Robert Coughlin, MassBio CEO (MassBio)

Af­ter down year, 2020 brings new cash in­to Mass­a­chu­setts biotech

The sea of cash that has hit biotech since the pan­dem­ic be­gan has not left out its biggest sec­tor: Mass­a­chu­setts.

Through the first half of 2020, ven­ture cap­i­tal firms have poured more than $2.1 bil­lion in­to biotechs in the state, set­ting the sec­tor on a pace to re­bound af­ter a down year in 2019. The new fig­ure, in­clud­ed in a new in­dus­try snap­shot from the trade group Mass­Bio, is more than 2/3 the $3.1 bil­lion biotechs in the state raised through the en­tire­ty of last year, and would put the sec­tor on track to raise more than any year in the last decade be­sides 2018.

The his­toric IPO boom hasn’t passed the sec­tor over ei­ther. A third of biotech IPOs came from Mass­a­chu­setts, with each com­pa­ny av­er­ag­ing $187 mil­lion.

Eliz­a­beth Steele Mass Bio

“This is all hap­pen­ing dur­ing a pan­dem­ic that is crip­pling the world econ­o­my, but it is def­i­nite­ly putting a spot­light on our in­dus­try and bio­phar­ma in­no­va­tion,” Eliz­a­beth Steele, vice pres­i­dent of pro­grams and glob­al af­fairs at Mass­Bio and au­thor of the re­port, told End­points News. “In 2019, there was a dip in ven­ture cap­i­tal, there was a dip in IPOs over the year be­fore, and I think in 2020 every­one un­der­stands what it feels like to have an un­met med­ical need.”

The re­port comes out as BIO, PhRMA and the in­dus­tries they rep­re­sent go toe to toe again with the White House on pric­ing leg­is­la­tion, af­ter Pres­i­dent Trump on Fri­day signed ex­ec­u­tive or­ders de­signed to curb drug prices. BIO CEO Michelle Mc­Mur­ry-Heath spoke out against the or­ders — which are con­sid­ered large­ly sym­bol­ic on their own — on Fri­day.

In a state­ment, Mass­Bio CEO Robert Cough­lin ar­gued the Mass­a­chu­setts re­port and the de­flat­ed 2019 num­bers were ev­i­dence that drug-pric­ing leg­is­la­tion that ad­vanced last year, which in­clud­ed a bi­par­ti­san bill in the Sen­ate and a De­mo­c­ra­t­ic bill in the House, had culled in­vest­ment. No­tably, though, fund­ing in Mass­a­chu­setts had been down since the first half of 2019, be­fore ei­ther bill was in­tro­duced. The is­sue had, how­ev­er, al­ready ap­peared on the De­mo­c­ra­t­ic cam­paign trail.

“In 2019, we saw some of the most se­vere leg­is­la­tion around drug pric­ing for the in­dus­try, both in Mass­a­chu­setts and fed­er­al­ly, which led to a de­cline in in­vest­ment as we pre­dict­ed it would,” Cough­lin said. “The COVID-19 pan­dem­ic has since up­end­ed our coun­try’s econ­o­my, put a spot­light on the true val­ue of the bio­phar­ma in­dus­try in ad­dress­ing a hu­man health cri­sis, and cre­at­ed a bet­ter un­der­stand­ing of just how dif­fi­cult it is to de­vel­op a ther­a­py or vac­cine.”

The new re­port al­so shows that de­spite re­ports of traf­fic and over­crowd­ing in Kendall Square — or at least pre-pan­dem­ic re­ports of traf­fic and over­crowd­ing — Mass­a­chu­setts re­mains the fastest grow­ing state for biotech R&D jobs. Those jobs rose 18% last year to over 45,000, putting the state just be­hind Cal­i­for­nia. And to­tal Mass­a­chu­setts biotech jobs rose 7.7% last year to just un­der 80,000. Take­da and Sanofi were the largest em­ploy­ers.

Cam­bridge alone con­tin­ues to re­ceive 59% of all in­vest­ment, al­though Mass­Bio ex­pects to see that num­ber de­cline in the near fu­ture.

“We’re hop­ing that more mi­ni-clus­ters pop up in the ar­eas around Boston/Cam­bridge and push fur­ther out,” Steele said. “Cam­bridge is def­i­nite­ly spe­cial and re­mark­able but it doesn’t mean that a com­pa­ny can’t be based 20 min­utes away and still when the pan­dem­ic is over come in­to Cam­bridge for a cof­fee and meet peo­ple face to face.”

The lead­ing Mass­a­chu­setts pri­vate rounds came from Black­stone-backed An­thos Ther­a­peu­tics, which raised $250 mil­lion in a sin­gle round, El­e­vate Bio, and Beam Ther­a­peu­tics. The lead­ing IPOs came from For­ma Ther­a­peu­tics, which raised $278 mil­lion, and Black Di­a­mond Ther­a­peu­tics, which raised $231 mil­lion.

Steele said she ex­pects af­ter a huge year in 2018 and a down year in 2019, the next few years will bring the steady rise the in­dus­try saw for much of the 2010s.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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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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Pascal Soriot (AP Images)

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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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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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.

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.