Fortress Biotech takes out $60M loan for debt pur­pos­es; En­ta­sis pulls in $25M pri­vate place­ment for PhI­II tri­al

Fortress Biotech, the in­cu­ba­tor at the cen­ter of a stock mar­ket scan­dal two sum­mers ago, is tak­ing out a loan to re­fi­nance ex­ist­ing debt.

The com­pa­ny is bor­row­ing $60 mil­lion through Oak­tree Cap­i­tal Man­age­ment, with the loan ex­pect­ed to ma­ture in five years. Fortress will pay back the loan first with quar­ter­ly in­stall­ments of 11% in­ter­est un­til 2025, and then with the en­tire prin­ci­pal amount on the loan’s five-year an­niver­sary, ac­cord­ing to the SEC fil­ing.

Fortress can al­so re­pay Oak­tree be­fore the loan ma­tures at any time, with a pre­pay­ment fee re­quired with­in the first four years.

Back in Au­gust 2018, Reuters dropped a bomb­shell re­port about how Fortress bought and used a bro­ker­age firm, Na­tion­al Hold­ings, to tout its own star­tups with­out dis­clos­ing the con­nec­tion be­tween the two com­pa­nies un­til re­porters start­ed ask­ing about it. That in­clud­ed not in­form­ing in­vestors in an­a­lyst notes about po­ten­tial con­flicts of in­ter­est.

Fortress end­ed up sell­ing its 56.1% stake in Na­tion­al a few months lat­er to B. Ri­ley Fi­nan­cial.

Al­so on Fri­day, Fortress an­nounced that a Menkes dis­ease pro­gram from one of its part­ner com­pa­nies, Cypri­um Ther­a­peu­tics, had met its pri­ma­ry end­point of over­all sur­vival from birth. The av­er­age sur­vival was 14.8 years com­pared to 1.3 years in an un­treat­ed his­tor­i­cal con­trol group. — Max Gel­man

En­ta­sis pulls in $25 mil­lion pri­vate place­ment for PhI­II tri­al 

As­traZeneca spin­out En­ta­sis Ther­a­peu­tics is ex­pect­ed to close on a $25 mil­lion pri­vate place­ment with In­no­vi­va and oth­er in­vestors on Sept. 1.

The com­pa­ny plans to sell 9,345,794 shares at $2.675 apiece. The an­nounce­ment comes two years af­ter En­ta­sis’ $ET­TX Nas­daq de­but. In Sep­tem­ber 2018, the Waltham, MA-based com­pa­ny priced shares at $15 apiece, be­low a set range of $16 to $18.

En­ta­sis plans on us­ing pro­ceeds to con­tin­ue a Phase III tri­al of its sul­bac­tam-dur­lobac­tam, used to treat pneu­mo­nia and blood­stream in­fec­tions caused by car­bapen­em-re­sis­tant Acine­to­bac­ter bau­man­nii. The drug, an in­hibitor of Class A, C, and D β-lac­ta­mases, has been grant­ed FDA fast-track des­ig­na­tion. — Nicole De­Feud­is 

Virios files for a $35 mil­lion IPO to de­vel­op fi­bromyal­gia drug

Al­pharet­ta, GA-based Virios Ther­a­peu­tics $VIRI an­nounced on Fri­day that it’s look­ing to go pub­lic. The biotech filed for a $35 mil­lion raise, which it plans on us­ing to push its fi­bromyal­gia drug to Phase III.

The num­ber of biotech de­buts this year have al­ready sur­passed that of 2019. Com­pa­nies prof­it­ing from the boom have raised more than $11 bil­lion com­bined.

Virios, found­ed in 2012, says it will use IPO funds to com­plete a Phase IIb tri­al and chron­ic tox­i­col­o­gy stud­ies of its lead can­di­date, IMC-1. The an­tivi­ral ther­a­py is de­signed to sup­press her­pes sim­plex virus-1 ac­ti­va­tion and repli­ca­tion. Virios ex­pects to read out topline da­ta from the IIb in ear­ly 2022. — Nicole De­Feud­is 

Pfiz­er ex­tends an­oth­er CRO, this time with Parex­el

The big CRO Parex­el an­nounced a new con­tract with Pfiz­er to pro­vide clin­i­cal de­vel­op­ment ser­vices.

Parex­el will work with the Big Phar­ma for the next three years with an op­tion to ex­tend the part­ner­ship for an­oth­er two. The com­pa­nies have col­lab­o­rat­ed for the last decade, Parex­el said in a state­ment.

The ser­vices will be ad­min­is­tered across all of Pfiz­er’s ther­a­peu­tic ar­eas, in­clud­ing rare dis­eases, on­col­o­gy, in­flam­ma­tion and im­munol­o­gy and in­ter­nal and hos­pi­tal-based med­i­cines.

This marks the fourth CRO agree­ment Pfiz­er has agreed to over the last few months, adding the Parex­el deal to oth­ers with Icon, Sy­neos Health and the PPD. — Max Gel­man

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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