Lin­ing up against ri­vals, Am­gen and No­var­tis build a block­buster case for their CGRP mi­graine drug

Am­gen $AMGN and its part­ners at No­var­tis $NVS rolled out a fresh batch of solid­ly pos­i­tive da­ta from the lat­est Phase III study of their CGRP mi­graine drug erenum­ab, back­ing up their be­lief that they can break past a line­up of ri­vals and make a block­buster score fol­low­ing a near cer­tain ap­proval now on the hori­zon.

The drug, which they plan to sell as Aimovig, will like­ly be chal­lenged by a group of com­peti­tors from Eli Lil­ly $LLY, Te­va $TE­VA and Alder $AL­DR that have all demon­strat­ed broad­ly sig­nif­i­cant da­ta in cut­ting the num­ber of mi­graine days ex­pe­ri­enced by a chron­ic suf­fer­er. So they plan to hit the mar­ket with a bat­ter­ing ram of da­ta to help clear the way with providers.

To that end, this new study demon­strat­ed a sig­nif­i­cant re­sponse in cut­ting the num­ber of mi­graine days for pa­tients who had failed two to four dif­fer­ent lines of ther­a­py by at least 50%. Com­pared with a place­bo, the drug al­so hit all the sec­on­daries on the need for res­cue meds, 75% and 100% re­spon­ders, and more.

Sean Harp­er

I talked to Am­gen R&D chief Sean Harp­er about this drug at JP­Mor­gan ear­li­er in the month, and he agreed that the drug was a near cer­tain lock at the FDA, with a like­ly ar­rival of a slate of ri­vals along­side it.

“On ef­fi­ca­cy,” he notes, “the drugs are all seem­ing to have sim­i­lar ef­fi­ca­cy. I think that’s fair.”

But that doesn’t mean that Am­gen and No­var­tis, with all their con­sid­er­able mar­ket­ing clout, can’t make their drug the stand­out.

The broad late-stage pro­gram in­cludes unique car­dio da­ta, says Harp­er, that should help make their case. And they were care­ful to come up with what they see as the best de­liv­ery op­tion, with a sim­ple once-month­ly au­toin­jec­tor that doesn’t re­quire pa­tients to take load­ing dos­es, which he says the com­pe­ti­tion will re­quire.

And it’s a mas­sive mar­ket, with some 6 to 8 mil­lion pa­tients who fit the se­vere suf­fer­er pro­file for the drug.

“These da­ta in pa­tients with mul­ti­ple treat­ment fail­ures, who are not on­ly con­sid­ered dif­fi­cult to treat but al­so have few op­tions avail­able, add to the con­sis­tent body of ev­i­dence for Aimovig,” Harp­er said in a state­ment. “We look for­ward to work­ing with reg­u­la­tors to bring the first pre­ven­tive op­tion specif­i­cal­ly de­vel­oped for mi­graine to pa­tients world­wide.”

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.

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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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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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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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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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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No longer ‘dead or just hi­ber­nat­ing,’ drug­mak­ers re­turn to heart med­i­cines

In 2015, now-FDA Commissioner Robert Califf joined industry, academic and regulatory representatives in Washington to discuss why more drugs weren’t in development for cardiovascular diseases, the leading US cause of death and once a mainstay of pharmaceutical industry blockbusters.

The group pointed to many reasons. Clinical trials could take years and testing was expensive. Wide availability of generic drugs made the commercial prospects uncertain. Their paper title summed up the mood: “Cardiovascular Drug Development: Is it Dead or Just Hibernating?”

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