Really Sean ? A trend ? What total bullshit. Romo fails to beat placebo. What spin will you deliver when the ARCH results come out... Let's see Romo month 12 - 73% vert reduction Prolia month 24 75% vert reduction Two years of Prolia 71% vert reduction Romo followed by Alendronate (ARCH) what if this is 73 78 - is Prolia a failure ? what about Romo followed by Prolia (FRAME) 2 Osteonecrosis of the Jaw 1 Atypical Fracture Romo followed by Alendronate (ARCH) 1 Osteonecrosis of the Jaw Two years of Alendronate - NO OSTEONECROSIS OF THE JAW Two years of Alendronate - 68% vertebral fracture The program is a failure, the results will damage Prolia
Shares of Radius Health (NASDAQ:RDUS) are up 26% Monday after Amgen (AMGN) said its similar osteoporosis candidate, romosozumab, showed a 73% reduction in the risk of vertebral fracture, versus a 83% reduction from Radius Health’s candidate abaloparatide. Radius’ marketing application for abaloparatide is currently under review in Europe, and expects to file a New Drug Application in the U.S. RDUS last traded at $34.61, towards the lower end of its 52-week range of $24.75 to $84.64. Amgen shares are lower at $148.80 with a 52-week range of $130.09 to $181.81.
Why the hell didn't the company test for efficacy at 18 or 24 months of romo dosing, efficacy might have beat the Radius molecule.
radius is a daily injection, romo is once a month and limited to 12 months of therapy only but why would any one use when forte will be generic soon and you get nearly the same result using prolia twice per year and it will be a whole lot cheaper, romo will be limited to really severe op patients only and hard as hell to get because they are nearly all medicare patients and it will be retail. patients limited to a year for a life too maybe this drug reaches 350 peak
Yes folks, baseball season is officially back, and so are the baseball-related puns. Just a few days ago, biotech blue-chip giant Amgen (NASDAQ:AMGN) and its development partner UCB announced the highly anticipated phase 3 results from the FRAME trial involving romosozumab in postmenopausal women with osteoporosis. On the top-line, romosozumab, which has been hailed as a drug capable of $1 billion or more in annual sales, hit both of its co-primary endpoints of reducing new vertebral fractures through 12 months and 24 months. Specifically, the press release notes a 73% reduction in the relative risk of vertebral fractures through 12 months, and an even better 75% reduction in relative risk through 24 months. Additionally, romosozumab, a once-monthly injection, wound up hitting another important secondary endpoint: reducing the incidence of composite vertebral and non-vertebral fractures through month 12 by 36%. However, the duo announced that clinical significance was not reached in months 12 or 24 when examining romosozumab's impact on reducing non-vertebral fractures, which was another secondary endpoint. After meeting both primary endpoints, Amgen and UCB plan to discuss romosozumab's development with regulators, potentially leading to a new drug application filing sometime this year. But did romosozumab just whiff at the plate when it mattered most? Did romosozumab fail to live up to expectations? Here's the concern with Amgen's and UCB's highly touted experimental bone drug: it lacks preferred differentiation. Romosozumab is pretty much competing with two other players in this space: Eli Lilly's(NYSE:LLY) Forteo, which was approved late last decade, and an experimental drug being developed by Radius Health (NASDAQ:RDUS) known as abaloparatide, which first announced its phase 3 studies in 2014 and provided an update last year. Eli Lilly's Forteo and Radius' abaloparatide (assuming approval) are once-daily injectable therapies. By comparison, Amgen's and UCB's romosozumab holds the convenience "holy grail" of being a once-monthly injectable solution. If romosozumab demonstrated superiority over the placebo in both primary and secondary endpoints, it would likely be the clear leader in treating osteoporosis among postmenopausal women. But romosozumab's failure to meet statistical significance in non-vertebral fractures now casts some degree of doubt over its future. Lilly's Forteo likely won't be a huge player for too much longer, especially with the possibility of two new entrants. Its patent is set to expire in December 2018, and as is often the case, pricing pressure may start to get the better of Forteo sooner rather than later. Radius' abaloparatide, on the other hand, actually