Gilead for­ti­fies its pi­o­neer­ing cell ther­a­py sta­tus, ex­pand­ing in­to three new fa­cil­i­ties and team­ing with NCI

Af­ter the com­pa­ny’s $12 bil­lion buy­out of Kite last year, Gilead is wast­ing no time ce­ment­ing its sta­tus as a leader in cell ther­a­py. The com­pa­ny an­nounced plans Tues­day to beef up its op­er­a­tions with three new fa­cil­i­ties around the globe — and inked a re­search agree­ment that could con­nect the com­pa­ny with more cut­ting-edge work in the field.

John Mil­li­gan

Be­com­ing an overnight leader in adop­tive cell ther­a­py af­ter its pur­chase of Kite, Gilead is now pri­or­i­tiz­ing the R&D and man­u­fac­ture of these drugs. In the Nether­lands, Gilead has leased a 117,000 square-foot man­u­fac­tur­ing site in Hoofd­dorp, al­low­ing the com­pa­ny to make and de­liv­er cell ther­a­pies to peo­ple liv­ing with can­cer in Eu­rope. Among oth­er drugs, the fa­cil­i­ty will man­u­fac­ture the CAR-T axi­cab­ta­gene ciloleu­cel (which goes un­der the brand name Yescar­ta here in the US). The ther­a­py is cur­rent­ly un­der re­view by the Eu­ro­pean Med­i­cines Agency.

“This new Eu­ro­pean man­u­fac­tur­ing fa­cil­i­ty will en­able per­son­al­ized cell ther­a­pies to be man­u­fac­tured in clos­er ge­o­graph­ic prox­im­i­ty to the pa­tients who will re­ceive them, po­ten­tial­ly short­en­ing the turn­around time for peo­ple who ur­gent­ly need care,” said Gilead’s pres­i­dent and CEO John Mil­li­gan in a state­ment.

On top of the Nether­lands fa­cil­i­ty, Kite bought a new build­ing in San­ta Mon­i­ca — where it’s long been head­quar­tered — from Astel­las Phar­ma. That fa­cil­i­ty will be used for cell ther­a­py R&D and the ex­pan­sion of clin­i­cal man­u­fac­tur­ing ca­pa­bil­i­ties, the com­pa­ny said.

Alessan­dro Ri­va

On the oth­er side of the coast, Kite has leased a 26,000 square-foot build­ing in Gaithers­burg, Mary­land, which will serve as home base for a new re­search project with the Na­tion­al Can­cer In­sti­tute. You’ll note that NCI is home to Steve Rosen­berg, who’s pi­o­neered the de­vel­op­ment of im­munother­a­pies and gene ther­a­pies for ad­vanced can­cers. That Co­op­er­a­tive Re­search and De­vel­op­ment Agree­ment will fo­cus on de­vel­op­ing adop­tive cell ther­a­pies tar­get­ing pa­tient-spe­cif­ic tu­mor neoanti­gens.

“We are proud to be at the fore­front of ad­vanc­ing cell ther­a­py, which we be­lieve has the po­ten­tial to trans­form can­cer treat­ment,” said Alessan­dro Ri­va, Gilead’s head of cell ther­a­py and ex­ec­u­tive VP of on­col­o­gy ther­a­peu­tics, in a state­ment. “The ad­di­tion of these three new fa­cil­i­ties and the ex­pand­ed CRA­DA with our re­search col­lab­o­ra­tors at the NCI will help us bring cell ther­a­pies to more peo­ple with can­cer around the world.”

This is the lat­est in a se­ries of steps Gilead has tak­en to ramp up its ef­forts in next-gen cell ther­a­py. These three new fa­cil­i­ties — along with the new NCI re­search agree­ment — come just months af­ter Gilead agreed to ac­quire Cell De­sign Labs in a $567 mil­lion deal.

 

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

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When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

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First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

Mallinck­rodt, once the na­tion’s largest oxy­codone pro­duc­er, an­nounces ten­ta­tive $1.6B set­tle­ment

Three years after it first paid out fines for its role in the US opioid abuse epidemic, Mallinckrodt has announced an agreement-in-principle that will see the company pay out $1.6 billion and place its generics unit in bankruptcy.

The tentative deal would settle hundreds of lawsuits from state and local governments over Mallinckrodt’s role in the epidemic, while also helping address the company’s increasingly mountainous debt. Although Purdue Pharma has drawn the bulk of both public and legal acrimony for opioid sales, documents made public earlier this year showed that Mallinckrodt subsidiary SpecGx, along with the generic subsidiaries of Teva and Endo Pharmaceuticals, accounted for the vast majority of the 76 billion opioid pills distributed from 2006 to 2012. Mallinckrodt was at the top of that list.