Anthera Pharmaceuticals Inc (NASDAQ:ANTH)

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AllStarPortfolio (21.62)
Submitted October 15, 2010

On September 13, 2010 at 1:05 PM, zzlangerhans (99.50) wrote: My next selection: Anthera Pharmaceuticals (ANTH). Please enter a limit pick of 3.4. Anthera is the Oliver Twist of baby biotechs. Their share price seems to have been jinxed from… More

zzlangerhans (99.84)
Submitted December 08, 2016

I've sat on an Anthera red thumb for a long time previously before it paid off, and I may have to do so again if the company reports meeting the primary endpoint of the SOLUTION phase III trial of Sollpura later this month. It is very likely that… More

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Member Avatar DigitalDisco (85.80) Submitted: 5/1/2017 1:02:57 PM : Underperform Start Price: $2.29 ANTH Score: +18.14

reverse split

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Member Avatar oscillation (73.49) Submitted: 1/26/2017 2:39:06 PM : Outperform Start Price: $4.64 ANTH Score: -68.45

nev

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Member Avatar zzlangerhans (99.84) Submitted: 12/8/2016 11:55:47 AM : Underperform Start Price: $15.09 ANTH Score: +102.02

I've sat on an Anthera red thumb for a long time previously before it paid off, and I may have to do so again if the company reports meeting the primary endpoint of the SOLUTION phase III trial of Sollpura later this month. It is very likely that they will, because Sollpura is just a variation of pancreatic enzyme replacement therapy, of which several have been generic for many years. The market reaction to this is unpredictable, of course, because it depends if the history of Sollpura will be taken into account or ignored. Liprotamase, the active ingredient of Sollpura, was originally submitted to the FDA in 2010 under the brand name Trizytek by Alnara, which was subsequently acquired by Eli Lilly. In 2011, an FDA advisory committee recommended against approval of Trizytek and the FDA subsequently issued a CRL. Lilly subsequently sold lipromatase to Anthera for undisclosed compensation, where it was rebranded as Sollpura.

Since CRL's are almost never made public, it is not possible to ascertain the exact reasons Trizytek was rejected. Lilly only admitted that new clinical trials were requested, which is actually about as bad as a company-released rationale for a CRL can get. Since CRL's are almost never made public, it is not possible to ascertain the exact reasons Trizytek was rejected. Lilly only admitted that new clinical trials were requested, which is actually about as bad as a company-released rationale for a CRL can get. However, the Ad Comm Summary Minutes are available here: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/UCM242264.pdf

Several major points can be derived from these minutes:

1. Despite coefficient of fat absorption (CFA) having been accepted as a surrogate for pancreatic enzyme replacement therapy (PERT) in the past, 11/11 panel members were either uncomfortable with or completely dismissive of CFA as a surrogate endpoint for PERT efficacy. [The primary endpoint of SOLUTION is change from baseline CFA]

2. 11/12 panel members indicated there was a need for additional clinical studies. Among the recommendations for these additional studies were head-to-head comparison with existing PERT, duration of treatment for at least a year, clinical primary endpoints including BMI and blood markers of nutritional status, and secondary endpoints related to quality of life and symptomatology. [SOLUTION only addresses the first of these recommendations, and as noninferiority to existing PERT. The duration of treatment in SOLUTION is eight weeks. There are no clinical primary endpoints and no secondary endpoints except safety]

3. The panel was equally split regarding disqualifying safety issues for lipromatase, with particular concerns being growth retardation and fibrosing colonopathy. [It is unclear to what extent SOLUTION addresses these safety concerns, but safety outcome measure is at 18-20 weeks whereas panel recommended studies of at least one year's duration]

Based on my review of the minutes, I believe that Sollpura is dead in the water from a regulatory perspective regardless of whether or not the primary endpoint is met in SOLUTION.

Regarding the rest of Anthera's pipeline, the stock got a big lift this week from the company's PR that "Anthera Reports Blisibimod BRIGHT-SC IgA Nephropathy Continues to Demonstrate Positive Trends in the Week 48 Analysis". However, reading the body of the PR reveals that the headline is false. Baseline 24hr urinary protein excretion was 2.02 in the blisibimod group and 2.35 in the placebo group [a substantial variation between study groups]. At 48 weeks, 24hr urinary protein excretion was 1.86 in the blisibimod group and 2.07 in the placebo group. Neither the absolute or proportional reduction in 24hr urinary protein excretion was better with blisibimod. The company released data on a small number of patients who had been studied for 96 weeks which did show a worsening of 24hr urinary protein excretion in the placebo group and not the blisibimod group, but the sample sizes are tiny and the standard deviations obliterate any shred of significance. The stock remains strong despite the transparent ridiculousness of this PR, indicating that traders are holding on for SOLUTION topline data rather than taking profits.

