Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Be­fore remde­sivir soaked up the spot­light amid the coro­n­avirus cri­sis, Gilead’s fil­go­tinib was the star ex­per­i­men­tal drug tapped to rake in bil­lions com­pet­ing with oth­er JAK in­hibitors made by ri­vals in­clud­ing Ab­b­Vie and Eli Lil­ly.

Now, long term da­ta on the drug — dis­cov­ered by Gilead’s part­ners at Gala­pa­gos and post­ed as part of a vir­tu­al med­ical con­fer­ence — have so­lid­i­fied the dura­bil­i­ty and safe­ty of fil­go­tinib in pa­tients with rheuma­toid arthri­tis, span­ning da­ta from three late-stage tri­als. An FDA de­ci­sion on the drug is ex­pect­ed this year.

Last Oc­to­ber, the com­pa­nies showed that the drug’s 52-week da­ta from the two main tri­als FINCH 1 and FINCH 3 were con­sis­tent with their 24-week re­sults. On Thurs­day, fur­ther analy­ses of the da­ta sug­gest­ed that pa­tients on the fil­go­tinib arm had a nu­mer­i­cal ad­van­tage in re­mis­sion rates.

At the 24-week cut­off, 48% of pa­tients en­rolled in the high­er 200 dose of fil­go­tinib arm were in re­mis­sion in the FINCH 1 tri­al that com­pared the drug to adal­i­mum­ab (Ab­b­Vie’s Hu­mi­ra). By the end of 52 weeks, that re­mis­sion rate rose to 52%. The per­cent­age in the Hu­mi­ra arm rose too, but the num­bers fa­vored fil­go­tinib across mul­ti­ple mea­sures of ef­fi­ca­cy. Da­ta from the FINCH 3 tri­al echoed that trend.

Fil­go­tinib’s biggest ri­val is Ab­b­Vie’s Rin­voq — the re­place­ment for its cash cow and world’s best sell­ing drug Hu­mi­ra. Rin­voq is slat­ed to be a block­buster, but car­ries the dread­ed black box warn­ing for throm­bo­sis, even though the event was rare in Ab­b­Vie’s de­vel­op­ment pro­gram.

The move by the FDA is more pre­cau­tion­ary giv­en that the JAK class of drugs has long been plagued by safe­ty con­cerns. Pfiz­er’s JAK1/JAK3 in­hibitor Xel­janz’s use has been blight­ed by reg­u­la­to­ry re­stric­tions af­ter the high­er dose of the block­buster drug was found to be as­so­ci­at­ed with the risk of blood clots and death. Eli Lil­ly’s JAK1/JAK2 Olu­mi­ant, mean­while, was ini­tial­ly re­ject­ed by the US agency due to safe­ty con­cerns — on­ly to even­tu­al­ly se­cure ap­proval for the low­er dose. Lil­ly’s part­ner, In­cyte, elect­ed to walk away from co-fund­ing the drug’s de­vel­op­ment as fears about the ben­e­fit-risk pro­file of the class of drugs ac­cu­mu­lat­ed.

Gala­pa­gos $GLPG, which once part­nered with Ab­b­Vie on fil­go­tinib, has pre­sent­ed it­self as a safer al­ter­na­tive to its ri­vals us­ing a pooled analy­sis of safe­ty da­ta com­piled from sev­en rheuma­toid arthri­tis tri­als. The analy­sis showed that the rate of ve­nous throm­boem­bolism, a key safe­ty con­cern, was low­er in pa­tients giv­en fil­go­tinib ver­sus those on place­bo.

“While filg’s pro­file has been quite clean so far, giv­en the his­to­ry of Jak in­hibitor ap­provals/re­jec­tions, we be­lieve the biggest risk to the pro­gram re­mains if any safe­ty im­bal­ances (even if seem­ing­ly mi­nor) emerge and de­rail ap­prov­abil­i­ty of the most ac­tive high dose (200mg) of the drug, or of the drug al­to­geth­er,” not­ed RBC Cap­i­tal Mar­kets an­a­lyst Bri­an Abra­hams in a note.

“In an­a­lyz­ing the de­tailed da­ta, we do not see any ma­jor new con­cerns and con­tin­ue to see a good like­li­hood of ap­proval, with a low se­ri­ous in­fec­tion rate pro­vid­ing a po­ten­tial safe­ty ad­van­tage vs. com­peti­tors. How­ev­er, we do see a slight im­bal­ance in over­all deaths for high­er vs. low­er dose fil­go­tinib that could be scru­ti­nized by the agency and may be a small risk to keep an eye on.”

Gilead paid $750 mil­lion up­front to part­ner with Gala­pa­gos years ago, ex­pand­ing the col­lab­o­ra­tion to an up-to $5.1 bil­lion deal last year. Fil­go­tinib, which is at the heart of the deal, is al­so be­ing test­ed for oth­er au­toim­mune con­di­tions such as Crohn’s dis­ease, ul­cer­a­tive col­i­tis and pso­ri­at­ic arthri­tis. Last Oc­to­ber it was re­vealed the drug failed mid-stage stud­ies in lu­pus and Sjö­gren’s dis­ease.

Janus ki­nase (JAK) in­hibitors are named af­ter the two-faced Ro­man god Janus and the fam­i­ly con­sists of four en­zymes: JAK1, JAK2, JAK3 and TYK2, which are as­so­ci­at­ed with cy­tokine re­cep­tors on the sur­face of cells and form part of a path­way in­volved in in­flam­ma­to­ry and im­mune re­spons­es.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.