Te­va turns the last cor­ner in the CGRP mi­graine drug race with its 2nd round of promis­ing PhI­II da­ta

Te­va has brought in its sec­ond suc­cess­ful Phase III study of its CGRP mi­graine drug fre­manezum­ab (TEV-48125), rack­ing up a fresh slate of promis­ing da­ta across all end­points that will soon be pack­aged and de­liv­ered in­to the hands of reg­u­la­tors.

Te­va re­cruit­ed a heav­i­ly af­flict­ed group of pa­tients for this episod­ic study with a mean num­ber of 9.1 mi­graine days per month go­ing in. Their $TE­VA core da­ta boils down to this: a 1.5-day ad­van­tage in re­duced mi­graine days for the drug arm, putting it in the mix of around 2 days im­prove­ment across a full slate of CGRP ri­vals test­ed in a wide va­ri­ety of mid- and late-stage stud­ies.

Umer Raf­fat at Ever­cor­eISI has been fol­low­ing the num­bers, and high­light­ed this point:

(I)n to­day’s da­ta, there is an­oth­er impt tid­bit:  Te­va prospec­tive­ly ran­dom­ized a sub­group of pa­tients in this episod­ic tri­al on sta­ble pro­phy meds … and in this sub­group, Te­va showed a 1.7-2 day stat sig mi­graine day re­duc­tion (both for quar­ter­ly and month­ly dos­es).  This may al­so help from la­bel­ing per­spec­tive.

Raf­fat de­clined to com­pare these new num­bers for episod­ic mi­graine with Am­gen or Lil­ly, not­ing the dif­fer­ence in tri­al length that makes it im­pos­si­ble to line up the stats.

The de­tails:

Fre­manezum­ab giv­en month­ly im­proved the av­er­age num­ber of mi­graine days, rel­a­tive to base­line, by 41.6% for the du­ra­tion of the tri­al (-3.7 days vs. -2.2 days for place­bo, p < 0.0001). Num­ber of days with dis­abil­i­ty were de­creased by 64.7% (p =0.0021) and med­ica­tion con­sump­tion was de­creased by 39.0%( p < 0.0001). The quar­ter­ly SC dose, which was unique­ly test­ed in this pro­gram, al­so yield­ed high­ly sig­nif­i­cant re­sults for de­crease in mi­graine days (-3.4 days or 37.0%, p < 0.0001) and for all oth­er com­par­isons. Al­so unique to this de­vel­op­ment, both dose reg­i­mens high­ly sig­nif­i­cant­ly im­proved mi­graine in sub­jects on sta­ble dos­es of oth­er pro­phy­lac­tic med­ica­tions (-4.0 days for month­ly dose vs -2.0 days for place­bo, p = 0.001; -3.7 days for quar­ter­ly dose, p = 0.006).

It all looks good enough for an ap­proval, with de­cent odds that this drug will ap­pear on the mar­ket along­side a slate of ri­vals next year. Te­va, though, is hop­ing that its month­ly and quar­ter­ly dos­ing reg­i­mens will help dif­fer­en­ti­ate it from the com­pe­ti­tion to come.

Michael Hay­den, Te­va

“Te­va’s HA­LO tri­als are the on­ly Phase III an­ti-CGRP stud­ies to demon­strate ef­fi­ca­cy with both month­ly and quar­ter­ly dos­ing for chron­ic and episod­ic pa­tients and in pa­tients al­ready re­ceiv­ing pre­ven­tion ther­a­pies. This is a ma­jor ad­vance on ex­ist­ing da­ta. The ef­fi­ca­cy and rapid on­set, as both add-on and monother­a­py, quar­ter­ly dos­ing, and ef­fect on dis­abil­i­ty and qual­i­ty of life in­di­cate that this ther­a­py has the po­ten­tial to set new and dif­fer­ent bench­marks in the re­lief of mi­graine suf­fer­ing,” said Te­va R&D chief Michael Hay­den in a state­ment. “We are im­mense­ly proud to be able to bring to the mi­graine com­mu­ni­ty the hope that they might soon have a new op­tion that could pro­vide a mean­ing­ful re­duc­tion in the mi­graine bur­den pa­tients ha­bit­u­al­ly suf­fer.”

A few weeks ago it was Eli Lil­ly’s $LLY turn to cel­e­brate its Phase III re­sults for gal­canezum­ab, with a con­sis­tent 2-day re­duc­tion in month­ly mi­graines. Lit­tle Alder $AL­DR is al­so plan­ning to wage a com­mer­cial war with their drug. And Al­ler­gan $AGN has a late-stage pro­gram un­der­way for an oral CGRP ther­a­py it in-li­censed from Mer­ck in 2015 with a $250 mil­lion up­front. No­var­tis $NVS and Am­gen $AMGN — cred­it­ed as the fron­trun­ners in the race to the first OK — were the first to come up with pos­i­tive Phase III da­ta for erenum­ab (AMG 334) last fall, when a 70 mg dose scored an av­er­age 1.1 day per month drop in mi­graine episodes.

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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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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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.

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.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

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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FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.