No­var­tis re­it­er­ates its faith in Eylea ri­val Beovu; An­ti-NGF drug from Lil­ly, Pfiz­er is ac­cept­ed for FDA re­view

→ Last month, the Chica­go-based Amer­i­can So­ci­ety of Reti­na Spe­cial­ists high­light­ed 14 cas­es of reti­nal vas­culi­tis that have re­cent­ly emerged with Re­gen­eron’s Eylea ri­val — No­var­tis’ Beovu. An­a­lysts al­so iden­ti­fied 36 se­ri­ous cas­es re­port­ed to the FDA Ad­verse Event Re­port­ing Sys­tem, with 2 cas­es of vas­culi­tis, 6 cas­es of blind­ness and 4 cas­es of eye in­flam­ma­tion. No­var­tis, which has pre­vi­ous­ly said it had en­gaged an ex­ter­nal safe­ty re­view com­mit­tee to look in­to these post-mar­ket­ing safe­ty con­cerns, is­sued a press re­lease on Mon­day back­ing the drug, say­ing it be­lieves the in­ci­dence of these events is con­sis­tent with the med­i­cine’s pack­age in­sert.

In con­trast to Beovu, there were no record­ed cas­es of reti­nal vas­culi­tis in late-stage tri­als of Eylea. In piv­otal stud­ies of the No­var­tis ther­a­py, in­traoc­u­lar in­flam­ma­tion and blind­ness were re­port­ed in 4% and 1% of pa­tients, re­spec­tive­ly. “No­var­tis stands be­hind the safe­ty and ef­fi­ca­cy of Beovu when used as in­di­cat­ed,” the com­pa­ny re­it­er­at­ed.

An FDA spokesper­son on Mon­day told End­points News that it “takes re­ports of ad­verse events very se­ri­ous­ly and we are look­ing in­to the is­sue.”

→ About a decade ago, drugs de­signed to tar­get nerve growth fac­tors (NGF) to man­age chron­ic pain were aban­doned af­ter sig­nif­i­cant safe­ty con­cerns cropped up in tri­als. But some drug de­vel­op­ers, in con­sul­ta­tion with the FDA, sol­diered on in a bid to carve a safer path for­ward for this fam­i­ly of com­pounds. Pfiz­er and Eli Lil­ly think their an­ti-NGF — tanezum­ab — fits the bill, with the two part­ners hop­ing they can squeeze past the FDA with the low-dose ver­sion of the ther­a­py. On Mon­day, Lil­ly dis­closed the FDA had ac­cept­ed for re­view the mar­ket­ing ap­pli­ca­tion for tanezum­ab 2.5 mg for pa­tients with chron­ic pain due to os­teoarthri­tis.

→ Three years af­ter it first paid fines for its role in the US opi­oid abuse epi­dem­ic, Mallinck­rodt last week agreed-in-prin­ci­ple to shell out $1.6 bil­lion and place its gener­ics unit in bank­rupt­cy. On Mon­day, the em­bat­tled UK-based drug­mak­er said it had ini­ti­at­ed a rolling mar­ket­ing ap­pli­ca­tion with the FDA for its kid­ney drug, ter­li­pressin. Piv­otal da­ta in pa­tients with a life-threat­en­ing, pro­gres­sive rare com­pli­ca­tion of liv­er dis­ease that trig­gers kid­ney fail­ure called he­pa­tore­nal syn­drome type 1 (HRS-1), which af­fects an es­ti­mat­ed 30,000 to 40,000 in the Unit­ed States each year, was pub­lished in Au­gust.

→ Im­muno-on­col­o­gy com­pa­ny Mark­er Ther­a­peu­tics has en­tered in­to a deal where Chica­go-based in­sti­tu­tion­al in­vestor and long-term share­hold­er As­pire Cap­i­tal Fund will buy up to $30 mil­lion of its stock.

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.

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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.

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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.

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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.

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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.