Shire plots an AD­HD pub­lic spin­off as CEO Orn­skov com­pletes a top-to-bot­tom over­haul

Hard on the heels of win­ning an ap­proval for its long-last­ing ver­sion of Adder­all for AD­HD, Shire says it’s now con­sid­er­ing spin­ning off its block­buster fran­chise drugs in that field in­to a new pub­lic com­pa­ny, mark­ing a fi­nal re­struc­tur­ing that will leave the Boston-based biotech fo­cused on rare dis­eases.

Shire said in its Q2 state­ment Thurs­day morn­ing that the com­pa­ny has been do­ing a strate­gic re­view of its neu­ro­sciences di­vi­sion, con­sid­er­ing its op­tions on how best to han­dle the fran­chise, and says that a pub­lic list­ing is one big op­tion. Shire’s stock $SH­PG jumped more than 3% on the news.

A spin­off would in­clude the new­ly ap­proved My­dayis, de­signed to work over 16 hours a day, as Shire po­si­tioned its pipeline to pro­tect a dom­i­nant AD­HD fran­chise, with $2.4 bil­lion in sales last year for Adder­all XR and Vy­vanse. My­dayis is set to launch in this quar­ter.

Flem­ming Orn­skov

“We are at an ex­cit­ing in­flec­tion point,” said CEO Flem­ming Orn­skov in a state­ment, “with both our rare dis­ease and neu­ro­science busi­ness­es per­form­ing strong­ly and each hav­ing sig­nif­i­cant growth po­ten­tial over the com­ing years. The strength and scale of our busi­ness pro­vides us with the op­por­tu­ni­ty to fur­ther op­ti­mize our fran­chise port­fo­lio — one of our key pri­or­i­ties com­mu­ni­cat­ed ear­li­er this year. By year end, we ex­pect to com­plete a for­mal eval­u­a­tion of the full range of strate­gic op­tions for the neu­ro­science fran­chise, in­clud­ing the po­ten­tial for its in­de­pen­dent pub­lic list­ing.”

Orn­skov and his team have re­made the com­pa­ny dur­ing his 4-year tenure as CEO. Re­ly­ing on its main­stay drugs for a steady source of cash, Shire bagged Bax­al­ta last year in a $32 bil­lion buy­out, set­ting the com­pa­ny on course to stream­line op­er­a­tions and fo­cus on build­ing its rep for rare dis­eases.

In the mean­time, gener­ic ver­sions of Adder­all have been eat­ing in­to the fran­chise, mak­ing this par­tic­u­lar de­ci­sion a choice be­tween its ag­ing fran­chise meds and its de­vel­op­ment of new ther­a­pies for rare dis­eases.

The fu­ture al­ways wins.

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.”

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 Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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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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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.