Strug­gling in R&D, GSK lines up an FDA pitch on COPD with mixed da­ta

One of the few things that Glax­o­SmithK­line’s phar­ma R&D group got right in the last few years was mepolizum­ab, ap­proved for se­vere asth­ma in 2015 and sold as Nu­cala. And now, with ri­vals look­ing to com­pete over mar­ket turf in its core res­pi­ra­to­ry field, in­ves­ti­ga­tors have mapped out a shot at an ex­pan­sion in­to the COPD mar­ket for pa­tients at high risk of ex­ac­er­ba­tions.

But hit­ting that goal will re­ly on shaky da­ta, with plen­ty of holes in the ev­i­dence and a heavy re­liance on a bio­mark­er for dis­ease sever­i­ty.

Em­ma Walm­s­ley File pho­to

Re­searchers for the phar­ma gi­ant — which has been re­group­ing as new CEO Em­ma Walm­s­ley has been think­ing through a change-up in R&D — say that mepolizum­ab scored on the pri­ma­ry end­point of cut­ting the rate of ex­ac­er­ba­tions in one of two Phase III COPD tri­als, with an ad­just­ed p-val­ue of 0.036 among pa­tients with a high blood eosoniphil count. But the high­er dose didn’t work in their dose-rang­ing study and the same pos­i­tive/neg­a­tive split was seen as in­ves­ti­ga­tors tracked the time to first sig­nif­i­cant ex­ac­er­ba­tion, a key sec­ondary.

None of the oth­er sec­on­daries hit in the place­bo com­par­i­son for ei­ther tri­al, in­clud­ing the num­ber of hos­pi­tal­iza­tions or ER vis­its as well as the re­sults of a ques­tion­naire.

GSK has had one of the weak­est pipelines in Big Phar­ma, a point that Walm­s­ley un­der­scored with a re­cent de­ci­sion to clear the decks in R&D — dump­ing its oth­er re­cent­ly ap­proved drug Tanzeum along with a deeply trou­bled late-stage pro­gram for the rheuma­toid arthri­tis sirukum­ab, which is ap­par­ent­ly go­ing nowhere for J&J af­ter a re­cent neg­a­tive pan­el vote. The R&D group con­tin­ues to pur­sue new in­di­ca­tions for Nu­cala, though, as the drug gained some trac­tion as new meds in the field line up to vie for a bet­ter po­si­tion.

Steve Yancey, GSK

While the phar­ma gi­ant’s HIV and vac­cines groups have con­tin­ued to do sig­nif­i­cant work with new pro­grams, the phar­ma R&D group has been large­ly in­ef­fec­tive in stir­ring any kind of ex­cite­ment. Walm­s­ley is out to change that, in part by dou­bling down on can­cer af­ter GSK made the ques­tion­able de­ci­sion to swap out its late-stage on­col­o­gy port­fo­lio in ex­change for No­var­tis’ vac­cines group.

Steve Yancey, who leads the de­vel­op­ment work on mepolizum­ab for GSK, said:

“We be­lieve the da­ta pub­lished to­day in the New Eng­land Jour­nal of Med­i­cine demon­strate the ben­e­fits of a per­son­al­ized med­i­cine ap­proach in the treat­ment of COPD with mepolizum­ab, us­ing blood eosinophils as a bio­mark­er. Based on the clin­i­cal­ly mean­ing­ful re­duc­tions in ex­ac­er­ba­tions shown in these stud­ies, we plan to progress reg­u­la­to­ry fil­ings this year.”

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

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Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

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