Ipsen re­cruits Steven Hilde­mann as CMO; Eli Lil­ly of­fers two more low-cost in­sulin op­tions

→ Af­ter los­ing their CEO last month, Ipsen — who’s grap­pling with an FDA hold af­ter safe­ty con­cerns emerged from late-stage stud­ies of its lead rare dis­ease drug palo­varotenehas tapped for­mer Mer­ck Serono ex­ec Steven Hilde­mann as EVP, chief med­ical of­fi­cer, head of glob­al med­ical af­fairs and phar­ma­covig­i­lance. Dur­ing his time at Mer­ck, Hilde­mann served as CMO and SVP and head of glob­al med­ical af­fairs and pa­tient safe­ty. His pre­vi­ous ex­pe­ri­ence spans Mer­ck/Scher­ing Plough, Am­gen and Pfiz­er/Phar­ma­cia.

→ In a new at­tempt to ad­dress crit­i­cism on the high cost of in­sulin, Eli Lil­ly is rolling out two ad­di­tion­al cost-sav­ing op­tions to Hu­ma­log Mix75/25 KwikPen (in­sulin lispro pro­t­a­mine and in­sulin lispro in­jectable sus­pen­sion 100 units/mL) and Hu­ma­log Ju­nior KwikPen (in­sulin lispro in­jec­tion 100 units/mL). The list prices of both will be 50% low­er com­pared to the brand­ed ver­sions and will be avail­able by mid-April. The com­pa­ny of­fered its first half-price al­ter­na­tive to Hu­ma­log, In­sulin Lispro in­jec­tion (100 units/mL), in May 2019, though sen­a­tors have since slammed Lil­ly for not liv­ing up to its promise as the in­jec­tion is still not wide­ly avail­able (an ac­cu­sa­tion that CEO Dave Ricks called “non­sense“).

→ With ri­vals gun­ning at their star block­buster Soliris, Alex­ion is fo­cus­ing on ini­ti­at­ing a Phase III study of their fol­low-on drug Ul­tomiris (ravulizum­ab) in amy­otroph­ic lat­er­al scle­ro­sis. CHAM­PI­ON-ALS will be a 50-week glob­al study with ap­prox­i­mate­ly 350 adult pa­tients. The pri­ma­ry end­point of the study, which the biote­hc ex­pects to launch this quar­ter, will be change in the ALS func­tion­al rat­ing scale-re­vised (ALS­FRS-R) score.

→ Pfiz­er is team­ing up with Alex Zha­voronkov’s AI-shop In­sil­i­co Med­i­cine to uti­lize In­sil­i­co’s tech and pan­domics dis­cov­ery plat­form. The goal of the col­lab­o­ra­tion is to iden­ti­fy re­al-world ev­i­dence for po­ten­tial ther­a­peu­tic tar­gets im­pli­cat­ed in a va­ri­ety of dis­eases.

→ DNA se­quenc­ing gi­ant Il­lu­mi­na — who just tore up a $1.2 bil­lion buy­out of Pa­cif­ic Bio­sciences due to FTC “mo­nop­o­list” ac­cu­sa­tions — has forged a 15 year, non-ex­clu­sive col­lab­o­ra­tion agree­ment with Roche. The deal will help “ac­cel­er­ate the avail­abil­i­ty of dis­trib­utable NGS-based in-vit­ro di­ag­nos­tic (IVD) tests on Il­lu­mi­na’s di­ag­nos­tic (Dx) se­quenc­ing sys­tems.”

Oys­ter Point Phar­ma has rolled out pos­i­tive da­ta from its Phase II MYS­TIC study in test­ing their nasal spray against dry eye dis­ease. The re­sults showed a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in Schirmer’s score from base­line at Day 84 in both dos­es as com­pared to the con­trol group. The study demon­strat­ed that OC-01 was well-tol­er­at­ed at the two dos­es test­ed and there were no re­ports of se­ri­ous treat­ment-emer­gent ad­verse events.

Adimab is ex­tend­ing its li­cense agree­ment with No­vo Nordisk that it start­ed in 2013. Un­der the terms of agree­ment, the Dan­ish drug­mak­er will have con­tin­ued ac­cess to a hu­man an­ti­body li­brary and will re­ceive a li­cense to the Adimab plat­form for use on an un­lim­it­ed num­ber of tar­gets. Adimab is re­ceiv­ing an undis­closed ex­ten­sion fee as well as de­vel­op­ment and sales mile­stones plus tiered roy­al­ties on the an­nu­al net sales.

The 20 un­der 40: In­side the next gen­er­a­tion of bio­phar­ma lead­ers

“Each generation needs a new music,” Francis Crick wrote in 1988, reflecting back on his landmark discovery. Crick was 35, then, in 1953, when he began working with a 23-year-old named James Watson, and 37 when the pair unveiled the double helix. Rosalind Franklin, whose diffraction work undergirded their metal model, was 32.

