Te­va gets a bad­ly need­ed win: FDA OKs their run­ner-up CGRP mi­graine drug, with Eli Lil­ly trail­ing be­hind

Kåre Schultz

The FDA has come through with a de­layed OK for Te­va’s new mi­graine drug. And this one rep­re­sents a bad­ly need­ed win for the new man­age­ment team as they look to re­gain some lost re­spect.

Te­va put out the word about the ap­proval late Fri­day. Its shares $TE­VA were up 6% in af­ter-mar­ket trad­ing.

This new drug fre­manezum­ab — to be mar­ket­ed as Ajovy — comes in as the sec­ond ap­proval for the batch of CGRP drugs in the pipeline. Am­gen scored brag­ging rights, as well as an op­por­tu­ni­ty to set the bar on the price, as first mover with Aimovig. Now Eli Lil­ly re­mains in its fa­mil­iar po­si­tion to­wards the end of the line, with a PDU­FA date set for next month. Alder re­mains at the back of the pack af­ter de­lays pushed back any de­ci­sion in­to next year.

Te­va — pushed back 3 months by some man­u­fac­tur­ing is­sues at a fa­cil­i­ty run by Cell­tri­on — does have some spe­cial boast­ing rights here that will play out in the un­fold­ing mar­ket­ing bat­tle, herald­ing an OK for a drug that proved ef­fec­tive with month­ly and quar­ter­ly dos­ing.

The com­pa­ny plans to start sell­ing the drug in the US at $575 per month­ly dose and $1,725 per quar­ter­ly dose. That will line up right along­side Am­gen’s price for Aimovig, set at $6,900 a year for a month­ly dose. 

For Te­va, the news had to spark more than a few high-fives in the C-suite. Bloomberg’s con­sen­sus on sales is set at $500 mil­lion in 2022. But some added re­spect af­ter watch­ing the gener­ic busi­ness get torn up — while its lead in­no­v­a­tive drug for mul­ti­ple scle­ro­sis was fi­nal­ly axed by re­peat clin­i­cal fail­ures — is price­less for CEO Kåre Schultz, who is work­ing to turn the com­pa­ny around. 

Leerink’s Ge­of­frey Porges joined in the ap­plause for Te­va, not­ing that Am­gen’s ear­ly suc­cess with Aimovig un­der­scores the drug cat­e­go­ry’s $5 bil­lion to $6 bil­lion po­ten­tial by the mid-’20s as the full field of drugs de­vel­ops the mar­ket.

Here’s what Umer Raf­fat had to say:

The sto­ry at TE­VA has re­al­ly been about es­tab­lish­ing cred­i­bil­i­ty with in­vestors- es­pe­cial­ly with the tar­gets they have set for them­selves. Many in­vestors had pegged CGRP ap­proval as one of these key tar­gets. Hit­ting this tar­get is very im­por­tant val­i­da­tion for man­age­ment’s cred­i­bil­i­ty.

Ami Fa­dia at Leerink al­so is bet­ting that peak sales can do bet­ter than the Bloomberg con­sen­sus.

Te­va ex­pects Ajovy to be avail­able in ~2 weeks, and the com­pa­ny has pre­vi­ous­ly in­di­cat­ed that the fre­manezum­ab launch will in­volve “giv­ing away free drug” at least dur­ing the ini­tial launch pe­ri­od and that no earn­ings con­tri­bu­tion is in­cor­po­rat­ed in­to 2018 guid­ance (we as­sume on­ly $3M this year). Our sales es­ti­mates have as­sumed time­ly ap­proval of Ajovy, which we be­lieve po­si­tions it to reach peak share with­in the in­jectable CGRPs of 20%. Rais­ing our PoS to 100% (from 75%) in­creas­es our US Ajovy sales in 2019 to $108M (vs $81M) and sales in 2023 to $629M (from $471M).

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.

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.

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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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.