Ten big lob­by­ing groups turn their guns on Al­ler­gan's con­tro­ver­sial patent gam­bit

Brent Saun­ders, CEO Al­ler­gan

Ten of the biggest health­care lob­by­ing groups in Wash­ing­ton, DC have joined the grow­ing forces lined up against Al­ler­gan’s patent gam­bit in­volv­ing Resta­sis.

In a let­ter to Con­gress, the al­liance — which in­cludes the Amer­i­can Hos­pi­tal As­so­ci­a­tion and Amer­i­ca’s Health In­sur­ance Plans — blast­ed Al­ler­gan $AGN for putting prof­its ahead of pa­tients and put their CEO in the same camp with no­to­ri­ous bio­phar­ma bad boy Mar­tin Shkre­li, the price-goug­ing ex­ec at Tur­ing who’s now chill­ing in a fed­er­al prison await­ing sen­tenc­ing on three felony con­vic­tions.

The ac­tions tak­en by Al­ler­gan and the St. Reg­is tribe to en­sure that pa­tients and pay­ors do not ben­e­fit from time­ly gener­ic com­pe­ti­tion to Resta­sis is an alarm­ing new ex­am­ple of the steps that brand name drug com­pa­nies will take to put prof­its above the pub­lic in­ter­est. Over the last two years there has been a great deal of con­gres­sion­al, me­dia and pub­lic fo­cus and scruti­ny paid to brand­ed prod­ucts like Dara­prim (by Shkre­li) and EpiPen (My­lan). Giv­en the on­go­ing con­cern about drug costs, it war­rants men­tion that Resta­sis gen­er­ates more in an­nu­al rev­enue than both of those prod­ucts com­bined.

That fol­lows crit­i­cism from a grow­ing line­up of De­moc­rats and Re­pub­li­cans who be­lieve that Al­ler­gan is up to no good.

Just weeks ago Al­ler­gan found it­self in a bright pub­lic spot­light af­ter hand­ing over patent rights on Resta­sis to the Saint Reg­is Mo­hawk Tribe, which runs its own casi­no, in ex­change for some hefty pay­ments. Right af­ter, the tribe went to court to claim that its sov­er­eign im­mu­ni­ty sta­tus trumped an in­ter partes re­view of the patent, which threat­ened the com­pa­ny’s $1.5 bil­lion drug fran­chise.

The 10 groups not­ed:

For less than 0.01 per­cent of the drug’s an­nu­al sales, Al­ler­gan’s deal could de­lay com­pe­ti­tion (by pro­tect­ing its new patents from re­view) for at least six ad­di­tion­al years.

Al­ler­gan CEO Brent Saun­ders has dug in deep, re­fus­ing to budge and vow­ing to pro­tect a move that he feels is com­plete­ly jus­ti­fied. Tak­ing to the op-ed pages of the Wall Street Jour­nal, Saun­ders once again tried to turn the dis­cus­sion to what he be­lieves is an un­fair IPR process.

He wrote:

IPR’s flaws have been ex­ploit­ed by gener­ic man­u­fac­tur­ers and a new breed of “re­verse trolls.” There have been many cas­es of hedge funds that de­mand­ed cash from brand­ed bio­phar­ma com­pa­nies as a pay­off for not fil­ing IPR chal­lenges. Al­ler­gan has been the tar­get of one of these ex­tor­tion-like at­tacks. Hedge funds have al­so tak­en short po­si­tions in com­pa­nies and then filed IPR chal­lenges to dri­ve down their stock val­ue.

The ques­tion now is whether law­mak­ers can quick­ly ramp up new leg­is­la­tion to throt­tle the move by Al­ler­gan, or if the courts take over for a lengthy re­view of the le­gal is­sues.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

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It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Bobby Sheng, Bora Pharmaceuticals CEO

With new ac­qui­si­tion, Bo­ra to ven­ture in­to bi­o­log­ics

Last week, Taiwan-based CDMO Bora Pharmaceuticals announced that it acquired Eden Biologics. Now, it says that purchase has helped established Bora Biologics, expanding into the biopharmaceutical market.

The acquisition of the company’s assets, which are located in the Hsinchu Biomedical Science Park in Taiwan, is helping Bora build its presence in the biopharma world by expanding production capacity of cell lines for the production of protein drugs. It will also improve the quality control and inspection specifications, as well as cell bank generation. The facility has four 500-liter bioreactors that have been approved by European and Taiwanese regulators.

Paul Chaplin, Bavarian Nordic president and CEO

With mon­key­pox cas­es ris­ing, one Eu­ro­pean coun­try is lock­ing down a small­pox vac­cine con­tract

As the global number of confirmed and suspected monkeypox cases continues to slowly climb, one country is trying to get a head start on potential vaccine stocking.

Bavarian Nordic signed a contract with an undisclosed European nation to supply its smallpox vaccine in response to new cases this month, the company announced Thursday morning. The continent saw its first monkeypox case confirmed about two weeks ago, with both the UK and Portugal seeing cases, according to the Washington Post.

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