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.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

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You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Rob Califf (AP Photo/Pablo Martinez Monsivais, File)

Biden like­ly to nom­i­nate Ver­i­ly's Rob Califf to lead the FDA again

Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee.

A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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