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.

On the heels of promis­ing MCL da­ta, Kite hus­tles its 2nd CAR-T to the FDA as the next big race in the field draws to the fin­ish line

Three days after Gilead’s Kite subsidiary showed off stellar data on their number 2 CAR-T KTE-X19 at ASH, the executive team has pivoted straight to the FDA with a BLA filing and a shot at a near-term approval.

In a small, 74-patient Phase II trial reported out at the beginning of the week, investigators tracked a 93% response rate with two out of three mantle cell lymphoma patients experiencing a complete response.

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Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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As­traZeneca joins Mer­ck, Bris­tol-My­ers in Chi­na's check­point race as reg­u­la­tors OK first PD-L1

AstraZeneca has made a stride toward realizing its ambitions in China as regulators greenlight Imfinzi as a treatment for non-small cell lung cancer.

In particular, the PD-L1 agent is filling a void for immunotherapies in Stage III unresectable case, the company said, where the cancer has not spread to the rest of the body. It is to be used, with curative intent, in patients whose cancer hasn’t progressed following concurrent platinum-based chemotherapy and radiation therapy.

Cor­re­vio is putting it­self up on the auc­tion block af­ter FDA re­view pan­el points to an­oth­er re­jec­tion

For 13 years, the Canadian biotech Correvio tried to get the FDA to accept a heart drug since abandoned by Merck and Astellas. Yesterday, the agency’s outside experts voted 11-2 against approval, all but assuring another rejection for the atrial fibrillation compound vernakalant.

And today Correvio announced that Correvio may soon be no more. The company said it is looking to sell itself as its stock plummets into penny-stock territory $CORV and its potential moneymaker sputters once more.

Psilocybin mushrooms (via The Denver Post)

In a key step for psy­che­del­ic re­search, mag­ic mush­room com­pound clears first clin­i­cal safe­ty hur­dle

Exasperated with the often-ineffective existing slate of antidepressants, COMPASS Pathways set up shop in London 2016 — and made a beeline for psilocybin, the psychoactive ingredient in magic mushrooms.

On Wednesday, the startup said its man-made version of the chemical — which is illegal across geographies in its natural fungi form — had been well-tolerated in an early-stage, placebo-controlled trial in 89 healthy volunteers.

Al­pham­ab On­col­o­gy rounds out HKEX's sec­ond biotech IPO year with $230M raise and high lo­cal in­ter­est

Alphamab Oncology has inspired a surge of local interest in what will likely be the Hong Kong Stock Exchange’s last biotech run of the year, pricing its IPO on the high end of the range and raising over $230 million (HK$1.83 billion).

After rejigging the offering structure and making up to 50% available for enthusiastic local investors, the biotech sold 179.4 million shares at $1.31 (HK$10.2) and saw its stock rise to $1.77 ($13.8) on the first day of trading.

For sale: Long-act­ing PhI­II GLP-1 di­a­betes drug that’s way be­hind ri­vals, now spurned by Sanofi

Almost exactly 4 years ago Sanofi came to the bargaining table with South Korea’s Hanmi bearing $434 million dollars in cash and offering about $4 billion in milestones to in-license their once-weekly GLP-1 injectable. The pact was intended to revive their ailing diabetes division. Instead, it turned into a very expensive grave to mark the end of Sanofi’s R&D ambitions in the field.

Sanofi CEO Paul Hudson used efpeglenatide’s demise — while committing to paying hundreds of millions of more dollars to push it through 5 late-stage studies — as a marker of the company’s determination to stay focused on first and best-in-class drugs.

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What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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Parkin­son's trans­plants emerge as stem cell pi­o­neer Jeanne Lor­ing joins R&D race

Jeanne Loring hadn’t studied Parkinson’s in 22 years when she got an email from a local neurologist.

The neurologist, Melissa Houser, didn’t know Loring had ever published on the disease. She was just looking for a stem cell researcher who might hear her out. 

“I think I was just picked out of a hat,” Loring told Endpoints News. 

At a meeting in Loring’s Scripps Research office, Houser and a Parkinson’s nurse practitioner, Sherrie Gould, asked her why there was so much research done in stem cell transplants for other neurodegenerative diseases but not Parkinson’s. They wanted to know if she would work on one.