Shire wins a block­buster OK for pipeline star lanadelum­ab, boost­ing Take­da’s $62B takeover deal

The FDA wast­ed no time in stamp­ing their quick ap­proval on Shire’s mar­ket­ing ap­pli­ca­tion for lanadelum­ab — one of the year’s top like­ly block­busters in the in­dus­try pipeline. And that’s a crit­i­cal en­dorse­ment for Take­da, which wants to pro­vide some com­pelling rea­sons be­hind its $62 bil­lion deal to buy Shire to help sat­is­fy its crit­ics.

The drug will now hit the mar­ket as Takhzy­ro. A spokesper­son for the com­pa­ny says that is pro­nounced “Tek-zye-roe.” And you can find out what it will be priced at in the next week.

There wasn’t much dra­ma be­hind this OK. Shire had pro­vid­ed stel­lar da­ta to sup­port the use of lanadelum­ab in treat­ing hered­i­tary an­gioede­ma — or HAE — a rare and life threat­en­ing ge­net­ic con­di­tion.

In what could well prove a chief part of Flem­ming Orn­skov’s lega­cy as the last Shire CEO, the com­pa­ny ac­quired this drug in a $6.5 bil­lion buy­out of Dyax in 2015. Then the re­search team steered it through a piv­otal stage study, where a 300 mg dose of the drug twice a month de­liv­ered an 87% re­duc­tion in mean HAE at­tack fre­quen­cy, com­pared to 0% in the place­bo group. It hit the pri­ma­ry end­point with “high­ly” sta­tis­ti­cal­ly sig­nif­i­cant re­sults as well as all the sec­on­daries.

Now an­a­lysts ex­pect the drug will push ahead to around $1.3 bil­lion in peak sales, pro­tect­ing a key fran­chise for the com­pa­ny as Take­da works to com­plete the takeover deal in 2019.

“Look­ing to the fu­ture, we con­tin­ue to work to­wards our goal of a world in which those liv­ing with HAE can aim for ze­ro at­tacks,” not­ed the re­cent­ly named Shire R&D chief An­dreas Busch.

Glob­al­Da­ta high­light­ed the drug’s dom­i­nance in a chart re­lat­ed to fu­ture sales es­ti­mates for Shire’s pipeline ther­a­pies, where it eas­i­ly over­shad­owed every­thing else in R&D. And Clar­i­vate pegged the drug as num­ber 9 on its list of 12 block­busters up for an FDA de­ci­sion this year.

Dyax share­hold­ers will be cheer­ing the news this evening. They will get $4 per share they owned un­der the con­tin­gent val­ue right deal they struck at the time of the ac­qui­si­tion.

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

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.

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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