Take­da, Fra­zier cre­ate Phath­om Phar­ma­ceu­ti­cals to spur de­vel­op­ment of GI drug vono­prazan in $140M play

With four­teen gas­troen­terol­o­gy as­sets in its pipeline, Take­da $TAK has its hands full. The com­pa­ny — new­ly merged with Shire — is thus farm­ing out the ex-Japan de­vel­op­ment of its acid-fight­er Vono­prazan to a com­pa­ny it has cre­at­ed with the ven­ture part­ners at Fra­zier: Phath­om Phar­ma­ceu­ti­cals.

Vono­prazan is a P-CAB — a class of drugs that blocks the potas­si­um-bind­ing site of gas­tric hy­dro­gen potas­si­um AT­Pase (al­so known as the pro­ton pump), which is the en­zyme large­ly re­spon­si­ble for acid­i­fi­ca­tion of the stom­ach — dis­cov­ered and de­vel­oped by Take­da. The drug — which is de­signed to over­come many of the per­ceived weak­ness­es of tra­di­tion­al pro­ton pump in­hibitor ther­a­py (such as short half-life, re­quir­ing 3–5 cy­cles of ad­min­is­tra­tion be­fore achiev­ing full ef­fect) — was ap­proved in 2015 by Japan­ese reg­u­la­tors for var­i­ous GI con­di­tions in­clud­ing gas­tric and duo­de­nal ul­cers as well as H. py­lori in­fec­tions.

Asit Parikh

While Phath­om has in-li­censed the drug from Take­da for the de­vel­op­ment and ex­clu­sive com­mer­cial­iza­tion rights to Vono­prazan in North Amer­i­ca and Eu­rope — Take­da and Ot­su­ka will con­tin­ue to co-pro­mote the drug in Japan. Take­da, which in 2017 saw 21.6% of its rev­enue growth come from its GI port­fo­lio, will al­so con­tin­ue to mar­ket Vono­prazan in sev­er­al Asian mar­kets (Malaysia, Philip­pines, Sin­ga­pore, South Ko­rea, Tai­wan and Thai­land) where it has launched.

Phath­om has com­plet­ed a $90 mil­lion pri­vate fi­nanc­ing led by Fra­zier, with in­vest­ments from Medicxi, RA Cap­i­tal Man­age­ment, Abing­worth, cer­tain ac­counts man­aged by Janus Hen­der­son In­vestors, BVF Part­ners LP, Green­spring As­so­ci­ates, Richard King Mel­lon Foun­da­tion, Sah­sen Ven­tures and undis­closed in­sti­tu­tion­al in­vestors. The com­pa­ny, which is be­ing run by Fra­zier ven­ture part­ner David Socks as in­ter­im chief, has al­so se­cured a $50 mil­lion term loan fa­cil­i­ty with Sil­i­con Val­ley Bank.

“Take­da em­braces col­lab­o­ra­tion to fur­ther de­vel­op and cre­ate val­ue around promis­ing as­sets where part­ner­ship makes more sense for our busi­ness,” said Asit Parikh, head of the gas­troen­terol­o­gy ther­a­peu­tic area unit at Take­da, in a state­ment.

 

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

CDC’s Robert Redford, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA, ques­tions need to length­en process

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

Chair of FDA's vac­cine ad­comm — who's al­so a lead in­ves­ti­ga­tor of Mod­er­na's vac­cine — re­cus­es her­self from Covid-19 talks

When the FDA’s Vaccines and Related Biological Products Advisory Committee meets next month to discuss the development and authorization of Covid-19 vaccines, the chairwoman won’t be there.

Hana El Sahly has recused herself from the expert panel’s review of the topic, citing her role as a lead investigator in Moderna’s Phase III trial, Reuters reported. An associate professor of virology and microbiology at Baylor College of Medicine in Houston, El Sahly was appointed the chairwoman last year.

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

Jim Roberts and Brian Finrow (Lumen Bioscience)

With a $4M fed­er­al grant, Lu­men jumps in­to the Covid-19 treat­ment race

It’s been less than a month since Lumen Bioscience announced a $16 million Series B to engineer spirulina — a nutrient-packed super food — for diseases like traveler’s diarrhea, norovirus and C. difficile colitis. And now, the biotech has pulled in another $4 million to do the same for Covid-19.

The approach is quite similar to other gastrointestinal targets the company is pursuing, co-founders and Brian Finrow and Jim Roberts said. The Seattle-based company is working on a camelid antibody cocktail to combat GI infection common among Covid-19 patients. In a study published in the American Journal of Gastroenterology, a majority of Covid-19 patients showed GI and respiratory symptoms, and 25% had only GI symptoms.

CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.