Alex­ion takes its first step re­build­ing the pipeline, adding a rare dis­ease drug in $855M cash buy­out

Biotech buy­outs are all the rage these days. To­day, it’s Alex­ion’s $ALXN turn to score with a deal that adds a Phase III drug for a rare dis­ease to its pipeline — mark­ing the new ex­ec­u­tive crew’s “first step” in re­or­ga­niz­ing the pipeline.

Alex­ion struck a deal to buy Stock­holm-based Wil­son Ther­a­peu­tics for $855 mil­lion in cash, of­fer­ing its back­ers a rich pay­day af­ter gath­er­ing a set of mid-stage da­ta demon­strat­ing their drug can flush ex­cess cop­per from the blood of pa­tients with Wil­son dis­ease.

Jonas Hans­son, Wil­son CEO

Wil­son’s last pub­lic ven­ture raise came 4 years ago, when Abing­worth and MVM Life Sci­ence Part­ners stepped up with a $40 mil­lion B round with found­ing in­vestor Health­Cap. And the num­bers in­di­cate that they made out hand­some­ly with the buy­out deal to­day.

Their drug, WTX101, binds to cop­per and al­bu­min, al­low­ing it to be cleared. And Alex­ion had time to con­sid­er proof-of-con­cept num­bers on its safe­ty and ef­fi­ca­cy — with a dis­play planned at EASL this week — as they swooped in to nab the Phase III pro­gram.

The ac­qui­si­tion deal puts Alex­ion on track to play a role in a high-pro­file de­bate over the cost of drugs in the US. Wil­son dis­ease is treat­ed with a drug called Syprine, which was ac­quired by Valeant — and which then spiked the price in a clas­sic price-goug­ing move that Amer­i­can gov­ern­ment of­fi­cials are help­less to pre­vent. Te­va re­cent­ly came along with a gener­ic, but caused out­rage when they set the price at $18,375 for a bot­tle of 100 pills, which the New York Times re­port­ed is 21 times what the orig­i­nal brand­ed drug cost in 2010.

Ac­cord­ing to a state­ment from Wil­son Ther­a­peu­tics’ board, Alex­ion wasn’t the on­ly bid­der, with Lazard gath­er­ing bids in a com­pet­i­tive process launched ear­ly this year.

But it was the most ea­ger.

The deal comes on the heels of a re­or­ga­ni­za­tion at Alex­ion af­ter Lud­wig Hantson stepped in to lead the com­pa­ny last year, bring­ing in a new crew and mak­ing plans to re­lo­cate to Boston. Hantson made it crys­tal clear that aside from the big fran­chise drug Soliris and a next-gen fol­lowup, he didn’t find much to get ex­cit­ed about. That fol­lowup drug, though, wasn’t good enough to prove su­pe­ri­or to Soliris, which could leave the com­pa­ny vul­ner­a­ble as ri­vals gath­er with late-stage tests of their own.

The buy­out al­so spot­lights the M&A spree now un­der­way in biotech, com­ing fast af­ter No­var­tis’ $8.7 bil­lion ac­qui­si­tion of AveX­is on Mon­day. A busy start to Q2 fol­lows a big M&A fren­zy in Q1, with Sanofi buy­ing Biover­a­tiv and Abl­ynx and Cel­gene bag­ging Juno. And more deals are like­ly to fol­low as top play­ers snap up fresh as­sets af­ter a drought of deals last year.

“Wil­son dis­ease is a rare dis­or­der that can lead to se­vere liv­er dis­ease, in­clud­ing cir­rho­sis and acute liv­er fail­ure, as well as de­bil­i­tat­ing neu­ro­log­i­cal mor­bidi­ties such as im­paired move­ment, gait, speech, swal­low­ing, and psy­chi­atric dis­or­ders. WTX101 is an in­no­v­a­tive prod­uct that ad­dress­es the un­der­ly­ing cause of the dis­ease and has the po­ten­tial to de­fine a new stan­dard of care in treat­ing Wil­son dis­ease, an area that has not had a new treat­ment in over two decades,” said Hantson in a state­ment. “The ac­qui­si­tion of Wil­son Ther­a­peu­tics is a strong strate­gic fit for Alex­ion giv­en the over­lap with our cur­rent clin­i­cal and com­mer­cial fo­cus on meta­bol­ic and neu­ro­log­ic dis­or­ders, and is an im­por­tant first step in re­build­ing our clin­i­cal pipeline.”


Im­age: Lud­wig Hantson, Alex­ion CEO.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.

On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.

Sil­ver­back dish­es out two pro­mo­tions in C-suite; Leg­end CEO post changes hands again

→ Accompanying the news that they just scored an $85 million Series C round, Laura Shawver-led Silverback Therapeutics has promoted two execs, with Valerie Odegard adding president to her CSO duties and Naomi Hunder moving to CMO. A Novo Nordisk alum, Odegard has been with the Seattle-based biotech since 2016 and the CSO the last 2 years. Before Silverback, she was VP of research at Juno Therapeutics.