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Would also sound like a dangerous game TEVA is playing if they are pricing 40mg lower. NVS will get its market share.
10-23 Rx
NrX
Copax: 2615 Glatopa: 227 Total: 2842
TrX
Copax: 10690 Glatopa: 828 Total: 11518
FWIW I just searched through their slides (couldn't suffer through an entire hour and 15 minutes them talking about Perrigo) and listened to the Q&A and nary a peep on copaxone (surprised Ronny Gal didn't say anything) and many a peep about perrigo.
yeah..AMPH reports Q3 Nov 12
As I mentioned on PM, it's pretty incredible ENTA is still trading where it is now that the dust has settled considering the pretty miniscule monetary value the new label will actually cost ENTA in the end.
Can't listen to MYL call right now, but if anyone us would love an update if they mention Gx copax :)
will also be curious to see what MYL has to say about their generic when they report
wonder where they get that 39% number from symphony... I'm assuming they pull from a bloomberg which is where I get my symphony #s
Maybe I'm missing something but I'm a little confused on how it "grew"? Anyone care to chime in?
This is from Q2
Sandoz continued to strengthen its leading position in differentiated generics, with global sales of Biopharmaceuticals (which include biosimilars, biopharmaceutical contract manufacturing and Glatopa) up 57% (cc) to USD 222 million in the second quarter, driven in part by shipping of initial trade inventories of Glatopa in June.
well per Rx glatopa has 7-10% of the Copax market right now. NVS and maybe MNTA (can't recall) has mentioned Rx services aren't reporting all scripts, but that may just be for IMS so who knows (until tomorrow). All the analysts have dropped their PT a buck or two in anticpitation of not so hot sales so there's that. TEVA did $870m US copaxone sales last Q btw.
Thnaks Flo!
Just curious, has there ever been this kind of peer reviewed post approval equivalence study release for a generic before? I can't recall if there was the same thing for enox or not. Anyone have any idea if the FDA is looking at this stuff while they are looking at other Gx copax apps?
thanks. Well said. Seems extremely overdone esp w next-gen around the corner.
So what the heck happened you think?
Also, do you actually think ESRX will change its formulary?
10-16 Symphony Rx
NrX
Copax: 2699 Glatopa: 252 Total: 2951
TrX
Copax: 10457 Glatopa: 797 Total: 11254
Abbvie Hep C Drug Safety Warning Prompts Panic Selling, Totally Unjustified
ByAdam FeuersteinFollow | 10/22/15 - 03:50 PM EDT
Abbvie (ABBV - Get Report) shares plunged as much as 15% Thursday afternoon after U.S. regulators issued a safety warningtying its hepatitis C drugs to an increased risk of serious liver injury.
Investors are totally over-reacting to what might be a small hit to Abbvie's hepatitis C revenue.
That's because Abbvie's hepatitis C drugs Viekira Pak and Technivie are already not recommended or approved for hepatitis C patients with underlying, severe liver disease such as cirrhosis. Doctors shouldn't be prescribing the drugs to these advanced liver disease patients, yet some were apparently, resulting in severe liver injuries which were reported to the U.S. Food and Drug Administration. The result: Thursday's safety warning.
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Even if the FDA safety warning dents Viekira Pak and Technivie sales, the drugs only represent about 7% of Abbvie's total revenue. With so little revenue at risk, a $13 billion loss in Abbvie's market value is insanity.
Enanta Pharmaceuticals (ENTA - Get Report) helped develop some of the drugs used in Abbvie's hepatitis C regimens and receives royalties on sales. When the FDA safety warning hit, Enanta shares lost more than half their value. Again, investors are panic selling over a minor negative.
The new reality for biotech and drug stocks appears to be sell first, think second.
incredible timing. well done.
"Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy," Jackie Finley, a spokeswoman for AbbVie, wrote in an e-mail. "Estimates of frequency cannot be made and a causal relationship between treatment and these events has not been established."
Perhaps that VRX PR just put a bottom on the recent biotech tank
Numbers I post are from Symphony (pulled from bloomberg terminal. I can send you exactly what I see want to give me your email).
Those are IMS #s which Craig Wheeler and I think Sandoz (can't recall) have stated is underreporting. Why? Couldn't tell ya.
I'll throw my hat in the ring for $90m sales this Q.
10-9 Rx (not much movement)
NrX
Copax: 2433 Glatopa: 223 Total: 2656
TrX
Copax: 10646 Glatopa: 813 Total: 11459
[Synthon] Generic Glatiramer Matches Branded Copaxone in Clinical Efficacy
- But don't expect a break from the high annual cost
http://www.medpagetoday.com/Neurology/MultipleSclerosis/54098
A generic version of glatiramer acetate produced by the Dutch firm Synthon showed equivalent efficacy, safety, and tolerability as Copaxone, the original branded drug, in a randomized trial among patients with relapsing-remitting multiple sclerosis (RRMS).
