Are­na bounces back. Stock soars on ozan­i­mod ri­val's PhII suc­cess

Its di­et pill was a com­mer­cial flop that al­most sent Are­na to the grave. Now — with its sec­ond pipeline drug re­port­ing pos­i­tive mid-stage da­ta — Are­na is mak­ing a come­back.

Af­ter a rocky few years that in­clud­ed mas­sive lay­offs, com­pa­ny­wide re­struc­tur­ing, and an oblit­er­at­ed stock, Are­na now has a fresh pipeline with two drugs that have pro­duced sol­id Phase II da­ta. The San Diego com­pa­ny’s stock $AR­NA, once in the gut­ter, has more than dou­bled since this time last year.

Amit Mun­shi

The stock price flew up 25% overnight fol­low­ing news late Mon­day that its ul­cer­a­tive col­i­tis drug etrasi­mod proved promis­ing in a Phase II study. The once-dai­ly oral drug is a S1P re­cep­tor mod­u­la­tor that works much like the block­buster hope­ful ozan­i­mod. That drug was the sub­ject of Cel­gene’s $7.2 bil­lion buy­out of an­oth­er San Diego com­pa­ny, Re­cep­tos, and has been tout­ed as $1 bil­lion-plus per year as­set. Its fu­ture, how­ev­er, is un­clear af­ter the FDA kicked back Cel­gene’s mar­ket­ing ap­pli­ca­tion just last month.

In a lengthy con­ver­sa­tion last year, Are­na’s CEO Amit Mun­shi told me its drug etrasi­mod was like ozano­mid… but bet­ter. “We be­lieve it’s safer and po­ten­tial­ly more ef­fi­ca­cious (than ozan­i­mod),” Mun­shi said.

In the re­cent Phase II study, Are­na re­port­ed pa­tients on the 2-mg dose of the drug had sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments over the place­bo in all pri­ma­ry, sec­ondary, and clin­i­cal re­mis­sion end­points.

Some in­vestors, how­ev­er, wor­ry the FDA’s re­cent re­ac­tion to ozan­i­mod might sig­nal safe­ty is­sues and a po­ten­tial class ef­fect that would cast a shad­ow on etrasi­mod. Biotech an­a­lysts at Leerink, though, see no rea­son to jump to that con­clu­sion.

We don’t think this is the case, or else they would have re­port­ed it by now, giv­en its ma­te­ri­al­i­ty. Man­age­ment has pre­vi­ous­ly spo­ken of S1P re­cep­tors 2 and 3 con­tribut­ing to car­diac, pul­monary, and pos­si­ble tu­mor-re­lat­ed risks. As a re­sult, ac­tiv­i­ty of S1P re­cep­tor mod­u­la­tors will man­i­fest un­want­ed car­diac AEs un­less the com­pound has se­lec­tiv­i­ty. Etrasi­mod has been de­signed to se­lec­tive­ly tar­get re­cep­tors 1, 4, and 5 for clin­i­cal ef­fi­ca­cy while avoid­ing 2 and 3. Sup­port­ing this claim, Are­na did not see any sub­stan­tial heart rate ef­fects in their Phase I study, which is re­flect­ed in the lack of dose titra­tion in the cur­rent Phase II study. Thus, al­though some in­vestors in­ter­pret the re­cent refuse-to-file let­ter for Ozan­i­mod to be due to safe­ty and a po­ten­tial class ef­fect, we con­tin­ue to think etrasi­mod could be dif­fer­en­ti­at­ed.

Pre­ston Klassen

Are­na is mov­ing the drug for­ward, not­ing that it would pur­sue new im­mune-re­lat­ed ap­pli­ca­tions for etrasi­mod, da­ta per­mit­ting. That means Are­na’s pipeline, once a one-trick pony with the com­mer­cial flop Belviq on cen­ter stage, is be­com­ing more ro­bust. In ad­di­tion to etrasi­mod, Are­na has a pul­monary ar­te­r­i­al hy­per­ten­sion drug, ra­linepag, which put up pos­i­tive Phase II da­ta last Ju­ly. The biotech plans to take that pro­gram in­to Phase III tri­als. The com­pa­ny al­so has a mid-stage cannabi­noid 2 re­cep­tor pain drug, APD3771, for pain as­so­ci­at­ed with Crohn’s dis­ease.

“We be­lieve these da­ta sup­port pro­ceed­ing to a Phase II pro­gram in ul­cer­a­tive col­i­tis and con­tin­u­ing ef­forts to un­der­stand the broad po­ten­tial util­i­ty of etrasi­mod in oth­er im­mune and in­flam­ma­to­ry dis­eases with sig­nif­i­cant un­met needs,” said Pre­ston Klassen, Are­na’s ex­ec­u­tive vice pres­i­dent of R&D and chief med­ical of­fi­cer. “Along with the pos­i­tive Phase II re­sults for ra­linepag re­port­ed last year, this im­por­tant mile­stone for the com­pa­ny fur­ther am­pli­fies our con­vic­tion in Are­na’s in­ter­nal­ly dis­cov­ered and de­vel­oped com­pounds and their po­ten­tial to be best-in-class.”

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.