Hal Barron [File photo]

Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Bar­ron and the new R&D team steer­ing Glax­o­SmithK­line’s pipeline.

The phar­ma gi­ant re­port­ed this morn­ing that its re­cent­ly ac­quired PARP, Ze­ju­la (ni­ra­parib), hit the pri­ma­ry end­point on pro­gres­sion-free sur­vival in a front­line main­te­nance set­ting for women suf­fer­ing ovar­i­an can­cer — fol­low­ing chemo and re­gard­less of their BR­CA sta­tus.

GSK bet $5 bil­lion on the Tesaro buy­out pri­mar­i­ly to get this drug, draw­ing the shak­ing heads of bio­phar­ma. Why pay a big pre­mi­um for a drug like this when As­traZeneca was go­ing from strength to strength with Lyn­parza, ran the ar­gu­ment, hav­ing won a huge­ly im­por­tant ac­cel­er­at­ed ap­proval to jump out ahead — way ahead — of the rest of the PARP play­ers? Lyn­parza — now co-owned by a pow­er­house can­cer team at Mer­ck — won the first ap­proval in front­line main­te­nance in ovar­i­an can­cer.

That field of al­so-rans al­so in­cludes Clo­vis and Pfiz­er.

Skep­tics scold­ed GSK for the ac­qui­si­tion, but Bar­ron re­mained con­stant to the no­tion that on­go­ing tri­als like this one would wedge open a much larg­er mar­ket op­por­tu­ni­ty. And do­ing it with an al­ready ap­proved can­cer drug that would set the stage for more ad­di­tions out of the on­col­o­gy pipeline.

Mon­day morn­ing Bar­ron un­der­scored that no­tion in a pre­pared re­mark, say­ing:

Al­most 300,000 women around the world are di­ag­nosed with ovar­i­an can­cer every year, yet on­ly about 15% of pa­tients are cur­rent­ly el­i­gi­ble to re­ceive PARP in­hibitors as their ini­tial ther­a­py. These ex­cit­ing da­ta demon­strate that ZE­JU­LA has the po­ten­tial to sig­nif­i­cant­ly ben­e­fit even more women with this dev­as­tat­ing can­cer.

We won’t get the hard da­ta un­til lat­er in the year, but you can ex­pect that the reg­u­la­to­ry team has been prepar­ing for this since GSK com­plet­ed the buy­out.

Em­ma Walm­s­ley

There’s more to come. CEO Em­ma Walm­s­ley high­light­ed the ovar­i­an can­cer play dur­ing the buy­out, not­ing ad­di­tion­al work for breast can­cer and non-small cell lung can­cer. Hal Bar­ron has al­so not­ed:

Our un­der­stand­ing of ovar­i­an can­cer is grow­ing all the time and we know now that the BR­CA mu­ta­tions are not the on­ly mu­ta­tions that cause this DNA re­pair prob­lem. In fact, clin­i­cal tri­als are un­der way to as­sess the use of Ze­ju­la in ovar­i­an can­cer pa­tients with what is known as ho­mol­o­gous re­com­bi­na­tion de­fects (HRD). These are the pa­tients who we be­lieve have a BR­CA-like tu­mor and could ben­e­fit from treat­ment with Ze­ju­la.

Bar­ron’s team won an ac­cel­er­at­ed re­view for that just a cou­ple of weeks ago, set­ting the stage for a unique in­di­ca­tion that could be worth con­sid­er­ably more to GSK. The PDU­FA date is Oc­to­ber 24.

Hav­ing con­vinced a group of an­a­lysts that GSK had made the wrong move in its quest to reignite en­thu­si­asm for the com­pa­ny’s pipeline, though, try­ing to whip up ex­cite­ment now is go­ing to be a hard sell. Skep­tics will want to see the hard cash. And that’s GSK’s next chal­lenge on the com­mer­cial side.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.

Ludwig Hantson, Alexion CEO

Why pay $4B for a steady di­et of dis­ap­point­ment? Porges turns thumbs down on Alex­ion’s M&A strat­e­gy, of­fers some point­ers

When Alexion announced recently that it was paying $1.4 billion to bag Portola and its underperforming Factor Xa inhibitor reversal agent, you could hear the head-scratching going on around virtual Wall Street.

Why was Alexion going down the discount lane for new products? And why something like this? Analysts have been urging Alexion to get serious about M&A for years if it was serious about diversifying the company beyond Soliris and its successor drug. But this wasn’t the kind of heavy-impact deal they were looking for.

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Mil­li­pore­Sig­ma to build new $20 mil­lion, 12,000-square-foot lab in Switzer­land

On the heels of opening a new laboratory in Shanghai last week, MilliporeSigma is continuing its construction push.

The Merck KGgA life science subsidiary announced Wednesday its intentions to build a new $20 million lab in Buchs, Switzerland to support its reference materials business. It’s estimated that the new facility will be completed in December 2021 and open in early 2022 and is expected to be 12,000 square feet.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

‘Plan­ning to vac­ci­nate every­one in the US,’ Mod­er­na out­lines ef­forts to sup­ply their Covid-19 vac­cine as man­u­fac­tur­ing ramps up ahead of PhI­II

Twelve days from the planned start of their Phase III pivotal trial, the executive crew at Moderna has set up the manufacturing base needed to begin production of the first 500,000 doses of their Covid-19 vaccine with plans to feed it into a global supply chain. But the initial batches will likely be ready in the US first, where company CEO Stéphane Bancel plans to be able to vaccinate everyone.

“We have started making commercial product at-risk, and will continue to do so every day and every week of the month,” Bancel told analysts during their morning call on the Phase I data just published in the New England Journal of Medicine.

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Covid-19 roundup: Vac­cine by end of 2020? Ken Fra­zier warns hype do­ing 'grave dis­ser­vice'

When it comes to setting expectations about a Covid-19 vaccine, Ken Frazier does not mince words.

Over a month after first casting doubts on the aggressive 12- to 18-month timeframe championed by the US government and his biopharma peers, the Merck CEO again cautioned against any hype around a quick vaccine approval.

In a wide-ranging interview with Harvard Business School professor Tsedal Neeley that touched other big topics such as race, Frazier emphasized that vaccines take a long time to develop. He would know: Out of the seven new vaccines introduced around the world in the past 25 years, four came from Merck.

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