FDA re­quests ad­di­tion­al time for Flex­ion's sN­DA; Genen­tech re­leas­es da­ta for PhI­II study of Rit­ux­an

In 2017, the FDA green­light­ed Flex­ion Ther­a­peu­tics‘ in­tra-ar­tic­u­lar ther­a­py, Zil­ret­ta, de­signed as a treat­ment for os­teoarthri­tis-re­lat­ed knee pain. Now, two years lat­er, the com­pa­ny has an­nounced that the FDA needs ad­di­tion­al time to com­plete the re­view of its sup­ple­men­tal NDA for Zil­ret­ta. The an­tic­i­pat­ed PDU­FA date was set for to­day. Al­though the FDA has not pro­vid­ed a new ac­tion date, Flex­ion says they were in­formed that the re­view should be com­plet­ed in the com­ing weeks. No ad­di­tion­al clin­i­cal da­ta has been re­quest­ed by the FDA.

Genen­tech has re­leased da­ta from its Phase III PEM­PHIX study eval­u­at­ing the ef­fi­ca­cy and safe­ty of Rit­ux­an (rit­ux­imab) com­pared to my­cophe­no­late mofetil (MMF), in adults with mod­er­ate to se­vere pem­phi­gus vul­garis (PV). The da­ta showed su­pe­ri­or re­sults in pa­tients giv­en Rit­ux­an, with 40.3% of pa­tients treat­ed with Rit­ux­an achiev­ing sus­tained com­plete re­mis­sion with­out the use of steroids for 16 con­sec­u­tive weeks or more, com­pared to 9.5% in the MMF arm (p<0.0001). The stud­ies pri­ma­ry end­point was reached at week 52.

John­son & John­son‘s drug Xarel­to (ri­varox­a­ban) has been ap­proved by the FDA for the pre­ven­tion of ve­nous throm­boem­bolism (VTE), or blood clots, in hos­pi­tal­ized, acute­ly ill med­ical pa­tients at risk for throm­boem­bol­ic com­pli­ca­tions who are not at high risk of bleed­ing. The ap­proval comes a few months af­ter J&J and Bay­er paid out $775 mil­lion to thou­sands of Xarel­to pa­tients af­ter a 5-year long le­gal war — the com­pa­nies were ac­cused of fail­ing to warn pa­tients prop­er­ly of the bleed­ing risk as­so­ci­at­ed with the blood thin­ner.

Ul­tragenyx Phar­ma­ceu­ti­cal has an­nounced that the FDA has ac­cept­ed their NDA for UX007 (tri­hep­tanoin) for the treat­ment of long-chain fat­ty acid ox­i­da­tion dis­or­ders. The PDU­FA is set for Ju­ly 31, 2020.

As­traZeneca, Pfiz­er and Take­da have come to­geth­er for a col­lab­o­ra­tion deal with Imag­inAb, agree­ing to guide a clin­i­cal tri­al for the imag­ing play­er in ex­change for ear­ly ac­cess to the da­ta. The study is aimed at as­sess­ing the util­i­ty and val­ue of Imag­inAb’s Im­munoPET tech­nol­o­gy, which us­es mi­ni an­ti­bod­ies and tags CD8+ T cells with ra­dioiso­topes to ren­der im­mune ac­tiv­i­ty vis­i­ble in a PET scan.

“One of our key ob­jec­tives is to stream­line the clin­i­cal de­vel­op­ment of next-gen­er­a­tion can­cer im­munother­a­pies so that ul­ti­mate­ly can­cer pa­tients have ac­cess to the best pos­si­ble treat­ments,” CEO Ian Wil­son said in a state­ment. “We be­lieve that work­ing with glob­al lead­ers in im­muno-on­col­o­gy will help us fur­ther de­vel­op CD8 Im­munoPET as a phar­ma­co­dy­nam­ic mark­er for use in drug de­vel­op­ment and, in the fu­ture, as a di­ag­nos­tic and pre­dic­tive test for use in hos­pi­tals.”

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

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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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UP­DAT­ED: 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.

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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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.