Bio­gen’s an­swer to Alk­er­mes’ Tec­fidera threat? Buy it, but don’t spend too much

Bio­gen $BI­IB has dealt de­ci­sive­ly with a po­ten­tial luke­warm threat from Alk­er­mes $ALKS to its cru­cial Tec­fidera fran­chise in mul­ti­ple scle­ro­sis.

They bought it.

In a deal an­nounced this morn­ing, Bio­gen agreed to pay $28 mil­lion to ante up on a part­ner­ship on ALKS 8700 that gives the Boston biotech glob­al com­mer­cial­iza­tion rights to the late-stage ther­a­py. That first pay­out cov­ers Bio­gen’s share of the re­search costs in 2017. And Bio­gen ex­pects to shell out $50 mil­lion on the first mile­stone in the deal be­fore the end of the year. That comes with a deal em­bed­ded with $200 mil­lion in mile­stones and mid-teen roy­al­ties on any sales.

Richard Pops, Alk­er­mes

That’s not a lot of cash in the world of late-stage drug part­ner­ing, which may un­der­score some of the mod­est ex­pec­ta­tions Alk­er­mes’ new drug has man­aged to in­spire thus far.

Alk­er­mes’ me-bet­ter pipeline of­ten shoots for new drugs with an im­proved safe­ty pro­file. In this case, they were look­ing for a drug that was just as ef­fec­tive as Tec­fidera but with few­er GI side ef­fects.

Alk­er­mes post­ed some sup­port­ive da­ta from a sin­gle-arm study a month ago, with a dis­con­tin­u­a­tion rate of on­ly 3.7% over three months, but an­a­lysts haven’t al­ways been im­pressed by the drug’s earn­ing po­ten­tial.

Leerink’s Paul Mat­teis looked it over in Oc­to­ber and con­clud­ed:

(T)he da­ta sug­gest that ALKS8700 could be an ap­prov­able as­set that stands to gar­ner some share in the MS mar­ket if the nec­es­sary mar­ket­ing sup­port and/or pric­ing strat­e­gy is put be­hind it. Even if the im­plied dif­fer­en­ti­a­tion pro­file proved to be more mod­est in a sep­a­rate, on­go­ing, per­haps more com­mer­cial­ly im­por­tant head-to-head study vs Tec­fidera — “EVOLVE-2” — a small amount of share for ‘8700 in the large MS mar­ket cat­e­go­ry could have mean­ing­ful im­pli­ca­tions for the ALKS P&L.

Alk­er­mes CEO Richard Pops had this to say on Bio­gen’s be­half:

Bio­gen has a broad prod­uct port­fo­lio and a high­ly ex­pe­ri­enced com­mer­cial team. In Bio­gen’s hands, we be­lieve that pa­tients will have broad­er and more rapid ac­cess to this im­por­tant med­i­cine. Mean­while, we will fo­cus our grow­ing com­mer­cial ca­pa­bil­i­ties on our ex­pand­ing port­fo­lio of med­i­cines in psy­chi­a­try, in­clud­ing ad­dic­tion, schiz­o­phre­nia and de­pres­sion.

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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