WuXi Biologics CEO Chris Chen

Look­ing to build a 'd­ual sourcing' sup­ply chain, WuXi Bi­o­log­ics shells out $183M for Bay­er drug sub­stance plant

Bi­o­log­ics have been par­tic­u­lar­ly hot in 2020 with big drug­mak­ers look­ing to bol­ster their port­fo­lio — a trend that has been a se­ri­ous boon for con­tract man­u­fac­tur­ers. WuXi Bi­o­log­ics start­ed off the year adding to its own pro­duc­tion ca­pac­i­ty in Ger­many to keep up with that ex­pect­ed de­mand, and now it’s go­ing back to Deutsch­land for an­oth­er ex­pan­sion.

Shang­hai-based Wuxi will drop rough­ly 150 mil­lion eu­ros—or $183.3 mil­lion— in an ac­qui­si­tion deal for Bay­er’s 330,000 square-foot drug sub­stance fa­cil­i­ty in Wup­per­tal, Ger­many, as it seeks to en­hance a sup­ply net­work of Covid-19 vac­cines and oth­er bi­o­log­ics. The newest fa­cil­i­ty will al­so add to WuXi’s “glob­al dual sourc­ing” strat­e­gy to add re­dun­dan­cy in­to its sup­ply chain, CEO Chris Chen said in a re­lease.

The fa­cil­i­ty hous­es three 1,000-liter per­fu­sion re­ac­tors for bi­o­log­ics as well as six 1,000-liter fed-batch biore­ac­tors, WuXi said. Those two man­u­fac­tur­ing lines will in­clude in­de­pen­dent down­stream suites, ac­cord­ing to a re­lease.

Both com­pa­nies al­so plan to en­ter in­to a long-term sub­lease agree­ment and a tran­si­tion ser­vice con­tract, they said in a press re­lease. Once the trans­ac­tion, which is still sub­ject to reg­u­la­to­ry ap­proval, is ap­proved and fi­nal­ized, WuXi will add thou­sands of liters to its man­u­fac­tur­ing out­put, the com­pa­ny said.

The for­mer Bay­er fa­cil­i­ty is ex­pect­ed to be ready for drug sub­stance and prod­uct man­u­fac­tur­ing in 2021; by 2023, WuXi ex­pects its to­tal ca­pac­i­ty at fa­cil­i­ties in the U.S., Chi­na, Ire­land, Ger­many and Sin­ga­pore will ex­ceed 280,000 liters.

WuXi has now book­end­ed 2020 with pur­chas­ing Bay­er fa­cil­i­ties in Ger­many, as it al­so bought a Lev­erkusen man­u­fac­tur­ing plant in Jan­u­ary. That site al­so serves as a back-up pro­duc­tion site for Bay­er’s Ko­val­try, a he­mo­phil­ia A ther­a­peu­tic.

As of June 30, WuXi said it had a to­tal of 286 in­te­grat­ed projects, in­clud­ing 141 projects in pre-clin­i­cal de­vel­op­ment stage, 125 projects in ear­ly-phase clin­i­cal de­vel­op­ment, 19 projects in late-phase de­vel­op­ment and one project in com­mer­cial man­u­fac­tur­ing.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Noubar Afeyan (Sebastien Micke/Paris Match/Contour by Getty Images)

As Mod­er­na rose, Flag­ship cashed in for $1.4B — with a lot more wealth still re­main­ing

For nearly a decade, Flagship poured record-setting levels of cash into Moderna, even as they faced setbacks on early programs and skeptics wondered whether the company’s science could ever match its hype.

Now that the science has delivered, Flagship is cashing in.

Over the last 13 months, since the World Health Organization declared a pandemic, Flagship has sold off Moderna shares worth $1.4 billion. The sales, first reported by Forbes, came as the Cambridge biotech’s shares soared from just under $20 per share on Jan. 3, 2020, to $169.50 when markets opened Thursday.

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Werner Lanthaler, Evotec CEO

Evotec strength­ens its French con­nec­tion, pledg­ing to drop $120M in­to Toulouse plant for Covid-19 an­ti­bod­ies

Much of the recent focus on manufacturing capacity for Covid-19 has been on vaccines, and for good reason, too. But countries are also hoping to build a big enough footprint to produce pandemic-level monoclonal antibodies, and now France is working with Germany’s Evotec to stay prepared.

Evotec will lay out $120 million with a $60 million boost from multiple French governments and investors to build a new biologics facility in Toulouse that will expand its capacity to produce therapeutic antibodies for Covid-19, the German CDMO and biotech said this week.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.