J&J takes an­oth­er big step for­ward with next-gen prostate can­cer block­buster apa­lu­tamide

J&J needs a big win from its phar­ma R&D group. And now it’s tak­ing its shot.

Over the last year, J&J and Pfiz­er have been bat­tling it out to ex­pand the mar­ket for their ri­val prostate can­cer drugs Zyti­ga and Xtan­di, of­fer­ing da­ta that could ex­pand their reach in­to new pa­tient groups. But J&J has now tak­en an even big­ger move: fil­ing for an ap­proval of apa­lu­tamide with the FDA for non-metasta­t­ic, cas­tra­tion-re­sis­tant prostate can­cer.

Any­one fol­low­ing the field close­ly will re­call that J&J spent $650 mil­lion in cash and of­fered an­oth­er $350 mil­lion in mile­stones to bag Rich Hey­man’s Aragon in 2013, just so it could have this drug. Af­ter large­ly stay­ing qui­et for a few years as they di­rect­ed the ther­a­py in­to their Phase III SPAR­TAN study, J&J has re­cent­ly be­gun talk­ing this drug up as a near-term block­buster-to-be. And if they win an ap­proval, J&J be­lieves it has an­oth­er big earn­er it can add to its can­cer port­fo­lio at a time the phar­ma gi­ant has been strug­gling to prove it can gen­er­ate more phar­ma cash.

Pe­ter Lebowitz

Apa­lu­tamide (ARN-509) fin­ished the Phase III SPAR­TAN study in June, but we don’t know the da­ta for this next-gen oral ther­a­py that blocks an­dro­gen from bind­ing to the an­dro­gen re­cep­tor — pre­vent­ing testos­terone from fu­el­ing the dis­ease. In a state­ment on Wednes­day, J&J said that it plans to re­lease the re­sults at an up­com­ing sci­en­tif­ic con­fer­ence. But what­ev­er it was, the da­ta must have been good enough to pitch to reg­u­la­tors.

An ap­proval here would po­si­tion J&J to go in­to prostate can­cer pa­tients at an ear­li­er stage, a key to ex­pand­ing its fran­chise rev­enue.

Zyti­ga and Xtan­di have been game-chang­ers in treat­ing ad­vanced prostate can­cer, chang­ing the stan­dard of care for pa­tients. And now J&J be­lieves it can take an­oth­er big step in the same di­rec­tion — with bil­lions on the line.

“We have demon­strat­ed that treat­ing pa­tients be­fore the dis­ease has metas­ta­sized im­proves out­comes,” said J&J on­col­o­gy chief Pe­ter Lebowitz in a state­ment. “We are thrilled to have com­plet­ed our sub­mis­sion of the SPAR­TAN da­ta to the FDA and we look for­ward to a promis­ing treat­ment that can pro­vide new hope and ex­pec­ta­tions for men fac­ing this dis­ease.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

UP­DAT­ED: Am­gen halts some drug dis­counts for safe­ty net hos­pi­tals as SCO­TUS takes on 340B case

Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.

Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”