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

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.

Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Covid-19 roundup: White House re­veals vac­cine do­na­tion plan; EU opts in for an­oth­er 150 mil­lion dos­es from Mod­er­na

President Joe Biden’s administration on Monday revealed the distribution list for 55 million of the 80 million doses of Covid-19 vaccines America plans to donate to lower-income nations:

Roughly 14 million doses will head to Latin America and the Caribbean, for a list of countries that includes Brazil, Argentina, Dominican Republic, Panama and Costa Rica.
Another 16 million doses are headed to Asia to help the following countries: India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Bhutan, Philippines, Vietnam, Indonesia, Thailand, Malaysia, Laos, Papua New Guinea, Taiwan, Cambodia, and the Pacific Islands.