Once thought un­like­ly as a mech­a­nism of ac­tion in vac­cines, mR­NA-based shots have stormed out to a lead in the fight against Covid-19. But mR­NA’s po­ten­tial ef­fect isn’t lim­it­ed to just vac­cines, and now Ger­man drug­mak­er Mer­ck KGaA is look­ing to find out just how far it can take the tech­nol­o­gy.

The Darm­stadt, Ger­many based bio­phar­ma has ac­quired mR­NA CD­MO AmpTec in Ham­burg, say­ing it plans to strength­en its own ca­pac­i­ties to de­vel­op and man­u­fac­ture mR­NA for cus­tomers to use in “vac­cines, treat­ments and di­ag­nos­tics ap­plic­a­ble in Covid-19 and many oth­er dis­eases.”

Fi­nan­cial terms of the agree­ment weren’t dis­closed.

Ste­fan Os­chmann

In a state­ment, Mer­ck KGaA CEO Ste­fan Os­chmann said the promise shown for mR­NA’s use in Pfiz­er and Mod­er­na’s Covid-19 vac­cines piqued the com­pa­ny’s in­ter­est in snap­ping up AmpTec.

“By com­bin­ing AmpTec’s PCR-based mR­NA tech­nol­o­gy with our ex­ten­sive ex­per­tise in lipids man­u­fac­tur­ing, we are able to pro­vide a tru­ly dif­fer­en­ti­at­ed and in­te­grat­ed of­fer­ing across the mR­NA val­ue chain, which will sig­nif­i­cant­ly de­crease sup­ply chain com­plex­i­ty and en­hance speed-to-mar­ket,” Os­chmann said.

AmpTec al­so boasts a di­ag­nos­tics busi­ness that fo­cus­es on pro­duc­ing “cus­tomized long RNAs and DNAs for in vit­ro di­ag­nos­tics,” which will fur­ther com­ple­ment a key com­po­nent of Mer­ck KGaA’s ex­ist­ing ser­vices. All told, the com­pa­ny said it aims to scale up both at AmpTec’s Ham­burg and at the Mer­ck KGaA glob­al head­quar­ters in Darm­stadt.

The ac­qui­si­tion con­tin­ues some re­cent and sub­stan­tive ex­pan­sion plays by Mer­ck KGaA, which an­nounced in De­cem­ber that it agreed to a three-year-deal with Ar­tios worth $30 mil­lion up­front and an­oth­er $865 mil­lion wait­ing in the wings, to dis­cov­er and de­vel­op small mol­e­cule can­cer drugs that tar­get DNA re­pair en­zymes.

Mer­ck KGaA made waves in Sep­tem­ber af­ter it named Belén Gar­i­jo as its new chief ex­ec­u­tive, mak­ing her one of on­ly two women CEOs at Big Phar­ma com­pa­nies. Gar­i­jo will suc­ceed Os­chmann when his tenure ends by the close of April.

In 2019, GSK paid up to $4.2 bil­lion for Mer­ck KGaA’s bi­func­tion­al fu­sion pro­tein-based can­cer im­munother­a­py, bin­tra­fusp al­fa, as the com­pa­ny be­gan a for­ay in­to on­col­o­gy in ad­di­tion to its mR­NA ser­vices.

Al­so of note, in 2017, End­points News re­port­ed, Mer­ck bought four DNA dam­age re­sponse mol­e­cules from Ver­tex for $230 mil­lion. That in­clud­ed two ATR in­hibitors that are now in the clin­ic for their ef­fi­ca­cy in treat­ing sol­id can­cer tu­mors.

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.

The Washington-based CDMO AGC Biologics has been tapped to manufacture the type 1 diabetes treatment Tzield from Provention Bio.

AGC Biologics will produce Tzield at its Seattle protein biologics site. It was chosen after AGC helped to guide the product through process performance qualification (PPQ) manufacturing and validation batches, and, ultimately, FDA approval. Tzield is the only immunomodulatory treatment approved to delay the onset of Stage 3, type 1 diabetes in children and adults aged eight and older.

Contract manufacturer Abzena has permanently laid off 66 employees at one of its San Diego sites, marking the latest in a string of layoffs spanning the biotech industry.

The layoffs took effect on Jan. 11 at the company’s 8810 Rehco Road site, according to a WARN notice filed with the Employment Development Department of California.

Abzena does have another location in the San Diego area, where the manufacturer invested $60 million and added 50,000 square feet in 2020. Endpoints News reached out to Abzena but has not received a response as of press time.