Block­buster dreams quashed, Iron­wood drops As­traZeneca's $1.3B gout drug dis­as­ter

As­traZeneca paid $1.3 bil­lion to buy the ex­per­i­men­tal gout drug lesin­u­rad. They hand­ed over US rights to Iron­wood $IR­WD for much, much less two years ago — af­ter it was ap­proved on mixed ef­fi­ca­cy and safe­ty da­ta. And now the Cam­bridge, MA-based biotech is punt­ing it back af­ter watch­ing the treat­ment floun­der on the mar­ket.

Pe­ter Hecht

Iron­wood dis­missed lesin­u­rad (Zu­rampic) in its Q2 re­port. CEO Pe­ter Hecht summed it up this way:

Af­ter ini­ti­at­ing the lesin­u­rad mar­ket tests in ear­ly 2018 and as­sess­ing the re­sults in Ju­ly, we have de­cid­ed to ter­mi­nate our li­cens­ing agree­ment with As­traZeneca in its en­tire­ty. This ac­tion is not tak­en light­ly, but it is an im­por­tant de­ci­sion that we be­lieve en­ables us to al­lo­cate cap­i­tal to the high­est re­turn op­por­tu­ni­ties and dri­ve growth. We are work­ing to main­tain ap­pro­pri­ate avail­abil­i­ty of lesin­u­rad for pa­tients and physi­cians dur­ing the ter­mi­na­tion pe­ri­od.

Alex Den­ner

The drug — once a Hecht fa­vorite be­fore ac­tivist in­vestor Alex Den­ner start­ed to press for a re­vamp — con­tributed on­ly $1.1 mil­lion in Q2 topline rev­enue out of the $81 mil­lion record­ed at Iron­wood. Now Hecht is ex­it­ing out of his $265 mil­lion deal with As­traZeneca as Iron­wood looks to spin off its R&D op­er­a­tions in­to a new com­pa­ny in the first half of 2019 in a quest to be­come com­mer­cial­ly suc­cess­ful.

Iron­wood is al­so lay­ing off 125 staffers in the re­or­ga­ni­za­tion, most sales staff that had been de­vot­ed to the launch fail­ure. The biotech’s shares were down about 4% in ear­ly af­ter­noon trad­ing.

There’s no im­me­di­ate word what As­traZeneca plans to do with lesin­u­rad.

The drug fell short of hit­ting all its pri­ma­ry end­points in a slate of three late-stage stud­ies, and a slight mi­nor­i­ty of 6 of the FDA’s ex­pert ad­vis­ers fret­ted that the drug’s safe­ty pro­file did not mer­it an ap­proval, leav­ing As­traZeneca with a nar­row one-vote mar­gin in its fa­vor. (The ad­vi­so­ry group vot­ed 10 to 4 for an ap­proval.) And those safe­ty con­cerns were al­so re­flect­ed in the agency’s in­ter­nal re­view. Nev­er­the­less, the FDA ap­proved it in late 2015.

None of that will im­prove the drug’s pro­file for any prospec­tive part­ner. And now that it’s a bust on the mar­ket, the ther­a­py — once tapped as a block­buster af­ter be­ing shoved for­ward as a top late-stage prospect — is even more tar­nished.



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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.