déclaration intéressante de Ashton (Psivida) suite Q4 (12.2.2010)
“We are very encouraged by the recently released top-line 24 month safety and efficacy
data from the ongoing Phase III Iluvien® trials for the treatment of diabetic macular
edema (DME),” said Dr. Paul Ashton, President and CEO of pSivida.
The Phase III trials are being conducted and funded by the Company’s collaborative
partner Alimera. On the basis of these data, Alimera has announced plans to file an NDA
with the FDA in the second calendar quarter of 2010 and to request Priority Review. If
approved, this would be the first ophthalmic drug therapy for DME, a potentially blinding
eye disease that affects more than one million people in the United States alone.
Receiving Priority Review status could result in a decision from the FDA by as early as
the end of 2010 and, if positive, Alimera anticipates first sales of Iluvien could be as early
as the first calendar quarter of 2011. Alimera is also conducting investigator-sponsored
studies designed to assess the safety and efficacy of Iluvien in wet and dry age-related
macular degeneration and retinal vein occlusion.
“Commencing April 2010, the annual interest rate on our $15 million conditional note
from Alimera increases to 20% and monthly principal payments of $500,000 are
scheduled to begin,” said Dr Ashton. “The occurrence of certain Alimera liquidity events,
such as an acquisition or IPO generating over $75m in gross proceeds, would accelerate
payment of the note. In addition, FDA approval of Iluvien would trigger a $25 million
milestone from Alimera and, once commercialized, pSivida would be entitled to receive
20% of any Iluvien profits,” explained Dr. Ashton.
“Beyond the Iluvien trials, we are advancing the development of non-Iluvien product
candidates through our ongoing collaboration agreement with Pfizer, Inc. and through
the application our BioSilicon technology. We are excited by the opportunities in our
product pipeline,” concluded Dr. Ashton.
Our first generation Durasert product BrachySil was approved by the FDA in 1996 for the treatments of CMV retinitis. That's an AIDS-associated infection. Our second generation Retisert product was approved for the treatment of post dated UVI just in 2005. These products are both licensed to and sold by Bausch & Lamb. Our third generation and most advanced Durasert product currently in clinical trial is Iluvien. Iluvien is not completing Phase III clinical trials in diabetic muscular edema, a huge indication affecting approximately a million patients in the US alone. About 10% of all diabetics will develop DME some stage in the disease. In terms of dollars, the DME market is being estimated at between $1.5 billion and $3 billion annually in the US and there are currently no FDA approved drugs for this disease.
