Am­gen hands off rights to lep­rosy, tu­ber­cu­lo­sis med picked up as part of $13.4B Ote­zla deal

Am­gen scored a big pick­up with its ac­qui­si­tion of im­munol­o­gy block­buster Ote­zla from Bris­tol My­ers Squibb late last year. But that deal al­so came with a mol­e­cule for tu­ber­cu­lo­sis and lep­rosy with sig­nif­i­cant­ly less com­mer­cial val­ue, and Am­gen is ready to wipe its hands clean.

As part of the $13.4 bil­lion deal, Am­gen took over what be­came AMG 634 — a phos­pho­di­esterase type 4 in­hibitor cur­rent­ly in Phase II tri­als that is be­ing in­ves­ti­gat­ed for the treat­ment of both tu­ber­cu­lo­sis and ery­the­ma no­dosum lep­ro­sum, a com­pli­ca­tion from lep­rosy.

Now, Am­gen will li­cense that drug to Med­i­cines De­vel­op­ment for Glob­al Health, a non­prof­it bio­phar­ma com­pa­ny, and will keep its hands off of any fu­ture de­vel­op­ment or com­mer­cial rights to the ther­a­py.

David Reese Am­gen

As part of the agree­ment, Am­gen will con­tin­ue to sup­port the two Phase II tri­als — one study­ing tu­ber­cu­lo­sis and the oth­er study­ing ENL — and will fund the ENL study, the com­pa­nies said in a press re­lease. MDGH will as­sume full re­spon­si­bil­i­ty mov­ing for­ward for any fur­ther de­vel­op­ment and com­mer­cial­iza­tion of AMG 634.

“Am­gen sought an or­ga­ni­za­tion that could sup­port the de­vel­op­ment of AMG 634 to ad­dress the glob­al health un­met need,” David Reese, Am­gen’s R&D ex­ec­u­tive vice pres­i­dent, said in a state­ment. “MDGH’s track record and ex­pe­ri­ence in prod­uct de­vel­op­ment, glob­al health, and ne­glect­ed in­fec­tious dis­eases makes them an ide­al com­pa­ny to fur­ther de­vel­op AMG 634 for the ben­e­fit of pa­tients.”

The deal was an­nounced on the same day Am­gen re­vealed the fail­ure of a new asth­ma drug in a Phase III tri­al.

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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.

John Oyler, BeiGene CEO (Paul Yeung/Bloomberg via Getty Images)

Bris­tol My­ers wants to pull out of its Abrax­ane deal in Chi­na. BeiGene says no way

A year and a half after Chinese officials ordered BeiGene to stop selling Bristol Myers Squibb’s Abraxane in the wake of an alarming inspection of a US facility, the manufacturing issues at the root of the import suspension still appear unresolved.

And Bristol Myers wants to axe the Abraxane supply deal altogether.

But BeiGene, which is currently in arbitration proceedings against its Big Pharma partner, won’t let it off the hook so easily.

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Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Eric Roman, Pace Analytical CEO

This mid­west­ern CD­MO just picked up 3 ac­qui­si­tions in less than a week

A relatively quiet Minneapolis-based CDMO is making waves, announcing its third acquisition in just one week.

Pace has acquired Velesco Pharmaceuticals Services, which will add to its liquid, semi-solid and oral solid dose manufacturing, the company said. The CDMO has also brought on BC Laboratories out of California and ProScience Analytical Services

The Velesco acquisition allows Pace to broaden its drug delivery options, and tailor them for clients’ modules, dose range and drug delivery route. With the acquisition, Pace will get Velesco’s clinical trial manufacturing capacity, which includes specialized, small-scale customized experiments, softgel capsule, suspension and non-sterile liquid drug support and expertise in non-clinical toxicology studies.