At­las wraps Arteaus sto­ry with $260M roy­al­ty sale as Em­gal­i­ty sales inch­es up­ward

Six months af­ter Eli Lil­ly notched a sec­ond-run­ner-up ap­proval for its CGRP mi­graine drug Em­gal­i­ty, the At­las-found­ed biotech that brought it over the proof-of-con­cept gate five years ago has sold all its roy­al­ty in­ter­est for $260 mil­lion.

In Arteaus’ “fi­nal chap­ter” — as At­las part­ner Bruce Booth calls it — the now-de­funct biotech hand­ed Roy­al­ty Phar­ma all pro­ceeds it would earn on fu­ture glob­al net sales of Em­gal­i­ty. The deal marks the fi­nal mon­e­ti­za­tion from Arteaus, which ceased op­er­a­tions as an in­de­pen­dent en­ti­ty af­ter Eli Lil­ly bought back rights to the drug in 2014.

Bought back, be­cause the drug was Lil­ly’s to start with. Arteaus was cre­at­ed cir­ca 2010 as a “built to buy” com­pa­ny amid dis­cus­sions be­tween At­las and Eli Lil­ly to ex­ter­nal­ize the Big Phar­ma’s R&D ef­forts. A lean team of ex­pe­ri­enced biotech ex­ecs (led by Dave Grayzel) li­censed what was then called gal­canezum­ab, raised $18 mil­lion in Se­ries A mon­ey and de­liv­ered re­sults from two dose as­cend­ing stud­ies as well as a Phase II ef­fi­ca­cy study with­in three years.

“Based on­ly on pub­lic dis­clo­sures, Arteaus has gen­er­at­ed north of $300M in pay­ments across the up­front, mile­stones, and roy­al­ties – af­ter spend­ing less than $18M in eq­ui­ty cap­i­tal,” Booth writes in a blog­post. “A su­perb ven­ture re­turn.”

Booth adds that part­ner­ing with roy­al­ty port­fo­lio firms like Roy­al­ty Phar­ma was al­ways the plan “giv­en the tem­po­ral chal­lenge of a closed-end time-lim­it­ed ven­ture fund and the long tail of fu­ture roy­al­ty pay­ments.”

Dave Grayzel

Em­gal­i­ty was the third CGRP in­jectable to join the mi­graine pre­ven­tion par­ty, fol­low­ing af­ter Am­gen/No­var­tis’ Aimovig and Te­va’s Ajovy. But un­like its ri­vals and an­a­lysts, who have con­ced­ed that da­ta un­der­ly­ing the three prod­ucts are large­ly sim­i­lar, Lil­ly made the case that its me-too drug was in fact a touch above the rest, and its sales strat­e­gy would do the rest.

De­spite some­what dis­ap­point­ing sales of $5 mil­lion in the three months in 2018, Eval­u­atePhar­ma is fore­cast­ing 2024 sales of $1.2 bil­lion for Em­gal­i­ty, match­ing Roy­al­ty Phar­ma’s block­buster hopes that the drug will carve out a sub­stan­tial share of the mam­moth mar­ket that ad­dress­es 30 mil­lion Amer­i­cans (worth $5 bil­lion to $6 bil­lion by some es­ti­mates).

Mean­while, Em­gal­i­ty has al­so been grant­ed pri­or­i­ty re­view by the FDA to pre­vent episod­ic clus­ter headaches in adults, an un­der-rec­og­nized and of­ten mis­di­ag­nosed dis­or­der that has no FDA-ap­proved pre­ven­ta­tive treat­ments so far.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.