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).

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.