John Thero (Christopher Goodney/Bloomberg via Getty Images)

Amarin CEO John Thero pass­es ba­ton to Eu­rope com­mer­cial chief as M&A hopes con­tin­ue to de­flate

Karim Mikhail

As Amarin breaks in­to the Eu­ro­pean mar­ket, John Thero is head­ing out.

Af­ter steer­ing the ship for 7 years, Thero is hand­ing the CEO job to Karim Mikhail, who came on board ear­li­er this year to head the com­mer­cial­iza­tion of Amarin’s fish oil pill in Eu­rope. Mikhail’s ap­point­ment is ef­fec­tive Aug. 1, when Thero will of­fi­cial­ly re­tire and tran­si­tion to an ad­vi­sor role un­til the end of 2021.

Since join­ing Amarin in 2009, Thero has been cred­it­ed for a slate of achieve­ments that gave in­vestors lots to be ex­cit­ed about. Un­der his watch, Vas­cepa — the phar­ma­ceu­ti­cal grade omega-3 fat­ty acid prod­uct first ap­proved in 2012 — was cruised to a pos­i­tive Phase III da­ta read­out de­spite some con­tro­ver­sy, spurring an im­pres­sive re­duc­tion in risk of car­dio­vas­cu­lar events that led to a quick FDA add-on ap­proval.

The one thing he is leav­ing with­out is a multi­bil­lion-dol­lar buy­out — and, with the doors ap­par­ent­ly closed to a patent ex­ten­sion, the hopes are dim­ming by the day.

All of that sig­nals a “tough road ahead,” ac­cord­ing to Jef­feries an­a­lyst Michael Yee, who’s been a big cheer­leader for Thero:

Thus, in­vestors may be dis­ap­point­ed in the tran­si­tion and that it may sig­nal no near term M&A on the ta­ble (which is the clear and pri­ma­ry bull case to the stock). That said – one might ar­gue per­haps a change means new mgmt may po­si­tion AM­RN in a way to be eas­i­er to sell via M&A and/or that this opens the co up to more op­tions, but we don’t think that is like­ly and the most log­i­cal sce­nario is AM­RN will go for­ward with a Q3 EU launch which will take time.

In a state­ment, Amarin praised Mikhail’s cre­den­tials in launch­ing new drugs — topped by a stint as glob­al com­mer­cial leader for Mer­ck’s $4 bil­lion lipid fran­chise. In that role, the com­pa­ny high­light­ed, “he was re­spon­si­ble for re­vers­ing the busi­ness’ de­cline in the US mar­ket and glob­al­ly, ac­cel­er­at­ing rev­enue by an ad­di­tion­al $380 mil­lion through the launch of ATOZET and dri­ving EBIT­DA growth through in­ter­na­tion­al ex­pan­sion.”

Amarin will need it. Yee ex­pects the US sales for Q1 to come in just shy of con­sen­sus, even as its gener­ic com­peti­tors at Hik­ma and Dr. Red­dy’s are hav­ing is­sues with man­u­fac­tur­ing and scal­ing up.

“(It) looks like Amarin should be okay in the near term and main­tain 80-90% share, but un­cer­tain­ty re­mains around even­tu­al dura­bil­i­ty of US sales (i.e., what per­cent tail val­ue is re­tained over 2-5+ years),” he wrote.

Fresh­ly ap­proved as Vazkepa in Eu­rope just days ago, the drug is set for a near-term launch and should score an­oth­er OK in Chi­na lat­er this year, Mikhail added.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).