My­ovant grabs $40M up­front in re­gion­al deal for re­l­u­golix; Akero an­nounces NASH suc­cess but Covid-19 de­lays

→ Hav­ing just filed for the Eu­ro­pean ap­proval of its uter­ine fi­broids drug re­l­u­golix, My­ovant has sold the re­gion­al rights off to Hun­gar­i­an biotech Gedeon Richter. Com­pris­ing $40 mil­lion in up­front, $40 mil­lion in reg­u­la­to­ry mile­stones and $107.5 mil­lion in sales-re­lat­ed pay­ments, the deal cov­ers not just Eu­rope but al­so Rus­sia, Latin Amer­i­ca, Aus­tralia and New Zealand. My­ovant, a women’s health and prostate can­cer spin­off of Vivek Ra­maswamy’s Roivant that is now ma­jor­i­ty-owned by Sum­it­o­mo Dainip­pon Phar­ma, in-li­censed the com­pound from Take­da and finds it­self in com­pe­ti­tion with Orilis­sa from Ab­b­Vie and Neu­ro­crine.

→ Rare dis­ease play­er Pro­QR said its RNA ther­a­py is show­ing ear­ly promise against a ge­net­ic dis­or­der that caus­es vi­sion and hear­ing loss. In an in­ter­im analy­sis of the Phase I/II tri­al, in­ves­ti­ga­tors found QR-421a to be safe. Two of the eight re­tini­tis pig­men­tosa pa­tients treat­ed with the drug saw im­prove­ments by mul­ti­ple mea­sures (one each on the low and medi­um dos­es), while the six pa­tients on the place­bo arm ex­pe­ri­enced no mean­ing­ful ben­e­fits. The biotech plans to ex­pand the medi­um 100 µg co­hort while adding a high, 200 µg dose to the tri­al, be­gin­ning dos­ing as soon as it can un­der a cloud of Covid-19 un­cer­tain­ty.

→ Af­ter a year of fail­ures and de­lays in NASH, a mid-size biotech is of­fer­ing a glim­mer of up­side. Akero Ther­a­peu­tics an­nounced that its lead com­pound passed the week 12 pri­ma­ry end­point in Phase IIa tri­al, with the 59 pa­tients who re­ceived the drug see­ing ab­solute liv­er fat re­duc­tions of 12-14%. Pa­tients in the high­est dos­ing arm al­so saw re­duc­tions in fat of over 70% rel­a­tive to place­bo, hit­ting a sec­ondary end­point. The com­pa­ny, though, said that Covid-19 could in­ter­rupt the tri­al. It had al­ready led them to de­lay the start of one study co­hort and could in­ter­fere with da­ta col­lec­tion for the tri­al.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,200+ biopharma pros reading Endpoints daily — and it's free.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

A low-pro­file biotech bests Re­gen­eron in high-pro­file patent suit

For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.

Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.

Bull­ish biotech mar­ket pro­pels Pli­ant to $144M IPO — as No­var­tis pro­vides a $10M boost

After pharma partner Novartis boosted its IPO with a $10 million private placement, Pliant Therapeutics has wrapped its journey to the Nasdaq on a high note.

Pliant had penciled in a $86 million raise back in May. But as has become the norm in recent months, that initial number has turned out to be a mere placeholder, making way for the final haul of $144 million.

The South San Francisco biotech did so by pricing at $16, the high end of the range, while bringing the number of shares offered up to 9 million.

Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,200+ biopharma pros reading Endpoints daily — and it's free.

FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,200+ biopharma pros reading Endpoints daily — and it's free.

For­bion leads $62.5M round for neu­ro start­up as ex-Te­va R&D chief takes con­trol; CSL Behring inks gene ther­a­py pact in im­munol­o­gy

Forbion has led a $62.5 million round for Prilenia Therapeutics to fund two late-stage trials in Huntington’s disease and amyotrophic lateral sclerosis. Michael Hayden, the former Teva R&D chief who’s been serving as chairman, will now take over as CEO to oversee the program for pridopidine, which agonizes the sigma-1 receptor (S1R). Morningside and Sectoral Asset Management also joined, as did Talisman Capital Partners and Genworks 2.