Fer­ring buys up PhI­II mi­cro­bio­me drug with ac­qui­si­tion of Re­bi­otix

A Min­neso­ta com­pa­ny work­ing on a drug that could be the na­tion’s first pill packed with mi­crobes has been snatched up by Swiss drug mak­er Fer­ring Phar­ma­ceu­ti­cals.

The start­up, called Re­bi­otix, was ac­quired in a deal that closed Wednes­day with undis­closed terms. The com­pa­ny is de­vel­op­ing a fe­cal mi­cro­bio­ta trans­plant dubbed RBX-2660 that’s cur­rent­ly in Phase III tri­als. It’s be­ing test­ed against an in­fec­tion caused by C dif­fi­cile, a bac­te­ria that can in­duce symp­toms rang­ing from di­ar­rhea to life-threat­en­ing in­flam­ma­tion of the colon. The in­fec­tion of­ten oc­curs in old­er pa­tients in hos­pi­tals or long-term care who hap­pen to be tak­ing an­tibi­otics for a long pe­ri­od of time. Iron­i­cal­ly, the stan­dard treat­ment for C diff is to take the pa­tient off the an­tibi­ot­ic that caused the in­fec­tion… and then put them on an­oth­er an­tibi­ot­ic.

Re­bi­otix’s RBX-2660 works quite dif­fer­ent­ly than an an­tibi­ot­ic. It re­pop­u­lates the gut mi­cro­bio­me, and the trans­plant­ed mi­crobes then go to war with C diff, pre­vent­ing it from grow­ing and forc­ing it out of the gut. The treat­ment could be a game-chang­er for pa­tients, which is why the FDA gave it fast track, break­through, and or­phan drug des­ig­na­tions.

Michel Pet­ti­grew

Fer­ring says it’s not pick­ing up Re­bi­otix just for one as­set. It thinks the start­up’s drug plat­form will de­liv­er long-term gains.

“The sci­en­tif­ic ad­vances Re­bi­otix has made add sig­nif­i­cant strate­gic val­ue to Fer­ring’s lead­er­ship in gas­troen­terol­o­gy,” Michel Pet­ti­grew, COO and pres­i­dent of the ex­ec­u­tive board at Fer­ring Phar­ma­ceu­ti­cals said in a state­ment. “Ther­a­pies tar­get­ed to­wards the mi­cro­bio­me have the po­ten­tial to trans­form health­care. To­geth­er, we have a unique op­por­tu­ni­ty to help peo­ple liv­ing with de­bil­i­tat­ing and life-threat­en­ing con­di­tions like Clostrid­i­um dif­fi­cile in­fec­tion.”

On top of its buy­out of Re­bi­otix, Fer­ring has been in­vest­ing in the mi­cro­bio­me space for years. It’s got a li­cense agree­ment with My­Bi­otics for its women’s health ther­a­peu­tics and a re­search deal with Metabo­Gen for a mi­cro­bio­me-based treat­ment for tra­hep­at­ic cholesta­sis of preg­nan­cy. The com­pa­ny al­so has part­ner­ships with re­search or­ga­ni­za­tions in mi­cro­bio­me are­na, in­clud­ing with the Karolin­s­ka In­sti­tutet and Sci­ence for Life Lab­o­ra­to­ry, and the Cen­tre for Trans­la­tion­al Mi­cro­bio­me Re­search, among oth­ers.

Im­age: Clostrid­i­um dif­fi­cile bac­te­ria, 3D il­lus­tra­tion. SHUT­TER­STOCK

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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David Chang, WuXi AppTec

A 'love sto­ry': WuXi AppTec wraps UK-based CRO in­to its cell and gene ther­a­py unit

When WuXi AppTec, one of China’s largest contract research organizations, started working with UK-based Oxgene about a year ago, it was “love at first sight,” CEO David Chang jokes.

Oxgene, a roughly decade-old CRO focused on scalable gene therapy tech, began licensing some of their plasmid work to WuXi just over a year ago. And when that pilot went well, WuXi expressed interest in investing, Oxgene CEO Ryan Cawood said.

Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.