GSK banks on promis­ing da­ta from its PhI­II Gem­i­ni pro­gram to stare down Gilead on HIV — but there are plen­ty of skep­tics

Af­ter more than a decade’s worth of work, Glax­o­SmithK­line $GSK re­searchers to­day are un­veil­ing pooled da­ta from their two late-stage tri­als of a two-drug reg­i­men for keep­ing HIV in check. Fac­ing off against some deep-seat­ed skep­ti­cism and a pow­er­house ri­val at Gilead $GILD, the phar­ma gi­ant’s ma­jor­i­ty owned sub­sidiary Vi­iV says the com­bo per­formed just as well as a triplet in their big face­off in­volv­ing treat­ment-naive pa­tients, mak­ing it a like­ly new en­try in the glob­al fight against the virus that spurs AIDS.

“Ther­a­py has got­ten bet­ter, peo­ple are liv­ing longer,” says Vi­iV CSO John Pot­tage. “Then you have to think about treat­ing peo­ple for their life­time, decades of ther­a­py.”

The sim­pler, the bet­ter.

John Pot­tage

Click on the im­age to see the full-sized ver­sion

The two drugs Vi­iV put to­geth­er in its big Gem­i­ni Phase III pro­gram are do­lute­gravir and lamivu­dine (3TC). The pooled da­ta demon­strat­ed a 91% con­trol rate, with the bulk of the pa­tients un­der the rate of HIV-1 RNA<50 copies/mL com­pared with 93% in a three-drug arm fea­tur­ing do­lute­gravir and two nu­cle­o­side re­verse tran­scrip­tase in­hibitors: teno­fovir diso­prox­il fu­marate/emtric­itabine.

Pot­tage al­so says that the da­ta hold up when you pull out the pa­tients with high vi­ral loads. 

This is one-year da­ta, mean­ing that re­searchers will con­tin­ue to watch on dura­bil­i­ty, a key fea­ture for any new treat­ment in this field, where pa­tients are mon­i­tored to see if their treat­ment reg­i­men is los­ing ef­fect and re­quires a shift to keep the virus at bay.

“It used to be month-to-month,” Pot­tage says to me about the drug changeover rate. “Here they last for years.”

In that sce­nario, the few­er drugs you use, the less like­ly you’ll run in­to prob­lems, in­clud­ing few­er drug-drug in­ter­ac­tions as these pa­tients get old­er and face mul­ti­ple co-mor­bidi­ties. It’s an edge, and an edge can amount to a ma­jor mar­ket niche in HIV.

If the da­ta hold up un­der reg­u­la­to­ry scruti­ny at the FDA, the EMA and in­deed around the world, GSK will quite like­ly have a new prod­uct in this block­buster are­na. Reg­u­la­tors and physi­cians love al­ter­na­tive drug op­tions to put on their list of go-to ther­a­pies for chron­ic dis­eases. But just get­ting an OK like­ly won’t damp­en the skep­ti­cism some an­a­lysts have of­fered about GSK as the UK phar­ma gi­ant bat­tles a dom­i­nant Gilead on what amounts to be their home turf.

Ge­of­frey Porges, Leerink

One of the most skep­ti­cal watch­ing the bat­tle of the HIV gi­ants is Leerink’s Ge­of­frey Porges, who re­cent­ly ticked off a line­up of hur­dles GSK will like­ly find dif­fi­cul­ty clear­ing. GSK al­ready fell be­hind Gilead’s lat­est 3-drug com­bi­na­tion Bik­tarvy with their oth­er two-drug com­bo Ju­lu­ca, us­ing do­lute­gravir and rilpivirine. That, he said, was clear­ly in­fe­ri­or.

Gilead looks to re­main the dom­i­nant play­er, he adds, not­ing:

Though we be­lieve physi­cians will be more will­ing to pre­scribe a two-drug HIV reg­i­men that in­cludes 3TC in­stead of rilpivirine, all of the HIV pre­scrip­tion trends and our pro­pri­etary sur­vey work sug­gest that GSK’s two-drug reg­i­mens will not un­der­mine Gilead’s in­creas­ing HIV mar­ket share trend over the next 3 years, and we do not an­tic­i­pate any val­ue ero­sion in Gilead’s stock from these dis­clo­sures or even the ap­proval of this sec­ond 2 drug com­bi­na­tion from Vi­iV.

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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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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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.