Mi­rati teams with Sanofi on PhI/II tri­al for KRAS treat­ment com­bo; Ab­b­Vie los­es in lat­est Hu­mi­ra biosim­i­lar de­vel­op­ment

Charles Baum

Mi­rati and Sanofi on Fri­day an­nounced their new non-ex­clu­sive, clin­i­cal col­lab­o­ra­tion to eval­u­ate com­bin­ing Mi­rati’s in­ves­ti­ga­tion­al KRAS G12C in­hibitor ada­gra­sib with Sanofi’s in­ves­ti­ga­tion­al SHP2 in­hibitor RMC-4630 in an up­com­ing Phase I/II study.

Sanofi is tak­ing re­spon­si­bil­i­ty for spon­sor­ing and op­er­at­ing the study, while shar­ing over­sight and costs with Mi­rati, ac­cord­ing to a Mi­rati state­ment. The an­nounce­ment of the study, which will be in pa­tients with pre­vi­ous­ly-treat­ed NSCLC and KRAS G12C mu­ta­tions, comes on the heels of Sanofi’s an­nounce­ment of suc­cess yes­ter­day in ad­min­is­ter­ing their flu vac­cine si­mul­ta­ne­ous­ly with Mod­er­na’s Covid-19 boost­er shot.

“Mi­rati is ag­gres­sive­ly ad­vanc­ing a broad ada­gra­sib de­vel­op­ment pro­gram, which in­cludes pur­su­ing nov­el com­bi­na­tion ap­proach­es in­clud­ing through this col­lab­o­ra­tion with Sanofi,” said Mi­rati pres­i­dent, founder and head of R&D Charles Baum. — Paul Schloess­er

Ab­b­Vie los­es Hu­mi­ra trade se­crets case, but fight over biosim­i­lar is not over

What may prove to be the fi­nal feud over the best sell­ing drug of all time is be­gin­ning with an Ab­b­Vie loss.

Ear­li­er this year, Ab­b­vie sued Ice­landic biosim­i­lar de­vel­op­er Alvotech claim­ing that one of its man­u­fac­tur­ing ex­ecs, Rongzan Ho, emailed him­self “con­fi­den­tial and pro­pri­etary” in­for­ma­tion about Hu­mi­ra’s man­u­fac­tur­ing just be­fore leav­ing the com­pa­ny and join­ing Alvotech. But Ho no longer works for Alvotech.

In a de­ci­sion on Wednes­day, Judge Har­ry Leinen­we­ber of the Illi­nois North­ern Dis­trict Court threw out the case for lack of “per­son­al ju­ris­dic­tion,” ac­cord­ing to the rul­ing — grant­i­ng Alvotech’s mo­tion to throw out the suit.

While the de­ci­sion marks a win for Alvotech, the com­pa­ny has at least an­oth­er year to go be­fore it can launch its pro­posed Hu­mi­ra biosim­i­lar in the US mar­ket — all thanks to a still-on­go­ing patent tri­al. In that suit, the court plans to rule by the end of next Oc­to­ber, and the next court date is in Au­gust.

In the mean­time, the biosim­i­lar com­pa­ny is hop­ing to win FDA ap­proval and a de­sired in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra biosim­i­lar. — Paul Schloess­er

J&J seeks a new in­di­ca­tion for Ste­lara

J&J’s block­buster Ste­lara is look­ing to rack up an­oth­er new in­di­ca­tion in its belt of ap­provals.

The drug­mak­er sub­mit­ted an sBLA for Ste­lara in chil­dren with ju­ve­nile pso­ri­at­ic arthri­tis, J&J an­nounced Fri­day morn­ing, fo­cus­ing on pe­di­atric pa­tients old­er than five years. Tar­get­ing IL-12 and IL-23, Ste­lara has been on the mar­ket for adults since 2009 in mod­er­ate to se­vere plaque pso­ri­a­sis.

Since then, the best-sell­ing drug has racked up for ad­di­tion­al ap­provals: chil­dren aged 6 and old­er with mod­er­ate to se­vere plaque pso­ri­a­sis, adults with pso­ri­at­ic arthri­tis, adults with mod­er­ate to se­vere Crohn’s dis­ease and adults with mod­er­ate to se­vere ul­cer­a­tive col­i­tis.

The newest re­quest of reg­u­la­tors is root­ed in both adult and pe­di­atric stud­ies com­pris­ing near­ly 4,000 pa­tients, J&J said. Re­searchers ex­trap­o­lat­ed da­ta from nine dif­fer­ent stud­ies to help J&J make its FDA pitch giv­en the “lim­it­ed avail­abil­i­ty” of re­cruitable chil­dren. Should the FDA take up the ap­pli­ca­tion, a de­ci­sion is ex­pect­ed in late 2022.

J&J says there are about 20 to 45 cas­es of ju­ve­nile pso­ri­at­ic arthri­tis per 100,000 chil­dren in the US, with the dis­ease char­ac­ter­ized by both joint in­flam­ma­tion and pso­ri­at­ic skin le­sions that re­sem­ble the adult con­di­tion. — Max Gel­man

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges


Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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vTv Ther­a­peu­tics cuts 65% of em­ploy­ees in shake­up; Freenome bags $300M in Se­ries D to ex­pand mul­ti­omics plat­form

vTv Therapeutics has decided to chop down its workforce by almost two-thirds.

The High Point, NC biotech announced Monday that it would pivot and now prioritize its lead program, the oral glucokinase activator TTP399, as it gears up for Phase III pivotal trials.

The drug was granted breakthrough therapy designation after showing a 40% reduction in hypoglycemic episodes compared to placebo, and back in October vTv announced positive results in a study showing no increased risk for ketoacidosis, a severe complication of diabetes.

Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.