Mer­ck KGaA blue­prints a $115M 'col­lab­o­ra­tion cam­pus' for Mass­a­chu­setts

Mer­ck KGaA is join­ing the glob­al mi­gra­tion to the greater Boston biotech hub.

The Ger­man bio­phar­ma is build­ing a new life sci­ences cam­pus in Burling­ton, styling the 280,000-square-foot fa­cil­i­ty as a “cus­tomer col­lab­o­ra­tion lab­o­ra­to­ry and train­ing cen­ter.” And it’s one of 9 col­lab­o­ra­tion com­plex­es planned for Brazil, Chi­na, France, In­dia, Sin­ga­pore and South Ko­rea.

The com­pa­ny is spend­ing $115 mil­lion on the project, with room left for a 70,000-square-foot ad­di­tion, if it needs it. Mer­ck’s sub­sidiary, Mil­li­pore­Sig­ma, will re­lo­cate its 850 full-time Bil­ler­i­ca-based em­ploy­ees when con­struc­tion is com­plete in the sec­ond half of 2017.

Like a long list of bio­phar­ma com­pa­nies, Mer­ck KGaA al­ready has a sig­nif­i­cant R&D pres­ence in the greater Cam­bridge/Boston area. And like oth­ers, it’s mov­ing more of its R&D work in­to an area that has a rep as one of the world’s most im­por­tant biotech hubs, with MIT and Har­vard and oth­er aca­d­e­m­ic in­sti­tu­tions act­ing as a brain­storm­ing arm for new drug de­vel­op­ment.

That pro­file has per­suad­ed Pfiz­er, Mer­ck, Bris­tol-My­ers, Shire and many oth­ers to con­cen­trate in the area, as a tor­rent of in­vestor cash backs a wave of lo­cal biotech star­tups. And more are like­ly to jump in in com­ing years.

Mer­ck KGaA has had to sur­vive a tu­mul­tuous decade, marked by a se­ries of set­backs in the clin­ic. Four years ago it opt­ed to close its Gene­va op­er­a­tions, 5 years af­ter it got the cam­pus in its $13 bil­lion Serono buy­out. That ma­jor shake­up cost hun­dreds of jobs, with hun­dreds more shift­ed to its head­quar­ters in Darm­stadt. And through­out, Mer­ck KGaA has yet to de­vel­op a sin­gle ma­jor new drug. On the oth­er hand, Pfiz­er paid a record $850 mil­lion up front to part­ner on a check­point in­hibitor, which may rank as the fifth en­try in that field.

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Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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President Trump (left) and NIAID chief Anthony Fauci in the White House press room, April 22, 2020 (Michael Reynolds/Sipa via AP Images)

White House tries to dis­cred­it An­tho­ny Fau­ci — could he be on his way out?

For two months in late winter and early spring, Anthony Fauci and President Trump stood in uneasy co-existence at White House briefings — an unlikely truce between an infectious disease official who had helped combat AIDS and Ebola and a president who repeatedly denied the danger of a virus that would go on to kill 100,000 Americans, repeatedly rejected masks and certain social distancing efforts, and promoted a drug with little scientific basis.

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Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

A top an­a­lyst turns the spot­light on Mod­er­na, fu­el­ing a fast-and-fu­ri­ous Street race over the fu­ture of mR­NA

Bioregnum Opinion Column by John Carroll

Four months ago, one of the favorite talking points on the biopharma social media wave length was whether Moderna shares $MRNA were priced right or were wildly inflated.

After all, said the naysayers, the company had never actually pushed a treatment to an approval. Did messenger RNA really work, coding cells to make a drug or a vaccine? And how about all that chatter about how ‘secretive’ they are, or were?

Now, as CEO Stéphane Bancel and the top execs push the company to the forefront of a frantic race to develop the first vaccine to fight against the reignited wildfire spread of Covid-19, all those questions have been magnified — along with the stock price.

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En­gi­neer­ing an on/off switch for CAR-T out of yeast and Juras­sic Park

Almost as soon as CAR-T emerged in the mid-2010s as a near-cure for some cancers, so did a question: How do you give this without risking killing patients?

At the time, James Patterson was wrapping an MD-PhD at a yeast lab at London’s Francis Crick Institute. Yeast may seem an unlikely place to find a fix for cancer therapy, but reading through other researchers’ solutions to CAR-T’s toxicity, Patterson wondered if a method long used by yeast biologists called auxotrophy might be useful. You genetically modify cells to make them dependent on a particular nutrient. Then you can make them live or die — proliferate or deplete — by giving or taking away that nutrient.

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Albert Bourla, AP

Covid-19 roundup: CanSi­no eyes more over­seas PhI­II sites as Cana­da tri­al re­port­ed­ly stalls; In­di­an drug­mak­er surges on 30-per­son da­ta

Having leveraged connections in Canada for a planned Phase III trial of its Covid-19 vaccine, CanSino is venturing out to a few more others as it plots a global late-stage program.

“We are contacting Russia, Brazil, Chile and Saudi Arabia, and it’s still in discussion,” Dongxu Qiu, executive director and co-founder of CanSino, said at a conference in Suzhou, China, per Reuters.

The trial is likely to start “pretty soon,” he added, with plans to recruit 40,000 participants total.

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Play­ing catch-up, Roche out­lines plans for a PhI­II he­mo­phil­ia A pro­gram — next year

For now, the big focus in the hemophilia A gene therapy race has been centered on frontrunner BioMarin, with an expected OK just weeks away, and the crew from Sangamo/Pfizer, which has been looking to play catch-up with a pivotal study in the works.

But now Roche’s new gene therapy division at Spark has updated its own schedule, saying they’re looking at a Phase III start sometime next year as they optimize the dose and immunomodulatory regimen in order to avoid any future mishaps that could derail the program.

CEO John Oyler at the Endpoints/PharmCube BIIS18 conference in Shanghai (Photo: Endpoints News)

Chi­na's BeiGene now has $5B+ cash in its cof­fers. How's the Am­gen-part­nered biotech go­ing to spend it?

When Amgen wagered $2.7 billion to grab a 20.5% stake in BeiGene late last year, execs saw themselves buying into a “world-class operation” that would help them tap into the world’s most populous country and a growing biopharma powerhouse.

It turns out they were just getting started.

Over the weekend, BeiGene $BGNE brought in a hefty $2.08 billion — $421 million from Amgen — through a direct offering of its Nasdaq shares exclusively involving existing investors. New York-based hedge fund Baker Bros. Advisors also bought a chunk of new shares.

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Levi Garraway, Roche CMO

Roche’s PD-L1 play­er Tecen­triq fails PhI­II for ovar­i­an can­cer

Roche’s hit-and-miss record on Tecentriq has posted another miss.

The pharma giant reported this morning that the PD-L1 checkpoint failed a Phase III trial for women with advanced, front line ovarian cancer, one of several hard-to-hit cancers that’s defied a variety of approaches. Much of the new R&D in ovarian cancer remains focused on PARP, where AstraZeneca’s Lynparza holds sway.

In this trial Roche combined their PD-L1 Tecentriq with Avastin. But it’s been one of dozens of Phase III trials in the works for the checkpoint crew, as more companies angle to jump into the market behind the two leaders — Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo.