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.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

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Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

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