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Historical comparisons are misleading for the last few years, because Abraxane revenue slipped when they took the sales in-house away from AZN. Current quarter over last year's quarter, the growth was around 25% ($88m vs $70m), and pre-merger that was about the annual growth rate that analysts were estimating.
Peter
Current Abraxane sales are around $300m, but growing at 25% a year. If the drug succeeds in other indications like lung and pancreatic (it has a good shot in both in my view), then peak sales in excess of $2 billion are plausible.
CELG just paid around $2.8 billion plus some milestones for essentially Abraxane alone - the rest of the company isn't much at this point.
Peter
I think the most successful 505b2 drug ever has been Abraxane.
I couldn't find an example of a non-AB substitutable generic approved with an ANDA. Stazvor happened to turn up when I searched the Orange Book for non-AB rated generics. Many of the other non-AB drugs I found are obscure drugs that were approved a long time ago and they are non-AB because of lack of proof of bioequivalence.
Peter
Doing some searching, there seem to be very few modern-day non-AB substitutable generics at all.
Here's one example I found - a generic for Depakote that presumably has different PK:
http://www.stavzor.com/healthcare/stavzor-unique-formulation.php
Peter
Oops - now that I look at it more closely, the non-substitutable version was in Germany, not the US.
Peter
I personally don't believe the possibility of Teva getting approval as a non-substitutable generic is realistic. The FDA would essentially be saying it's not the same drug, but is nevertheless safe and effective, and I just don't see them doing that without requiring trials.
"Fully substitutable" is of course a very big deal in terms of sales.
Peter
I'm not sure I've ever seen a generic copy that is not substitutable. There are some non-substitutable generics that are slightly different chemical entities than the original drug - a good example is Sanofi's clopidogrel - there the first approved generics were different salts - for example, bisulfate vs. besylate.
There is even this quote by the FDA's Woodward in Congressional testimony:
Thanks - that is indeed it.
But as you said, redacted to within an inch of its life.
I do note the royalty rate appears to be tiered.
Peter
If the statisticians at the FDA have their way, in a few years all antibiotic research will pretty much grind to a halt. It's not just their ever-changing non-inferiority standards - it's what happens if standards are written by people completely out of touch with the real world.
A good example is the FDA requiring fever resolution as an endpoint in skin and soft tissue trials (ABSSSI). They apparently came up with this by looking at trials from 70 years ago, ignoring the fact that the vast majority (maybe 85%) of patients with these infections today do not present with fever at all. I recently had dinner with someone who is perhaps the best-known expert in the US on antibiotic resistance and he was spitting blood at the FDA guidance and ever-changing goalposts.
Here's a good discussion of the non-inferiority mess:
http://antibiotics-theperfectstorm.blogspot.com/2010_08_01_archive.html
(There are other good posts on this blog).
Of interest is this nugget from the FDA in its response to the Citizen's Petition:
>Vanco generics
Interesting paper.
FWIW, these were Colombian generics - don't know if the same applied to US products.
Seems like Lilly lost an opportunity to effectively extend its monopoly by challenging the equivalence of these generics.
Here's the proposed explanation given in the paper:
>>I can't think of one company which has recently gotten approval that isn't dramatically lower then the announcement day
ACOR is about 20% higher than it was on its approval date in January this year.
I don't disagree with you on the "manipulation" theories though.
Some months ago I said on this forum that I though the most likely outcome was MNTA approval and a Teva "no decision." Looks like that is where we are. My current guess is that Teva will have to resubmit, and so a competitor is a year or two off. Meantime MNTA should make a fair amount of money, although I believe the Teva overhang will continue to prevent MNTA receiving a decent PE multiple.
My view is nevertheless that MNTA stock will outperform over the next year though.
Peter
<MDV3100>
I think the drug will very likely work, and will even work in some situations where Abiraterone fails, precisely because it hits downstream of the androgen receptor. So I could see it working in EFGR-driven prostate ca as well as androgen-driven. There were some concerns about seizures in early stage trials, but I always thought they were overblown.
The drug has impeccable credentials (developed by Charles Sawyer), and so I don't think it should be tarred with the failed Alzheimer drug brush.
Peter
A quick google search reveals this:
http://www.idenix.com/hepc/drug/IDX184_Phase_IIa_data_EASL_2010_handout_FINAL.pdf
Two grade 1 creatinine elevations that normalized when the drug was stopped and didn't reappear when the drug was started again.
Today's NEJM article on Provenge refutes that short-attack letter you linked to that claimed that the "placebo" arm in the Provenge trial was actually harmful:
The 21.7-month median survival of patients in the placebo group compares favorably with that in control groups in other randomized trials involving similar patient populations (range, 15.5 to 21.7 months),3,5 indicating that the treatment effect cannot be attributed to a poor outcome in the placebo group.
