Treve­na forges plan to take once-re­ject­ed opi­oid across fin­ish line, af­ter 'pro­duc­tive' FDA meet­ing

Tiny Treve­na may have a new lease on life for its con­tro­ver­sial opi­oid painkiller — re­ject­ed by the FDA last No­vem­ber cit­ing the dearth of drug safe­ty da­ta — fol­low­ing a scathing in­ter­nal staff cri­tique and lop­sided ex­pert pan­el re­view.

The com­pa­ny’s shares $TRVN swelled near­ly 120% on Mon­day af­ter Treve­na said the agency had agreed that the drug’s ex­ist­ing safe­ty data­base would suf­fice for a par­tic­u­lar dose of the drug — help­ing forge a path for­ward for the biotech to re­sub­mit its mar­ket­ing ap­pli­ca­tion.

The IV in­jec­tion, oliceri­dine, was de­vel­oped to help adult pa­tients man­age mod­er­ate to se­vere acute pain. It is de­signed to in­duce a sim­i­lar anal­gesic ef­fect as mor­phine, but work faster and re­duce the messy side ef­fects of se­da­tion, res­pi­ra­to­ry de­pres­sion and slow­ing gas­troin­testi­nal motil­i­ty. But mixed tri­al re­sults and gaps in safe­ty da­ta in­clud­ing QT in­ter­val da­ta — the time the heart mus­cle takes to recharge be­tween beats — prompt­ed the reg­u­la­tor to even­tu­al­ly re­ject the opi­oid in ear­ly No­vem­ber. At the time, the agency asked for a big­ger safe­ty data­base for the drug, as well as “cer­tain ad­di­tion­al non­clin­i­cal da­ta and val­i­da­tion re­ports”.

Car­rie Bour­dow

On Mon­day, Treve­na said its cur­rent safe­ty da­ta would sup­port la­bel­ing at a max­i­mum dai­ly dose of 27 mg, and that the FDA had agreed that the com­pa­ny con­duct a study (in­clud­ing place­bo- and pos­i­tive-con­trol arms) in healthy vol­un­teers to amass the re­quest­ed QT in­ter­val da­ta.

The Chester­brook, Penn­syl­va­nia-based drug de­vel­op­er in­tends to sub­mit a pro­to­col and analy­sis plan to the FDA short­ly and, up­on re­ceipt of reg­u­la­to­ry feed­back, ex­pects to ini­ti­ate the study in the first half of 2019. The com­pa­ny added it does not need any more ef­fi­ca­cy da­ta to re­sub­mit its mar­ket­ing ap­pli­ca­tion for the drug, but did not pro­vide any de­tails on when that re­sub­mis­sion could be ex­pect­ed.

CEO Car­rie Bour­dow said she was “en­cour­aged by the pro­duc­tive dis­cus­sion” with the FDA in a state­ment.

Max­ine Gowen

Back in 2016, un­der the be­hest of CEO Max­ine Gowen, Treve­na had sug­gest­ed an end-of-Phase II meet­ing with the FDA had cul­mi­nat­ed in a gen­er­al agree­ment about the Phase III de­sign for oliceri­dine, and that Gowen was “very pleased” with the dis­cus­sion. But it was on­ly last year that it was re­vealed that the FDA had in fact in­di­cat­ed oth­er­wise — the agency had dis­agreed with pro­posed dos­ing and the pri­ma­ry end­point in the late-stage pro­gram. This rev­e­la­tion prompt­ed at­tor­neys at Bern­stein Lieb­hard to ac­cuse Treve­na ex­ecs, par­tic­u­lar­ly for­mer CEO Max­ine Gowen, of mis­lead­ing in­vestors for rough­ly two years.

FDA pol­i­cy dic­tates it must not re­lease any in­for­ma­tion re­lat­ed to dis­cus­sions with drug spon­sors un­til a drug is up for re­view. Com­mis­sion­er Scott Got­tlieb had ini­tial­ly made promis­es to arm the agency to re­veal more in­for­ma­tion, for in­stance the reg­u­la­tor’s rea­son­ing be­hind is­sued CRLs, but that has not come to fruition.

Mean­while, the FDA’s ap­proval of an­oth­er opi­oid amidst a na­tion­al cri­sis of opi­oid abuse, mis­use and ad­dic­tion that kills about 130 Amer­i­cans each day will like­ly cause more fric­tion. Acel­Rx’s $ACRX ap­proval for its opi­oid Dsu­via last year sparked a flur­ry of in­tense crit­i­cism, even prompt­ing a mem­ber of the FDA’s own ex­pert pan­el to call out the agency’s at­ti­tude to­ward opi­oids as “will­ful blind­ness that bor­ders on the crim­i­nal.

John Hood [file photo]

UP­DAT­ED: 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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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.

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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