No­var­tis drums up an­tic­i­pa­tion for block­buster-to-be with PhII da­ta on asth­ma drug, beat­ing Ad­vair in head-to-head

An asth­ma drug that No­var­tis has tapped as a big mon­ey­mak­er has de­liv­ered a clean sweep in Phase II, boost­ing its block­buster case months ahead of a Phase III read­out.

Lin­da Arm­strong LinkedIn

The two stud­ies com­pared QVM149 to Glax­o­SmithK­line’s Ad­vair and place­bo, re­spec­tive­ly. Re­sults sug­gest that the in­haled triple — in­da­caterol ac­etate, gly­copy­rro­ni­um bro­mide and mometa­sone furoate de­liv­ered with the Breezhaler de­vice — beat both in im­prov­ing lung func­tion, as cap­tured by vari­a­tions of the forced ex­pi­ra­to­ry vol­ume in 1 sec­ond (FEV1) met­ric.

Ad­vair, a block­buster that has brought in bil­lions in an­nu­al sales, is the stan­dard of care in this in­di­ca­tion. But it’s al­so off-patent and re­cent­ly faced its first gener­ic com­peti­tor from My­lan.

In that study (CQVM149B2208), both once-dai­ly dos­es of QVM149 notched sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments of peak FEV1 com­pared to twice-dai­ly sal­me­terol/flu­ti­ca­s­one pro­pi­onate “ with mean dif­fer­ences of 172 mL (95% CI: 137, 208) and 159 mL (95% CI: 123, 195), re­spec­tive­ly (p<0.001).”

Mean­while in CQVM149B2209, in­ves­ti­ga­tors found that the treat­ment main­tained the same 24-hour ben­e­fit whether it was ad­min­is­tered in the morn­ing or evening — po­ten­tial­ly sig­nif­i­cant as asth­ma symp­toms tend to be worse at night and the wee hours. Mean dif­fer­ences in FEV1 over 14 days ver­sus place­bo were 610 mL (90% CI: 538, 681) and 615 mL (90% CI: 544, 687) for the two dos­es test­ed.

“De­spite the avail­abil­i­ty of nu­mer­ous asth­ma treat­ments, more than one-third of asth­ma pa­tients re­main un­con­trolled and con­tin­ue to ex­pe­ri­ence symp­toms and/or ex­ac­er­ba­tions,” said Lin­da Arm­strong, who leads No­var­tis’ res­pi­ra­to­ry de­vel­op­ment unit.

QVM149 com­bines a long-act­ing be­ta ag­o­nist, or LA­BA, with a long-act­ing mus­carinic re­cep­tor an­tag­o­nists (LAMA), packed to­geth­er with an in­haled cor­ti­cos­teroid and a de­vice that No­var­tis has used for COPD.

The drug is the on­ly res­pi­ra­to­ry prod­uct among the 14 block­buster launch­es that CEO Vas Narasimhan out­lined in the be­gin­ning of the year. The Phase III tri­al — which in­cludes 1251 pa­tients com­pared to 154 to­tal in these two stud­ies — ex­pect­ed to com­plete lat­er in 2019, with com­mer­cial­iza­tion planned in 2020 if all goes well.

So­cial im­age: SHUT­TER­STOCK

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology

ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development

CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at with any issues.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Ted Ashburn. Oncorus

Cowen, Per­cep­tive lead $79.5M Se­ries B for 's­tand­out' biotech shep­herd­ing on­colyt­ic virus to clin­ic

As several Big Pharma players secure biotech partners in the oncolytic virus space for new immuno-oncology combos, Cowen and Perceptive Advisors have come out with their own bet on a startup that promises to shine.

The marquee investors are joining MPM, Deerfield, Celgene, Astellas, Arkin and UBS in backing the drug developer, Oncorus, which will now deploy the $79.5 million in Series B cash toward clinical development of its lead program. Other new investors include Surveyor Capital, Sphera Funds, IMM Investment, QUAD Investment Management, UTC Investment, SV Investment Corp and Shinhan Investment-Private Equity, the last five of which are Korean-based funds.

Fu­til­i­ty analy­sis au­gurs de­feat in piv­otal tri­al test­ing of Nu­Cana's lead drug in metasta­t­ic pan­cre­at­ic can­cer

Nearly two years after making its public debut, UK-based NuCana’s mission to make chemotherapies more potent and safer was dealt a blow, after a pivotal study testing its lead experimental drug halted enrollment in a hard-to-treat advanced form of cancer, following a futility analysis.

The drug, Acelarin, is being evaluated for use in metastatic pancreatic cancer patients who were not considered suitable for combination chemotherapy. In the late-stage ACELARATE study — which compared the experimental drug against the chemotherapy gemcitabine — 200 patients had been enrolled by the sponsor, Clatterbridge Cancer Centre, before an analysis from an independent safety and data monitoring panel suggested the study’s main goal would not be met.

UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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