J&J takes a $630M as­set hit on the books, shut­ter­ing PhI­Ib tri­als as its $1.75B RSV drug teeters on the brink

Al­most ex­act­ly 4 years af­ter J&J paid $1.75 bil­lion for a lit­tle biotech called Alios, one of the cen­tral drugs fea­tured in the deal ap­pears to be in deep trou­ble. Re­searchers at the com­pa­ny vol­un­tar­i­ly sus­pend­ed ad­vanced tri­als on the drug months ago and now the phar­ma gi­ant is tak­ing a heavy hit on the books as it re­assess­es the drug’s fast-dwin­dling as­set val­ue.

The phar­ma gi­ant re­vealed in an SEC fil­ing that it is tak­ing an af­ter-tax im­pair­ment charge of about $630 mil­lion on AL-8176 — lu­mic­itabine — an an­ti-RSV drug de­signed to pre­vent a com­mon res­pi­ra­to­ry in­fec­tion in chil­dren. And it adds that it will keep an eye out on the rest of the $900 mil­lion still on the books, sug­gest­ing they may have a com­plete write-off on their hands.

The move was briefly not­ed in J&J’s 10Q filed last Au­gust. That fil­ing not­ed:

Late in the fis­cal sec­ond quar­ter of 2018, in­for­ma­tion be­came avail­able which led the Com­pa­ny to sus­pend on-go­ing Phase 2B tri­als un­til an analy­sis of this in­for­ma­tion is com­plet­ed. The Com­pa­ny will re­assess the car­ry­ing val­ue of the in-process re­search and de­vel­op­ment as­set up­on com­ple­tion of the analy­sis. If the de­vel­op­ment time­line is sig­nif­i­cant­ly de­layed or de­vel­op­ment is aban­doned the Com­pa­ny may in­cur an im­pair­ment charge.

In an up­date, a J&J spokesper­son tells me that the Phase IIb tri­als have now been scrapped as they re­turn to a pre­clin­i­cal stage of de­vel­op­ment.

This de­ci­sion was made due to the on­go­ing analy­sis of new pre­clin­i­cal da­ta and the need to per­form fur­ther pre-clin­i­cal stud­ies. Gen­er­a­tion and analy­sis of these da­ta is an­tic­i­pat­ed to re­quire ad­di­tion­al time.

A de­ci­sion on fur­ther clin­i­cal tri­als for lu­mic­itabine will be made once the eval­u­a­tion of the da­ta has been com­plet­ed.

J&J bought out the biotech af­ter tak­ing a close look at its Phase II da­ta.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,200+ biopharma pros reading Endpoints daily — and it's free.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hoge, Moderna president (Moderna)

On morn­ing of FDA Covid-19 ad­comm, Mod­er­na com­pletes PhI­II en­roll­ment, putting them neck-and-neck with Pfiz­er

Weeks away from a potential EUA application, Moderna announced they have completed enrollment in their 30,000-person Phase III Covid-19 vaccine trial, with over a third of volunteers non-white and a quarter over the age of 65.

The announcement caps what has been the most closely-watched recruitment race in the history of drug development, as Pfizer and Moderna rushed to get enough volunteers to prove whether or not experimental vaccines could actually protect people from contracting Covid-19. Pfizer reached that mark on Sept. 15. Moderna said around the same time that they would slow down enrollment to ensure they enrolled enough participants from minority and at-risk groups.

Pfiz­er scoops up an an­tibi­ot­ic in rare M&A deal, bag­ging a vir­tu­al start­up op­er­at­ing on a shoe­string bud­get

Pfizer is stepping up with a rare antibiotics buyout deal today, grabbing Palo Alto, CA-based Arixa Pharmaceuticals in a bid to add a new oral version of avibactam, a beta lactamase inhibitor — or BLI — approved back in 2015 as part of the IV treatment Avycaz.

The Arixa acquisition follows some encouraging Phase I responses demonstrating that 60% to 80% of the oral drug is absorbed into the bloodstream. Only 7% of the IV version is absorbed orally, far below the 30% threshold Arixa has pointed to as a therapeutic threshold. The buyout gives Pfizer’s hospital group a line on a new oral combo with antibiotics like ceftibuten to go after drug-resistant cases of urinary tract infections and other ailments.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,200+ biopharma pros reading Endpoints daily — and it's free.

News brief­ing: UK biotech 4D phar­ma heads for Nas­daq via SPAC; Dr. Red­dy's shuts down man­u­fac­tur­ing af­ter cy­ber­at­tack

Another pharma company is intending to use a SPAC to join the Nasdaq.

4D pharma, a UK-based biotech, is reverse-merging with a blank check company in a deal worth up to $37.6 million. The move will give 4D pharma a new Nasdaq ticker, which will be $LBPS, using the American Depositary Share program.

As a result of the move, 4D pharma will gain $14.6 million in cash held by the blank check company, dubbed Longevity. The merger is expected to be completed in early 2021, after which shares will be immediately tradeable.

Can B cells break the bound­aries of cell ther­a­py? Long­wood start­up has $52M to prove a new en­gi­neer­ing tech

Back in December 2017, as the cell therapy world was still basking in the virtually back-to-back approvals of two pioneering CAR-Ts, researchers at Seattle Children’s Research Institute reported a scientific first in a different corner of the field: engineer B cells to treat disease.

The team, led by David Rawlings and Richard James, eventually worked with Longwood Fund to start a biotech around those findings. And now Atlas Venture and RA Capital Management are coming on board to lead a $52 million launch round, joined by Alta Partners, for Be Biopharma.

Jason Kelly, Gingko Bioworks CEO (Mike Blake/Reuters via Adobe)

Ex­clu­sive: Eye­ing big Covid-19 test­ing ex­pan­sion, Gink­go rolls out 50M rapid anti­gen di­ag­nos­tics

In what they hope will be a key part of an extensive effort to boost Covid-19 testing in the US, Ginkgo Bioworks is acquiring and distributing 50 million rapid antigen tests that can potentially be used for virus surveillance in schools and communities and for quick, on the ground diagnoses.

The tests, developed by SD Biosensor, are in line with proposals from the Rockefeller Foundation and Harvard epidemiologists, among others, to blanket the country with fast, low-cost tests. Although not yet authorized in the US, they are a key part of testing efforts from the Bill and Melinda Gates Foundation, who announced plans last month to distribute 120 million of them in low and middle income countries. Roche has commercialized the diagnostic in Europe.

Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,200+ biopharma pros reading Endpoints daily — and it's free.

HHS secretary Alex Azar (at the podium) and FDA commissioner Stephen Hahn (Pete Marovich/Getty Images)

Covid-19 roundup: Azar open­ly plan­ning Hahn ouster — re­port; Vul­ner­a­ble pop­u­la­tions like­ly to get vac­cines by Jan­u­ary

The relationship between HHS secretary Alex Azar and FDA commissioner Stephen Hahn has deteriorated to the point where Azar has suggested replacing Hahn, according to a Politico report.

Azar was angered by the FDA’s pushback of the Trump administration’s proposals for authorizing Covid-19 vaccines, so much so that he began openly floating potential replacements for Hahn. The report cited six unnamed sources that said Azar discussed bringing up Hahn’s removal to the White House.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,200+ biopharma pros reading Endpoints daily — and it's free.