Replies to post #266984 on Amarin Corp Plc (AMRN)

[amarininvestor]

Some selected portions from my previous post:

Unexpected results,

The prior art is either silent or teaches that there is no statistically significant change in Apo-B levels when patients with TG levels less than 150 mg/dl or between
150-499 mg/dl are treated with either 96% pure ethyl-EPA or a mixture of ethyl-EPA and DHA, or when a mixture of ethyl-EPA and DHA was administered to patients with TG levels above 500 mg/dl


In summary, based on the above prior art it was completely unexpected to observe an 8.5% decrease in Apo-B when patients with TG levels above 500 mg/dl were administered 4 g of 96% pure ethyl-EPA. Also, based on the fact that the
MARINE trial (Bays et. al. Am. J. Cardiol. (2011) 108:682-690) shows the criticality of the 4 g per day dose, as opposed to the 2 g per day dose wherein no Apo-B effect was observed, and based on the importance of lowering Apo-B in these patients, it is concluded that Applicant has effectively shown unexpected results for his invention

Long felt unmet medical need.

The prior art teaches only two other drugs that have been approved for the treatment of triglycerides in patients with TG above 500 mg/d (very high)l:
1- Lovaza (a mixture of EPA and DHA), and
2- Triplix (a fenofibric acid).
Both treatments lower TG significantly (50-60%), however both treatments also
raised LDL-C (the bad cholesterol) significantly (about 50%) (See Lovaza package and Triplix Package; see also Table 1 on page 13 of Applicant’s arguments dated 09/21/2011).

According to Dr. Weintraub there is a need for a treatment for patients with TG above 500 mg/dl (very high) that not only reduces the level of TG but also does not increase LDL-C which is associated, like Apo-B, with an increase in cardiovascular diseases (see applicant’s response dated 09/21/2011, pages 14-21). When combined with the fact that the levels of Apo-B are also decreased, this treatment: the administration of 4 g daily of 96% pure ethyl EPA for a period of at least 12 weeks to patients with TG above 500 mg/dl that are not on concomitant lipid altering therapy, becomes the only one available that, besides significantly lowering TG levels, also does not increase LDL-C levels and decreases apolipoprotein B levels, two important markers strongly associated with increase in cardiovascular diseases. The above justifies the allowance of the instant claims in their full scope.

[dukesking]

Amarininvestor, Thanks for sharing this information. This is important factual information that hopefully will aid in winning the appeal along with the procedural errors. IMO.