Look­ing at a ground­break­ing ad­vance, My­ovant gets a pri­or­i­ty re­view at FDA; Agenus, G1 forge new Chi­na deals

→ Just weeks af­ter post­ing promis­ing piv­otal re­sults for re­l­u­golix in prostate can­cer, My­ovant has picked up a pri­or­i­ty re­view from the FDA, which isn’t plan­ning an ex­pert com­mit­tee re­view be­fore mak­ing its de­ci­sion. While much of the at­ten­tion in this class is fo­cused on uter­ine fi­broids, an OK here would make this the first GnRH re­cep­tor an­tag­o­nist treat­ment for men with ad­vanced prostate can­cer.

A cou­ple of new Chi­na deals ar­rived in to­day’s news feed. Agenus struck an agree­ment with Bet­ta Phar­ma­ceu­ti­cals for an ex­clu­sive col­lab­o­ra­tion and li­cense agree­ment for the de­vel­op­ment and com­mer­cial­iza­tion of bal­stil­imab and za­l­ifre­limab in Greater Chi­na. Agenus will re­ceive $35 mil­lion, which in­cludes $15 mil­lion in up­front cash and a $20 mil­lion eq­ui­ty in­vest­ment. The agree­ment al­so in­cludes $100 mil­lion in po­ten­tial mile­stones plus roy­al­ties on net sales. Al­so, G1 Ther­a­peu­tics and Genor Bio­phar­ma an­nounced an ex­clu­sive li­cense agree­ment for the de­vel­op­ment and com­mer­cial­iza­tion of le­ro­ci­clib in the Asia-Pa­cif­ic re­gion (ex­clud­ing Japan). G1 will re­ceive an up­front cash pay­ment of $6 mil­lion and be el­i­gi­ble to re­ceive up to an ad­di­tion­al $40 mil­lion in de­vel­op­ment and com­mer­cial mile­stone pay­ments.

→ Shang­hai’s STAR board has wel­comed its largest biotech, as Sinocell­Tech lands on the sci­ence and tech­nol­o­gy-fo­cused board with a $181 mil­lion raise in hand and sport­ing a $5 bil­lion mar­ket cap. Qim­ing Ven­ture Part­ners led its Se­ries A back in 2017, and many of its ex­per­i­men­tal prod­ucts — span­ning mon­o­clon­al an­ti­bod­ies, re­com­bi­nant pro­teins and vac­cines — have now en­tered Phase III.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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Mod­er­na es­tab­lish­es pub­lic health-fo­cused char­i­ty; FDA ap­proves As­traZeneca di­a­betes drug for pe­di­atric use

To help promote public health and healthcare in underserved areas of the world, Moderna will establish a charity with a $50 million endowment.

The Cambridge, MA-based company announced the board of directors’ approval Thursday. The foundation will focus on “charitable, scientific and educational endeavors” with an emphasis on promoting public health and the access to healthcare, the press release said. The foundation will start operations once its status as a 501(c)(3) is approved.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.