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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

Karuna li­cens­es Goldfinch as­sets to com­pete with Boehringer In­gel­heim in neu­ro­science

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.