PSIVIDA CORP. REPORTS RESULTS FOR 4TH QTR AND FISCAL YR.
For the year ended June 30, 2009, the company reported a consolidated net loss of $2.5 million, or $0.14 per share, compared to a consolidated net loss of $75.7 million, or $4.17 per share, for the year ended June 30, 2008, also reflecting the $60.1 million impairment charge. Revenues for the year ended June 30, 2009 were $12.2 million compared to revenues of $3.5 for the year ended June 30, 2008.
Revenues for the three and twelve month periods ended June 30, 2009 and 2008 were predominantly related to the company's amended and restated collaboration agreement with Alimera Sciences, Inc. (Alimera). "We are expecting the 2-year top line safety and efficacy data from the ongoing Phase III Iluvien trials for the treatment of DME at the end of this calendar year," stated Dr. Paul Ashton, president and CEO of pSivida. "These trials are being conducted by Alimera, and Alimera's planned NDA filing remains on schedule for early calendar 2010. Additionally, we are targeting BioSilicon as the second prong of our drug delivery platform in addition to the Durasert technology system on which Iluvien is based."
Dr. Ashton continued, "We are entering an important and exciting phase of development and our programs are progressing according to schedule. With expected cash from our existing collaborations and planned spending levels, we believe we can fund our operations as currently conducted through FDA approval of Iluvien. Beginning in April 2010, we are due to receive monthly principal payments of $500,000 under a $15 million conditional note issued by Alimera and, if Iluvien is approved, we are due to receive a $25 million milestone payment and, once commercialized, a 20% profit share."
The company's lead development product, Iluvien, is a tiny injectable device that delivers the drug fluocinolone acetonide (FA) directly to the back of the eye for up to three years. Iluvien, formerly known as Medidur FA for DME, is licensed on a worldwide basis to Alimera, which is conducting fully-enrolled Phase III clinical trials studying a low dose and a high dose for the treatment of diabetic macular edema (DME). Alimera expects that 24-month interim data from these clinical trials will be available in late 2009, and we currently anticipate that Alimera will file a New Drug Application (NDA) with the FDA in early 2010. DME is a potentially blinding eye disease that affects over one million people in the United States. Currently there are no FDA-approved drugs for the treatment of DME.
Alimera is also sponsoring studies designed to assess the safety and efficacy of Iluvien in wet and dry age-related macular degeneration and retinal vein occlusion.
About pSivida Corp.
pSivida is a world leader in the development of tiny, sustained release, drug delivery products that are administered by implantation, injection or insertion. pSivida's lead development product delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME). This product candidate, formerly known as Medidur FA for DME, is licensed to Alimera, which is conducting fully recruited Phase III clinical trials and intends to commercialize the product under the name Iluvien. pSivida also has two products approved by the Food and Drug Administration (FDA): Retisert for the treatment of uveitis and Vitrasert for the treatment of AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. under which Pfizer may develop additional ophthalmic products.
pSivida owns the rights to develop and commercialize a modified form of silicon known as BioSilicon, which has potential therapeutic applications. The most advanced BioSilicon product candidate, BrachySil, delivers a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors. pSivida has completed an initial safety clinical trial of BrachySil for the treatment of pancreatic cancer and is nearing completion of a follow-on dose-ranging clinical trial.
pSivida's intellectual property portfolio consists of 62 patent families, over 100 granted patents, including patents accepted for issuance, and over 200 patent applications. pSivida conducts its operations from Boston in the United States and Malvern in the United Kingdom.
For more information, call 312/943-1123.
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|Publication:||Biotech Financial Reports|
|Article Type:||Financial report|
|Date:||Nov 1, 2009|
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