex­ion got out of the $8.4 bil­lion Synage­va buy­out, SBC-103, which made the whole deal sus­pect. An ap­proved drug out of Synage­va, Kanu­ma, has been a ma­jor dis­ap­point­ment on the sales side.

Hantson al­so now faces sev­er­al ri­vals to Soliris in the clin­ic now, which hope to top­ple the com­pa­ny’s big fran­chise drug.

Hantson, who’s aware of all of that, was look­ing at a glass more than halfway full this morn­ing, hint­ing at some pos­si­ble deals to come.

Says Hantson:

Alex­ion is on-track to achiev­ing its near-term pri­or­i­ties, in­clud­ing: grow­ing its com­ple­ment and meta­bol­ic fran­chis­es; ob­tain­ing ap­proval of Soliris in re­frac­to­ry gMG; and ad­vanc­ing its pipeline pro­grams in­clud­ing ALXN1210 and eculizum­ab in re­laps­ing NMOSD. I al­so look for­ward to build­ing our fu­ture R&D and com­mer­cial growth strate­gies which will be guid­ed by the Com­pa­ny’s long-stand­ing goal of trans­form­ing lives.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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Ben Dake (Source: Aerovate)

RA Cap­i­tal-backed Aerovate launch­es with $72.6M to treat PAH with a re­pur­posed can­cer med

The landmark cancer drug imatinib has been on the market since 2001, first sold by Novartis as Gleevec and in recent years as a generic. Now, a new Boston biotech is aiming to repurpose the drug as a treatment for pulmonary arterial hypertension.

Aerovate emerged from stealth Thursday and announced a $72.6 million Series A, which will be used to develop and run trials for its candidate AV-101 — a dry powder version of imatinib meant to be used with an inhaler. The company emerged from RA Capital’s incubator and funding was led by Sofinnova.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Covid-19 roundup: 34 AGs call for ‘march-in’ rights on remde­sivir; Hahn pleads with pub­lic to trust FDA's vac­cine re­view

A bipartisan group of 34 attorneys general have asked the federal government to bypass Gilead’s patent rights on remdesivir and begin scaling and distributing the Covid-19 antiviral, or to allow the states to do it themselves.

In a letter to HHS secretary Alex Azar, the AGs expressed frustrations over the $3,250 price tag Gilead placed on the the drug, citing the federal funding that went into its developments. And they noted the sustained difficulties hospitals have faced in getting supplies from either the California biotech or their contract manufacturer AmerisourceBergen.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Ab­b­Vie aban­dons a pi­o­neer­ing CRISPR R&D al­liance with Ed­i­tas as Brent Saun­der­s' deal is cast out

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.