Split the pot? Ra­dius shows its os­teo­poro­sis cards in fi­nal block­buster match with Am­gen

Ra­dius Health $RDUS has tak­en an­oth­er big leap down the fi­nal stretch of its Phase III race with Am­gen $AMGN, post­ing Phase III re­sults that show abaloparatide’s clear clin­i­cal ben­e­fit over a place­bo in treat­ing os­teo­poro­sis. But while the da­ta pro­vide a fresh ar­gu­ment in fa­vor of its near-term ap­proval at the FDA and EMA, there’s still a big ques­tion left unan­swered: Just how com­pet­i­tive will this drug be against Am­gen’s Phase III ri­val, as well as Eli Lil­ly’s ag­ing For­teo? And mean­while, the roll up to the FDA is al­so light­ing a fresh fire un­der the heat­ed de­bate over the cost of drugs, both old and new.

First, the num­bers, pub­lished in the Jour­nal of the Amer­i­can Med­ical As­so­ci­a­tion. In a large Phase III tri­al, just four of 824 pa­tients tak­ing Ra­dius’s abaloparatide suf­fered a spinal frac­ture af­ter 18 months. In a place­bo arm, that po­ten­tial­ly dev­as­tat­ing event was ex­pe­ri­enced by 30 pa­tients—giv­ing the ex­per­i­men­tal drug a clear ad­van­tage. But in the For­teo arm with 818 pa­tients, there were 6 spinal frac­tures. That’s slight­ly worse, but the study wasn’t large enough to show a clear dif­fer­ence be­tween the stan­dard of care and the new drug.

Pa­tients on the Ra­dius Health drug al­so ex­pe­ri­enced im­prove­ments in bone min­er­al den­si­ty. In­ves­ti­ga­tors in the study con­cen­trat­ed on old­er women with a his­to­ry of frac­tures, the at-risk pop­u­la­tion that the drug is pri­mar­i­ly aimed at, though it is be­ing stud­ied in oth­er pop­u­la­tions as well.

Not in­clud­ed in this matchup is Am­gen’s ro­mosozum­ab, it’s own bone-build­ing drug that was filed for an ap­proval on Ju­ly 21. Am­gen is part­nered with UCB on the drug. Back in Feb­ru­ary, in­ves­ti­ga­tors not­ed that their Phase III study came out with a 73% re­duc­tion in the risk of frac­tures, which paled a bit in re­la­tion to Ra­dius’s 86% risk re­duc­tion. That sparked a de­bate among an­a­lysts whether Am­gen’s drug could dis­tin­guish it­self with a much eas­i­er dos­ing reg­i­men — once month­ly ver­sus once dai­ly.

An­a­lysts’ peak sales pro­jec­tions have been all over the map. Deutsche Bank last year pegged aba­lo’s peak at $1.1 bil­lion, though they be­lieved that ro­mo would come out on top as the bet­ter drug with a big­ger mar­ket share, de­pend­ing on how the gener­ics shake out.

While both Am­gen and Ra­dius stand a good chance of win­ning an ap­proval, com­mer­cial suc­cess is a com­plete­ly dif­fer­ent is­sue. As The New York Times re­ports, pa­tients are gen­er­al­ly start­ed on bis­pho­s­phanates like Fos­amax, which are old and cheap. But they’re al­so lim­it­ed, un­able to build bone the way For­teo and the two new drugs are de­signed to do.

Lil­ly, mean­while, has been rapid­ly jack­ing up the price of For­teo ahead of its loss of patent pro­tec­tion. The Times re­ports that the whole­sale price has soared to $3,100 a month, more than three times its price in 2010. Lil­ly has been in­creas­ing the price twice a year, for 6 years.

Now the ques­tion is whether the new drugs will cost as much or more than For­teo, which is gen­er­al­ly lim­it­ed to two years of ther­a­py due to fears about po­ten­tial can­cer risks. And in­sur­ers – who are like­ly to re­strict ac­cess to these drugs to pa­tients with the high­est risk fac­tors – have grown leery about cov­er­ing the Lil­ly drug, of­ten re­quir­ing big co-pays from pa­tients.

Dr. Do­lores Shoback

Dr. Do­lores Shoback, a pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co, told the Times:

“The cost in the pri­vate sec­tor is get­ting pro­hib­i­tive. You have to hunt for a rea­son, find a very strong rea­son that is iron­clad,” to get an in­sur­er to ap­prove For­teo, she added. “We find it can be ex­treme­ly dif­fi­cult to get it cov­ered.”

Ra­dius may have just high­light­ed a clear path to an ap­proval. But po­si­tion­ing this drug to win the four-way com­mer­cial pok­er match ahead is far more prob­lem­at­ic.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

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Why wait? Cel­gene re­struc­tures a big Jounce pact — ze­ro­ing in on new I/O path­way with $530M deal and bump­ing ICOS

Celgene’s business team isn’t waiting for the big merger with Bristol-Myers Squibb to go through before syncing its strategy with the new mother ship.

Tuesday evening the big biotech unveiled a $530 million deal — $50 million in upfront cash — to amend their alliance with Jounce Therapeutics $JNCE to gain worldwide rights to JTX-8064, an antibody that targets the LILRB2 receptor on macrophages. Their old, $2.6 billion deal is being scrapped, leaving Jounce with a pipeline that includes the lead drug, the ICOS-targeting vopratelimab.

PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.