Am­gen’s star PhI­II os­teo­poro­sis drug ro­mo slammed by sur­pris­ing car­dio risk, a big plus for ri­val Ra­dius drug

Am­gen’s ro­mosozum­ab, one of its top late-stage drug prospects aimed at os­teo­poro­sis, is in some se­ri­ous trou­ble.

Late Sun­day the big biotech $AMGN and its part­ner UCB an­nounced what at first glance would ap­pear to be hap­py news: the late-stage tri­al com­par­ing ro­mosozum­ab to Fos­amax hit its pri­ma­ry and key sec­ondary end­points. But as you wind through the re­lease, some big is­sues start to rise up that raise se­ri­ous ques­tions about its fu­ture — if it has one. And that could make a big dif­fer­ence for its new­ly ap­proved ri­val at Ra­dius Health $RDUS.

Big event one: There was a no­table car­dio risk im­bal­ance be­tween ro­mo and Fos­amax; 2.5% for ro­mo and 1.9% for Fos­amax.

Big event two: The FDA wants to eval­u­ate the new set of head-to-head da­ta in siz­ing up an ap­proval. And that means no de­ci­sion is ex­pect­ed this sum­mer, as had been as­sumed ear­li­er.

Am­gen shares dropped 2.3% in pre-mar­ket trad­ing, while UCB plunged 14.5%. Ra­dius shares jumped about 15% on the news.

Umer Raf­fat at Ever­core ISI spot­ted the sig­nif­i­cance quick­ly. He not­ed:

Am­gen’s Ph 3 up­date on bone drug just now is clear­ly neg­a­tive, and very sur­pris­ing.  At this point, we are tak­ing out all ro­mo sales from the mod­el.  Con­sen­sus has ~$800M peak for this drug – if you take it out (and bake in the part­ner­ship split with UCB), EPS re­vi­sion of ~$0.32/share.  We sus­pect stock like­ly down ~3-4% on this.

That all sound­ed sus­pi­cious­ly like odanacat­ib, Mer­ck’s os­teo­poro­sis drug which the phar­ma gi­ant de­cid­ed to shelve last fall af­ter wit­ness­ing an in­crease risk of stroke for the drug. And Ge­of­frey Porges at Leerink cal­cu­lat­ed the odds of Am­gen scrap­ping the drug.

We be­lieve that the prod­uct now has on­ly a 50/50 prob­a­bil­i­ty of com­ing to mar­ket at all, and these odds are sub­ject to the re­sults of dis­cus­sions with spe­cial­ists and in­ves­ti­ga­tors, as well as full dis­clo­sure of the na­ture and sever­i­ty of the car­dio­vas­cu­lar events ob­served in both stud­ies.

Just a few weeks ago Ra­dius won their first ever drug ap­proval for abaloparatide, now be­ing lined up for the os­teo­poro­sis mar­ket as Tym­los. An­a­lysts like Ge­of­frey Porges had thought Ra­dius may try to go af­ter a unique mar­ket with a com­mer­cial strat­e­gy tak­ing in­to ac­count Eli Lil­ly’s ag­ing For­teo with the ri­val ro­mosozum­ab from Am­gen and UCB be­ing steered in­to a Ju­ly 19 PDU­FA date.

But that’s at the very least sig­nif­i­cant­ly de­layed — Ra­dius CEO Bob Ward said it nev­er was a fac­tor — as far as ro­mo is con­cerned.

Last fall an­a­lysts were talk­ing more about a straight shot at a quick ap­proval for ro­mo this sum­mer — with some sig­nif­i­cant caveats. Ro­mo — which tar­gets the scle­rostin pro­tein — fol­lowed by Am­gen’s Pro­lia (deno­sum­ab) clear­ly vault­ed the bar in Phase III for re­duc­ing ver­te­bral frac­tures, with a hefty 75% risk re­duc­tion com­pared to a place­bo plus deno­sum­ab. In­ves­ti­ga­tors al­so were able to show a bet­ter safe­ty pro­file in its pre­sen­ta­tion at the an­nu­al con­fab of the Amer­i­can So­ci­ety for Bone Min­er­al Re­search. And there was an in­crease in bone min­er­al den­si­ty among the drug arm in the study, which re­cruit­ed 7,180 high-prism post­menopausal women.

But the drug missed a key sec­ondary end­point. The drug did not sig­nif­i­cant­ly im­prove pa­tients’ risk of non-ver­te­bral frac­tures, leav­ing Ra­dius Health — which has post­ed an 86% risk re­duc­tion in ver­te­bral frac­tures — with a pos­si­ble dis­tinct ad­van­tage on that score.

Am­gen and its part­ners at UCB didn’t ig­nore the sit­u­a­tion to­day, af­ter high­light­ing the pos­i­tive.

Iris Loew-Friedrich

“We are im­pressed with the sta­tis­ti­cal­ly sig­nif­i­cant su­pe­ri­or frac­ture risk re­duc­tion of EVENI­TY over al­en­dronate, a cur­rent stan­dard of care in os­teo­poro­sis. When we think that pa­tients who have had a frac­ture are high­ly like­ly to suf­fer an­oth­er one, the im­por­tance of post-frac­ture care can­not be em­pha­sized enough,” said Iris Loew-Friedrich, UCB’s chief med­ical of­fi­cer. “We are work­ing on un­der­stand­ing the ob­served car­dio­vas­cu­lar safe­ty sig­nal and will con­tin­ue to dis­cuss these re­sults with glob­al reg­u­la­tors and ex­perts in the field.”

This is a bad twist for Am­gen. The bio­phar­ma play­er has had a se­ries of is­sues, in­clud­ing a big back­lash by pay­ers tar­get­ing its PC­SK9 drug. Watch­ing an­oth­er late-stage drug go un­der a cloud like this won’t help Am­gen’s rep with an­a­lysts.

Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb tried to ban

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $6.7B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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For­bion spot­lights late-stage plays, carves out new €250M growth fund

Having staked its rep on picking out a mix of biotech investment opportunities across the “build,” “enable,” “growth” continuum, Forbion is launching its first fund dedicated to late-stage opportunities.

Forbion Growth Opportunities Fund’s first close brought in €185 million ($208 million). Existing investors Pantheon, KfW Capital and the European Investment Fund came on board, joined by new backers Eli Lilly, Horizon Therapeutics, Belgian Growth Fund and New Waves Investments.

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

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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Mer­ck ex­pands scope of Zymeworks an­ti­body al­liance, adding close to $900M in mile­stones

Nearly a decade after first partnering with Merck, Vancouver-based biotech Zymeworks has expanded its collaboration with the pharma giant once again.

Zymeworks re-upped with Merck in a new licensing agreement, granting the New Jersey pharma giant the right to develop up to 3 additional multispecific antibody candidates. In exchange, the biotech will receive an undisclosed upfront payment — Merck is always loath to discuss cash terms — and nearly $900 million in combined regulatory ($411 million) and commercial ($480 million) milestones.

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Ed Engleman (Stanford Blood Center)

Stan­ford star on­col­o­gy sci­en­tist Ed En­gle­man helped cre­ate the im­munother­a­py field. Now he wants to shake up neu­rode­gen­er­a­tion R&D

Over the last generation of drug R&D, Ed Engleman has been a standout scientist.

The Stanford professor co-founded Dendreon and provided the scientific insights needed to develop Provenge into a pioneering — though not particularly marketable — immunotherapy. He’s spurred a slate of startups, assisted by his well-connected perch as a co-founder of Vivo Capital, and took the dendritic cell story into its next chapter at a startup called Bolt.

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