Rob Brainin (Genuity)

Meet the lat­est ge­nom­ic da­ta com­pa­ny — aka WuXi NextCODE with­out the Chi­na op­er­a­tions

Just five years af­ter WuXi en­gi­neered a deal to merge its genome cen­ter with NextCODE Health, the WuXi NextCODE brand is be­com­ing his­to­ry as the com­pa­ny cuts off the Chi­nese op­er­a­tions and fo­cus­es on the US, Ice­land and Ire­land.

The new name, Ge­nu­ity Sci­ence, eras­es all ref­er­ences to WuXi NextCODE’s sto­ried his­to­ry. The US and Ice­land of­fices of the ge­nomics com­pa­ny were spun out of de­CODE Ge­net­ics af­ter it got ac­quired by Am­gen — with its own twists and turns. Its $400 mil­lion ex­pan­sion in­to Ire­land took place in late 2018, com­plete with the ac­qui­si­tion of Ge­nomics Med­i­cine Ire­land.

Where­as WuXi NextCODE had moved its head­quar­ters from Shang­hai to Cam­bridge over two years, Ge­nu­ity will shift its com­mand cen­ter to Boston.

Ac­cord­ing to the com­pa­ny, the rea­son for cut­ting off its Chi­na ties is pure­ly le­gal. Chi­na tight­ened its Hu­man Ge­net­ics Re­source Reg­u­la­tion and oth­er rules in mid-2019, and NextCODE was among many com­pa­nies that were des­ig­nat­ed as for­eign en­ti­ties — erect­ing se­ri­ous con­straints to their work and pos­si­bil­i­ty for growth overnight.

The ca­pa­bil­i­ties they had in Shang­hai were “val­ued by a num­ber of our in­ter­na­tion­al cus­tomers,” said Rob Brain­in, whose cards now say CEO of Ge­nu­ity.

Now that it’s gone, they have poured more re­sources in both Dublin and Woburn, MA, to do some of the things their Chi­nese col­leagues used to han­dle.

Be­tween the three re­main­ing sites, Ge­nu­ity has more than 200 em­ploy­ees sourc­ing, con­sol­i­dat­ing and an­a­lyz­ing ge­nom­ic da­ta for part­ners. Re­cent­ly, they’ve be­gun sup­port­ing Irish re­search in­sti­tu­tions in se­quenc­ing the genomes of Covid-19 pa­tients.

Of­fi­cial sep­a­ra­tion from the Shang­hai of­fice is slat­ed for lat­er this year, al­though Ge­nu­ity is al­ready con­sid­er­ing what to do with it.

De­spite the shake­up, its in­vestor base ac­tu­al­ly re­mains the same, fea­tur­ing some mar­quee names such as Temasek, ARCH and Se­quoia Cap­i­tal. None of them, Brain­in felt com­pelled to add, will have ac­cess to sen­si­tive in­for­ma­tion or in­ter­nal da­ta.

As he clar­i­fied in an email:

WuXi NextCODE is not owned by WuXi AppTec or oth­er WuXi com­pa­nies. Since 2017, WuXi NextCODE has been op­er­at­ing as an in­de­pen­dent pri­vate com­pa­ny with for­mer WuXi Phar­maT­e­ch share­hold­ers serv­ing among the com­pa­ny’s many in­vestors.

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Christian Hogg, Hutchmed CEO

Hutchmed files for $600M+ IPO in Hong Kong as lead on­col­o­gy drug su­r­u­fa­tinib awaits FDA's good graces

In oncology, a flush of Chinese-developed drugs has the biopharma industry rethinking the poles of power in R&D as the blossoming nation continues to make a name for itself and pick up bundles of cash in the process. Now, as its lead drug faces a pivotal FDA review, the company formerly known as Chi-Med is planting its flag on home soil with a massive public offering.

Hutchmed — recently renamed from Chi-Med, or Hutchison China MediTech — will look to raise $603 million as part of a Hong Kong IPO that serves as a homecoming of sorts for the Chinese-based oncology player, which has listed on Nasdaq since 2016.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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As drug­mak­ers spend $6B an­nu­al­ly on DTC ads, sen­a­tors re­vive bill to in­clude list prices in ads

A new GAO report on biopharma companies’ $6 billion annual spending on direct-to-consumer advertising is pushing US Senate Majority Whip Dick Durbin (D-IL) and Sen. Chuck Grassley (R-IA) to reintroduce legislation that would require price disclosures in the ads.

The GAO found that drugmakers spent almost half—$8.2 billion of the $17.8 billion from 2016 to 2018—on DTC ads for drugs in three therapeutic categories, including inflammatory conditions (e.g., arthritis, gout), endocrine and metabolic disorders (e.g., type 2 diabetes, hypothyroidism), and conditions affecting the central nervous system (e.g., depression, multiple sclerosis), according to the new report.