The other striking thing about the data shown in the article was how Provenge beat placebo not just overall, but in virtually every subgroup they looked at (maybe 20 in all). Obviously not stat. sig. in the individual subgroups, but it's the sort of forest plot that reassures me that the effect is real
Peter
are clinical data that are not covered by H-W proprietary?
Yes, they could easily be. For example, try to use FOIA to see the full contents of an ancient NDA - you'll still get rejected because of the proprietary information it contains.
Here's a discussion of this (in the context of the secrecy surrounding clinical trial data):
While companies interact closely with the FDA through meetings and correspondence, neither the data that supports an NDA nor the full analysis and reasoning that supports an FDA regulatory decision is made public. In some cases, a subset of information about a drug may be obtained from the FDA by filing a request under the Freedom of Information Act (FOIA). However, submissions to the FDA are typically protected from public disclosure, even under FOIA, because FOIA allows the US government to withold publication of proprietary information such as trade secrets. Therefore, the vast majority of information about clinical trials — until quite recently, even the existence of a clinical trial — has remained a secret shared between the sponsoring company and the FDA.
http://www.empiricist.ca/blog/?tag=clinical-trials
Statutory protection is parallel to trade secret protection. Statutory protection is obviously easier and clearer, but its existence doesn't negate trade secret protection.
For example, Sanofi's production process, although available to the FDA, remains Sanofi's trade secret. If it was accessible to anyone, then Teva and others would have no problem copying Lovenox.
Trade secrets can remain valuable even without patent protection. For example, I recall Sepracor licensing Zopiclone's European data package ahead of the approval of Lunesta.
Peter
Momenta's launch is not "at-risk."
I was replying to Mouton's question/comment about why companies can launch a generic at-risk and not generally be subject to an injunction. The standard for granting a TRO or preliminary injunction is similar in that situation and the current one.
It's hard to get one in an at-risk launch and it's even harder (in my judgment) for Sanofi to get one here.
Peter
There is no specific legislation I know of related to at-risk drug launches that protects against TROs.
Every now and then a company in fact succeeds in getting a TRO against an at-risk launch - a good example is AZN got a TRO to halt Teva's at-risk launch of Pulmicort.
Here's a powerpoint discussing legal issues surrounding at-risk launches:
http://www.google.com/url?sa=t&source=web&cd=1&ved=0CBYQFjAA&url=http%3A%2F%2Fwww.fr.com%2Ffiles%2Fuploads%2Fpublications%2Fpharmaipsummit%2FHough_Siem-At-Risk_Launch_Slide_Deck.pdf&ei=FwNPTKSuOI28sQPqprCWBw&usg=AFQjCNGheco0BCYB9ng7gzOuEzyQ-ldlzA&sig2=bb0os9inlg6ISQmd2v5NOw
It's tough to get a TRO.
Here is a typical list of standards that should all be met:
(1) a strong likelihood of success on the merits,
(2) the possibility of irreparable injury to plaintiff if preliminary relief is not granted,
(3) a balance of hardships favoring the
plaintiff, and
(4) advancement of the public interest
It's not clear that Sanofi could meet any one of these. The court at the outset would tend to defer to the FDA, which is in conflict with (1); Sanofi would not suffer irreparable damage (as monetary damages would suffice); the balance of hardship is equal or in Momenta's favor; and if they defer to the FDA judgment on safety/efficacy the public interest supports competition.
Peter
I agree that in theory it is quite outside the FDA's ambit to make a decision based on pricing.
But it is within the FDA's discretion just how many resources to devote to a review. And they prioritize based on their judgment of "need" and these days I think it would be naive to assume pricing might not play a part here. After all, pretty much the entire rationale for generic drugs is pricing considerations.
So no, they wouldn't accept or reject Teva's application based on NVS/MNTA's pricing. But I could see them applying more or less effort to the review based partly on pricing.
Peter
That should of course be "authorized generic" not "branded generic" - my Maxalt hasn't kicked in yet. :)
Peter
Congratulations to MNTA holders - alas I just have a very small position picked up a few weeks ago.
Seems like an interesting buy at these prices - clearly the market is not assuming there will be a duopoly, instead it appears to assume approval of other entrants down the road.
These two documents are relevant for judging how likely that is:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220023.htm
and the more detailed:
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM220083.pdf
(the response to the Sanofi citizen's petition).
Peter
I agree the Loraceserin safety data is good, but there is still the concern that the AC might want to see data on combination therapy with phentermine (because the drugs are invariably going to be used together) and also might want to see a safety study combined with SSRIs (SSRIs were excluded from the Arena studies). The issue with SSR's arises because of possible concern with serotonin syndrome - any time you have multiple drugs touching serotonin the possibility of the syndrome is of concern.
I ended up buying a little bit of ARNA after the NEJM article - I sold them on today's pop.
The VVUS drug is not dead in my view - the 2-year safety data comes out next quarter, and if the data is good that might well be enough to tilt the FDA.
Peter
OK, so I withdraw my bumblebee analogy. It's not logically crazy, just farfetched.
Peter