J&J positions blockbuster contender daratumumab for a multiple myeloma showdown against Kyprolis!

$10.5 Billion dollars paid for Onyx. Not only will the new Takeda/Millenium ORAL drug, ixazomib, destroy Kyprolis but so will this new drug!

You will never hit the peak revenues in time to justify the Onyx acquisition. If Repatha doesn't make up enough $$$, Bob will RIF you guys some more! BYE BYE AMGEN! Someone will buy you then strip you all good!


Johnson & Johnson ($JNJ) and Genmab have played another card in their deck of data on the multiple myeloma blockbuster contender daratumumab, spelling out some encouraging data that's now being used to help persuade the FDA to deliver a fast marketing approval.

Focusing on the group of patients getting the top dose, investigators reported in the New England Journal of Medicine that the drug scored a 36% overall response rate among 42 patients with late-stage multiple myeloma--a step up from the 29% overall rate that was reported at ASCO earlier in the year. And two thirds of the responder group benefited from progression-free survival after 12 months of therapy. The dose-escalating study also satisfied researchers that they would be able to use the 16 mg dose for all future studies of the drug, an IgG1k antibody that binds to CD38 on the surface of multiple myeloma cells.

Daratumumab has excited a range of analysts happy to roll out multibillion-dollar projections for this drug. Kyprolis won an approval for Onyx with a 23% ORR, and then was bought out by Amgen, which recently scored a new combo approval for relapsed cases, looking for more of an edge in its fight to steal market share from Celgene's ($CELG) Pomalyst.

Daratumumab was near the front of the line when the FDA started handing out breakthrough therapy designations, giving this drug an inside track at the agency and a clear shot at an accelerated approval--particularly in light of the agency's open-door policy for most new cancer therapies.

 

A Word of Advice for Amgen: Objects in the Mirror Are Closer Than They Appear

Amgen's multiple myeloma drug Kyprolis recently had its label expanded, but sales growth is no guarantee, especially with a Johnson & Johnson experimental drug waiting in the wings.

I suspect that if Amgen looks closely enough in the rearview mirror, though, it'll seeJohnson & Johnson (NYSE:JNJ) and its multiple myeloma therapy daratumumab coming up quicker than it realizes.

Johnson & Johnson's daratumumab is coming on strongIn July, Janssen Pharmaceuticals, the pharmaceutical subsidiary of Johnson & Johnson, submitted its biologic license application for daratumumab as a third-line therapy in multiple myeloma.

The primary support or this indication comes from a phase 2 study known as SIRIUS. At the American Society of Clinical Oncology's annual meeting just three months prior, J&J announced its findings from the study, which included an overall response rate of 29% and a median duration of response of 7.4 months.

But SIRIUS is just one of many crucial data points that J&J is using in the hopes of getting daratumumab approved by the FDA. Earlier this week Johnson & Johnson published the findings from its GEN501 open label phase 1/2 study involving daratumumab. The study itself was primarily focused on safety and dose-finding, but a number of key secondary data on efficacy lent to daratumumab's potential in later-stage multiple myeloma.

As published in The New England Journal of Medicine, daratumumab led to a 36% overall response rate in the 16 mg/kg cohort, the chosen dose after escalation trials were run. Of the responders, 11 exhibited partial responses, two had very good partial responses, and two showed complete responses. Additionally, patients in the study had a median of four previous lines of therapy, with 79% of patients refractory (i.e., resistant) to their prior treatments. Finally, median PFS clocked in at 5.6 months, with 65% of responders remaining in remission at the 12-month mark.

The point worth noting here is that daratumumab's overall response rate in two studies now looks bigger than that of Kyprolis in late-line indications (although, of course, it's always difficult to compare between studies, so it's important to take that with a grain of salt). The two therapies also share similar safety profiles.

Could daratumumab push Kyprolis for multiple myeloma patients?First things first for J&J: it needs to get daratumumab approved by the FDA before it can think about marketing its next potential cancer product. However, based on the aforementioned data, an approval seems to me to be more likely than not.

The real question is whether daratumumab could displace Kyprolis for patients in the third- and fourth-line indications. Kyprolis is pretty well entrenched in these indications, and while estimates vary wildly, Kyprolis could generate in the neighborhood of three-quarters of a billion dollars in peak annual sales just from treating third-line and higher multiple myeloma patients. It's quite possible that daratumumab could begin eating into Kyprolis' market share, and it may even come after Kyprolis in a second-line setting.

There are also a couple of finer points that investors are going to want to keep an eye on as we move forward. First, we still don't have median overall survival data on daratumumab, as it's still maturing. This critical data is really where it could separate itself from Kyprolis, even more so than the overall response rate figures mentioned earlier. Obviously a statistically significant improvement in survival over the placebo, or even a strong trend relative to the placebo in overall survival, could sway physicians and consumers toward daratumumab and away from Kyprolis in late-stage multiple myeloma.

Secondly, we can't forget that pricing could come into play. As it stands now Kyprolis runs $10,000 per 28-day treatment cycle, making it the most expensive drug to treat multiple myeloma. If daratumumab is around the same price point or lower it could instantly become the therapy of choice. Of course, a lot will depend on its maturing survival data.

If there's a key takeaway here it's that Kyprolis may not be as safe as Wall Street and investors think. That's certainly not the end of the world for Amgen with its growing product portfolio and pipeline, nor will it be a dramatic boost for Johnson & Johnson, which has delivered seven new molecular entities since 2009 that are generating $1 billion-plus in annual sales. But daratumumab's march toward approval continues to look more and more like a positive for J&J and potentially bad news for Amgen and Kyprolis.

 

Yawn... Bring it!!!

 

Onyx reps are shitting a brick so thats why they are leaving

 

Nobody who has left is sh***g a brick. Get a life. Patients are surviving much longer with Kyprolis and all new therapies.
How about this for a change; you put yourself last and the patient first? How do you roll out of bed every day? You clearly are not connected in any way to medicine. It is really a shame that you can't be happy for the patients who get well. You must really, really hate yourself when you look in the mirror.

 

Amgen is gearing up to release onyx reps with minimal severance. Territories will be consolidated and OBU reps will have priority. Amgen is looking to provide only 3-4 weeks of severance with an additional week for every year of service. So max of 3-4 month severance if you were a legacy nexvar rep who had been here since 2006.
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Ludwig hates onyx reps and now is that under direction of senior management to cut costs as biosimilar neupogen and the lack of brodalumab makes hitting revenue goals harder. The easiest way is to cut cost to ensure margins are kept. First was ridding onyx reps of legacy benefits, next is laying majority off who already have an Amgen OBU counterpart. Amgen is redoing all onyx commercial work so the OBU salesforce will be given Kyprolis and will be retrained on it as Onyx marketibng work was deemed uncompliant and subpar by Amgen OBU management. Paulson thought Onyx US brand lead, SS, was "fluffy and not strategic" and someone Amgen would have never hired unless it was for eating skills.

 

I've heard Paulson, Hoffman, Ludwig, Jensen, Meyer and Hassard all make fun of Onyx's SS. It's the good ol Amgen boys club running the show now. They said at least Farnum is thin and looks competent unlike SS who was described as a "cookie eating champion".