Over a period of 9 months, the incidence, spectrum, and severity of reported adverse events, including injection site reactions, were similar in both the generic drug and brand drug groups, Jeffrey Cohen, MD, of the Cleveland Clinic, Cleveland, OH, and colleagues reported online in JAMA Neurology. (Some of the results had been reported in a 2014 conference presentation, but certain results were slightly different in the journal publication which also included more detail.)
The Glatiramer Acetate Clinical Trial to Assess Equivalence With Copaxone (GATE) study showed that the generic drug was effective and reduced gadolinium-enhancing lesions in RRMS to the same extent as the brand-name drug. And while equivalence margins for other magnetic resonance imaging (MRI) and clinical end points were not defined, the 95% confidence intervals (CIs) for the generic drug and brand drug groups substantially overlapped, said the investigators.
"The GATE study, to our knowledge, is the first phase III clinical trial to date of a generic disease-modifying medication for MS," they wrote. "These results may allow for a generic alternative to the originator brand glatiramer acetate, an RRMS treatment with established long-term efficacy and safety."
GATE used an equivalence design (as opposed to non-inferiority) to meet requirements for clinical trial assessment of efficacy, safety, and tolerability as regulated by the European Medicines Agency.
The FDA recently approved another generic glatiramer acetate drug made by Sandoz on the basis of the standard bioequivalency testing the agency uses in approving generics. The Synthon product has not yet been approved in the U.S.; its marketing application is still under review.
In GATE, 794 RRMS patients from 118 academic medical centers and clinical practices in 17 countries were randomized at a roughly 4:4:1 ratio to receive the generic product, the branded drug, and placebo, respectively, for 9 months.
Participants were 18 to 55 years of age and had experienced at least one relapse in the prior year, as well as from one to 15 gadolinium-enhancing lesions.
The primary end point was the total number of gadolinium-enhancing lesions during months 7, 8, and 9. Additional end points included other magnetic resonance imaging parameters, annualized relapse rate, and Expanded Disability Status Scale (EDSS) score.
Adverse events, injection site reactions, and laboratory test results were monitored to assess safety and tolerability.
The estimated mean numbers of gadolinium-enhancing lesions with generic drug and brand drug were lower than with placebo (ratio, 0.488; 95% CI, 0.365-0.651; P < .001), confirming study sensitivity, reported Cohen and colleagues. For gadolinium-enhancing lesions, the estimated ratio of generic drug to brand drug was 1.095 (95% CI, 0.883-1.360), which was within the predefined equivalence margin of 0.727 to 1.375.
The estimated annualized relapse rates were 0.31 (95% CI 0.20-0.48) for generic drug, 0.40 (95% CI 0.26-0.62) for brand drug, and 0.38 (95% CI 0.22-0.66) for placebo.
The percentages of participants confirmed relapse-free were:
79.3% for the generic
73.9% for Copaxone
73.8% for placebo
Mean EDSS scores were stable in the three treatment groups, Cohen and colleagues reported, and included 9.3% in the generic drug group, 9.2% in the brand drug group, and 7.1% in the placebo group.
Adverse effects were similar between the two versions and nothing unexpected was seen.
This study provides "reassurance that a properly manufactured generic glatiramer acetate can have efficacy similar to that of branded glatiramer acetate," Dennis Bourdette, MD, FAAN, and Daniel Hartung, DPharm, MPH, commented in an accompanying editorial.
"Based on the available evidence, neurologists who prescribe glatiramer acetate at a dose of 20 mg subcutaneously once a day should have confidence that FDA- and EMA-approved glatiramer acetate generics will be as efficacious and safe as branded glatiramer acetate," wrote Bourdette and Hartung, who are both with Oregon Health & Science University in Portland.
But in a commentary Bourdette and Hartung wrote for Neurology earlier this year with two colleagues, they cautioned that introduction of generic glatiramer acetate products may not do much to contain the high costs of MS drugs.
They noted that the actual cost for Sandoz's generic glatiramer acetate is estimated to be $63,000 a year. "This is just $11,000 less than branded glatiramer acetate ... and only $2,000 less annually than a new [less frequently dosed] branded glatiramer acetate," they wrote in the Neurology commentary.
The GATE study was funded by Synthon BV.
The authors disclosed relationships with Synthon BV, EMD Serono, Genentech, Genzyme, Innate Immunotherapeutics, Vaccinex, Roche, Biogen Idec, Novartis, Teva, Merck, Receptos, Neuron, BBB Therapeutics BV, Desitin GmbH, Bayer Schering Pharma, Sanofi Aventis, Biogen Idec, Novartis, and Jansen Research.
Cohen also disclosed that he is a co- editor of Multiple Sclerosis Journal – Experimental, Translational and Clinical.
