Vas­cepa sparkle set to light up Amar­in's fourth quar­ter rev­enue

Bask­ing in the glow of its keen­ly an­tic­i­pat­ed FDA ap­proval for its fish oil pill in the block­buster in­di­ca­tion of re­duc­ing car­dio­vas­cu­lar risk in pa­tients al­ready on statins, Amarin on Tues­day un­veiled its pre­lim­i­nary fourth-quar­ter rev­enue that beat Wall Street es­ti­mates.

Amarin ex­pects its to­tal 2019 rev­enue to come in at, or slight­ly ex­ceed, the up­per end of its pre­vi­ous­ly de­clared guid­ance of $410 mil­lion to $425 mil­lion, dri­ven by the sales of its flag­ship drug, Vas­cepa. That works out to rough­ly $140 mil­lion for the fourth quar­ter, north of the con­sen­sus pro­jec­tion of $131 mil­lion and Jef­feries’ es­ti­mate of $135 mil­lion, Jef­feries an­a­lysts wrote in a note.

“In­deed, the com­pa­ny has gen­er­al­ly met or ex­ceed­ed con­sen­sus in each of the last 5+ quar­ters and has con­tin­u­al­ly raised guid­ance,” they said. “We have con­fi­dence in our $3B+ peak es­ti­mate and be­lieve the stock re­mains gen­er­al­ly un­der­val­ued at its cur­rent $21 stock price, or $8.8B ful­ly di­lut­ed, im­ply­ing on­ly around 3x peak sales. We think it’s worth more around $12B or 4x peak sales or an­oth­er 25%+ up­side from here.”

Amarin’s Vas­cepa, known chem­i­cal­ly as icos­apent eth­yl, is an omega-3 fat­ty acid de­rived from fish oil that was orig­i­nal­ly en­dorsed by the US reg­u­la­tor as a treat­ment for el­e­vat­ed triglyc­erides. How­ev­er, last month the FDA sanc­tioned its use in a much broad­er pa­tient pop­u­la­tion af­ter a land­mark tri­al — RE­DUCE-IT — which showed the pill trig­gered a 25% re­duc­tion in the risk for the first oc­cur­rence of a ma­jor car­dio event, and a 26% re­duc­tion for 3-point MACE, a com­pos­ite of car­dio­vas­cu­lar death, non­fa­tal heart at­tack and non­fa­tal stroke.

On Tues­day, Amarin re­it­er­at­ed its 2020 sales ex­pec­ta­tions of $650 mil­lion to $700 mil­lion and pre­dict­ed that be­yond this year, it ex­pects its net rev­enue will grow in­to bil­lions of dol­lars.

The com­pa­ny al­so ex­pects its op­er­at­ing ex­pens­es to be high­er by $200 mil­lion to $250 mil­lion this year, ver­sus over 2019, trig­gered by costs as­so­ci­at­ed with the com­pa­ny’s planned ex­pan­sion of its sales team and RE­DUCE-IT pro­mo­tion­al ac­tiv­i­ties, in­clud­ing di­rect-to-con­sumer ad­ver­tis­ing. These opex es­ti­mates are high­er than what Wall Street was ex­pect­ing, but will like­ly be off­set by sales out­per­for­mance, Stifel an­a­lysts wrote in a note.

One press­ing is­sue for Amarin is the patent lit­i­ga­tion it is cur­rent­ly in­volved in against gener­ic drug­mak­ers Red­dy’s and Hik­ma. The tri­al be­gins on Jan­u­ary 13, and is ex­pect­ed to last three weeks — a de­ci­sion is ex­pect­ed by March/April, Jef­feries an­a­lysts said. “Based on our ex­pert conf calls and dili­gence, we are hope­ful for a set­tle­ment be­fore all of that or a pos­i­tive patent vic­to­ry which could clear a key over­hang for in­vestors,” they wrote.

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.

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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.