Sanofi, Re­gen­eron win a cru­cial stay of ex­e­cu­tion on Pralu­ent

Sanofi and Re­gen­eron’s Pralu­ent gets to stay on the mar­ket while the part­ners fight an­oth­er day in court for the PC­SK9 fran­chise.

Re­gen­eron $REGN an­nounced just af­ter the mar­ket closed on Wednes­day that the US Court of Ap­peals had grant­ed a stay of a con­tro­ver­sial de­ci­sion in ear­ly Jan­u­ary that Pralu­ent vi­o­lat­ed Am­gen’s patents on the ri­val PC­SK9 cho­les­terol drug Repatha, war­rant­i­ng its re­moval from the mar­ket.

With­out the stay, Pralu­ent would have been jerked in two weeks, an ex­tra­or­di­nar­i­ly rare move in bio­phar­ma, where patent fights are com­mon.

Ac­cord­ing to the de­ci­sion hand­ed down to­day:

Rule 8(a)(2) of the Fed­er­al Rules of Ap­pel­late Pro­ce­dure au­tho­rizes this court to grant a stay of an in­junc­tion pend­ing ap­peal.

Our de­ter­mi­na­tion is gov­erned by four fac­tors, the first two of which are the most crit­i­cal: (1) whether the movant has made a strong show­ing of like­li­hood of suc­cess on the mer­its; (2) whether the movant will be ir­repara­bly in­jured ab­sent a stay; (3) whether is­suance of the stay will sub­stan­tial­ly in­jure the oth­er par­ties in­ter­est­ed in the pro­ceed­ing; and (4) where the pub­lic in­ter­est lies.

See Nken v. Hold­er, 556 U.S. 418, 434 (2009).

With­out prej­u­dic­ing the ul­ti­mate dis­po­si­tion of this case by a mer­its pan­el, we con­clude based up­on the pa­pers sub­mit­ted that a stay is war­rant­ed here.

Am­gen says it has just be­gun to fight.

While we re­spect the Court’s de­ci­sion in stay­ing the in­junc­tion pend­ing the ap­peal, Am­gen re­mains con­fi­dent in the va­lid­i­ty of our patents and the cor­rect­ness of the ju­ry ver­dict and dis­trict court’s judg­ment.  We look for­ward to pre­sent­ing our case on the lack of mer­it in De­fen­dants’ ap­peal.

Now the fo­cus shifts back to the clin­ic as Re­gen­eron and Sanofi prep late-stage da­ta on car­dio out­comes, bad­ly need­ed now that Am­gen has de­clared its Phase III car­dio study FOURI­ER a suc­cess.

There’s no da­ta avail­able yet, but Am­gen re­port­ed that Repatha proved to sig­nif­i­cant­ly re­duce the risk of car­dio events in pa­tients with clin­i­cal­ly ev­i­dent ath­er­o­scle­rot­ic car­dio­vas­cu­lar dis­ease. The drug al­so hit on an end­point for cog­ni­tive func­tion. That kind of ev­i­dence is es­sen­tial if any of these play­ers ex­pect to earn more than the mar­gin­al sums they’ve seen so far from these two drugs. With­out ev­i­dence of a re­al health ben­e­fit, in­sur­ers have been loathe to pro­vide cov­er­age. With it, they’ll find it hard to de­ny pa­tients much longer.

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive PhI­II for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma. 

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.