Raptor Pharmaceutical Corp. (RPTP)

[IPO$]

Does this company really have the cure for liver disease?


16:41 ET 8/11/14 [StreetAccount] ICPT Follow-up x2: Intercept details FLINT trial data in 10Q ($237.18)

Company states that:
"NIDDK recently provided us with a draft manuscript intended for publication that describes the results from the FLINT trial. As the manuscript is in draft form and is expected to undergo peer review, it is subject to further modification prior to publication. The top-line information about the FLINT trial results described below is based on the draft manuscript provided to us by NIDDK."
Highlights from the data:
Secondary Efficacy Endpoints:
More patients in the OCA treatment group also experienced improvements in the following histological secondary endpoints (n=200):
All the individual components of NAS improved in OCA-treated patients (p-values ranged from 0.03 to <0.001 for each component vs. placebo);
NASH resolution: 22% of OCA-treated patients vs. 13% of patients on placebo (p=0.09); and
Fibrosis improvement (scored 0 – 4): 35% of OCA-treated patients vs. 19% of patients on placebo (p=0.01);
Decrease in mean value of 0.2 from a baseline mean of 1.9 in OCA-treated patients vs. increase in mean value of 0.1 from baseline mean of 1.8 in patients on placebo (p=0.01).
Metabolic Parameters:
OCA treatment was associated with the following changes in metabolic parameters at 72-weeks (n=257).
Statistically significant weight loss in patients on OCA treatment compared to patients in the placebo group (p=0.008);
Increase in a marker of fasting hepatic insulin resistance, HOMA-IR, in the OCA treatment group (p=0.01), although an even larger increase was observed in the placebo group at the conclusion of the 24-week follow-up phase; and
No changes in hemoglobin A1c over a period of approximately three months, in either OCA or placebo groups.
Serum Lipids:
OCA treatment was associated with changes in serum lipid levels that were observed within 12 weeks of initiating treatment (the first time point assessed), then decreased in magnitude while on treatment and effectively returned to baseline during the 24-week post-treatment period
Safety and Tolerability:
The draft FLINT manuscript reported that OCA was generally well tolerated based on the safety and tolerability data from all 283 patients randomized in the trial. The incidence of adverse events in the OCA and placebo treatment groups was similar for all symptoms except pruritus, which occurred more frequently (23% vs. 6%, p<0.001) and at a higher grade (predominantly moderate pruritus). One patient discontinued due to pruritus in the OCA treatment arm.
The incidence of severe or life threatening events was not different between the two treatment groups and most of the events in both groups were deemed to be unrelated to treatment, including all severe or life threatening cardiovascular events. There were two patient deaths in the trial that were previously disclosed in our 10K; neither death was considered related to OCA treatment.
Stock resumed trading at 16:40ET +47% to $350



*****Related comments from the archive:


11-Aug-14 16:24 ET
ICPT Follow-up: Intercept issues press release on Q2 results; provides business update ($237.18)

Note StreetAccount reported earnings from the company's 10-Q moments ago (see linked comments)
Summary of Key Development Programs, Updates and Anticipated Milestones:
NASH Program
FLINT trial data provided in 10-Q filing and to be discussed on today's conference call
The proportion of patients meeting the FLINT primary histological endpoint, defined as a decrease in the NAFLD Activity Score (NAS) of at least two points with no worsening of fibrosis, was 46% in the OCA treatment group and 21% in the placebo treatment group (p < 0.001, n=219).
Subgroup analyses showed a numerically higher response rate in OCA-treated patients with more advanced NASH, as assessed by NAS, fibrosis staging or co-morbid type 2 diabetes.
The mean pre-treatment baseline NAS for patients in the OCA treatment group was 5.3 of a total possible score of 8 (comprised of hepatocellular ballooning 0 – 2, lobular inflammation 0 – 3 and steatosis 0 – 3).
Further details can be viewed in the company's 10-Q (linked below), under the section "Recent Developments"
Phase 3 program initiation anticipated in 1H 2015, pending regulatory feedback
Phase 2 lipid metabolism trial initiation anticipated in 1H 2015
PBC Program
Phase 3 confirmatory trial protocol finalization anticipated in 3Q 2014 and initiation planned around year-end 2014
Pre-NDA and pre-MAA meetings anticipated in 4Q 2014 with completed filings anticipated in 1H 2015
Primary Sclerosing Cholangitis (PSC) Double-blind phase 2 trial initiation anticipated year-end 2014
INT-767 Phase 1 Trial Initiation Anticipated in 1H 2015
ICPT shares are halted; to resume trading at 16:40ET


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11-Aug-14 16:16 ET
ICPT Intercept Pharmaceuticals reports Q2 GAAP EPS $1.51 vs year-ago ($0.79) -- 10-Q ($237.18)

Reports Q2:
Reported EPS includes $55.8M gain on revaluation of warrants
Net Income $33.5M vs year-ago ($13.5M)
R&D expense $14.9M vs year-ago $5.1M
Cash and equivalents $45.0M vs year-ago $13.4M


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11-Aug-14 16:01 ET
ICPT Intercept Pharmaceuticals shares halted; news pending ($237.18)

Note the company is scheduled to report earnings this afternoon.


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StreetAccount alert for portfolio(s):
· CORE (ICPT)
· CLIENT (ICPT)

Tickers mentioned in/related to this story; follow link for 30-day news history: ICPT


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