Friday, December 16, 2011

Stocks DD Cites MNTA - Copaxone Characterization IP; Assignee: ScinoPharm Taiwan


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http://ip.com/patapp/US20110183426 (filed-08/2011)

The above could be Mylan/Nacto's copaxone characterization IP(guess). I see Nacto had some collaboration in the past with ScinoPharm, the assignee on this patent. Hence my guess. Of course, I could be wrong.
The difference b/w MNTA's analysis and the above, appears to be: MNTA has found a proxy signature "pyro-gluco" content and they use that for testing the sameness/equivalence. This may lend itself to testing in commercial manufacturing setting. However, the above IP indicates detailed MS analysis.

MNTA's copaxone characterization IP

Separately, a new Copaxone ANDA has been filed by Synthon.

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Stocks DD Cites: MNTA - Virdante acquistion


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Did some digging to understand how Virdante fits with MNTA, and more so the potential products/bio-betters that they are looking at. In terms of alignment, both companies research is based of how sugar(glycosylation) affects protein function. In pre-clinical research, Virdante found a sugar called Sialic acid, the presence of which gives anti-inflammatory effects to the anti-bodies. In the absence of sialic acid, the anti-inflammatory effects were not seen in the anti-bodies. The below article mentions that one of the areas they are looking at is the following: "Sialating" m-AB's like Humira and Enbrel could potentially be increasing it's inflammatory properties(less dosage, as much as 10 times lesser, and hence potentially higher safety). Of-course, even if these efforts are successful, we are at least 5-6 years away from a market launch of such a bio-better.

http://www.virdante.com/documents/VirdantePharmaceuticalsInc.Improvingantibodiesanti-inflammatoryproperties.pdf

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Monday, December 5, 2011

Stocks DD Cites MNTA - Notes from Deutsche Bank's cc 12/05/2011


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1. Company made the following comment on question on any speculation in potential settlement with Amphastar/lovenox or Teva/Copaxone. Made the distinction in settlement cases(and economic motives of the 2 parties) that typically happen in the marketplace and the lovenox case...most settlements are on patent infringement cases at the tail end of patent expiry period. Here it is different, MNTA's characterization patent is expiring in 2024 or something.So, the underlying implication, if legal case for MNTA is solid, the economic incentive has to be substantively better for MNTA to settle with Amphastar than typical infringement settlements.  Here is my speculation: I think from a timing perspective, it is more likely for a potential settlement in Copaxone(patents run to 2014/2015 here) case...both parties know their legal cases(trial has run its course), and may want to de-risk from an unfavorable judgement. Could it be no generic launch until q1-2013?
2. Dr Venkatraman talked in general about characterization of Lovenox and how it compares with Copaxone.
3. Question went somewhat like this: Why are you doing interchangeable FOB instead of bio-similar like how large companies(Eg: Hospira,Teva,etc) are pursuing ?
     a. Full characterization reduces clinical studies (Full Phase 1 & Full Phase 3 are required for biosimilar) and hence reduce duration of development & cost
     b. MNTA believes Interchangeability is key to market share
4. Broad-based FOB partnership likely in 2012

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Saturday, December 3, 2011

Fixed dose combo drugs & the Oct 2011 Juvisync example


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 Fixed Dose combination guidelines from FDA

 It appears the main things needed for approval of fixed dose combo are:
1. Data showing lack of interaction between active ingredients
2. Stability data of the combo
3. Assurance of reproducible drug release from the dosage form
Bio-availability data would be needed for FDCs to show that the combination product would produce blood levels for each of the active ingredients adequate to achieve efficacy.

V.  Clinical Considerations

"For many potential FDCs or co-packaged products (e.g., those in Attachment B), FDA believes adequate clinical studies confirming safety and efficacy of the combination have already been conducted, obviating the need for new clinical studies "

Juvisync
I think Juvisync is a relevant, recent example. It is for Diabetes control and lowering Cholesterol approved by FDA in Oct 2011. Juvisync is a combo of Sitagliptin/Junivia(>$2b/year) and Simvastatin/Zocor. Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body's own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Note Sitagliptin/Junivia is still under exclusivity and the same patents also protect Juvisync.

FDA's approval of Juvisync

The Label on Juvisync
Contains separately both the indications of statin as well as Junivia (note no separate study of the combo drug is in the label)

Juvisync -Exclusivity detail - Core patent(Patent No: 6699871) claims DP-IV inhibitor, or in combination with statin also protects the FDC's exclusivity. Of-course the simvastatin patent has long expired.

Ok. Why am I digging on Combo drugs regulations,label and such ? I am doing dd on possibility of Lipitor/Crestor combo with AMR101-Omega 3 Fatty acid in 2012 and FDA's requirements, and if Lipitor's/Crestor's very broad label can be retained without extensive clinical trials on Combo. Let's remember the only other prescription Omega 3 fatty acid in the market is not approved as Combo therapy with statin in the larger (TG: 200-500mg/dl) indication , as it increase LDL.

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Thursday, December 1, 2011

AMRN - 12/052,598 - Terminal disclaimer approved by uspto

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Basically Amarin appears to have filed composition of matter patent Link 1 , Link 2 as an extension of 2001(12-14-2001) granted patent . This is done in case where a new patent filing is some what of an obvious variation and would not be patentable over 1st patent (double-patenting). By filing terminal disclaimer, since Amarin owns the 1st granted patent, they would get the claims (still not sure if further prosecution is required or claims would be granted) in second filing, but the patent period would be from the time of granted patents, in this case 2001(12-14-2001 ). The terminal disclaimer was approved by uspto. I consider this as minor positive(it appears nothing is conclusive yet if claim would actually be granted as prosecution is not final on this yet?), as this filing, among other filings, gives a chance to purportedly extend exclusivity of AMR101 to 2021, at the minimum.

The 2 granted patents general claim is for "preferably at least 95%, is in the form of EPA and where less than 5%, and preferably less than 3%, is in the form of DHA is provided for the treatment of a psychiatric or central nervous disorder"   

The new patent filing just claims on "similar" composition of matter (no method of use at least in the claims).Link Reader's thoughts are welcome.

Check the below links
-> What is terminal disclaimer
-> Read page 15 of this 
-> Granted patents(listed under Laxdale which Amarin acquired)  Link(812)   Link(077) 
-> Pending patent application Link 1 
    Link 2
-> Terminal disclosure request from amarin Link

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