I'm sure it's a piece of it, I'd say it's the Leerink one dollar less PT (on weaker than expected glatopa sales) + the general biotech weakness that is mainly pushing it down today. Biotech investors don't think that far ahead :P
Well Leerink just lowered their PT....by one dollar :P
Sorry guys was in Bahamas last week :)
9-25
NrX
Copax: 2413 Glatopa: 214 Total: 2627
TrX
Copax: 10485 Glatopa: 813 Total: 11298
10-2
NrX
Copax: 2469 Glatopa: 230 Total: 2699
TrX
Copax: 10979 Glatopa: 813 Total: 11792
9-18 Rx
NrX: Copax = 2311 Glatopa = 254 Total = 2565
TrX: Copax = 10,810 Glatopa = 845 Total = 11655
9-11 Rx (short week)
NrX: copax = 1992 glatopa = 194 Total = 2186
TrX: copax = 9294 glatopa = 707 Total = 10001
MNTA Oct Calls: Any of our options experts car to opine on what all the volume is about if anything?
jbog is right, but my friend was out of the office Friday so haven't seen yet...Might be able to get them today
To my knowledge that is the first I've heard of it regarding Glatopa. Could be wrong though. FWIW Symphony is probably capturing Rx info more accurately.
Not particularly. From what I recall (had it on in background mainly), MNTA still plans to partner their FOB platform by end of year which with 3 months left I fully expect them to do so at this point. They want a 50/50 split kind of thing (development costs and profit share) and mentioned they did the offering as leverage for that kind of deal.
He would not comment on Glatopa share (deferred to Sandoz) but did mention IMS is under reporting Galtopa Rx. Asked about sole generic and he seemed pretty confident MNTA will have it for some time, but obivously impossible to tell what other cos have. Good info on the other pipeline programs but nothing new per se.
Rick Shea sounds sleepier than ever. Time to give up Ricky boy! :)
I wonder if we can infer from Sandoz pricing strategy that they anticipate an elongated run as the sole Gx of copax? They seem to be playing the pricing card pretty carefully if that fierce article is to believe...Also could be they want to keep the price robust for 3x...
Guessing this article is part of it:
http://www.fiercepharma.com/story/why-novartis-copaxone-copy-lagging-its-all-about-coverage-analyst-explains/2015-09-11?utm_medium=rss&utm_source=rss&utm_campaign=rss
Why is Novartis' Copaxone copy lagging? It's all about coverage, analyst explains
September 11, 2015 | By Carly Helfand
Typically, the first generics for blockbuster meds get off to a running start. Not so with Novartis' ($NVS) generic of Teva's ($TEVA) multiple sclerosis standout Copaxone, though--and Bernstein analyst Ronny Gal thinks he can explain why.
The Swiss pharma giant's knockoff, dubbed Glatopa, right now has market share of only about 20%--as opposed to the roughly 50% some industry-watchers say it's capable of snagging. And that could be because coverage of the copy is "considerably behind that of Copaxone," he wrote in a Friday note to clients.
Copaxone reaches the "best available coverage" tier for 59% of covered lives, he pointed out, while Glatopa can only boast that level for 31%. Many payers have kept Teva's original as either preferred or equally accessible thanks to discounting, he noted, and on top of that, Glatopa--likely thanks to its high price--is treated by many plans as a branded product.
"It appears that the lower penetration is, for the most part, factual and simply reflects current formulary status coverage," Gal wrote. Teva is offering more discount to payers, and those payers are preferring its brand over equally or slightly more expensive Glatopa."
Novartis' Sandoz unit, though, appears to be taking that tack deliberately. It "can always lower its price and capture share," Gal noted, but right now, it "appears to be interested in building share cautiously in order to protect market price." The way he sees it, Sandoz is holding the reins, and as it gradually brings its price down, "share will shift," he wrote.
There's another question on the minds of industry-watchers, though, and that's how Glatopa will affect payer coverage on Teva's next-gen version of Copaxone. In July, Gal predicted Glatopa's presence would lead payers to restrict the newcomer version as they work to manage costs. And that could be bad news for Teva, which managed to convert patients over to the long-acting version at a rate that had analysts impressed.
9-4 Rx #s
NrX: Copax = 2754 Glatopa = 301 Total = 3055
TrX: Copax = 11071 Glatopa = 867 Total = 11938
FWIW symphony #s tell a little better story for Glatopa in overall copaxone than IMS.
Currently Glatopa is capturing 12% of NrX and has 8% of total market.
8-28 Rx #s (note these are symphony where jackmormon posted IMS)
NrX: Copax = 2586 Glatopa = 318 Total = 2904
TrX: Copax = 10660 Glatopa = 863 Total = 11523
Don't think I can get them until Tuesday..Pretty sure my buddy is out of the office until then.
Curious that no one on twitter posts these!