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).

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.