Verona signs Chi­na deal for PhI­II COPD drug; Te­va con­tin­ues le­gal bat­tle with Eli Lil­ly, al­leg­ing new patent in­fringe­ments on mi­graine drug

Af­ter a Feb­ru­ary Phase II win put Verona’s bad mem­o­ries of a 2019 flop be­hind them, the com­pa­ny is now en­gag­ing in part­ner­ships to ship out the ex­per­i­men­tal drug should it con­tin­ue to pro­duce pos­i­tive re­sults in Phase III.

Verona is team­ing up with Nu­ance Phar­ma on a $219 mil­lion col­lab­o­ra­tion to com­mer­cial­ize en­sifen­trine in Chi­na, Macau Hong Kong and Tai­wan, the com­pa­nies an­nounced Thurs­day. The deal in­cludes $25 mil­lion in up­front cash and a $15 mil­lion eq­ui­ty stake in Nu­ance Biotech, the par­ent com­pa­ny of Nu­ance Phar­ma. Verona is el­i­gi­ble for up to $179 mil­lion in mile­stones.

En­sifen­trine is an in­haled dual in­hibitor of the en­zymes phos­pho­di­esterase 3 and 4, en­abling it to com­bine both bron­chodila­tor and an­ti-in­flam­ma­to­ry ef­fects in one com­pound, Verona said. The hope is to trig­ger symp­tom re­lief like breath­less­ness, cough and in­flam­ma­tion as­so­ci­at­ed with COPD or trig­gered by virus­es.

Found­ed in 2005, Verona has built its com­pa­ny sole­ly around the com­pound, and said in 2018 that a Phase IIb study of 400 pa­tients, the neb­u­liz­er form beat place­bo at im­prov­ing lung func­tion. But the next year, it failed to sig­nif­i­cant­ly im­prove lung func­tion in a three-day study when giv­en on top of cur­rent COPD drugs.

Feb­ru­ary brought bet­ter tid­ings, how­ev­er, when all four dos­es of an in­haler form of the com­pound sig­nif­i­cant­ly im­proved lung func­tion in a 40-per­son Phase II tri­al of the chron­ic con­di­tion. — Max Gel­man

Te­va con­tin­ues le­gal bat­tle with Eli Lil­ly, al­leg­ing new patent in­fringe­ments on mi­graine drug

The le­gal saga be­tween Te­va Phar­ma­ceu­ti­cals and Eli Lil­ly con­tin­ues, as Te­va filed a new suit against Eli Lil­ly on Tues­day ar­gu­ing its mi­graine pre­ven­tion drug Em­gal­i­ty in­fringes up­on two new­ly grant­ed Ajovy patents.

Lil­ly got for­mal ap­proval for its CGRP drug Em­gal­i­ty back in 2018, and Te­va al­leged the drug in­fringed on nine Ajovy patents. That case was ex­pect­ed to be tried in 2022, ac­cord­ing to a Fierce Phar­ma re­port. Last year, the US Patent & Trade­mark of­fice in­val­i­dat­ed six of those patents, but up­held three.

Ajovy raked in $31 mil­lion in North Amer­i­ca Q1, while Em­gal­i­ty net­ted $119.5 mil­lion in glob­al sales. — Nicole De­Feud­is 

ITM keeps the cash ped­al to the medal with an­oth­er $30M

Ger­many’s ITM, or Iso­topen Tech­nolo­gien München, is con­tin­u­ing to make its mark on the ra­dio­phar­ma field. Less than two months af­ter scor­ing a nine-fig­ure loan fi­nanc­ing, the biotech has se­cured a new pri­vate eq­ui­ty raise.

ITM pulled in $30 mil­lion in the fundraise, the com­pa­ny an­nounced Thurs­day, aim­ing to sup­port on­go­ing glob­al ex­pan­sion of its pipeline, as well as the fur­ther ad­vance­ment of ex­ist­ing can­di­dates in on­col­o­gy. The funds come on top of a $109 mil­lion round of loan fi­nanc­ing un­veiled in April.

The biotech has de­vel­oped their own ther­a­peu­tic ra­dioiso­tope called Lutetium-177, CEO Stef­fen Schus­ter told End­points News in April, which emits a low amount of ra­dioac­tive en­er­gy. Their lead pro­gram com­bines this mol­e­cule with an edotreotide com­po­nent, which tar­gets re­cep­tors in neu­roen­docrine cells that have gone awry as a re­sult of the can­cer.

It’s a sim­i­lar con­cept to an an­ti­body drug con­ju­gate, but us­es the ra­dioac­tive iso­tope as the car­go. — 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.