Replies to post #179687 on Biotech Values

[drbio45]

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN; USD 280.22)
Why good Phase II squalamine data does not have to be bad for Eylea


FIRST GLANCE | COMMENT
June 23, 2014

RBC Capital Markets, LLC
Adnan Butt (Analyst) [phone]
John Chung (Associate)

Rating: Outperform



Phase II data for squalamine eye drops in wet AMD expected on 6/23 @ at 8:30 AM on OHRP call.


Interim Phase II data from OHRP’s squalamine in wet AMD are expected on June 23rd. While favorable results could be a significant positive for OHRP, as they could show a reduction in anti-VEGF injection frequency, they are not necessarily a negative for Eylea. Retina specialists agree that the ideal regimen would deliver anti-VEGF monthly or at least more frequently than the real world currently allows. In our view, if successful, chances of squalamine being used as an adjunct are higher than it replacing intravitreal injections altogether in wet AMD, RVO and/ or DME. OHRP is holding a call on June 23rd at 8:30 AM eastern to discuss interim results from its Phase II study.

Squalamine is a small-molecule eye drop that blocks VEGF, PDGF, and bFGF in Phase II for wet AMD. The Phase II trial enrolled 120 newly diagnosed wet AMD patients who received Lucentis on day 1 and were then randomized to placebo or squalamine drops twice per day. The primary efficacy endpoint is mean number of Lucentis injections while secondary endpoints are mean time to Lucentis retreatment and VA gains. Final data are expected by YE:14.

We envision four outcomes, three of which would not impact intravitreal anti-VEGF usage; however, some of them could still be beneficial for OHRP.

Reduction in injection frequency and improvement in vision – Eylea possibly impacted. This is the only scenario under which intravitreal anti-VEGF use could be impacted as it could show that squalamine has the potential to work by itself.
Reduction in injection frequency; no change in vision – Eylea not impacted or minimally impacted. There is a big difference between ‘on label’ and ‘real world’ injection frequency. Therefore, even if squalamine succeeds in increasing injection intervals it may not impact actual anti-VEGF injection usage unless it extends the period by more than 3- 4+ months.
No reduction in injection frequency but an improvement in vision – Eylea not impacted. Under this scenario anti-VEGF usage would not be impacted though squalamine could likely progress to Phase IIIs to evaluate adjunct use if final Phase II data are positive.
No reduction in injection frequency and no improvement in vision – Eylea not impacted. Since there are interim data final results could still matter for OHRP.
OHRP conference call on 6/23 at 8:30 AM eastern to discuss interim results. US: 1-877-407-0789; International: 201-689-8562.

[biocqr]

OHRP> Ohr Pharma announces interim top-line clinical results from Phase II Study of Squalamine eye drops in patients with Wet AMD; data demonstrated a positive benefit in visual function across multiple clinically relevant endpoints (11.40)

Co announced positive top-line interim results for its double-masked, placebo-controlled Phase II clinical trial of Squalamine eye drops in patients with wet age-related macular degeneration (wet AMD).

The data demonstrated a positive benefit in visual function across multiple clinically relevant endpoints, including a mean change in visual acuity at the end of study visit for the interim analysis group of +10.4 letters with Squalamine eye drops plus Lucentis PRN versus +6.3 letters in the placebo eye drops plus Lucentis PRN arm, a 65 percent additional relative benefit (p=0.18).

The visual acuity improvements were seen as early as four weeks and the relative difference in visual acuity between the two treatment arms continued to increase throughout the study.
Squalamine eye drops were well tolerated and had a comparable safety profile to placebo eye drops.

In the interim analysis, there were no significant differences in the frequency of Lucentis PRN injections, which was the primary endpoint of the study.

Conference call and webcast scheduled for 8:30 a.m. EDT

PR...http://finance.yahoo.com/news/ohr-pharmaceutical-announces-positive-interim-110000232.html