pSivida Corp. Reports Results for the Second Quarter Ended December 31, 2008; Iluvien? NDA filing remains on schedule for early calendar 2010; Final two-year patient visit scheduled for October 2009
pSivida Corp. (News) (NASDAQ: PSDV) (ASX: PVA) (FF: PV3), a drug delivery company, today announced financial results for the second quarter ended December 31, 2008.
For the quarter ended December 31, 2008, the Company reported a consolidated net loss of $870,000, or $0.05 per share, compared to a consolidated net loss of $5.8 million, or $0.32 per share, for the quarter ended December 31, 2007. Revenues for the three months ended December 31, 2008 were $3.0 million compared to revenues of $128,000 for the three months ended December 31, 2007. Cash and cash equivalents totaled $9.8 million at December 31, 2008.
?We are confident in our strategy and Iluvien? continues to be on schedule for an NDA filing in early calendar 2010,? stated Dr. Paul Ashton, President and Chief Executive Officer of pSivida Corp. ?Due to our existing partnerships and the significant reduction in cash burn we have achieved over the past two years, we believe we can fund our operations as currently conducted without the need to access the capital markets prior to FDA approval of Iluvien. If approved, we are due to receive a $25 million milestone payment.?
For the six months ended December 31, 2008, the Company reported a consolidated net loss of $1.3 million, or $0.07 per share, compared to a consolidated net loss of $6.6 million, or $0.36 per share, for the six months ended December 31, 2007. Revenues for the six months ended December 31, 2008 were $5.8 million compared to revenues of $231,000 for the six months ended December 31, 2007.
Revenues for the three and six month periods ended December 31, 2008 were predominantly related to the Company?s collaboration agreement with Alimera Sciences, Inc.
Iluvien is the anticipated name under which pSivida?s lead development stage product, Medidur? FA, will be marketed. Iluvien is a miniaturized injectable device that delivers the drug fluocinolone acetonide (FA), a corticosteroid, for up to three years after being injected into the vitreous of the eye. Iluvien is in fully enrolled Phase III clinical trials for the treatment of diabetic macular edema (DME), a potentially blinding disease that affects over one million people in the United States. Currently there are no FDA approved drugs for the treatment of DME.
?The Phase III clinical trial data will be analyzed after the collection of two years of data from all patients. The last patient is scheduled to have their two-year follow-up visit in October 2009 and filing for FDA approval is planned for early calendar 2010,? said Dr. Ashton. ?In addition, we have an ongoing PK study which also provides information on the safety and efficacy of Iluvien in the DME population. We were encouraged by the three and six month interim data where many patients showed a significant improvement in visual acuity. While early, these improvements are in line with our projections when designing the Phase III studies. We anticipate having twelve-month data from the PK study early in the second calendar quarter of this year.?
pSivida?s partner, Alimera Sciences, has worldwide marketing rights to Iluvien and is currently conducting the Phase III clinical trials and PK study. ----------- Wer nicht investiert, solange ein Risiko zu sehen ist, ist nie investiert. (Lothar Weniger, DG Bank AG)
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