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.”

Fangliang Zhang, AP Images

Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

David Meline (file photo)

Mod­er­na’s new CFO took a cut in salary to jump to the mR­NA rev­o­lu­tion­ary. But then there’s the rest of the com­pen­sa­tion pack­age

David Meline took a little off the top of his salary when he jumped from the CFO post at giant Amgen to become the numbers czar at the upstart vaccines revolutionary Moderna. But the SEC filing that goes with a major hire also illustrates how it puts him in line for a fortune — provided the biotech player makes good as a promising game changer.

To be sure, there’s nothing wrong with the base salary: $600,000. Or the up-to 50% annual cash bonus — an industry standard — that comes with it. True, the 62-year-old earned $999,000 at Amgen in 2019, but it’s the stock options that really count in the current market bliss for all things biopharma. And there Meline did well.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.