The CHABLIS-SC1 trial of blisibimod failed to meet the primary endpoint in September. Sister phase III trial CHABLIS 7.5 continues to enroll but prospects for blisibimod in lupus seem dim.

Anthera is burning a lot of cash given the small market cap and cash reserves. They kept the lights on with a large RDO of convertible preferred stock last quarter, but still only have enough cash to take them through the end of Q1 2017 unless BVF elects to exercise their option to purchase another 28M of preferred stock. Anthera is clearly hoping to bump the share price with SOLUTION enough to induce BVF to bite, but BVF is already under water on their prior purchase and may not want to get their hands even dirtier. I think they're more likely to want to convert their existing shares over the convertible price of 2.95, if the terms of the RDO allow it.

The bottom line is that I expect Anthera to be a great short if the share price bumps significantly on "positive" SOLUTION data, unless the CFA data somehow blows away the active control. Otherwise, I expect the stock to be an even better short going into the inevitable Ad Comm for Sollpura.

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zzlangerhans

zzlangerhans (99.84) Score: +301.17

Wow, overcame a -73 to get back on top here. Just goes to show, never let one bad call take you out of the game.

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Member Name Member
Rating
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Date
Call Time
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Start
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Stock
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Index
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Score Commentary
This player feels very strongly about this pick and has marked it a Top Pick. Top Picks do not affect a player’s score. Ravlan < 20 3/6/2013 Underperform 1Y $38.85 -94.65% +68.01% +162.67 0 Comment
IdahoInvestor 29.55 5/22/2013 Underperform 5Y $38.40 -94.59% +55.22% +149.81 0 Comment
zzlangerhans 99.84 12/8/2016 Underperform 1Y $15.09 -86.23% +15.79% +102.02 1 Comment
clangmead 63.15 8/21/2017 Outperform 5Y $1.29 +61.05% +7.05% +53.99 0 Comment
DigitalDisco 85.80 5/1/2017 Underperform 3Y $2.29 -9.28% +8.86% +18.14 1 Comment
billator 99.72 11/20/2017 Outperform 5Y $2.09 -0.60% +0.62% -1.22 0 Comment
cashsage 94.35 5/19/2017 Underperform 5Y $1.63 +27.24% +9.45% -17.80 0 Comment
77Domino 49.73 5/1/2017 Outperform 3Y $2.35 -11.60% +8.80% -20.39 0 Comment
kjh133 57.76 10/20/2017 Underperform 5Y $1.66 +24.98% +1.08% -23.91 0 Comment
This player feels very strongly about this pick and has marked it a Top Pick. Top Picks do not affect a player’s score. glenn12345 99.95 7/25/2017 Underperform 5Y $1.56 +33.17% +4.95% -28.22 0 Comment

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TrackJimCramer 85.15 6/17/2015 Outperform 3W $74.32 -97.20% +23.94% -121.15 0 Comment
TrackJMP 84.90 6/13/2012 Outperform NS $140.80 -62.04% -0.57% -61.47 6/28/2012 @ $53.45 0 Comment
TrackCanaccord 41.53 3/12/2012 Outperform NS $204.80 -98.99% +88.84% -187.83 0 Comment
TrackPoisedTo < 20 1/17/2012 Underperform 5Y $448.00 -47.86% +6.73% +54.59 3/13/2012 @ $233.60 0 Comment
TrackCollinsStew 75.74 12/2/2011 Outperform NS $405.12 -99.49% +105.95% -205.44 0 Comment
TrackDeutscheSec 88.51 11/1/2011 Outperform NS $412.80 -99.50% +112.58% -212.08 0 Comment
TrackMPAdvisors < 20 10/20/2010 Outperform NS $398.72 -67.90% +16.68% -84.58 4/17/2012 @ $128.00 0 Comment
TrackWedbush 87.23 10/6/2010 Outperform NS $267.84 +87.10% +12.63% +74.47 8/1/2011 @ $501.12 0 Comment

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