The model would become the score for a new era in biology, one devoted to cracking the basic structures turning inside life. Subsequent years would bring new conductors and new rhythms: Robert Swanson, 29 when he convinced a 39-year-old Herb Boyer to build a company off his work and call it Genentech; Phillip Sharp, 29 when he discovered RNA splicing and 34 when he co-founded Biogen; Frances Arnold, 36 when she pioneered directed evolution; Feng Zhang, 31 when he published his CRISPR paper.

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FDA Commissioner Stephen Hahn and President Donald Trump at a press briefing on March 19, 2020. (AP Images)

Biotech ex­ecs warn that the FDA is fum­bling their re­sponse to the Covid-19 open-door promise, de­lay­ing progress

A few days ago the FDA touted a procedure for Covid-19 meds that committed the agency to immediate action for developers, formalizing a high-speed response that’s been promised for weeks.

Bioregnum Opinion Column by John Carroll

Decisions that once required months would be measured in hours under the Coronavirus Treatment Acceleration Program. “In many cases” trial protocols could be hammered out in less than a single day. If you had a potential solution to the crisis, the appropriate staffer would be in touch “to get studies underway quickly.”

It would be the ultimate high-speed regulatory pathway from Phase I to approval. Red tape was banished.

But it’s clear that for some — and quite likely many — biopharma execs, the actual agency response has not measured up to the promise. Beyond the front ranks of advanced companies in the field, like Gilead, or for drugs endorsed by President Trump, it may not even come close.

“The first response is this form letter everyone gets,” says one biotech CEO who’s reached out to the FDA on Covid-19. And when you try to cut through that, the ball gets dropped as it is passed from top officials to the frontline staff actually charged with getting things done.

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GSK's Hal Bar­ron buys a $250M stake in George Scan­gos' Vir and makes a bee­line to the clin­ic with Covid-19 an­ti­bod­ies

GlaxoSmithKline is diving straight into the swirling waters of Covid-19 R&D work, and investing $250 million to grab a chunk of equity in one of the emerging stars in infectious disease research to make it official.

GSK put out word this morning that it is partnering with Vir Biotechnology $VIR, the infectious disease startup founded in the Bay Area by former Biogen CEO George Scangos. They’re planning a leap into Phase II studies for 2 preclinical antibody candidates — VIR-7831 and VIR-7832 — that have been engineered to target the SARS-CoV-2 spike protein.

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Ready to de­clare a de­fin­i­tive come­back in two months, Im­munomedics stops PhI­II ear­ly, re­cruits new CEO

More than a year ago, hit by a surprise complete response letter from the FDA, Immunomedics bid its then-CEO, Michael Pehl, adieu and began a 15-month quest to resolve the manufacturing issues cited in the CRL and seek a new leader — all the while moving forward with a Phase III study on its lead drug for metastatic triple-negative breast cancer.

Today the biotech said their stars are finally aligning. Not only is Novartis Oncology vet Harout Semerjian coming on board as CEO to steer what they believe will be a smooth sail to a new PDUFA date in June, Immunomedics has also been informed that their late-stage trial can be stopped early due to “compelling evidence of efficacy.”

An­oth­er day, an­oth­er boat­load for biotech. Deer­field adds $840M to rush of ven­ture dol­lars

The biotech dollars just keep rolling in.

Even as the world economy faces an economic contraction unprecedented in nature, biotech venture capital firms are announcing huge new investment pots. The latest? Deerfield Management Co.

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Small mol­e­cules, bi­o­log­ics and now gene ther­a­pies: Ger­many's Evotec adds an­oth­er feath­er to its R&D cap

German drug discovery company Evotec — which has a thriving rolodex of biopharma partners such as Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, Pfizer, Sanofi, and Takeda — is now venturing into gene therapies.

The company swallowed Seattle-based Just Biotherapeutics, a company focused on reducing the cost of manufacturing protein therapies last year. It is now setting up a dedicated R&D site for gene therapies in Austria, in an effort to achieve a “modality-agnostic” repertoire — small molecules, biologics and now gene therapies.

A pair of PhI­II fail­ures spells last rites for Men­lo’s once-promis­ing Mer­ck drug

Four months after an intercontinental merger, Menlo Therapeutics is counting yet another pair of trial failures — ones with significant consequences for the companies, their shareholders and the drug.

In two pivotal Phase III trials, Menlo’s lead drug serlopitant failed to treat pruritus associated with prurigo nodularis — basically itchiness from a particular skin disease that causes red lesions on a person’s arms or legs. Serlopitant has long been the company’s only drug and as recently as 2018, it looked promising enough to support a stock price of $37. In April of that year, a Phase II failure demolished the stock price overnight: $35 to $9. Other subsequent stumbles trickled the ticker down to just above $2.

Af­ter putting aside a bit­ter le­gal feud, Al­ny­lam and Dicer­na chiefs make nice with an RNAi col­lab­o­ra­tion

John Maraganore and Douglas Fambrough used to be at each other’s throats as Alnylam pursued claims that its RNAi rivals at Dicerna had improperly purloined the IP it had picked up from Merck in a bargain basement fire sale.

But that was all settled up close to 2 years ago with a settlement from Dicerna’s Fambrough. And now the two are moving ahead in a close R&D partnership that makes them collaborators on a couple of key disease targets.

UP­DAT­ED: A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Category 6 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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