Alimera Sciences (ALIM) is a development-stage company that has completed a Phase 3 study of Iluvien, its investigational device for the treatment of DME (Diabetic Macular Edema). Currently, patients with DME have an "unmet medical need."
Here is a link to the slide deck from a recent conference presentation:
http://files.shareholder.com/downloads/ABEA-4IAIIR/1039523696x0x402653/b9516ee7-fc7f-423c-8ef8-7d379993baa7/ALIM%20Presentation%2009.2010.pdf
DME is a swelling of the macular region of the retina which results in a loss of eyesight. The company's product is inserted into the back of the eye where it releases a constant low-dose stream of a steroid. In the P3 trial, the device was shown to result in a measurable restoration of vision within 3 weeks. Patients continued to experience vision improvement for the next 24 months.
ALIM will be presenting data from its P3 trial of Iluvien at the American Academy of Opthamology today, October 16th.
On August 30, 2010 ALIM received "Priority Review" for Iluvien. With the NDA for Iluvien having been filed June 29, 2010 the company now expects action on its NDA by the end of the current year.
Another interesting way to play the potential approval of Iluvien may be through PSDV, pSivida. PSDV will earn a 20% split of operating profits from the sale of Iluvien, and also will receive a $25 million "milestone payment" from ALIM upon FDA approval of Iluvien.
The equity market cap of PSDV currently is about $100 million and the company recently had balance sheet cash of $17.5 million not counting the milestone payment.
The equity market cap of ALIM is around $300 million. ALIM last week obtained a $32.5 million credit line, presumably in order to make the $25 million milestone payment to PSDV.
Currently, I do not know much about the intended pricing for Iluvien. However, the market opportunity appears to be large and growing rapidly, as it is related to the number of cases of diabetes.
I am hoping some of you Savientors can help on this idea.
One of my best friends is an eye doctor. I'll see what he knows re: DME and if he thinks this would be a big breakthrough.
ReplyDeleteI'll also start doing some digging into ALIM and PSDV as I've built up a lot of cash selling into the recent upswing.
I have some emails about this name from biotkmaven which express some issues about patents and other issues. I will try to summarize them. I have not yet pulled the trigger on these. but Sparton is doing well.
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