Deb­o­rah Dun­sire kicks off her new gig as Lund­beck CEO with a key PhI­II tri­al fail­ure

You have to feel al­most sor­ry for Deb­o­rah Dun­sire.

Deb­o­rah Dun­sire

No soon­er does the Mil­len­ni­um vet take the helm of Lund­beck af­ter back-to-back biotechs col­lapse on her watch than the com­pa­ny’s schiz­o­phre­nia drug can­di­date fails a Phase III study, tor­pe­do­ing the stock as shares plunge 30%.

Lu AF35700 failed to mea­sure up against con­ven­tion­al ther­a­py in its first Phase III study, like­ly elim­i­nat­ing any po­ten­tial up­side as far as reg­u­la­tors might be con­cerned. In­ves­ti­ga­tors test­ed the drug on 964 treat­ment-re­sis­tant pa­tients treat­ed over 10 weeks.

The com­pa­ny’s re­searchers based the drug de­sign on its pref­er­ence for the hu­man dopamine D1 re­cep­tor as op­posed to the dopamine D2 re­cep­tor, which they thought would give it an ad­van­tage on ef­fi­ca­cy as well as tol­er­a­bil­i­ty.

We don’t know what the hard da­ta are, but the com­pa­ny says it con­tin­ues to study the re­sults. Jef­feries had as­signed a po­ten­tial block­buster sta­tus for the drug, with peak sales pro­ject­ed at $1.2 bil­lion.

This is the com­pa­ny’s lead late-stage com­pound, shar­ing the Phase III col­umn with the Alzheimer’s drug br­ex­pipra­zole, dis­cov­ered at Ot­su­ka.

In May of last year, sev­en months af­ter Lund­beck and Ot­su­ka re­port­ed a Phase III flop for their Alzheimer’s drug idalopir­dine, the part­ners re­port­ed a hit-and-miss score on eas­ing Alzheimer’s ag­i­ta­tion for Rex­ul­ti (br­ex­pipra­zole).

Al­ready ap­proved for schiz­o­phre­nia and ma­jor de­pres­sion, the col­lab­o­ra­tors were look­ing for the first ap­proval of an an­tipsy­chot­ic specif­i­cal­ly for ag­i­ta­tion trig­gered by Alzheimer’s de­men­tia, a con­di­tion that af­flicts mil­lions of peo­ple in the US and mil­lions more world­wide. Ag­i­ta­tion can be ex­pressed in many ways, run­ning from wan­der­ing to ag­gres­sive be­hav­ior.

Now there’s a much big­ger set­back to deal with.

“This is a set­back for pa­tients with schiz­o­phre­nia, but we will con­tin­ue to ad­vance our pipeline of in­no­v­a­tive ther­a­pies to meet the needs of pa­tients suf­fer­ing from psy­chi­atric and neu­ro­log­i­cal dis­eases,” says An­ders Gersel Ped­er­sen, the head of R&D at the Dan­ish com­pa­ny.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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