Gentlemen don't be so despondent, given that the price has already dropped so much this is good news. All the bad stuff is on the table.
The FDA has announced that they have broken a contract which represented on AMRN's part a large investment of capital, the sooner the better in my opinion.
They broke their agreement based on studies of other substances, studies which were known before the reduce it trial began. This will not look good for the FDA in federal court.
Now AMRN can prepare for the lawsuit and file it the second after the FDA rejects the expanded indication in December.
We believe that Amarin has become an interesting speculative play at its current price. Certainly there are a lot of potential pitfalls. REDUCE-IT may still not result in label expansion approval and the outcome of that study is not expected until 2016. It is uncertain what peak sales Vasecpa can achieve with only its MARINE indication. As well, Amarin may still need to raise additional capital as it attempts to complete the REDUCE-IT study while continuing to increase Vascepa prescriptions. Amarin may also conclude that it is better to focus all its resources on targeting the MARINE population rather than continuing with the REDUCE-IT study.
The FDA decision does seriously limit the approved target market for Vascepa. However, Vascepa is still approved for its MARINE indication, which could still eventually represent a peak market of $1.2 billion according to Leerink Swann. As well, Vascepa may still be approved for its ANCHOR indication after the REDUCE-IT study is completed. We are going to assess Amarin's value based on its current situation in further detail below.
Slow But Steady Growth In New Prescriptions
After some strong early growth in new Vascepa prescriptions, the rate of increase has slowed, but appears to be growing linearly still. Rolling four week new prescriptions (NRx) have increased from 10,054 during the four weeks ending July 12 to 12,392 for the four weeks ending October 4. Average new prescriptions have increased by around 50 per week over the last 12 weeks, with growth picking up in September.
Four Weeks Ending
NRx
Increase in NRx
February 22, 2013
1,981
March 22, 2013
4,466
2,485
April 19, 2013
6,566
2,100
May 17, 2013
9,057
2,491
June 14, 2013
9,252
195
July 12, 2013
10,054
802
August 9, 2013
10,545
491
September 6, 2013
11,165
620
October 4, 2013
12,392
1,227
Prescription numbers from Symphony
Solid Projected Refill Numbers
We have modeled prescription refill rates at 50% for new users and 70% for users who have already refilled once, with the refill decision time being approximately seven weeks after the last prescription. We have found that this is a fairly accurate fit to past data as the table below shows and will monitor the prediction accuracy going forward.
Projected and actual Vascepa refills based on the above formula
Four Weeks Ending
Projected
Actual
April 19, 2013
1,361
1,647
May 17, 2013
3,059
3,054
June 14, 2013
5,023
5,493
July 12, 2013
7,033
7,076
August 9, 2013
9,000
8,397
September 6, 2013
10,182
9,966
October 4, 2013
11,536
11,642
What this implies is that each new Vascepa user will account for approximately 2.67 prescriptions over their lifetime (also that TRx/NRx will eventually approach 2.67). This is quite similar to Lovaza's 2013 TRx/NRx ratio of 2.80). There may be some slight upside for Vascepa if
Ajax No one "walked me off a gang plank "...you may be lead by "group think " but I am not, so don't include me in your "we "
There is plenty in peer reviewed journals and Heartwire video presentations by Drs Bay , Ballantyne et al arguing that elevated Tg's in at "at risk " population represents residual risk not treated by statin therapy.
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