Lynn Seely (Myovant)

Lynn Seely hits the ex­it as My­ovant grad­u­ates to com­mer­cial space — hand­ing the reins to Am­gen vet

When Lynn Seely took the helm at My­ovant as the new­ly-re­tired chief med­ical of­fi­cer of Medi­va­tion, the biotech was still a fledg­ling mem­ber of Vivek Ra­maswamy’s sprawl­ing Vant fam­i­ly, prepar­ing to take flight with a Phase III drug from Take­da. Four and a half years lat­er, every­thing has changed: My­ovant’s largest share­hold­er is now Japan­ese phar­ma Sum­it­o­mo Dainip­pon, and in just the past month, the FDA hand­ed re­l­u­golix its first ap­proval and Pfiz­er has en­gi­neered a $4.2 bil­lion com­mer­cial part­ner­ship.

And Seely, the found­ing CEO, is pass­ing the ba­ton.

Am­gen vet David Marek will step up as the next chief ex­ec­u­tive fol­low­ing Seely’s res­ig­na­tion on Sun­day, ac­cord­ing to My­ovant.

David Marek

Be­fore he took on his most re­cent gig as chief com­mer­cial of­fi­cer at Ax­some Ther­a­peu­tics, Marek has helped launch the mi­graine drug Aimovig, man­aged a pact with No­var­tis and led mar­ket­ing for Am­gen’s in­flam­ma­tion and nephrol­o­gy unit. Oth­er ex­pe­ri­ences span con­sumer ser­vice and ad­ver­tis­ing.

“My­ovant is en­ter­ing a crit­i­cal phase of its growth where launch strat­e­gy, ex­e­cu­tion, and com­mer­cial per­for­mance are es­sen­tial to the over­all suc­cess of the com­pa­ny,” Seely said in a state­ment, re­it­er­at­ing the progress and plans around re­l­u­golix. “With the ac­com­plish­ment of these im­por­tant mile­stones, the board and I have de­cid­ed to tran­si­tion the lead­er­ship of My­ovant to an ex­ec­u­tive with sig­nif­i­cant com­mer­cial ex­per­tise.”

Aside from prostate can­cer, where the drug has been ap­proved as Or­govyx, My­ovant al­so has an NDA in for a tablet com­pris­ing re­l­u­golix, estra­di­ol and norethin­drone ac­etate in uter­ine fi­broids. A third NDA for en­dometrio­sis is slat­ed for lat­er this year — a tes­ta­ment to the size of the Phase III pro­gram Seely has built over the years, with five com­plete tri­als un­der her belt.

In a state­ment, Marek vowed to as­sure that the drug de­vel­op­ment en­gine “con­tin­ues to grow the com­pa­ny.”

My­ovant dis­closed in a fil­ing that Seely will re­ceive “cash sev­er­ance of $1,788,750, a fis­cal year 2020 bonus of $405,000, up to 18 months health­care pre­mi­um cov­er­age, re­im­burse­ment of up to $20,000 for le­gal ex­pens­es and full vest­ing of her out­stand­ing eq­ui­ty awards.”

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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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.

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.

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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IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

José Baselga, AstraZeneca cancer chief (Brent N. Clarke/FilmMagic via Getty Images)

As­traZeneca's Calquence nabs an­oth­er win against Im­bru­vi­ca, but Eli Lil­ly is on its heels

Three years after first launching Calquence as a second generation BTK inhibitor, AstraZeneca continues to tout new data to compete with J&J and AbbVie’s first generation blockbuster Imbruvica.

The British pharma announced on Monday that Calquence passed a head-to-head Phase III study against Imbruvica in chronic lymphocytic leukemia, proving non-inferior — i.e. just as good — as the older drug. Although AstraZeneca did not break down any of the numbers, they said the drug proved superior on safety, triggering fewer cases of atrial fibrillation, an irregular heartbeat that can lead to stroke or heart failure.