Sarep­ta shakes up C-suite as they pre­pare to test FDA on Duchenne again

Af­ter slow­ly los­ing ex­ec­u­tives over the last two years, Sarep­ta has an­nounced a host of changes at its high­est lev­el.

Sarep­ta on Mon­day an­nounced a new CFO, chief com­mer­cial of­fi­cer, CSO and gen­er­al coun­sel, ef­fec­tive­ly giv­ing the biotech a new C-suite in a sin­gle press re­lease.

Sud­den and sweep­ing ex­ec­u­tive changes aren’t gen­er­al­ly a great in­di­ca­tor for a com­pa­ny’s health, but the cir­cum­stances around Sarep­ta’s lat­est changes are rel­a­tive­ly unique. The com­pa­ny hasn’t had a CSO since 2018, when Guriq Basi de­part­ed af­ter a one-year tenure. Their long­time chief com­mer­cial of­fi­cer, Bo Cum­bo, re­cent­ly spun out on his own, rais­ing $107 mil­lion for a new gene ther­a­py play. And their long­time CFO and CBO Sandy Ma­hatme “re­tired” in June for what turned out to be an op­por­tu­ni­ty to help run Bob Nelsen’s $800 mil­lion start­up Re­silience.

Louise Rodi­no-Kla­pac

Still, Sarep­ta has not been de­void of set­backs this year. In Sep­tem­ber, the biotech was forced to de­lay their Phase III tri­al af­ter the FDA flagged a prob­lem with one of their as­says, po­ten­tial­ly al­low­ing Pfiz­er to jump ahead in a two-horse race for the first Duchenne gene ther­a­py.

And last month, they an­nounced that they would de­fer the Phase III in fa­vor of a 10-per­son, non-ran­dom­ized study. The Phase III would start on­ly af­ter that was com­plete. With no agency as­sur­ances that the non-ran­dom­ized tri­al would be enough for ap­proval, they ef­fec­tive­ly sig­naled that one of the most con­tro­ver­sial biotechs of the last half decade would once again test the agency’s stan­dards for ap­proval.

In­vestors, though, haven’t reg­is­tered any un­easi­ness with the com­pa­ny’s course. Sarep­ta $SRPT shares have more than dou­bled since their nadir in April and jumped again on the news, from $167 to $178.

Ian Es­tepan

The new CSO is Louise Rodi­no-Kla­pac, who has di­rect­ed the com­pa­ny’s gene ther­a­py ef­forts for the last two years, af­ter the com­pa­ny lured her away from her lab at Na­tion­wide Chil­dren’s Hos­pi­tal, where she stud­ied gene ther­a­pies for Duchenne and limb gir­dle mus­cu­lar dy­s­tro­phies. It’s an un­sur­pris­ing choice, re­flec­tive of Sarep­ta’s near and long-term fo­cus, and Rodi­no-Kla­pac has al­ready filled the de fac­to CSO role on in­vestor calls, an­swer­ing key ques­tions about the com­pa­ny’s ex­per­i­men­tal ther­a­pies.

The new chief com­mer­cial of­fi­cer is Dal­lan Mur­ray, a J&J, Bio­gen, Gilead, and Ver­tex vet­er­an who has worked at the com­pa­ny since 2013, most re­cent­ly as head of com­mer­cial strat­e­gy and port­fo­lio man­age­ment. The new CFO is Ian Es­tepan, who joined in 2015 and had been serv­ing as chief of staff and cor­po­rate af­fairs.

Ryan Brown, who had been chief com­pli­ance of­fi­cer, will re­place Ty How­ton as in­ter­im gen­er­al coun­sel. How­ton joined Sarep­ta from Ver­tex in 2012. Sarep­ta said he re­tired.

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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Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

Friends and colleagues,

I am writing to provide our annual update on Roivant. These updates are usually restricted to our shareholders, but we are sharing this year’s letter more broadly to announce an upcoming change in my role from CEO to Executive Chairman and the promotion of Matt Gline to Chief Executive Officer.

Reflections on 2020

Much has transpired in the world and at our company since my last annual update in January 2020. One year ago we had just completed our $3 billion transaction with Sumitomo Dainippon Pharma (DSP), and we were evaluating how to reinvest in our business. At the same time, SARS-CoV-2 was still a distant virus barely on our minds. Today it has afflicted the entire world sparing literally no one from its effects.

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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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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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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.