In crowd­ed prostate can­cer mar­ket, Pfiz­er's Xtan­di notch­es third ap­proval for use in ear­li­er stage of dis­ease

Pfiz­er’s en­trenched an­dro­gen re­cep­tor in­hibitor Xtan­di has se­cured its third prostate can­cer ap­proval in a mar­ket flush with ri­vals.

On Mon­day, Pfiz­er and part­ner Astel­las an­nounced Xtan­di had scored FDA ap­proval in pa­tients with metasta­t­ic cas­tra­tion (or hor­mone)-sen­si­tive prostate can­cer (mC­SPC). It’s a form of prostate can­cer that has spread to oth­er parts of the body but still re­sponds to a med­ical or sur­gi­cal treat­ment that low­ers testos­terone — af­fect­ing rough­ly 40,000 men in the Unit­ed States cur­rent­ly. Xtan­di is now the on­ly oral FDA-ap­proved ther­a­py in three dis­tinct types of ad­vanced prostate can­cer, the com­pa­nies said.

Xtan­di in com­bi­na­tion with stan­dard an­dro­gen de­pri­va­tion ther­a­py (ADT) was test­ed against ADT plus place­bo in the ARCH­ES tri­al in 1,150 pa­tients with metasta­t­ic hor­mone (or cas­tra­tion) sen­si­tive prostate can­cer.

Da­ta showed the Xtan­di com­bi­na­tion re­duced the risk of ra­di­ograph­ic pro­gres­sion or death by 61% ver­sus place­bo plus ADT (con­fi­dence in­ter­val: 0.30-0.50; p<0.0001) — over­all sur­vival da­ta were not ma­ture at the time of analy­sis.

In the first nine months of 2019, the drug gen­er­at­ed $594 mil­lion in glob­al sales. An­ti-an­dro­gens drugs such as J&J’s Zyti­ga and Pfiz­er’s Xtan­di were first ap­proved in metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (mCR­PC) in 2011 and 2012 re­spec­tive­ly. Since then, this class of drugs has al­so shown to be ef­fec­tive in ear­li­er-dis­ease set­tings such as non-metasta­t­ic CR­PC and metasta­t­ic hor­mone-sen­si­tive prostate can­cer (mH­SPC).

In a note re­flect­ing dis­cus­sions by a pan­el of prostate can­cer ex­perts in Sep­tem­ber, Cowen an­a­lysts cit­ed a pan­elist that in­di­cat­ed that the sev­er­al an­ti-an­dro­gens on the mar­ket are on some­what “equal foot­ing” in the mH­SPC set­ting with sim­i­lar clin­i­cal da­ta. “Pa­tients in the U.S. pre­fer oral hor­mon­al agents over al­ter­na­tive chemother­a­py, so our ex­pert be­lieves Zyti­ga and Xtan­di could both hold sub­stan­tial mar­ket share in mH­SPC,” they wrote.

Prostate can­cer is the sec­ond most com­mon­ly di­ag­nosed ma­lig­nan­cy in men glob­al­ly, and treat­ment op­tions in­clude surgery, ra­di­a­tion treat­ment and ther­a­py us­ing hor­mone-re­cep­tor an­tag­o­nists. How­ev­er, in near­ly every case, the can­cer grows re­sis­tant to con­ven­tion­al hor­mone ther­a­py. Cas­tra­tion-re­sis­tant prostate can­cer (CR­PC) is an ad­vanced form of the dis­ease and is char­ac­ter­ized by per­sis­tent, high-lev­el an­dro­gen re­cep­tor (AR) func­tion and re­sis­tance to con­ven­tion­al an­ti-an­dro­gens.

Ear­li­er this year, Bay­er and Finnish part­ner Ori­on’s AR in­hibitor Nube­qa was ap­proved for pa­tients with cas­tra­tion-re­sis­tant prostate can­cer that has not spread to oth­er parts of the body (nm­CR­PC). Mean­while, PARP and PD-(L)1 agents are al­so be­ing test­ed for use in prostate can­cer.

So­cial im­age: Pfiz­er, Jeff Ru­mens

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

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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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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