Bank­rupt an­tibi­otics mak­er Ar­a­digm turns to old part­ner/in­vestor for fi­nal $3M fire sale

Gri­fols once paid Ar­a­digm $26 mil­lion for a stake in its in­haled an­tibi­otics. But with Ar­a­digm now in bank­rupt­cy, the Span­ish drug­mak­er is dish­ing out a fi­nal $3.2 mil­lion to buy it all.

The fire sale — which comes one year af­ter Ar­a­digm filed for Chap­ter 11 fol­low­ing a reg­u­la­to­ry tri­fec­ta for dis­as­ter — will see Gri­fols ob­tain as­sets and IP to Apul­miq (for­mer­ly Pul­maquin and Lin­haliq in Eu­rope), Lipo­quin and free ciprofloxacin. In ad­di­tion to waiv­ing its claims in the bank­rupt­cy case, Gri­fols al­so agreed to mile­stone pay­ments up to $3 mil­lion more up­on any reg­u­la­to­ry ap­provals.

But they will have quite a few hur­dles to over­come. Reg­u­la­to­ry agen­cies and out­side ex­perts alike made their skep­ti­cism to­ward Ar­a­digm’s da­ta clear. The FDA slapped down an ap­pli­ca­tion for Apul­miq and re­quest­ed a new Phase III tri­al back in 2017, and the com­pa­ny with­drew its sub­mis­sion in Eu­rope af­ter the EMA in­di­cat­ed it was go­ing to do the same.

Ar­a­digm’s idea had been to fight lung in­fec­tions with in­haled for­mu­la­tions of ciprofloxacin. Avail­able as pills, eye drops, ear drops and by IV, the an­tibi­ot­ic was al­ready de­ployed against a wide range of con­di­tions such as joint in­fec­tions, in­tra-ab­dom­i­nal in­fec­tions, in­fec­tious di­ar­rhea, res­pi­ra­to­ry tract in­fec­tions, skin in­fec­tions, ty­phoid fever and uri­nary tract in­fec­tions.

The Newark, CA-based com­pa­ny turned to an­tibi­otics af­ter an ef­fort, part­nered with No­vo Nordisk, to de­vel­op an in­hal­able form of in­sulin flailed.

Yet their Phase III stud­ies for Apul­miq in non-cys­tic fi­bro­sis bronchiec­ta­sis yield­ed mixed da­ta, as the drug on­ly hit the pri­ma­ry end­point — length­en­ing the me­di­an time to first pul­monary ex­ac­er­ba­tion — in one tri­al but not the oth­er.

Gri­fols did not elab­o­rate on what it now plans to do with the as­sets. It would like­ly in­volve a two-year tri­al that the FDA asked for but Ar­a­digm didn’t have the mon­ey to fund.

“Ex­clud­ed from the sale are all of the Com­pa­ny’s cash and cash equiv­a­lents, ac­counts or notes re­ceiv­able, cer­tain con­tracts, tan­gi­ble per­son­al prop­er­ty, the name Ar­a­digm Cor­po­ra­tion, ac­counts and records of Ar­a­digm Cor­po­ra­tion, all ben­e­fit plans and the shares of Ar­a­digm,” a state­ment not­ed.

Ar­a­digm was one of three an­tibi­otics play­ers to de­clare bank­rupt­cy last year. In a mar­ket where even com­pa­nies that come up with suc­cess­ful prod­ucts can’t sur­vive the com­mer­cial crunch, in­vestors seem to have even less pa­tience for the failed ones.

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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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Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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Mer­ck and Bay­er un­veil the da­ta be­hind their CV ‘suc­cess,’ un­der­whelm­ing the in­dus­try

Four months after Merck announced a surprise Phase III success on the heart drug they gave Bayer $1 billion for, the full data is out — and cardiologists, investors and payers are left wondering just how effective the drug really is.

The data, published in the New England Journal of Medicine and announced in the virtual American College of Cardiology meeting, showed that across 5,050 patients, vericiguat led to a 10% reduction in hospitalizations for heart failure. Although that met the primary endpoint — the composite of time until first death or hospitalization for heart failure — it underwhelmed, particularly as the drug did not lead to a statistically significant reduction in death.

As­traZeneca gets a green light on Imfinzi for small-cell lung can­cer — set­ting the stage for a bat­tle with Roche's Tecen­triq

The standard-of-care for small-cell lung cancer (SCLC) for decades was platinum-based chemotherapy, but that paradigm shifted in 2018, with the approval of Bristol Myers Squibb’s checkpoint inhibitor Opdivo in the second-line setting. Since then, a slate of immunotherapies have secured SCLC approvals, and the latest is AstraZeneca’s flagship Imfinzi, which was approved on Monday in combination with standard chemotherapy as the first line of defense in extensive-stage SCLC patients.

John Reed, Sanofi’s global head of R&D (Image: Endpoints News)

IL-6 to the res­cue? Sanofi, Re­gen­eron bar­rel ahead in­to an­oth­er piv­otal ef­fort test­ing Kevzara for Covid-19

Sanofi and Regeneron have hustled up a second pivotal trial for their IL-6 drug Kevzara as a potential therapy for severe cases of Covid-19. The partners swiftly assembled a study drawing patients from Italy, Spain, Germany, France, Canada and Russia, planning to sign up 300 patients in a Phase II to test a low and high dose of Kevzara against placebo, setting the stage for the Phase III followup.

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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