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.”

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.