Nanalyze

Investing in Nano Drug Delivery with pSivida (PSDV)

pSivida_Logo

One company that was heavily discussed in the Nanalyze forums is pSivida (NASDAQ:PSDV), an Australian company with a platform drug delivery system that according to the company “relies on nano structuring to achieve optimal drug delivery”.

pSivida is a provider of miniaturized, sustained-release drug delivery products with an intellectual property portfolio of 150 patents. As of August 2012 the company had 29 employees. The company trades in Australia on the ASX (ASX:PVA) and on Nasdaq (NASDAQ:PSDV). The share price of the Nasdaq issue has performed well over the past year having appreciated nearly 200%

pSivida_1_Year_Chart

Technology Platform
The company’s primary technology platform, Duraset, is a drug delivery system focused on treatment of chronic diseases of the back of the eye. The tiny device seen in the below picture can be administered during an office visit by injecting it into the eye using a small needle.

pSivida_Drug_Delivery

The device then releases drugs over a period of 30-36 months. Earlier versions of this technology have been licensed to Bausch & Lomb for two products; Vitrasert (1996) and Retisert (2005). The company stated in their 2012 10-K that royalties from these two products  are not expected to increase to a level sufficient to sustain their operations and may decline. pSivida’s hope is that their lead development product, Iluvien, will bring in significant revenue for the company and pave the way for future applications of Duraset technology.

Iluvien
Iluvien treats diabetic macular edema and is being marketed by Alimera Sciences (NASDAQ:ALIM), a 144 million dollar market cap company who pSivida has licensed Iluvien to. With only one product other than Iluvien, Alimeras’s success mainly hinges on the success of Iluvien. Alimera has received marketing approval for Iluvien in 6 European countries. The first patient was treated with commercially available Iluvien in Germany on May 2013,  however Alimera has not recognized any revenues yet from Iluvien or any other product for that matter.

FDA Approval

In June 2010, Alimera requested approval for ILUVIEN in the U.S. from the FDA. In December 2010 the FDA responded that Iluvien could not be approved in its current form and needed further analysis of safety and efficacy. In May 2011, Alimera submitted a response including additional safety and efficacy data. In November 2011, the FDA communciated that Iluvien could still not be approved since Alimera did not provide sufficient data to support that ILUVIEN is safe and effective in the treatment of patients with DME. The FDA stated that the risks of adverse reactions shown for ILUVIEN were significant and were not offset by the benefits demonstrated by ILUVIEN in clinical trials. The FDA asked for two additional clinical trials to demonstrate that the product is safe and effective for the purpose indicated. In May 2013 Almera announced their resubmission to the FDA which addressses the concerns posed with an expected response from the FDA expected on October 17, 2013.

Going forward it will be interesting to watch Alimera’s quaterly earnings reports to see when they start to recognize revenue from Iluvien in Europe which consequently will result in roylty revenue for pSivida. A key date will be October 17th 2013 when the FDA announces whether or not they will approve Iluvien for a third time.

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  • SharkInvestor

    The FDA did not approve for the third time. Not good.

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