Organon dou­bles down on mis­sion to pre­vent un­planned preg­nan­cies with $30M in­vest­ment

Near­ly half of preg­nan­cies world­wide are un­planned, and far too of­ten, women re­ly on “Dr. YouTube” for their in­for­ma­tion on con­tra­cep­tives, Organon’s ex­ec­u­tive VP of ex­ter­nal af­fairs and ESG Ger­a­lyn Rit­ter said.

The Mer­ck spin­out is com­mit­ting $30 mil­lion to change that.

Ger­a­lyn Rit­ter

Organon on Wednes­day un­veiled its three-year “Her Plan is Her Pow­er” ini­tia­tive to sup­port sex­u­al and re­pro­duc­tive health (SRH) ed­u­ca­tion, ac­cess and in­no­va­tion around the world. That in­cludes the in­au­gur­al launch of a glob­al grants pro­gram and a col­lab­o­ra­tion with UNF­PA, the UN’s sex­u­al and re­pro­duc­tive health agency.

The ini­tia­tive builds on Organon’s pri­or com­mit­ment to pre­vent 120 mil­lion un­planned preg­nan­cies in some of the world’s least de­vel­oped coun­tries by 2030. And it’s no co­in­ci­dence the an­nounce­ment was made on In­ter­na­tion­al Women’s Day.

“Un­for­tu­nate­ly, the world isn’t al­ways go­ing in the right di­rec­tion on this pri­or­i­ty. And so we felt like to­day, on In­ter­na­tion­al Women’s Day, now is the time to re­al­ly re­dou­ble our com­mit­ment,” Rit­ter told End­points News. 

Among the first 13 coun­tries to re­ceive grants will be the Do­mini­can Re­pub­lic, South Ko­rea, Ger­many and Thai­land. The grants will fo­cus on ed­u­ca­tion and ac­cess to health­care. Some of the funds, for ex­am­ple, will be used to cre­ate a dig­i­tal app on sex­u­al and re­pro­duc­tive health in­for­ma­tion to be used by front­line health­care work­ers around the world, Rit­ter said.

The grants are not one-size-fits-all, she em­pha­sized, adding that “we want to hear what they need and we have the flex­i­bil­i­ty to re­spond where we feel like the need is the great­est, but al­so [where] we can have the great­est im­pact.”

“One hall­mark of the pro­gram is that we re­al­ly want a sig­nif­i­cant por­tion of the fund­ing to go to com­mu­ni­ty-based pro­grams, com­mu­ni­ty-led pro­grams. We think those are go­ing to have a tremen­dous im­pact,” she said. There will al­so be a prod­uct do­na­tion com­po­nent, though the com­pa­ny’s still ham­mer­ing out the de­tails on that.

Mer­ck an­nounced plans to spin out its women’s health and biosim­i­lar port­fo­lio in­to a new com­pa­ny called Organon back in 2020 as sales were on a downslide. The com­pa­ny’s port­fo­lio boasts a range of con­tra­cep­tives, in­clud­ing the con­tra­cep­tive Nex­planon and the re­mov­able birth con­trol Nu­vaR­ing.

“So many of our em­ploy­ees came to Organon be­cause of our mis­sion,” Rit­ter said. “This is the com­pa­ny walk­ing the talk.”

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.

Luke Miels, GSK chief commercial officer

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

Editor’s note: This is a live story and will be updated.

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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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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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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Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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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.