Akira Kato, Shionogi CEO

Sh­iono­gi to pro­vide glob­al ac­cess to its an­tibi­otics, with fo­cus on poor coun­tries, as re­sis­tance fears grow

As the world faces a grow­ing chal­lenge of pathogens re­sis­tant to an­tibi­otics, Sh­iono­gi and the GARDP have com­mit­ted to an ex­e­cu­tion of a li­cense and tech­nol­o­gy trans­fer agree­ment with the Clin­ton Health Ac­cess Ini­tia­tive (CHAI).

Ac­cord­ing to Sh­iono­gi, the col­lab­o­ra­tion agree­ment will aim to in­crease ac­cess to an­tibi­otics for coun­tries around the world, with an em­pha­sis on low­er- and mid­dle-in­come na­tions. The agree­ment will fo­cus on ce­fide­ro­col, an an­tibi­ot­ic for the treat­ment of se­ri­ous Gram-neg­a­tive bac­te­r­i­al in­fec­tions.

De­spite bumps in the road in get­ting the drug off the ground, ce­fide­ro­col was even­tu­al­ly added to the WHO’s mod­el list of es­sen­tial med­i­cines and does tar­get sev­er­al Gram-neg­a­tive WHO pri­or­i­ty pathogens. The drug was even­tu­al­ly ap­proved by the FDA in 2019 and by the EMA in 2020.

Takuko Sawa­da

“Sh­iono­gi is com­mit­ted to en­sur­ing that ce­fide­ro­col is ac­ces­si­ble world­wide as a po­ten­tial treat­ment op­tion for cer­tain high­ly re­sis­tant Gram-neg­a­tive in­fec­tions,” said Takuko Sawa­da, SVP of the in­te­grat­ed dis­ease care di­vi­sion at Sh­iono­gi, in a state­ment.

Ac­cord­ing to Sh­iono­gi, the agree­ment will see GARDP man­u­fac­ture and com­mer­cial­ize ce­fide­ro­col through sub-li­censees to around 135 coun­tries that have de­layed ac­cess to new­er an­tibi­otics. The li­cense in­cludes all low-in­come coun­tries, low­er mid­dle- and up­per mid­dle-in­come coun­tries, and se­lect high-in­come coun­tries. The deal al­so in­cludes a sig­nif­i­cant pro­por­tion of the world’s pop­u­la­tion liv­ing in ar­eas most af­fect­ed by an­tibi­ot­ic re­sis­tance.

Fi­nan­cial de­tails of the deal were not dis­closed.

The agree­ment al­so in­cludes pro­vi­sions to work with min­istries of health and oth­er ex­perts to strength­en hos­pi­tal-based stew­ard­ship pro­grams that en­sure ap­pro­pri­ate use. These pro­vi­sions are es­pe­cial­ly im­por­tant to avoid fu­el­ing re­sis­tance to ce­fide­ro­col.

While the drug is now ap­proved, it did go through quite a ride to get the green­light. In 2019, in­ves­ti­ga­tors pro­vid­ed pos­i­tive da­ta for the drug to treat cas­es of com­plex uri­nary tract in­fec­tions, but an FDA re­view flagged an im­bal­ance of deaths be­tween the an­tibi­ot­ic and a con­trol arm — with a “high­er mor­tal­i­ty in ce­fide­ro­col-treat­ed pa­tients was ob­served in a tri­al in crit­i­cal­ly ill pa­tients with a va­ri­ety of in­fec­tions due to car­bapen­em-re­sis­tant or­gan­isms.”

Sh­iono­gi it­self is fresh off a deal part­ner­ing with F2G, a self-de­scribed “rare fun­gal dis­ease com­pa­ny,” to push F2G’s olo­rofim through clin­i­cal tri­als and reg­u­la­to­ry ac­tion in Eu­rope and Asia. Sh­iono­gi paid F2G $100 mil­lion up­front, fol­lowed by up to $380 mil­lion in down­stream mile­stones and dou­ble-dig­it roy­al­ties on po­ten­tial sales.

De­spite all the part­ner­ships and deals, Sh­iono­gi $SGIOF is still feel­ing the bite of the bear mar­ket as the com­pa­ny sees its stock down 30% since the be­gin­ning of the year.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.

Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.