What's he think­ing about? Vivek Ra­maswamy lines up a heavy­weight ti­tle fight for a late-stage di­a­betes drug

Vivek Ra­maswamy

Vivek Ra­maswamy has carved out a late-stage al­liance with a small biotech to take him in­to one of the most dif­fi­cult big mar­kets in the bio­phar­ma hand­book.

Ra­maswamy’s Roivant — the par­ent com­pa­ny to a line­up of “vant” star­tups — has agreed to pay Pox­el $50 mil­lion in cash and up to $600 mil­lion in mile­stones to take their di­a­betes drug in­to Phase III in the world’s biggest mar­kets. The up­front in­cludes $15 mil­lion for an eq­ui­ty stake.

A spokesper­son for Roivant con­firmed to me that Ra­maswamy will now set up a new biotech which will now build a pipeline in the field. This will be his 7th, and Ra­maswamy ev­i­dent­ly has the name picked out. We spied this list­ing in Bermu­da: Meta­vant.

The part­ner­ship brings to­geth­er two dif­fer­ent play­ers with their own off­beat strate­gies in drug de­vel­op­ment.

Thomas Kuhn, Pox­el

Mer­ck KGaA spin­out Pox­el (EPA: $POX­EL) has gar­nered sub­stan­tial at­ten­tion for its suc­cess­ful Phase IIb tri­al in Japan of imeglim­in, track­ing he­mo­glo­bin A1c re­duc­tions of 0.52%, 0.94% and 1.00% for the 500 mg, 1000 mg and 1500 mg dose twice-dai­ly. The da­ta brought in Sum­it­o­mo Dainip­pon Phar­ma to part­ner on Asia in a $300 mil­lion deal, with $42 mil­lion up front. And that came some months af­ter Pox­el CEO Thomas Kuhn had vowed to do it alone in Japan, telling me that they could get an ap­proval on a scaled down Phase III with 1,000 pa­tients.

Kuhn had es­ti­mat­ed a US tri­al would re­quire 7,000 pa­tients, which is why small biotechs don’t do late-stage di­a­betes drug de­vel­op­ment in the big mar­kets.

Now Ra­maswamy will be tack­ling a po­ten­tial­ly enor­mous­ly ex­pen­sive de­vel­op­ment pro­gram with a high reg­u­la­to­ry bar on safe­ty, with Pox­el on the hook for $25 mil­lion of the costs. And the biotech en­tre­pre­neur, re­cent­ly slammed by the com­plete fail­ure of its orig­i­nal ef­fort on Alzheimer’s, hint­ed that it plans to make more deals around meta­bol­ic drugs.

While Roivant has been hit hard by clin­i­cal fail­ure, Ra­maswamy re­mains one of the most ef­fec­tive fi­nan­cial en­gi­neers in the busi­ness. He’s raised $2.5 bil­lion in a lit­tle more than three years, in­clud­ing $1.1 bil­lion from Soft­Bank. So far, his in-li­cens­ing deals have been con­cen­trat­ed heav­i­ly around Big Phar­ma’s pipeline dis­cards, or in fields where the big play­ers were look­ing for a part­ner to help shoul­der ricks and ex­pense.

He’ll now be tack­ling a field dom­i­nat­ed by a few big play­ers like No­vo Nordisk, Sanofi and Eli Lil­ly, which have the kind of deep pock­ets need­ed to push through late-stage de­vel­op­ment.

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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