With high ex­pec­ta­tions on Provenge, Den­dreon is 'sol­d' (again) in $832M deal

Den­dreon — and its fad­ed can­cer star Provenge — is chang­ing hands for the sec­ond time in less than two years.

Their new own­er is Nan­jing Xin­bai, a de­part­ment store con­glom­er­ate that’s been beef­ing up its phar­ma­ceu­ti­cal busi­ness, which first pro­posed to snap up the prostate can­cer cell ther­a­py last No­vem­ber.

Jim Caggiano

The deal is val­ued at $872 mil­lion (CNY 59,680,000,000), though no cash is in­volved. San­pow­er Group, which cur­rent­ly owns Den­dreon through a Hong Kong-based sub­sidiary called Shid­ing Sheng­wu Biotech­nol­o­gy, is al­so a con­trol­ling stock­hold­er of Xin­bai. Mov­ing Den­dreon in­to pub­licly trad­ed Xin­bai “has been San­pow­er’s long-term plan since ac­quir­ing Den­dreon in 2017,” Den­dreon CEO Jim Caggiano wrote via email.

In ex­change for pass­ing off Shid­ing, San­pow­er’s get­ting 180 mil­lion more of Xin­bai’s shares, boost­ing its hold­ing from 33.1% to 42.43%.

These are ex­pen­sive shares. San­pow­er is ef­fec­tive­ly bet­ting $511 mil­lion on Den­dreon’s fu­ture earn­ing po­ten­tial by pay­ing a 60% pre­mi­um over Xin­bai’s cur­rent stock price. And that’s af­ter pay­ing $820 mil­lion in cash to nab the com­pa­ny from Valeant in the first place.

“San­pow­er sac­ri­ficed CNY3.5 bil­lion of its own in­ter­est to in­fuse Den­dreon in­to Nan­jing Xin­bai as promised,” Guikan Hua, San­pow­er vice pres­i­dent and spokesper­son, told The Pa­per, “show­ing the stock­er­hold­ers’ full sup­port and op­ti­mism to­ward Nan­jing Xin­bai.”

That lev­el of con­fi­dence would fit with the im­pres­sion I got from Caggiano, who told me late last year — be­fore Xin­bai would an­nounce its in­ten­tions to buy the com­pa­ny — that San­pow­er “has proven to be a great part­ner” who’s very hands off in the US while lead­ing the charge to bring Provenge to Hong Kong and main­land Chi­na.

Ac­cord­ing to him, there will be no changes to struc­ture, strat­e­gy or per­son­nel at the com­pa­ny af­ter the change of own­er­ship.

Cur­rent­ly ap­proved in the US, Provenge is an au­tol­o­gous cell ther­a­py that re­quires a quick turn­around in the man­u­fac­tur­ing process. With help from San­pow­er, Seal Beach, CA-based Den­dreon has pur­chased an im­munother­a­py man­u­fac­tur­ing fa­cil­i­ty in Hong Kong with goals of fil­ing an NDA in the re­gion soon.

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.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Brian Stuglik, Verastem CEO

The du­velis­ib hot pota­to is tossed to a new own­er as Ve­rastem looks to re­or­ga­nize around the pipeline

When Infinity put up duvelisib for a no-money-down instant deal, the biotech was looking for a quick exit from a clinical disaster. AbbVie had walked away from their alliance after looking at how the data stacked up in a crowded field.

And while it was approvable, it wasn’t looking pretty to anyone who thought in commercial terms.

One Big Pharma’s trash, though, was seen as a biotech treasure as a deeply troubled Verastem stepped up to grab the PI3K-delta/gamma — promising to run it across the goal lines at the FDA. And they did just that, only with little to show for it.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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