Vi­iV, GSK gam­ble a sur­prise $130M chip in a high-stakes HIV play­off with Gilead

Glax­o­SmithK­line $GSK hasn’t had much to boast about over the last cou­ple of years when it comes to new drug de­vel­op­ment. But Vi­iV — the HIV spe­cial­ist which it con­trols a ma­jor­i­ty stake in — has proven to be a no­table ex­cep­tion to that rule.

To­day, Vi­iV con­tin­ued to live up to its star billing in­side GSK cir­cles, not­ing that it filed twin ap­pli­ca­tions at the FDA and the EMA for a com­bi­na­tion of do­lute­gravir (Tivicay) and rilpivirine (J&J’s Edu­rant), which it plans to mar­ket as the world’s first two-drug main­te­nance ther­a­py for keep­ing a lid on the lethal virus.

In a sur­prise, Vi­iV says that GSK re­cent­ly ac­quired a pri­or­i­ty re­view vouch­er (PRV) for $130 mil­lion and will use it to shave four months off the FDA re­view process. That should give it a clear shot at beat­ing Gilead to the mar­ket lat­er this year.

A spokesper­son for GSK de­clined to com­ment when I asked who they bought the vouch­er from. I have a query in to Marathon, which bagged a PRV in its con­tro­ver­sial ap­proval for an old steroid called de­flaza­cort af­ter gain­ing an ap­proval specif­i­cal­ly for Duchenne mus­cu­lar dy­s­tro­phy, but have yet to hear back.

Be­ing first to mar­ket here can be a valu­able ad­van­tage. The HIV mar­ket is worth bil­lions of dol­lars, and new com­bi­na­tions like these of­fer pro­longed hope for pa­tients hold­ing the virus at bay for years, with a grow­ing risk for ad­verse events from the meds keep­ing them alive. For GSK, main­tain­ing a lead­ing role with Vi­iV is ab­solute­ly es­sen­tial to re­tain­ing its in­vestors loy­al­ty.

Gilead $GILD re­cent­ly de­clared that all four of its Phase III stud­ies test­ing a com­bi­na­tion ther­a­py that adds bicte­gravir to its back­bone HIV ther­a­pies proved non-in­fe­ri­or to do­lute­gravir and oth­er an­ti­retro­vi­ral ther­a­pies. But it didn’t prove su­pe­ri­or, a prospect which had rat­tled GSK in­vestors. GSK’s stock surged on Gilead’s read­out, with Vi­iV seen ward­ing off a ma­jor threat by Gilead, which has been a dom­i­nant ri­val for years.

Gilead re­cent­ly ac­quired its own PRV from Sarep­ta for $125 mil­lion and is wide­ly ex­pect­ed to use it in its race against GSK/Vi­iV. As Gilead’s block­buster hep C fran­chise has be­gun to fade, the big biotech is in­creas­ing­ly re­liant on its main­stay HIV work. And any added pres­sure by GSK is like­ly to in­crease an­a­lysts’ fo­cus on a ma­jor deal to get Gilead’s num­bers point­ed back north.

“Tra­di­tion­al­ly, we have used a reg­i­men of three or more drugs to main­tain HIV vi­ral sup­pres­sion, but to best serve peo­ple liv­ing with HIV we must al­ways ques­tion the sta­tus quo,” not­ed Vi­iV chief sci­en­tist John C. Pot­tage in a state­ment. “We be­lieved that do­lute­gravir would have the right pro­file to be a core agent in a two-drug reg­i­men. Da­ta from the SWORD stud­ies sup­port­ed our hy­poth­e­sis that a two-drug reg­i­men of do­lute­gravir and rilpivirine could main­tain vi­ral sup­pres­sion and these reg­u­la­to­ry sub­mis­sions mark what may be a step change in HIV treat­ment.  We are grate­ful to the study par­tic­i­pants and clin­i­cians who have con­tributed so much to mak­ing these sub­mis­sions pos­si­ble.”

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. The idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.

Ver­tex deal for Scot­land — no deal for Eng­land

Cystic fibrosis (CF) drug maker Vertex Pharmaceuticals — which is still locked in negotiation with NHS England to endorse the use of its medicines — has successfully negotiated a deal with Scottish authorities.

A month ago, the Scottish Medicines Consortium spurned two of the company’s medicines — Orkambi and Symkevi — citing uncertainty over their long-term efficacy in relation to their cost.

Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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