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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Mar­ket­ingRx roundup: Phar­mas lay off Twit­ter ads for an­oth­er week; WPP un­cov­ers LGBTQ+ mar­ket­ing find­ings

When Twitter’s new owner Elon Musk tweeted this weekend, “Just a note to thank advertisers for returning to Twitter,” he likely wasn’t talking about big pharma companies. The vast majority of the top spending pharma advertisers had not returned last week, according to updated tracking data Pathmatic for Endpoints News.

Only three pharma advertisers spent any money at all, which is about the same as the past several weeks. AstraZeneca rejoined the active advertiser list, although at $700 spent hardly worth a personal Musk expression of gratitude. GSK remained active with $3,500 spent ad much lower than its previous spending, according to the Pathmatics data. Only Bayer spent any significant amount in advertising, with $244,000 spent last week, but that’s a considerable drop from almost $500,000 spent on OTC, prescription and corporate Twitter ads in each of the previous two weeks.

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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Jonathan Montagu, HotSpot Therapeutics CEO

Ab­b­Vie puts up $40M to li­cense a treat­ment from HotSpot Ther­a­peu­tics

HotSpot Therapeutics has managed to gain some steam financially in the past few years, as the company wrangled several multi-million dollar raises. But its latest deal not only puts more cash into its pockets, it also connects with a major name in pharma.

On Tuesday, AbbVie and HotSpot announced they have entered an “exclusive” global collaboration, with the option to license HotSpot’s IRF5 program, which is designed to treat autoimmune diseases. The deal will see AbbVie hand HotSpot $40 million upfront, with the biotech eligible to receive $295 million in “option fees” and R&D milestones.

Jay Lichter, Arialys Therapeutics CEO (Avalon Ventures)

Scoop: Aval­on, MPM back new CNS biotech with sci­en­tif­ic chops from Astel­las

A preclinical central nervous system biotech is in the works in La Jolla, CA, and the drug developer has reeled in capital from a syndicate of investors, Endpoints News has learned.

Arialys Therapeutics filed incorporation documents in the Golden State last December and applied its name for trademark protection with the US Patent and Trademark Office the week prior to that. Paperwork with the SEC also outlines plans to offer up equity in exchange for $55 million.

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