A UK-based CD­MO has land­ed a sup­ply agree­ment with Ver­sameb to pro­vide its dog­gy­bone DNA for the com­pa­ny’s pipeline, in­clud­ing for its lead can­di­date to treat stress uri­nary in­con­ti­nence.

Touch­light will sup­ply Ver­sameb with its en­zy­mat­ic DNA as the biotech pre­pares to en­ter VMB-100 in­to Phase I clin­i­cal tri­als in the sec­ond half of this year. The deal will al­low Ver­sameb to uti­lize Touch­light’s dbD­NA, al­so called dog­gy­bone DNA, for all fu­ture pipeline prod­ucts.

dbD­NA is a lin­ear, dou­ble-strand­ed co­va­lent­ly closed DNA vec­tor, that is adapt­able for a num­ber of ge­net­ic med­i­cines, mak­ing it high­ly scal­able. It elim­i­nates bac­te­r­i­al se­quences and can be pro­duced quick­er than oth­er types of DNA. dbD­NA of­fers a syn­thet­ic al­ter­na­tive to plas­mid RNA, a key part of mR­NA vac­cines and ther­a­pies. It can take just five days to pro­duce ver­sus more typ­i­cal man­u­fac­tur­ing months, and has a small­er man­u­fac­tur­ing foot­print. That means it can be quick­ly scaled up and is high­ly trans­portable.

Touch­light sup­plies DNA as a start­ing ma­te­r­i­al as well as an ac­tive phar­ma­ceu­ti­cal in­gre­di­ent. Be­cause its DNA is syn­thet­ic, CEO Karen Fall­en said that it’s vi­tal to the mar­ket, be­cause the en­zy­mat­ic man­u­fac­tur­ing process can be com­plet­ed in just five days, a huge shift from mi­cro­bial and E. coli man­u­fac­tur­ing.

“What you put in, you get out. It faith­ful­ly repli­cates what you get in, so we don’t have the same sta­bil­i­ty is­sues that you can have with E. coli,” she said in an in­ter­view with End­points News. “They de­cid­ed to use us for not just their lead can­di­date, but all of the mol­e­cules in their pipeline, so very ex­cit­ing for us.”

She added that Touch­light sees the move as sol­id val­i­da­tion of its tech­nol­o­gy.

In Sep­tem­ber, the com­pa­ny an­nounced that it would near­ly dou­ble its work­force both in the UK and North Amer­i­ca from around 65 em­ploy­ees to 125 by the end of the year. That news fol­lowed its $125 mil­lion fi­nanc­ing round in March, which led the com­pa­ny to build the ca­pac­i­ty to triple the pro­duc­tion of dbD­NA. That will, the com­pa­ny hopes, set it­self up to be­come the largest syn­thet­ic DNA man­u­fac­tur­er in the world.

Klaas Zuide­veld

“We are ex­cit­ed to be dri­ving the nec­es­sary ac­tiv­i­ties to take our lead as­set to the clin­ic in the short­est pos­si­ble time­frame,” Ver­sameb CEO Klaas Zuide­veld said in a state­ment. “Work­ing with a com­pa­ny such as Touch­light and to uti­lize dbD­NA as a start­ing ma­te­r­i­al for the pro­duc­tion of our mR­NA ther­a­peu­tics as­sures a pro­duc­tion process which is in­no­v­a­tive and gives a com­pet­i­tive ad­van­tage. The high sta­bil­i­ty, qual­i­ty and speed of­fered by syn­thet­ic repli­ca­tion of DNA, the start­ing ma­te­r­i­al for mR­NA, plays a key role in the pro­duc­tion of Ver­sameb’s pro­pri­etary bi­o­log­i­cal­ly op­ti­mized VER­Sag­ile mR­NA pipeline.”

Tough­light is al­so work­ing with Van­der­bilt Uni­ver­si­ty and the De­fense Ad­vanced Re­search Pro­jects Agency — al­so known as DARPA — on DNA vac­cine de­vel­op­ment for head and neck can­cer and Covid-19, as well as syn­thet­ic DNA-based an­ti­body re­search.

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.