Are­na sheds ties to weight drug Belviq, com­plet­ing a makeover

Amit Mun­shi, Are­na

From now on, you can scratch any lin­ger­ing rep Are­na Phar­ma­ceu­ti­cals $AR­NA had as an obe­si­ty-fo­cused biotech. Four-and-a-half years af­ter the FDA ap­proved its weight drug Belviq for mar­ket­ing, and long af­ter vi­sions of block­buster sales van­ished like a mi­rage, the biotech has sold off rights to the drug to its part­ner Ei­sai and backed away from any re­main­ing fi­nan­cial com­mit­ment for fur­ther tri­al work.

Right on cue, Are­na al­so filed a $50 mil­lion ATM Wednes­day af­ter­noon.

In its place Are­na will take a promise for up to $26 mil­lion in com­mer­cial mile­stones and redi­rect about $80 mil­lion it es­ti­mates were ear­marked for Belviq. That mon­ey will now be put it in ser­vice of three mid-stage drugs in its pipeline. There’s an­oth­er $23 mil­lion in sup­port pay­ments and a 31.5% roy­al­ty will be re­placed with roy­al­ty pay­ments of 9.5% on an­nu­al glob­al net sales of lor­caserin less than or equal to $175 mil­lion, 13.5% on an­nu­al glob­al net sales greater than $175 mil­lion but less than or equal to $500 mil­lion and 18.5% on an­nu­al glob­al net sales greater than $500 mil­lion.

Quar­ter­ly sales and roy­al­ties for the drug, though, have been in de­cline.

The move com­pletes a shift set in mo­tion by CEO Amit Mun­shi, who stepped in last spring just as his for­mer biotech — the biosim­i­lar man­u­fac­tur­er Epirus —  was about to crash and burn. Mun­shi has al­ready re­or­ga­nized Are­na, lay­ing off 120 full time po­si­tions; the biotech now has about 50 staffers for its de­vel­op­ment mis­sion. And Mun­shi’s set to look to four da­ta read­outs on Are­na’s whol­ly-owned or part­nered as­sets.

Their top clin­i­cal pro­gram is for etrasi­mod (APD334), which Mun­shi de­scribes as the “sec­ond S1P mod­u­la­tor be­hind Re­cep­tos (ozan­i­mod),” bought out by Cel­gene for more than $7 bil­lion. Phase II da­ta is due in late 2017. Ra­linepag (ADP811) will de­liv­er mid-stage da­ta on pul­monary ar­te­r­i­al hy­per­ten­sion lat­er in the year. And their cannabi­noid 2 re­cep­tor ag­o­nist for Crohn’s pain wraps the in-house pipeline. Nelotanserin, a 5-HT2A in­verse ag­o­nist, is part­nered with Ax­o­vant for de­men­tia as­so­ci­at­ed psy­chosis.

If you look back at the wave of obe­si­ty drugs near­ing the FDA at the same time in 2012, Mun­shi tells me, each was linked by “some an­a­lyst with bil­lion-plus peak sales. Each are sub-$50 mil­lion to­day.” Lin­ger­ing safe­ty con­cerns from an ear­li­er gen­er­a­tion of weight drugs cre­at­ed an over­hang of con­cerns that Are­na and Ei­sai were nev­er able to shake, says the CEO. Pay­ers nev­er stepped up with a com­mit­ment to re­im­burse for the drugs. But he says he still be­lieves that Ei­sai can turn it around, look­ing for more da­ta from a longterm car­dio out­come tri­al.

Now, though, the new, slimmed down mis­sion at Are­na will be mi­nus the weight of Belviq.

Mer­ck is tak­ing the ax to its US op­er­a­tions, cut­ting 500 jobs in its lat­est re­or­ga­ni­za­tion

Merck is cutting 500 jobs in its US sales and headquarters commercial teams in its latest effort to find new ways to streamline the operation.

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Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Ronald Herb­st fol­lows Med­Im­mune ex­o­dus to Pyx­is CSO post; Jeff God­dard to suc­ceed CEO of AIT Bio­science

→ The outflow of top execs from MedImmune continues to fill the leadership ranks of smaller biotechs. The latest to take off is Ronald Herbst, the head of oncology research, who’s assuming the CSO post at Pyxis Oncology.  

Herbst was part of the old MedImmune organization AstraZeneca CEO Pascal Soriot restructured earlier this year, reorganizing the company and eliminating the storied subsidiary as a separate organization.

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UP­DAT­ED: J&J's Xarel­to, Amar­in's Vas­cepa are cost-ef­fec­tive, not bud­get friend­ly — ICER

ICER, an increasingly influential cost-effectiveness watchdog in the United States, has concluded in its review of treatments for cardiovascular disease that while the cost of J&J’s Xarelto and Amarin’s Vascepa meet its benchmark for value pricing — the two treatments will not likely treat as many patients as hoped without surpassing the annual budget threshold calculated by ICER for each therapy.

Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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