Bruce Car (Credit: Bristol-Myers Squibb)

Agios taps Bris­tol-My­ers vet Bruce Car to re­place re­tir­ing CSO

Jack­ie Fouse has filled an­oth­er top role as she gets her team at Agios ready for a sec­ond decade, plot­ting fol­low-ons to its nascent com­mer­cial port­fo­lio.

Five months af­ter Agios an­nounced the re­tire­ment of long­time CSO Scott Biller, the biotech has found his suc­ces­sor from Bris­tol-My­ers Squibb, which has been re­mak­ing its own struc­ture as it ab­sorbs Cel­gene’s lead­er­ship.

Scott Biller

In join­ing Agios, Bruce Car — the phar­ma gi­ant’s in­ter­im head of drug dis­cov­ery — leaves be­hind a decades-long ca­reer fo­cused on ear­ly-stage re­search work with roles span­ning tox­i­col­o­gy, drug op­ti­miza­tion and trans­la­tion­al sci­ence. He start­ed out at DuPont Phar­ma­ceu­ti­cals a few years be­fore it was ac­quired by Bris­tol-My­ers.

“I’ve long been im­pressed by the in­no­va­tion and pro­duc­tiv­i­ty of the re­search team at Agios,” Car said in a state­ment. “I’m ex­cit­ed to take on this unique op­por­tu­ni­ty at a com­pa­ny with ex­pan­sive me­tab­o­lism ex­per­tise and a ro­bust pre­clin­i­cal pipeline across on­col­o­gy and rare ge­net­ic dis­eases.”

He in­her­its an ex­pan­sive pre­clin­i­cal pipeline cov­er­ing can­cer as well as rare ge­net­ic dis­eases. Cel­gene, where CEO Fouse had a high­ly ac­claimed tenure, is part­nered on pro­grams tar­get­ing MAT2A as well as meta­bol­ic im­muno-on­col­o­gy.

Jack­ie Fouse

Aside from IDH, the en­zymes that in­spired Agios’ first mar­ket­ed drugs Id­hi­fa and Tib­so­vo, the com­pa­ny has al­so iden­ti­fied PKR, MAT2A and DHODH as their key tar­gets.

Car’s re­cent ex­pe­ri­ence build­ing a group ded­i­cat­ed to bio­mark­ers and phar­ma­co-di­ag­nos­tics could be par­tic­u­lar­ly rel­e­vant as much of Agios’ suc­cess will de­pend on their abil­i­ty to con­vince physi­cians to test for the ge­net­ic mu­ta­tions their drugs hit.

He joins as Agios ex­pands its man­age­ment or­ga­ni­za­tion, ap­point­ing Jonathan Biller to the new­ly cre­at­ed role of chief le­gal of­fi­cer just days ago and beef­ing up the com­mer­cial op­er­a­tions by pro­mot­ing Dar­rin Miles to SVP, US com­mer­cial and glob­al mar­ket­ing and kick­ing off a search for some­one to lead in­ter­na­tion­al sales.

Biller, mean­while, will re­main a strate­gic ad­vi­sor through 2020.

“I want to thank Scott for con­tri­bu­tions to our pipeline, peo­ple and cul­ture over the last nine years. He has men­tored, chal­lenged and sup­port­ed count­less em­ploy­ees and led by ex­am­ple in his re­lent­less fo­cus on mak­ing a dif­fer­ence for pa­tients,” Fouse said in a send­off.

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,300+ biopharma pros reading Endpoints daily — and it's free.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

New play­ers are jump­ing in­to an old vac­cine game as pan­dem­ic pan­ic spreads fast — putting their tech to the test

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,300+ biopharma pros reading Endpoints daily — and it's free.

Roche cracks Chi­na's ADC mar­ket open as Kad­cy­la scores its first breast can­cer OK in the coun­try

Roche’s Kadcyla has become the first antibody-drug conjugate to enter the Chinese market, marking a dramatic advance for both the Swiss pharma giant and the therapeutic class.

The local arm of Roche announced the approval late Tuesday, which covers the therapy’s use in the adjuvant setting in patients with early HER-2 positive breast cancer who still have residual invasive disease after receiving paclitaxel and Herceptin as neoadjuvant treatment.

Pascal Soriot, Getty

Pas­cal So­ri­ot and As­traZeneca com­mit to car­bon neu­tral­i­ty by 2025. Where's the rest of Phar­ma?

Pascal Soriot has spent more than 20 years at the top of an industry recently found to emit more carbon than the automotive industry.

He called himself a “global citizen,” and traveled often across three-plus continents. While CEO of AstraZeneca, he commissioned a flight service — media-dubbed AstraZeneca airlines — from Cambridge to the company’s other European hub in Gothenburg. He made few, if any, public statements on the environment or his companies’ impact on it.

Fresh tri­al da­ta for­ti­fy po­si­tion of Roche's oral ther­a­py in spinal mus­cu­lar at­ro­phy bat­tle­ground

With an FDA decision date looming, Roche on Wednesday unveiled positive pivotal data on its blockbuster-bound oral spinal muscular atrophy (SMA) drug in patients with the most severe form of the muscle-wasting disease.

The FDA is set to make its decision on the therapy, risdiplam, by May 24. It is expected to compete with Biogen’s Spinraza and Novartis’ Zolgensma.

Partnered with PTC Therapeutics, the Roche drug was tested in 41 patients aged 1-7 months with type 1 SMA, a rare genetic muscle-wasting disease. The trial, dubbed FIREFISH, measured efficacy via the proportion of infants sitting without support after 12 months of treatment, and longer.

Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

Hal Barron and Emma Walmsley, GSK

GSK’s ‘break­through’ BC­MA can­cer drug gets a pri­or­i­ty re­view — and a big win for the on­col­o­gy R&D team

After largely whiffing the past 2 years on the pharma R&D front, GlaxoSmithKline research chief Hal Barron has seized boasting rights to a key win that puts them back in the cancer drug development game.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,300+ biopharma pros reading Endpoints daily — and it's free.