With patent con­cerns loom­ing, Roche gets a new pri­or­i­ty re­view on block­buster IPF drug

Sev­en years af­ter the FDA first ap­proved Es­bri­et, the block­buster Roche IPF drug is get­ting an ex­pe­dit­ed re­view for a sec­ond in­di­ca­tion.

On Thurs­day, the agency gave Es­bri­et pri­or­i­ty re­view for un­clas­si­fied in­ter­sti­tial lung dis­eases, or forms of pul­monary in­flam­ma­tion and scar­ring that don’t fit eas­i­ly in­to the over 200 known types of ILD. The move comes 10 months af­ter Es­bri­et re­ceived break­through des­ig­na­tion and sets Roche up for a de­ci­sion by May.

The Swiss phar­ma is bid­ding for a new in­di­ca­tion at an acute pe­ri­od for their long­time block­buster. One of two ma­jor id­io­path­ic pul­monary fi­bro­sis drugs along­side Boehringer In­gel­heim’s Ofev, Es­bri­et con­tin­ues to bring over $1 bil­lion per year. But sales growth has slowed, par­tic­u­lar­ly in the US, and the com­pa­ny’s or­phan des­ig­na­tion pro­tec­tions in IPF be­gin to ex­pire this year.

With that dead­line loom­ing, Roche has sought to guard against would-be gener­ics, fil­ing around a dozen law­suits to stop Te­va, San­doz and oth­ers from re­leas­ing cheap­er, copy­cat ver­sions of the drug. Es­bri­et’s an­nu­al whole­sale cost is around $100,000.

Roche ac­quired Es­bri­et in their $8.3 bil­lion buy­out of the Cal­i­for­nia biotech In­ter­Mune, two months be­fore the FDA would give the drug a green light. The agency had ini­tial­ly re­ject­ed the drug in 2010, de­mand­ing In­ter­Mune run a sec­ond Phase III tri­al.

The Big Phar­ma, though, would not put the drug in­to a piv­otal tri­al for un­clas­si­fi­able in­ter­sti­tial lung dis­ease un­til 2017. In 2019, in­ves­ti­ga­tors pub­lished Phase II re­sults from 253 un­clas­si­fi­able ILD pa­tients, show­ing pa­tients who took the drug had sig­nif­i­cant­ly more sta­ble lung func­tion, as mea­sured by an end­point called forced vi­tal ca­pac­i­ty.

The new in­di­ca­tion is just one route Roche is us­ing to try to keep its fi­bro­sis fran­chise alive. The com­pa­ny has al­so in­vest­ed in find­ing a new block­buster for IPF, ac­quir­ing Prome­dior and its pipeline of an­ti-fi­brot­ic mol­e­cules for up to $1.4 bil­lon in 2019. The lead drug, which has re­ceived break­through des­ig­na­tion, went in­to Phase III ear­li­er this year.

So far, Roche has stayed ahead of Boehringer in that search; two months af­ter Roche start­ed their Phase III, the Ger­man phar­ma dropped out of its own $1 bil­lion fi­bro­sis pact, cit­ing tox­i­c­i­ty with their part­ner’s drug.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Presage teams with Mer­ck on its Phase 0 test­ing; Kem­Pharm AD­HD drug wins ap­proval in chil­dren aged 6 and up

Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.

Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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