Roche nabs pri­or­i­ty re­view for Eylea com­peti­tor; Italy's An­geli­ni eyes CNS, rare dis­ease star­tups with $35M Lu­mi­ra fund

The teams at Roche and Genen­tech are off and run­ning at the FDA, with reg­u­la­tors ac­cept­ing a quick pitch for what would be the first bis­pe­cif­ic an­ti­body de­signed for the eye.

Roche an­nounced late Wednes­day that its ap­pli­ca­tion for faricimab has been ac­cept­ed un­der pri­or­i­ty re­view to treat wet AMD and di­a­bet­ic mac­u­lar ede­ma. In ad­di­tion, the sub­mis­sion for di­a­bet­ic retinopa­thy was al­so ac­cept­ed, the com­pa­ny said.

Levi Gar­raway

“If ap­proved, faricimab would be the first in a new class of eye med­i­cines tar­get­ing two key path­ways that dri­ve reti­nal dis­or­ders, with the po­ten­tial to of­fer durable vi­sion out­comes with few­er eye in­jec­tions than the cur­rent stan­dard of care,” CMO Levi Gar­raway said in a state­ment.

Over the last sev­er­al months, Roche has been dol­ing out da­ta in or­der to try to com­pete with Re­gen­eron’s Eylea. In Feb­ru­ary, Roche un­veiled a new dataset say­ing half of pa­tients treat­ed with the ex­per­i­men­tal faricimab in a Phase III study were able to be dosed every four months af­ter the first year of treat­ment, com­pared to the once-every-eighth week Eylea reg­i­men.

The faricimab pro­gram has al­ready demon­strat­ed non-in­fe­ri­or­i­ty in both dis­eases, and cou­pled with the ex­tend­ed time be­tween dos­es, the can­di­date has emerged as the “top com­pet­i­tive threat” to the Re­gen­eron fran­chise, Cowen’s Yaron Wer­ber wrote at the time. — Max Gel­mam

Italy’s An­geli­ni eyes CNS, rare dis­ease star­tups with $35M Lu­mi­ra fund

When Lu­mi­ra Ven­tures re­vealed its lat­est $220M fund, co-founder and man­ag­ing part­ner Ger­ry Brunk teased a new $35 mil­lion strate­gic fund in part­ner­ship with an un­named phar­ma com­pa­ny.

A few days lat­er, we now know who that is: Italy’s An­geli­ni Phar­ma is pro­vid­ing the mon­ey to set up An­geli­ni Lu­mi­ra Bio­sciences Fund, which will fo­cus on brain health and rare dis­eases.

Fol­low­ing a search in­volv­ing more than 100 VCs world­wide, Lu­mi­ra stood out as one of the most ac­tive in these ar­eas, said An­geli­ni CEO Pier­lui­gi An­tonel­li. The new fund’s di­rec­tion will align with Lu­mi­ra’s own strat­e­gy of pur­su­ing “un­der­served” ar­eas in the US and Eu­rope, he added, but will look at ear­li­er stage com­pa­nies — 10 to 12 in to­tal.

In ad­di­tion to buy­ing in at a bet­ter val­u­a­tion, An­tonel­li hopes con­nect­ing ear­ly with star­tups would give An­geli­ni an edge in co-de­vel­op­ment or com­mer­cial part­ner­ship talks, as they try to tap in­to a swirl of new ap­proach­es com­ing to the CNS space like RNA bi­ol­o­gy, an­ti­sense oligonu­cleotides and gene ther­a­py, as well as tech­nolo­gies for cross­ing the blood-brain bar­ri­er.

“When pos­si­ble we will al­so co-in­vest in ALBF port­fo­lio com­pa­nies and seek board seats,” he wrote to End­points News. “We can help cre­ate val­ue in the port­fo­lio com­pa­nies by pro­vid­ing ac­cess to our mul­ti­dis­ci­pli­nary (or ver­ti­cal) knowl­edge of the CNS/rare dis­ease space.” — Am­ber Tong

Tonix brings vac­cine pro­duc­tion fa­cil­i­ty in-house 

Tonix Phar­ma­ceu­ti­cals has some new prop­er­ty.

Seth Le­d­er­man

The Chatham, NJ-based biotech ac­quired an ap­prox­i­mate­ly 48,000 square foot fa­cil­i­ty to sup­port its “ex­pand­ing in­fec­tious dis­ease pipeline,” the com­pa­ny an­nounced ear­li­er this week. Tonix not­ed the aid will go to­ward three vac­cine can­di­dates, two of which are aimed at Covid-19 and the third be­ing test­ed for small­pox and mon­key­pox.

Tonix ac­quired the fa­cil­i­ty, lo­cat­ed in Fred­er­ick, MD, from a col­lab­o­ra­tion part­ner for two of their vac­cine pro­grams. The biotech ex­pects op­er­a­tions to be up and run­ning by the fourth quar­ter this year.

“We view con­trol of in-house fa­cil­i­ties as a strate­gic ca­pa­bil­i­ty to en­sure the speed and ef­fi­cien­cy with which we can de­vel­op vac­cines and an­tivi­ral prod­ucts in the fu­ture against known, emerg­ing or nov­el pathogens,” CEO Seth Le­d­er­man said in a state­ment. — 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

KEY POINTS

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.