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Here's another abstract w/ more detail:
Very good synergy w/ IFN/rRBV in a 28-day trial. Don't know if the same is true for all nucleotides or not.
>>VRUS
You have any comments on their just-released AASLD PSI-7977 abstract? On the surface it looked very good to me, but this isn't a space I follow closely enough for me to be able to judge properly.
BMY's NS5A drug looked pretty exciting too.
Peter
AASLD abstracts up:
http://www.aasld.org/lm/abstracts/Pages/default.aspx
Peter
I was just basing it on the $40m profit (based on a 10% profit share) for MNTA that seems to be the consensus in the 2-way plus authorized generic case, and assuming Teva's COG and sales costs are similar to those of Sandoz.
So to answer your question, it's based on whatever tL revenue leads to $40m income to MNTA in this 2+1 case. :)
Peter
>>tanezumab
Here's the editorial:
http://www.nejm.org/doi/full/10.1056/NEJMe1004416?query=TOC
FDA Awards $1.1 Million Grant To School Of Pharmacy To Compare Generic And Brand Epilepsy Pills
Main Category: Epilepsy
Also Included In: Pharmacy / Pharmacist; Regulatory Affairs / Drug Approvals; Pharma Industry / Biotech Industry
Article Date: 24 Sep 2010 - 4:00 PDT
The University of Maryland School of Pharmacy has begun a unique study of the "switchability" of federally approved generic and brand anti-epileptic drugs, funded by a $1.1 million, 2-year grant from the U.S. Food and Drug Administration.
Principle investigator James Polli, PhD, a professor with the school, says the study is designed to address patient and health care provider concerns about whether FDA-approved generic and brand anti-epileptic drugs, specifically carbamazepine and levetiracetam, can continue to be considered equally safe and effective.
Polli's team will analyze and assess tablets of the two drug versions for pharmaceutical quality, and "switchability-related" side effects or seizures in epileptic patients who have reported problems. Patients will participate in clinical trials from the University of Maryland Medical Center and the Veterans Administration Hospital in Baltimore.
The research team will "fully characterize" the drug products in terms of potency, impurity, in vitro dissolution, and other quality attributes. "The outcome of this study can help address the public concerns regarding the quality of generic antiepileptic drugs (AEDs) and improve regulatory review practices of generic AEDs when necessary," says Polli.
Polli says, few such comprehensive comparative studies have been published. "This research is a good start on such comparisons because several epilepsy organizations do express concerns about the interchangeability of AEDs and claim that there is an increase in seizure frequency after a generic substitution for many AEDs".
In 2007, the American Academy of Neurology issued a position statement opposing generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending physician's approval.
The FDA requires tests and procedures to assure that an approved generic drug provides the same therapeutic effect and safety profile as the corresponding brand product. An FDA-approved generic drug is then considered interchangeable with the brand product under all approved indications and conditions of use, and no additional testing of patients is necessary when a generic substitution occurs. This interchangeability also applies to a generic to generic switch when both are deemed equivalent to a brand product.
The principle investigators are Polli, Tricia Ting, MD (co-principal investigator at U of Maryland), and Elizabeth Barry, MD (co-principle investigator at Baltimore VA Medical Center). Other faculty researchers are Allan Krumholz, MD, Maureen Kane PhD, Stephen Hoag, PhD, and Thomas Dowling, PhD.
Source: University of Maryland Baltimore
http://www.medicalnewstoday.com/articles/202326.php
I don't disagree - I could well see companies saying "Well if you think the drug is so good, how come you don't want to spend any of yourmoney developing it."
I'm mostly commenting on how I think the market would react to a deal where MNTA spends a whole bunch of its revenue on this program.
Peter
IJ,
All I really know is that it's a "bet your company" type project - huge development costs and huge potential reward.
This is not a space where I have any real (or even imaginary :) ) expertise, so I'll leave it to Dew and others to debate the risk/reward ratio of the drug.
Peter
I personally think VVUS still has a decent shot of approval - not by the PDUFA date, but after the FDA has reviewed 2-year safety data.
I've never really understood the enthusiasm for Contrave compared with Qnexa. After all both of Contrave's constituents have black box warnings (for hepatic tox and suicidality respectively) whereas neither of Qnexa's components has a black box.
Peter
Wei figured this out on his own.
He looked at some FDA guidance documents from 1998 and 2008 (the latter relates to cardiovascular risk in diabetes drugs) that call for a 2.5% Type 1 error when using a one-tailed test. He also used a statistical consultant.
Nice call by him, although it's worth noting that he points out that the difference between a 50% and 55% upper bound is perhaps not significant.
Peter
Yes, for most folks that take migraine drugs prophylactically, they do take them for years at a time. Many women (who are 2/3 of migraine sufferers) can stop after menopause though.
There are no migraine prophylactic drugs that weren't originally designed and approved for a completely different indication (e.g. beta blockers and calcium channel blockers are cardiac drugs, amitriptyline is an old tricyclic antidepressant, Topamax and Zonegran are anti-epileptics, etc.) All these drugs are intended for chronic use.
Peter
>>Toipramate
So you believe it shouldn't be approved or used for migraine? Is migraine a more serious condition than morbid obesity in your view?
The cognitive effects are real in some people. But they go away within days of discontinuance.
Peter
Here's the actual language from the guidance:
>>Cop + Albuterol
In my view you are making a legitimate point here that I have often wondered about.
But really we have no way of knowing what characterization methods Teva have used, let alone whether those methods may infringe MNTA's patents (assuming the patents hold up). And even assuming Teva are infringing, it's not clear to me how MNTA would know they are infringing.
But these patents may certainly be another potential hurdle for Teva - we just have no way of knowing.
Peter
>> [SPA] that was a turning point for INCY's stock price
For good reason - nobody at the time knew whether the FDA would accept reduction in spleen size as an endpoint. Given that such reduction was pretty much a layup for INCY (as I posted on SI at the time), the SPA was tantamount to approval.
In the case of ARIA, the clinical endpoints for CML are well established. These patients have all failed the other drugs, and so if they get hematological and molecular responses it's clear that the drug is efficacious.
So I don't see the situations as comparable at all. I agree with rkrw that an SPA is not needed here and has likely not even been sought.
Peter