Three Ohio-based con­tract or­ga­ni­za­tions win $149M deal for neu­ro­log­i­cal can­di­dates

Three con­tract or­ga­ni­za­tions based near the cap­i­tal of Ohio are start­ing the year with a mul­ti­mil­lion-dol­lar deal.

The sci­ence and tech­nol­o­gy com­pa­ny Bat­telle, con­tract re­searcher Am­pli­fy­Bio and CD­MO An­de­lyn Bio­sciences have net­ted an eight-year, $149 mil­lion in­def­i­nite de­liv­ery, in­def­i­nite quan­ti­ty con­tract from the Na­tion­al In­sti­tute of Neu­ro­log­i­cal Dis­or­ders and Stroke to help ad­vance ther­a­pies for treat neu­ro­log­i­cal con­di­tions.

A Bat­telle spokesper­son told End­points News via email that the com­pa­ny’s role will in­volve pro­gram man­age­ment and tech­ni­cal lead­er­ship in as­say de­vel­op­ment.

Am­pli­fy­Bio’s role will fo­cus on pre­clin­i­cal stud­ies, such as de­sign and sup­port around neu­ro­log­i­cal safe­ty and ef­fi­ca­cy. Ac­cord­ing to an Am­pli­fy­Bio spokesper­son, that work will in­clude sup­port for nov­el and spe­cial­ized dose routes, in vit­ro analy­sis of drug ef­fi­ca­cy and neu­robe­hav­ioral stud­ies. An­de­lyn’s the man­u­fac­tur­ing part­ner for the deal.

Ac­cord­ing to Am­pli­fy­Bio’s spokesper­son, the con­tract it­self cov­ers eight ther­a­peu­tic types in­clud­ing: oligonu­cleotides, vi­ral vec­tors, pu­ri­fied pro­teins, pep­tides, AD­Cs, cell ther­a­pies, genome-edit­ing modal­i­ties and nanopar­ti­cle-based for­mu­la­tions. How­ev­er, the Bat­telle spokesper­son did state that “we will have to wait and see what task or­ders are is­sued.”

The deal is al­so a strong step for­ward for all the par­ties in­volved.

“It will al­low us to ap­ply our ex­per­tise in the neu­ro space to as­sess the safe­ty and ef­fi­ca­cy of these drugs and sup­port in the rich char­ac­ter­i­za­tion of those drugs to bet­ter po­si­tion them for suc­cess­ful com­mer­cial­iza­tion.  Al­so, this con­tract al­lows us to con­tin­ue our strong part­ner­ship with Bat­telle, and be­gin a new one with An­de­lyn Bio­science, high­light­ing the strength of the Cen­tral Ohio hub for ad­vanc­ing nov­el drugs,” the Am­pli­fy­Bio spokesper­son said.

Am­pli­fy­Bio, which spun out of Bat­telle in 2021, ex­pand­ed rapid­ly across the Colum­bus, OH area last year. In May, the CRO re­ceived around $150 mil­lion to es­tab­lish a new 350,000-square-foot fa­cil­i­ty, in ad­di­tion to rais­ing close to $200 mil­lion.

And in the wake of PACT Phar­ma’s lay­offs last year, Am­pli­fy­Bio al­so grabbed space out west, specif­i­cal­ly a 46,280 square-foot lab in South San Fran­cis­co, CA, with around 40 em­ploy­ees spe­cial­iz­ing in cell and gene ther­a­py de­vel­op­ment from PACT.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

Karuna li­cens­es Goldfinch as­sets to com­pete with Boehringer In­gel­heim in neu­ro­science

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.