J&J wins snap ap­proval of apa­lu­tamide, the first drug OK'd for non­metasta­t­ic prostate can­cer

Richard Padzur

The FDA has giv­en J&J a big boost to­day, cut­ting its pri­or­i­ty re­view for apa­lu­tamide down to a quick once over and a snap ap­proval months ahead of its PDU­FA date for non­metasta­t­ic prostate can­cer.

The drug will now be sold as Er­leade, hand­i­ly beat­ing a ri­val sup­ple­men­tal ap­pli­ca­tion from Pfiz­er on its can­cer drug Xtan­di. This ap­proval came through just two months af­ter the agency of­fered to give it a pri­or­i­ty re­view, un­der­scor­ing how fast reg­u­la­tors are will­ing to act.

Eval­u­ate Phar­ma has pegged 2022 sales at $1.6 bil­lion for apa­lu­tamide, flag­ging some of the zeal that an­a­lysts have for this drug. A spokesper­son for the com­pa­ny says that the “whole­sale ac­qui­si­tion cost (WAC) of a 30-day sup­ply of ER­LEA­DA is $10,920.00 per bot­tle of 120 tablets (60 mg tablets), which is in line with oth­er oral on­col­o­gy med­i­cines.”

The ap­proval couldn’t come too soon. J&J is fac­ing the near-term loss of patent pro­tec­tion on Zyti­ga, which is sold for metasta­t­ic prostate can­cer.

“This ap­proval is the first to use the end­point of metas­ta­sis-free sur­vival, mea­sur­ing the length of time that tu­mors did not spread to oth­er parts of the body or that death oc­curred af­ter start­ing treat­ment,” said Richard Paz­dur, di­rec­tor of the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence. “In the tri­al sup­port­ing ap­proval, Er­lea­da had a ro­bust ef­fect on this end­point. This demon­strates the agency’s com­mit­ment to us­ing nov­el end­points to ex­pe­dite im­por­tant ther­a­pies to the Amer­i­can pub­lic.”

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.

Just days ago in­ves­ti­ga­tors spelled out some im­pres­sive da­ta. Their piv­otal tri­al hit a me­di­an MFS rate of 40.5 months vs 16.2 months in the place­bo group. “Sec­ondary end­points (TTM, PFS, and Sym­Prog) were all sig­nif­i­cant­ly im­proved.

On the oth­er hand you have Pfiz­er, which post­ed an im­pres­sive 21.9-month im­prove­ment  in metas­ta­sis-free sur­vival for prostate can­cer — 36.6 months vs 14.7 months [P < .0001] — for Xtan­di as well as time to first use of new an­ti­neo­plas­tic ther­a­py (39.6 mo vs 17.7 mo [P < .0001]) and time to PSA pro­gres­sion (37.2 mo vs 3.9 mo).

J&J can now get a head start in the field, look­ing to score some block­buster rev­enue.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Cana­da’s drug price re­forms de­layed to 2021

Amendments to Canada’s Patented Medicines Regulations will now be put in place 1 January 2021, delaying implementation of the sweeping drug pricing reforms by six months.

The new timeline represents a further adjustment from the schedule laid out in 2017, when Health Canada first proposed overhauling its drug pricing review process.

Draft pricing guidelines promulgated by the government of Canada’s Patent Medicine Prices Review Board (PMPRB) have been available for stakeholder and public consultation since November 2019. Based on this feedback, the PMPRB will release a final set of revised guidelines the week of 15 June 2020, with a 30-day period of public written consultation to follow.

Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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