New PhI­II da­ta in hand, Pfiz­er, Astel­las hus­tle ahead in bid to ex­pand US mar­ket for Xtan­di

Mace Rothen­berg, Pfiz­er

Pfiz­er $PFE just got some bad­ly need­ed good news for its new­ly ac­quired can­cer drug Xtan­di.

Af­ter watch­ing sales sink right af­ter it ac­quired the ther­a­py and all of Medi­va­tion for $14 bil­lion, re­searchers say the drug cleared the Phase III study for non-metasta­t­ic, cas­tra­tion re­sis­tant prostate can­cer. And at least one promi­nent an­a­lyst says that’s a big deal as Pfiz­er and its part­ners at Astel­las look to build sales for this key ther­a­py.

Stick­ing with top line re­sults on­ly, the drug plus an­dro­gen de­pri­va­tion ther­a­py hit its mark on metas­ta­sis-free dis­ease, com­pared to ADT alone.

Not sur­pris­ing­ly, the big phar­ma part­ners plan to hus­tle ahead in search of a la­bel ex­pan­sion for a new group of pa­tients. And Ever­cor­eISI’s Umer Raf­fat for one is en­thu­si­as­tic about what this could mean on the rev­enue side. He not­ed:

The “PROS­PER tri­al just added a brand new leg of growth + tar­get pop­u­la­tion.  This eas­es in­vestor con­cerns around con­sen­sus es­ti­mates which had Xtan­di go­ing from <$600M run rate in US now to $1B+ in 2020 amidst this evolv­ing TRx tra­jec­to­ry in the ex­ist­ing in­di­ca­tion.

“Many prostate can­cer pa­tients who ini­ti­ate an­dro­gen de­pri­va­tion ther­a­py will ex­pe­ri­ence dis­ease pro­gres­sion il­lus­trat­ed by a ris­ing PSA lev­el, and cur­rent­ly, there are no FDA-ap­proved treat­ment op­tions for pa­tients with non-metasta­t­ic CR­PC un­til they de­vel­op con­firmed ra­di­ograph­ic metasta­t­ic dis­ease,” said Neal Shore, di­rec­tor of the Car­oli­na Uro­log­ic Re­search Cen­ter.

Pfiz­er’s can­cer drug de­vel­op­ment chief Mace Rothen­berg pro­vid­ed an en­cour­ag­ing cheer in a pre­pared state­ment. He said:

We are de­light­ed with the sig­nif­i­cant re­sults seen in the PROS­PER study, show­ing that XTAN­DI plus ADT de­layed clin­i­cal­ly de­tectable metas­tases com­pared to ADT alone in pa­tients with non-metasta­t­ic CR­PC whose on­ly sign of un­der­ly­ing dis­ease was a rapid­ly ris­ing prostate-spe­cif­ic anti­gen (PSA) lev­el. We look for­ward to dis­cussing the da­ta with reg­u­la­to­ry au­thor­i­ties.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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