Terrie Curran, Phathom Pharmaceuticals CEO (via Arcutis)

UP­DAT­ED: Take­da GI spin­out nabs ap­proval for on­ly drug — and piv­ots to a quick raise

Three years af­ter Fra­zier teamed up with Take­da to spin a gas­troin­testi­nal drug in­to a new start­up named Phath­om Phar­ma­ceu­ti­cals, the biotech has de­liv­ered an ap­proval.

The FDA has sanc­tioned two dif­fer­ent for­mu­la­tions of vono­prazan to treat H. py­lori in­fec­tion in adults: Vo­quez­na Triple Pak com­bines vono­prazan tablets with amox­i­cillin cap­sules and clar­ithromycin tablets, while Vo­quez­na Dual Pak con­tains on­ly vono­prazan and amox­i­cillin.

And short­ly af­ter an­nounc­ing the ap­proval, Phath­om fol­lowed it up with plans to raise up to $260 mil­lion. It’s a tac­tic be­ing used more fre­quent­ly as the biotech bear mar­ket con­tin­ues to maul pub­lic com­pa­nies, where pos­i­tive da­ta or good reg­u­la­to­ry news is quick­ly suc­ceed­ed by nine-fig­ure rais­es.

The $260 mil­lion con­sists of $100 mil­lion up­front and an­oth­er $160 mil­lion promised up­on ap­proval of vono­prazan in ero­sive esophagi­tis. Phath­om says the cash will be used to boost the com­mer­cial launch in both in­di­ca­tions (an EE de­ci­sion is ex­pect­ed in Q1 2023) as well as an EE Phase III study.

Phath­om was among the first in a string of biotech spin­outs Take­da launched — of­ten with the help of Fra­zier — to han­dle some of the pipeline as­sets that the Big Phar­ma didn’t have the band­width for but thought was still worth­while.

Ap­proved in Japan in 2015, vono­prazan be­longs to a class of prod­ucts known as PCAB, or potas­si­um-com­pet­i­tive acid block­ers. By block­ing the potas­si­um-bind­ing site of gas­tric hy­dro­gen potas­si­um AT­Pase (al­so known as the pro­ton pump), which is the en­zyme large­ly re­spon­si­ble for acid­i­fi­ca­tion of the stom­ach, it’s de­signed to over­come many of the per­ceived weak­ness­es of tra­di­tion­al pro­ton pump in­hibitor ther­a­py.

In a Phase III tri­al, both vono­prazan reg­i­mens were pit­ted against one such tra­di­tion­al ther­a­py, Pre­vacid, and showed “su­pe­ri­or erad­i­ca­tion rates,” said CEO Ter­rie Cur­ran in a state­ment.

“H. py­lori erad­i­ca­tion rates con­tin­ue to de­cline in part due to an­tibi­ot­ic re­sis­tance, in­ad­e­quate acid sup­pres­sion, and com­plex treat­ment reg­i­mens, re­sult­ing in treat­ment fail­ures and com­pli­ca­tions for pa­tients,” she added, not­ing that the Vo­quez­na prod­ucts would bring more op­tions to mil­lions in the US.

Phath­om is tout­ing the ther­a­py as the first acid sup­pres­sant from a new drug class ap­proved in the US in over 30 years.

This sto­ry has been up­dat­ed with de­tails of Phath­om’s $260 mil­lion raise. 

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Ankit Mahadevia, Spero CEO

Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”