Biotech Values

[DewDiligence]

(REGN/NVS/Roche)—I would not be so quick to dismiss PRN dosing of Lucentis as inferior to monthly dosing. According to data presented at ARVO:

• The RESTORE extension study of 240 patients with DME, using as-needed (“PRN”) dosing in the second and third years, found that patients maintained the visual gains in the first year using an average of 3.7 and 2.7 Lucentis injections during the second and third years, respectively.

• In a Swiss retrospective study, 316 AMD patients treated with Lucentis as-needed were able to maintain an average VA gain of 8 letters (after three years using 16 total injections (an average of 5.3 injections per year).

http://www.sec.gov/Archives/edgar/data/1114448/000110465912035563/a12-11794_16k.htm

“The vision gains seen at the end of three years of Lucentis treatment in wet AMD patients were favorable and similar when compared to the pivotal Phase III trials — MARINA and ANCHOR” said Prof. Sebastian Wolf, University of Bern, Switzerland. “However the number of injections, a mean of 16 during three years, is significantly less than the monthly regimen used in those studies. This data confirms that an individualized treatment regimen, now standard of care in Europe, is best for patients.”