Lund­beck bags a PhII Parkin­son's drug with $1.1B Prex­ton buy­out deal

Six years af­ter a team of glu­ta­mate re­cep­tor spe­cial­ists spun out of the wreck­age left be­hind by Mer­ck KGaA’s re­treat from Gene­va and launched Prex­ton Ther­a­peu­tics, Lund­beck is swoop­ing in to buy the com­pa­ny and its mid-stage Parkin­son’s drug. Lund­beck is hand­ing over $123 mil­lion and com­mit­ting to about a bil­lion dol­lars more in mile­stones — with more than half of that tied to sales goals.

Lund­beck is spend­ing its mon­ey on a sin­gle as­set: foliglu­rax.

François Con­quet

Prex­ton CEO François Con­quet spent his en­tire ca­reer fo­cused on the role of glu­ta­mate re­cep­tors for CNS dis­eases. He found­ed Ad­dex back in 2002 and ran it for three years, leav­ing it with an mGluR5 pro­gram — dipraglu­rant — now in a late-stage study for Parkin­son’s. And at Prex­ton he fo­cused in mGluR4 as an al­ter­na­tive ap­proach to us­ing dopamine to con­trol the mo­tor symp­toms of Parkin­son’s.

He told me last year that he was run­ning two stud­ies, one in Eu­rope on Parkin­son’s symp­toms and the oth­er in the US for lev­odopa-in­duced dysk­i­ne­sia.

Lund­beck has had some painful set­backs in neu­ro­sciences re­cent­ly, with some new fail­ures on Alzheimer’s to re­port. Its CEO Kåre Schultz al­so jumped ship to take the helm of a storm-tossed Te­va last fall.

An­ders Götzsche, in­ter­im CEO and CFO at Lund­beck, not­ed:

Foliglu­rax ad­dress­es high un­met needs with its po­ten­tial in­di­ca­tion in Parkin­son’s fit­ting per­fect­ly with­in Lund­beck’s core ar­eas and this treat­ment op­tion al­so ap­pears to be high­ly in­ter­est­ing for pa­tients, physi­cians and pay­ors.

Mer­ck Ven­tures helped launch the com­pa­ny and For­bion and Ser­o­ba Life Sci­ences stepped in to co-lead a $31 mil­lion round ear­ly last year.

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Mark Iwicki, Kala Pharmaceuticals CEO (Merus)

Al­con takes a crack at multi­bil­lion-dol­lar dry eye mar­ket, picks up 2 drugs from Langer spin­out

Kala Pharmaceuticals may have never come close to the blockbuster dreams it had for its dry eye disease treatment, but Alcon wants to see if it can take the drug further.

After giving commercialization its best shot over the past few years, Kala decided the marketing game is not for it after all. Instead, it will sell both of its commercial eye drop products — Eysuvis for dry eye disease, and Inveltys for post-operative inflammation and pain following ocular surgery — to Alcon for $60 million in cash, plus an undisclosed amount of milestones.

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Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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