Saturday, November 19, 2011

AMR101 Exclusivity

Read, understand and consent to the blog's disclaimer here before proceeding to read the article 

NCE Exclusivity period
 I would like to clarify on exclusivity period, if AMR101 gets NCE status(here was an informative article looking at the NCE status->Link). While NCE status guarantees 5 year exclusivity, the 30 month stay on Para iv ANDA's (most certainly, in my opinion, Amarin will list some Orange book patents) and an additional 6 month Pediatric exclusivity will take the exclusivity period to 8 years. Generally, the implied market exclusivity for NCE is 8 years(read comments section under) much greater than 5 years. So if one believes in AMR101 getting NCE status, the base valuation for AMR101 should be for a exclusive revenue period of 8 years, although in most cases the patents stretch this further out.  Patents are generally successful in extending exclusivity. Case in point is Abbott's Fibrate drugs. Abbott has managed to retain exclusivity on Fibrates for decades:  Link

Other notes on exclusivity:
1. Amarin has 7 patent applications that can be seen on USPTO site. However in a recent conf call it was mentioned only around half of the applications filed are actually published on the USPTO site. It is true that some of claims being prosecuted in marine patent are not even visible in USPTO site

2. Mochida has some interesting patent applications in the CV space on pure EPA, most of them related to findings in the large scale JELIS CV outcomes study. Note Amarin is well aware of Mochida's IP. In fact it turns out, Amarin out-licensed it's patents in CNS area for same EPA drug to Mochida some 5+ years back. So I wouldn't rule out some collaboration on the IP front here.

3. Marine indication(TG ≥500 mg/dL) - Even after reading the 2 rejection letters and the company's arguments, I continue to believe the company's arguments on LDL neutrality finding is strong and that specific claim has a fair chance of being granted. So if that claim is granted, that should serve to block generic entry until 2030 for this indication. I agree with the management that until a final decision by USPTO any arguments by the company in the public domain would be inappropriate and only serve to be counter-productive.

4. Anchor indication(TG ≥200 and <500mg/dL who are on statin) - Treating Triglycerides in this indication has prior art(Katayama et al).So it is unlikely that company would get that claim. Moreover treating EPA on top of Statin also has prior art (Aoki, et al - link). But lets look at other findings from Anchor trial: LDL-C (6.2%), apo B (9.3%), Lp-PLA2 (19%) and high-sensitivity C-reactive protein (hsCRP )(22%) above and beyond statin treatment . Some of these including LDL reduction seem new and non-obvious findings(Aoki patent also does not have any claim on LDL/apo B reduction above & beyond statin. I am not aware of other prior art?). There is a fair chance that LDL reduction & Apo B reduction would find it's way in the FDA label and would be blocking for generic competition seeking to obtain therapeutic equivalence rating. The other 2 emerging lipid markers hsCRP & lp-PLA2 are generally not seen in the label unless CV outcomes studies confirms its evidence.

My next write up would be on market value of AMR101 considering its launch in 2nd half of 2012 , the patent expiry for Lovaza, Lipitor, the recently published failed CV studies on Fibrates and Niaspan combo-therapy with Statin. This is one of the main reasons I continue to hold this stock.

And finally what was all the call option activity on Friday on March 12 $10 strike price (360K shares), and Jan 13 $10 strike price (157K shares)  Link

1 comment:

  1. Yes technically you are right.

    Although I believe it is very rare that 30 month stay had been shortened because court found patent was invalid. I would be interested to know an example and %age of brand drugs, where 30 month stay did not hold. If you provide me the info , I would be more than happy to provide a link to your info and give you the credit for correcting me on that.

    Considering the length of trials & plethora of motions a litigant can bring in to delay the case, and considering FDA backlog on generics(is it a 4 year backlog now?), i think 8 year exclusivity is given.

    From: Biotech Due Diligence
    Sent: Saturday, November 19, 2011 3:03 PM
    Subject: Re: AMR101

    The issue in the math is with the "2.5" corresponding to the 30 month stay. The 30 month is not automatic and absolute - it can be terminated early (or lengthened even...) by a court decision due to the judge deeming there to be non-cooperation, invalidity of the patent, or non-infringement, for example.

    On Sat, Nov 19, 2011 at 2:50 PM, IMHO DYDD wrote:

    Hello, Andrew

    Thank you for your email. Can you enlighten me where specifically you disagree on 8 years? As far as my experience goes, 8 years is a standard .
    I think we agree on 5 years for NCE status . 30 month stay is automatic if you have an orange book patent listed (it is given that Amarin will list at least 1 patent). 6 month PED exclusivity is additional to any exclusivity ..there is no reason why amarin will not conduct obligatory pediatric study . In fact they have stated in the past presentation that this is how they get to the 8 year exclusivity
    so it is 5 + 2.5 + 0.5 = 8