Un­fazed by dis­rup­tions, Cowen's in­vest­ment arm backs AM-Phar­ma's $176M piv­otal plan around lethal con­di­tion

It may not be the best time to start up a late-stage study un­re­lat­ed to Covid-19, but AM-Phar­ma isn’t let­ting a slight de­lay de­rail its over­all plan.

Erik van den Berg

The Dutch biotech has been sin­gu­lar­ly fo­cused on re­cAP, an an­ti-in­flam­ma­to­ry re­com­bi­nant hu­man form of an en­zyme orig­i­nal­ly found in cows called al­ka­line phos­phatase.

The one Phase III it be­lieves it needs for ap­proval was sched­uled for this sum­mer, fund­ed by a $133 mil­lion round last Ju­ly. Hav­ing pushed study ini­ti­a­tion to af­ter the sum­mer, AM-Phar­ma is adding $52 mil­lion for the reg­u­la­to­ry work need­ed to pre­pare for launch, in­clud­ing CMC val­i­da­tion and com­mer­cial sup­ply.

When the pan­dem­ic will peak is im­pos­si­ble to pre­dict, said CEO Erik van den Berg, but giv­en the sever­i­ty of the dis­ease that AM-Phar­ma is tack­ling — sep­sis-as­so­ci­at­ed acute kid­ney in­jury — they want­ed to start as soon as pos­si­ble and broad­ly stick to the orig­i­nal time­line. Da­ta from the Phase III tri­al are ex­pect­ed in 2023.

The new €23 mil­lion eq­ui­ty in­vest­ment by Cowen Health­care In­vest­ments, its first US-based in­vestor in the syn­di­cate, along­side the €24 mil­lion loan from the Eu­ro­pean In­vest­ment Bank, has boost­ed his con­vic­tion.

Right now, with all of AM-Phar­ma’s 23 staffers work­ing from home in Utrecht, the Nether­lands, crit­i­cal ac­tiv­i­ties are still on­go­ing. Doc­u­ments still need to be pre­pared for re­view be­fore sites can be ini­ti­at­ed — a siz­able project when you are plan­ning a tri­al in­volv­ing 1,400 pa­tients in 12 coun­tries.

“Our work is most­ly project man­age­ment and co­or­di­na­tion,” van den Berg said. “We don’t have any labs to close in this pe­ri­od. All of our sup­pli­ers are still on­line and al­so moved as much as pos­si­ble to home-based work­ing.”

There will be chal­lenges when the tri­al ac­tu­al­ly be­gins, as the pa­tients that will be re­cruit­ed tend to be treat­ed in in­ten­sive care units, many of which could be over­whelmed by se­vere coro­n­avirus pa­tients. While he is plan­ning for dif­fer­ent pos­si­bil­i­ties, van den Berg is hope­ful hu­man cre­ativ­i­ty will save them from the worst-case sce­nario.

In a sense it’s char­ac­ter­is­tic of a team that has built a busi­ness around of­fer­ing hope where there is lit­tle, re­duc­ing the mor­tal­i­ty rate by 40% ver­sus place­bo in Phase II. And it wouldn’t be the first time it has had to con­tend with un­fore­seen cir­cum­stances: van den Berg hadn’t been plan­ning on tak­ing the piv­otal pro­gram and com­mer­cial ef­forts un­til Pfiz­er pulled out of a deal to ac­quire the com­pa­ny, leav­ing it to go it alone.

“Worst case sce­nario is we’re sit­ting in our home of­fices for years,” he said. ”But I don’t think that’s re­al­is­tic. I don’t see it that bleak.”

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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James Dentzer, Curis CEO

FDA lifts par­tial hold on Curis' lym­phoma study — shares spike

Four months after the FDA put two clinical trials from Curis on clinical hold, the FDA is now apparently content with how the biotech will change up managing one of the studies.

The Massachusetts oncology biotech put out word early Thursday that the federal regulator lifted a partial clinical hold of the company’s Phase I/II study of emavusertib in lymphoma, following a new data package that the biotech recently submitted to the agency. Shares of the biotech $CRIS, hovering just above penny stock territory, shot up more than 55% in early trading before settling at close to a 30% share price boost.

Astel­las' hot flash­es drug will get speedy re­view at FDA; US opts out of Val­ne­va vac­cine

The FDA will decide on Astellas’ menopausal symptom drug by Feb. 22 of next year, as the Japanese pharma disclosed it had paid about $97 million to get a priority review voucher to speed up the review.

Astellas said the agency has accepted the pharma’s application for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS includes hot flashes and/or night sweats. The company said as many as 80% of women in the US experience those symptoms during or after the menopausal transition.

Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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