GSK widens the mar­ket for Ze­ju­la as FDA signs off on the PARP in­hibitor for use in ovar­i­an can­cer pa­tients with­out BR­CA mu­ta­tions

GSK has vast­ly ex­pand­ed its mar­ket for can­cer ther­a­py Ze­ju­la — the crown jew­el at the heart of its $5 bil­lion ac­qui­si­tion of Tesaro — by win­ning FDA ap­proval for the drug in a large sub­set of pa­tients with ovar­i­an can­cer.

The ap­proval comes for women with ad­vanced ep­ithe­lial ovar­i­an, fal­lop­i­an tube, or pri­ma­ry peri­toneal can­cer who ex­pe­ri­enced a com­plete or par­tial re­sponse to first-line plat­inum-based chemother­a­py — ac­count­ing for ap­prox­i­mate­ly 80% of all ovar­i­an can­cer pa­tients.

Pre­vi­ous­ly, the drug’s use was lim­it­ed to a sub­set of such can­cer pa­tients who car­ry BR­CA mu­ta­tions — the re­main­ing 20%.

“This ap­proval is high­ly an­tic­i­pat­ed as a po­ten­tial in­flec­tion for Ze­ju­la, which has been lag­ging its main com­peti­tor Lyn­parza,” SVB Leerink’s Ge­of­frey Porges said.

Every oth­er drug in its class — in­clud­ing As­traZeneca and part­ner Mer­ck’s Lyn­parza and Clo­vis On­col­o­gy’s Rubra­ca — are on­ly el­i­gi­ble to treat ovar­i­an can­cer pa­tients with BR­CA mu­ta­tions as a monother­a­py in first-line main­te­nance ther­a­py set­tings.

“Women with ad­vanced ovar­i­an can­cer have a five-year sur­vival rate of less than 50%,” said Hal Bar­ron, GSK’s chief sci­en­tif­ic of­fi­cer in a state­ment. “This ex­pand­ed in­di­ca­tion means that many more women with this dev­as­tat­ing dis­ease can re­ceive ear­li­er treat­ment with Ze­ju­la, which can ex­tend the time it takes for their can­cer to progress.”

Hal Bar­ron at End­points News’ UK­BIO19 event in Lon­don, Oc­to­ber 2019

Click on the im­age to see the full-sized ver­sion

Akin to GSK’s Ze­ju­la, Lyn­parza and Rubra­ca are poly-ADP ri­bose poly­merase (PARP) in­hibitors. PARP is a pro­tein used by dam­aged cells to ini­ti­ate re­pair, and by thwart­ing it, the class of drugs is en­gi­neered to pre­vent can­cer cells from re­pair­ing them­selves, there­by cat­alyz­ing their de­struc­tion.

While drug de­vel­op­ers have pri­mar­i­ly re­lied on BR­CA mu­ta­tions to iden­ti­fy pa­tients who can ben­e­fit from this fam­i­ly of ther­a­pies, sci­en­tists have sug­gest­ed that de­fects in oth­er genes in­volved in DNA re­pair — which ren­der cells can­cer­ous — could be prime tar­gets too.

As the sec­ond-to-mar­ket drug in the class, and viewed as lack­ing dif­fer­en­ti­a­tion, Ze­ju­la on­ly gen­er­at­ed ~25% of the rev­enue Lyn­parza did last year — £229 mil­lion ver­sus £921 mil­lion, not­ed Porges, adding that GSK man­age­ment has in­di­cat­ed Ze­ju­la cur­rent­ly on­ly has a mi­nor­i­ty share (15-20%) in the front-line set­ting, with the ma­jor­i­ty share tak­en by Lyn­parza.

Giv­en the coro­n­avirus pan­dem­ic, the Ze­ju­la launch in the new in­di­ca­tion will like­ly be im­pact­ed. Porges fore­cast £371 mil­lion in sales for Ze­ju­la by the end of 2020, pre­dict­ing it would rise to £851 mil­lion by 2025.

This new ap­proval for Ze­ju­la was based on the re­sults of the 733-pa­tient, place­bo-con­trolled PRI­MA study.

Da­ta on the me­di­an pro­gres­sion-free sur­vival for the tri­al pop­u­la­tion showed the drug in­duced a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment of 13.8 months com­pared with 8.2 months for those re­ceiv­ing place­bo.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.