Ac­ne was a bust, but ex­ces­sive sweat­ing scores FDA OK for Der­mi­ra — shares climb

Af­ter a cat­a­stroph­ic fail­ure in ac­ne that oblit­er­at­ed its stock just months ago, Der­mi­ra $DERM had some re­deem­ing news this morn­ing — the FDA has OK’ed its an­ti-sweat­ing drug gly­copy­rro­ni­um.

Tom Wig­gans

The med now goes un­der the brand name Qbrexza, and it’s a once-dai­ly, top­i­cal treat­ment for peo­ple with ex­ces­sive un­der­arm sweat­ing (al­so called pri­ma­ry ax­il­lary hy­per­hidro­sis). The treat­ment is ap­plied di­rect­ly to the skin, block­ing sweat gland ac­ti­va­tion.

“For years, der­ma­tol­o­gists have been telling us of the need for new treat­ment op­tions that ad­dress pri­ma­ry ax­il­lary hy­per­hidro­sis giv­en the stig­ma and bur­den as­so­ci­at­ed with this con­di­tion,” said Tom Wig­gans, chair­man and chief ex­ec­u­tive of­fi­cer at Der­mi­ra. “From the start, our goal was to de­vel­op an ap­proach that went be­yond mask­ing a per­son’s ex­ces­sive un­der­arm sweat­ing and in­stead fo­cused on treat­ing the con­di­tion in a clin­i­cal­ly mean­ing­ful way. We part­nered with der­ma­tol­o­gists and the FDA dur­ing the de­vel­op­ment stage and lis­tened to the peo­ple who have been liv­ing with this con­di­tion to un­der­stand how they would de­fine a mean­ing­ful ben­e­fit. It is our hope that Qbrexza will not on­ly pro­vide the clin­i­cal ben­e­fit these suf­fer­ers have been seek­ing, but help to re­duce the over­all bur­den on their lives.”

Ever­core in­dus­try an­a­lyst Umer Raf­fat wrote a note this morn­ing about his take on the ap­proval, which was based on re­sults from two Phase III tri­als.

“I have to ad­mit: I was in the more skep­tic camp on un­met need for drug treat­ments in hy­per­hidro­sis … un­til I saw a work­shop host­ed by FDA where I lis­tened to many pa­tient sto­ries about the so­cial stig­ma/un­suc­cess­ful job in­ter­views etc. At present, Der­mi­ra es­ti­mates 5 (mil­lion) hy­per­hidro­sis pa­tients have had a dis­cus­sion with the doc, but on­ly ~15% treat­ed. Der­mi­ra will have to work hard on cre­at­ing this mar­ket.”

Raf­fat not­ed that Botox is cur­rent­ly ap­proved in hy­per­hidro­sis, but the drug has seen no sales growth in the in­di­ca­tion, hold­ing steady at about $70 mil­lion per year. Ever­core is mod­el­ing $200 mil­lion in peak sales, start­ing in 2019 with about $30 mil­lion. Qbrexza is ex­pect­ed to be avail­able na­tion­wide in phar­ma­cies be­gin­ning in Oc­to­ber 2018.

Der­mi­ra’s stock is up 27% on the news. But it’s not yet enough to un­do pre­vi­ous dam­age, as the com­pa­ny’s share price cratered over 65% in March (from $25 per share to $8.59 in a mat­ter of days) fol­low­ing news that its Phase III ac­ne drug failed in tri­als and would be scrapped. To­day in pre-mar­ket trad­ing, it’s at $11.04.

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.