) -- With my apologies, last week's Biotech Stock Mailbag is a few days late.
"Patent" asks, "Your latest thoughts on
The next challenge for Amarin and its ultra-purified fish oil AMR101 comes from
as it gets ready to announce late-stage study results from a potentially competitive omega-3 fatty acid product.
Omthera's Epanova is a purified mixture of 55% EPA and 20% DHA with boosted bio-availability that is supposed to more effectively lower trigylcerides (TG) and perhaps stunt increases in LDL (bad) cholesterol. [Both EPA and DHA lower TG but DHA raises LDL.]
Lovaza, the currently marketed prescription grade omega-3 fish oil product, consists of 46% EPA, 37% DHA. Amarin's AMR101 is 96% EPA.
Epanova is not being studied head-to-head against AMR101 but that won't stop investors (and everyone else) from comparing the Epanova data with that from Amarin's phase III "Marine" study given both trials enrolled identical populations of patients with very high levels of baseline triglycerides (equal to or greater than 500 md/dl.)
Omthera is expected to release the Epanova data before the end of April. Here are the relevant AMR101 data from the "Marine" trial for comparison:
The 2 mg and 4 mg doses of AMR101 resulted in a 20% and 33% reduction in TG levels, respectively, compared to placebo. Both results were statistically significant.
The low- and high-dose of AMR101 also resulted in an 8% and 18% reduction in non-HDL-C compared to placebo (statistically significant) and a 5.2% increase and 2.3% decrease in LDL-C (not statistically significant.)
One more important data point: The TG baseline for patients in the AMR101 2 mg dose arm was 657 mg/dl and 680 mg/dl for the AMR101 4 mg dose.
With the caveat of reading across different trials, the AMR101 data in the population of patients with very high TG is superior to comparable Lovaza results. Now, we wait to see how AMR101 stacks up against Epanova.
Carson K. asks, "Can you interpret the stocks which did best at the hepatitis C conference last week?"
(GILD - Get Report)
emerged as the clear winner from the European Association for the Study of the Liver (EASL) annual meeting, says healthcare investor and
contributing columnist Nathan Sadeghi-Nejad.
Nate attended the EASL meeting in Barcelona last week. His
assessment and grading of all the major hepatitis C drug stocks
is published this morning, so definitely take a look. In addition to Gilead, Nate thinks
come out of EASL stronger, while questions swirl around
was a definite EASL loser, he says.
For more detail, please check out
Nate's comprehensive EASL report
@JonathanNovak1 asks, "Do you really think
(VNDA - Get Report)
is a takeover target or were you referring to retail speculation?"
Jon is referring to a
of mine riffing off GlaxoSmithKline's unsolicited bid for Human Genome Sciences: "Inevitable takeout rumors you will hear today, if not already: $NVS-$VNDA, Bayer-$ONXX, Eisai-$ARNA, $DNDN-take your pick"