wound up delivering superior results in its late-stage osteoporosis study. Vertebral fractures were reduced by a whopping 86% in the ACTIVE study at the 18-month mark, meeting the primary endpoint. But more importantly, Radius announced that its secondary endpoint of non-vertebral fractures was clinically significant, with a reduction of approximately 43%. Wall Street analysts had been looking for a similar figure from romosozumab, but it failed to deliver and differentiate itself from Radius Health's abaloparatide. Meanwhile, Radius plans to file for marketing approval for abaloparatide in March. Analyst John Newman with Canaccord Genuity had this to say following Amgen's and UCB's top-line data release: "Amgen announced that romosozumab did not reduce the incidence of non-vertebral fractures versus control at months 12 and 24, a major win for Radius' abaloparatide, in our view. We do not believe physicians will consider romosozumab a serious treatment option for osteoporosis vs. abaloparatide, given abaloparatide's 43% non-vertebral fracture reduction at 18 months [in the ACTIVE trial.]" Did Amgen really strike out? Although the duo's results were far from optimal, and it could certainly cost romosozumab market share in comparison to abaloparatide (assuming approval), I don't believe Amgen or its partner have completely struck out (last bad baseball pun, I swear).
o begin with, Amgen will still have its superior convenience to rely on. For some patients the prospect of daily injections may not be appealing. When it concerns strictly vertebral osteoporosis in postmenopausal women, it's possible romosozumab remains a strong choice. A lot will also depend on pricing. It's far too early to get into the specifics of what romosozumab or abaloparatide might cost if they're approved, but a substantial pricing difference between the two drugs could swing the pendulum. Amgen's deep pocketbook could help as well. Amgen is a company capable of producing more than $8 billion in annual free cash flow -- and this doesn't even take into account UCB's cash flow potential. Needless to say, both companies could throw a few dollars at marketing romosozumab and building rapport with physicians. Radius Health, which is still entirely in the clinical stages of its development, has no positive cash flow to speak of. Thus, while romosozumab didn't match Wall Street's expectations, it didn't exactly strike out, either.
I read that patients with RA will potentially endure more damage to their joints if they are exposed to romozosumab - then what future will this have in Rheumatology?
one study in mice showed a potential increase in RA, similar study showed nothing-boneheads do not see this as the issue, in fact most Rheums are interested in ROMO- its the price that some rheums are worried about--it has been WAY MORE FUN THAN SELLING REPATHA-- white team sux,gonna be hacked up with CV come layoffs-blue team place to be-sorry you were too scared to sell ROMO--good luck with no outcomes!!!
Bone: Romosozumab — getting there but not quite yet Socrates E. Papapoulos Nature Reviews Endocrinology 12, 691–692 (2016) doi:10.1038/nrendo.2016.179 Published online 04 November 2016 Injection site reactions were more common in romosozumab-treated patients; seven of 3,581 patients had serious adverse events characterized as hypersensitivity reactions to the antibody. One patient, with prodromal pain symptoms before the start of the study, sustained a femur fracture that met the criteria of an atypical femoral fracture 3.5 months after the first dose of romosozumab, while in two patients oral events were adjudicated as osteonecrosis of the jaw (one after 12 months and one after the first dose of denosumab). Before giving the opportunity to the scientific community to understand and interpret these results, the lay press delivered a front-page verdict: “Doctors had hoped that a new class of medications might avoid the rare side effects, but their hopes were dashed when Amgen announced the same problems in a clinical trial of a drug called romosozumab...” (Ref. 9). The continuing, fear-creating negative publicity of rare events during treatment of patients with osteoporosis has contributed greatly to the constant decline in the use of anti-osteoporotic medications, which has deprived high-risk patients of efficacious treatments.
lol.. no worries buddy, your time in there will end soon, blue team will keep Prolia with rheums and you will be fighting 10 other Repatha reps to keep your jobs when the axe comes down
