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

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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Arie Belldegrun, Endpoints @ JPM20 Breakfast Panel. Photography by Jeff Rumans.

Mo­tion de­nied: Gilead still on the hook for $1.5B in dam­ages over CAR-T patent dis­pute with Bris­tol My­ers Squibb

Gilead’s bid to overturn a jury verdict that ordered it to pay Bristol Myers Squibb about $752 million for CAR-T patents owned by its subsidiary Juno Therapeutics has ended in vain.

The ruling leaves Gilead vulnerable to an even bigger $1.5 billion payment that Bristol is now demanding — adding fuel to the fiery criticism some analysts are already heaping on its $11.9 billion Kite buyout.

In a 30-page document unsealed on Monday, Judge James Otero of the district court in Los Angeles struck down several different arguments for a new decision. Here are Morgan Stanley analysts’ takeaways:
The court, in particular, denied Kite’s contentions (1) that Juno’s patent is invalid, (2) the damages award was unreasonable, and (3) that a new trial should take place. The court also denied Kite’s argument that its infringement was not willful.
Gilead is likely to appeal to the federal circuit, they noted, but the odds are not in their favor as the same standard for evidence will be applied in that court. Appeals typically take 16 months.

A quiver of ar­rows for im­mune dis­or­ders: Pan­dion scores $80M in fresh fund­ing

Scientists began with making recombinant versions of naturally-occurring human proteins, then graduated to monoclonal antibodies. Now, rather than replicating moieties within the body, researchers are modifying these molecules to have precise biology in a functional manner.

This technology, referred to as bispecific antibodies, is already being employed to fight cancer. In early 2018, Pandion Therapeutics was born to reverse-engineer the science into the realm of autoimmune and inflammatory disorders.

It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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