Stéphane Bancel, CEO of Moderna

Mod­er­na re­fused to dis­close mR­NA vac­cine tech­nol­o­gy to Chi­na — re­port

Mod­er­na has been pro­tec­tive of the in­tel­lec­tu­al prop­er­ty sur­round­ing its vac­cine, in­clud­ing be­ing will­ing to go to court and ac­cus­ing oth­er com­pa­nies of patent in­fringe­ment. Now the most re­cent up­date puts a mag­ni­fy­ing glass on Mod­er­na’s deal­ings with Chi­na.

Per a re­port from the Fi­nan­cial Times over the week­end, Chi­na asked Mod­er­na to hand over the in­tel­lec­tu­al prop­er­ty be­hind its megablock­buster vac­cine known as Spike­vax. Cit­ing peo­ple “fa­mil­iar with the mat­ter,” the re­port notes that the mR­NA biotech was in ne­go­ti­a­tions with Chi­na in 2020 and 2021 to sell its prod­uct in the world’s most pop­u­lous coun­try.

But Mod­er­na backed out of those ne­go­ti­a­tions due to “safe­ty and com­mer­cial con­cerns,” per the re­port.

As the Times not­ed, Chi­na has of­fered on­ly two routes to al­low non-Chi­nese Covid-19 vac­cine mak­ers to dis­trib­ute in the coun­try: to hand over all the tech­nol­o­gy to a do­mes­tic drug­mak­er; or to break ground on a man­u­fac­tur­ing fa­cil­i­ty in the coun­try with a Chi­nese part­ner, yet re­tain con­trol of the tech­nol­o­gy.

How­ev­er, per the Times’ sources, Mod­er­na ex­ecs did not want to hand over the vac­cine “recipe” to a Chi­nese part­ner, be­cause if the com­pa­ny messed up on the man­u­fac­tur­ing, Mod­er­na feared dam­age to its rep­u­ta­tion.

Af­ter Chi­na’s re­port­ed de­mand, an­oth­er source added to the Times that the com­pa­ny had giv­en up on its ef­forts to en­ter the Chi­nese mar­ket.

Mod­er­na did not re­spond to a re­quest for com­ment from End­points News. How­ev­er, the com­pa­ny told the Times on record that “We are not cur­rent­ly en­gaged in sup­ply talks with Chi­na. We are open to speak­ing with coun­tries on their sup­ply needs for Covid-19 vac­cines.”

The mR­NA gi­ant had just re­cent­ly said that it would start to en­force its patent rights in wealth­i­er coun­tries. To that ex­tent, the com­pa­ny sued Pfiz­er and BioN­Tech in Au­gust, al­leg­ing that the vac­cine the pair de­vel­oped uti­lized parts of Mod­er­na’s tech­nol­o­gy that it had patent­ed be­tween 2010 and 2016.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Phar­maron ex­pand­ing Liv­er­pool man­u­fac­tur­ing fa­cil­i­ty with a $186M+ price tag

Liverpool may be known for rock and roll and premier league football, but the China-based contract manufacturer Pharmaron is looking to make it a bigger hub for cell and gene therapy manufacturing.

As part of Pharmaron’s further commitment to Merseyside county, it plans to build an 8,000-square-meter facility, or around 86,000 square feet, which includes a boost to the manufacturing capacity of 3,500 square meters, or 37,600 square feet. The price tag for the expansion will be £151 million ($186 million), with Pharmaron receiving a grant from the UK Government’s Life Sciences Innovation Manufacturing Fund (LSIMF).