Af­ter biotech im­plo­sions, ex-Mil­len­ni­um chief Deb­o­rah Dun­sire is tak­ing the helm at Lund­beck

Deb­o­rah Dun­sire is mov­ing to Den­mark.

Af­ter bounc­ing around the high-risk biotech world in Boston/Cam­bridge for the past few years, ex-Mil­len­ni­um chief Dun­sire is now tak­ing the top seat at Den­mark’s Lund­beck, left va­cant af­ter Kåre Schultz jumped to Te­va.

A high-pro­file ex­ec in the US, Dun­sire left Mil­len­ni­um as Take­da ab­sorbed and re­struc­tured the com­pa­ny, mak­ing it a cen­tral part of their US hub. She lat­er took the helm at Fo­rum Phar­ma­ceu­ti­cals, leav­ing not long af­ter the com­pa­ny was hit by a clin­i­cal hold on Alzheimer’s and a failed clin­i­cal pro­gram in schiz­o­phre­nia. 

Her next stop, XTu­it, was a com­bi­na­tion can­cer/fi­bro­sis com­pa­ny that has now fall­en off the map, with most of its se­nior staffers mi­grat­ing to new po­si­tions, the web­site down and the voice mail full, with no vis­i­ble signs of ac­tiv­i­ty. Dun­sire’s com­pa­ny email ad­dress is de­funct.

Dun­sire did not re­turn mes­sages over the week­end about the fate of XTu­it, which had an im­pres­sive brain trust that in­clud­ed MIT’s Bob Langer. (Po­laris part­ner Alan Crane con­firmed in a brief in­ter­view Mon­day morn­ing that the com­pa­ny has been shut­tered.)

Lund­beck, though, of­fers Dun­sire a chance to take a new, high-pro­file po­si­tion in the bio­phar­ma world — the kind in­volv­ing a vi­able com­pa­ny with rev­enue. It al­so takes her back to a field where she’s ex­pe­ri­enced a bit­ter set­back.

Iron­i­cal­ly, Dun­sire’s new po­si­tion takes her to a com­pa­ny that has deep ex­pe­ri­ence in Alzheimer’s — with plen­ty of fail­ures re­port­ed in re­cent years. When she made her move to XTu­it re­cent­ly af­ter the fail­ure at Fo­rum, she told me she was glad to be get­ting out of Alzheimer’s, where the bi­ol­o­gy is still murky, in­to a more clear­ly de­fined field like can­cer and fi­bro­sis.

Lund­beck Chair­man Lars Ras­mussen told Reuters that Dun­sire’s biggest re­spon­si­bil­i­ty will be in R&D, which is where she’s had the least suc­cess. As for Dun­sire, she’s look­ing to grow the pipeline, which may in­clude some new deals.

“I think my chal­lenge is to build sus­tain­abil­i­ty in­to the fu­ture and make sure Lund­beck is well-pre­pared for the next decade of growth,” she told Reuters. “Clear­ly there is go­ing to be some or­gan­ic growth, there’s some very in­ter­est­ing things in the pipeline, but I would nev­er rule out that there will be ex­ter­nal as­sets that we may look to ac­quire or part­ner.”

Dun­sire — the Africa-born daugh­ter of Scot­tish par­ents who grew up to be­come a doc­tor and even­tu­al­ly chief of No­var­tis’ North Amer­i­can on­col­o­gy busi­ness — was one of the orig­i­nal pi­o­neer­ing fe­male ex­ecs in bio­phar­ma. Years ago, when she was still run­ning Mil­len­ni­um, I asked her what were the most im­por­tant as­pects of be­ing an ef­fec­tive leader in the in­dus­try and be­com­ing suc­cess­ful. Work­ing with great peo­ple got a big thumbs up. Then she added some­thing that res­onates.

I’ve al­so ben­e­fit­ed from be­ing will­ing to step out­side my com­fort zone and risk fail­ing by try­ing new things–mov­ing out of clin­i­cal in­to com­mer­cial roles, mov­ing in­ter­na­tion­al­ly, and tak­ing on feed­back. I love learn­ing and grow­ing and this in­dus­try de­mands a lot of that! I feel I have al­so been blessed to work on great med­i­cines that turned out to bring rad­i­cal im­prove­ment to pa­tients. Not every­body gets that ex­pe­ri­ence, no mat­ter how good they are.

Dun­sire is mov­ing and grow­ing again. And the in­dus­try con­tin­ues to be de­mand­ing — in all sorts of ways.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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