Te­va gets a mixed bag of PhI­II da­ta as it lines up against a (bet­ter?) Neu­ro­crine ri­val for tar­dive dysk­i­ne­sia

Four months af­ter the FDA re­ject­ed Te­va’s “break­through” drug SD-809 for treat­ing chorea as­so­ci­at­ed Hunt­ing­ton’s dis­ease, the phar­ma group is back with a batch of mixed Phase III da­ta on tar­dive dysk­i­ne­sia, the in­vol­un­tary move­ments as­so­ci­at­ed with the de­gen­er­a­tive dis­ease. And once again Te­va is up­beat about the re­sults, say­ing the da­ta clears the way to a new mar­ket­ing pitch lat­er this year.

A year-and-a-half ago Te­va $TE­VA splurged on a $3.5 bil­lion ac­qui­si­tion of Aus­pex, bag­ging the new and what it hoped was an im­proved drug for Hunt­ing­ton’s. Now it’s say­ing that its sec­ond late-stage study shows that the drug is clear­ly a suc­cess, but there are still some sig­nif­i­cant prob­lems to ad­dress.

In­ves­ti­ga­tors say that a high and mid-range dose of their drug hit the pri­ma­ry end­point on the move­ment scale rat­ing for a “mod­i­fied in­tent to treat” group. The low dose failed to sep­a­rate sig­nif­i­cant­ly from the place­bo. But the high dose, mean­while, missed beat­ing the place­bo based on in­ves­ti­ga­tors’ as­sess­ment of how their pa­tients were do­ing.

Te­va’s big pro­gram for this drug puts it in a head-to-head show­down with Neu­ro­crine $NBIX, which not­ed just days ago that it has filed for an ap­proval on the ri­val drug val­be­nazine.

Neu­ro­crine ex­ecs not­ed in their Q2 call with an­a­lysts at the end of Au­gust that they are al­ready build­ing a mar­ket­ing group for the drug, which has al­so achieved a break­through drug des­ig­na­tion that could put it on track to an ap­proval as ear­ly as next spring. The drug is a VMAT2 in­hibitor, de­signed to mod­u­late dopamine re­lease dur­ing nerve com­mu­ni­ca­tion.

Baird’s Bri­an Sko­r­ney com­pared the two drugs, and vot­ed on Neu­ro­crine as the like­ly win­ner in this loom­ing show­down. Val­be­nazine did bet­ter at beat­ing a place­bo, with a 3.1 re­duc­tion com­pared to place­bo ver­sus a 1.9 dif­fer­ence in fa­vor of Te­va’s drug.

Added Sko­r­ney:

With at least a few months’ lead time and po­ten­tial un­cer­tain­ty around the meta­bol­ic pro­file of SD-809, we re­main con­fi­dent that val­be­nazine, now brand­ed as In­grez­za, can gar­ner stronger sup­port from physi­cians at launch.

Jef­feries’ Biren Amin agreed with Sko­r­ney on the time­line, putting Neu­ro­crine in the lead by sev­er­al months.

Te­va’s drug rep­re­sents a big bet for the Is­raeli com­pa­ny, which was hop­ing to be in the first wave of com­pa­nies to get an ap­proval for a deuter­at­ed drug, tak­ing an ex­ist­ing drug — in this case tetra­benazine (Xe­nazine) — and re­design­ing it to break down more slow­ly, a tweak which should make it pos­si­ble to pro­vide low­er dos­ing for max­i­mum ef­fect while im­prov­ing the safe­ty pro­file.

The FDA hasn’t re­quired a head-to-head study against tetra­benazine, which may come back to haunt Te­va if it does get a mar­ket­ing ap­proval. But it has asked for more work ex­am­in­ing the lev­els of metabo­lites in­volved in break­ing down the drug.

The ther­a­py—deutetra­benazine—is a small mol­e­cule in­hibitor of vesic­u­lar monoamine 2 trans­porter, or VMAT2, which is de­signed to reg­u­late the lev­els of dopamine in the brain.

A re­cent sto­ry in Bloomberg high­light­ed an­a­lysts’ pro­jec­tions of about a bil­lion dol­lars a year in an­nu­al rev­enue, if Te­va can make its case to pa­tients put off by the side ef­fects of the orig­i­nal drug, which in­clude de­pres­sion. More re­search work is be­ing done on Tourette syn­drome.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017.  Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin.

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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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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