pSivida Given a 'Speculative Buy Class A' Rating by Australian Bioshares Newsletter
The editors of the publication concluded "pSivida has important drug delivery assets in its possession. It has the right blend of emerging technologies that are just hitting the market with strong commercial potential, backed by its still to be commercialized BioSilicon(TM) technology. Overlaying this is a proven technology development team led by Paul Ashton."
“pSivida has important drug delivery assets in its possession. It has the right blend of emerging technologies that are just hitting the market with strong commercial potential, backed by its still to be commercialized BioSilicon(TM) technology. Overlaying this is a proven technology development team led by Paul Ashton.”
The editors of Bioshares specifically focused on Retisert(TM) and Medidur(TM), implantable drug delivery systems for the back of the eye that can be used to deliver drugs for the treatment of a number of sight threatening diseases.
Retisert(TM) is licensed to Bausch and Lomb, for the treatment of chronic non-infectious posterior segment uveitis, the third largest cause of blindness in the United States where it afflicts an estimated 175,000 people and 800,000 people worldwide. Retisert(TM) is co-marketed in the United States by Bausch & Lomb and Novartis.
Medidur(TM) is undergoing phase III clinical trials and is licensed to Alimera Sciences for the treatment of Diabetic Macular Edema (DME), the leading cause of vision loss in people under the age of 65 in the United States with an estimated 500,000 treatable cases. There are presently no FDA approved drug treatments for DME.
The Bioshares report analyses clinical test results demonstrating gains in the vision acuity of DME patients treated with Retisert(TM) as compared to alternate products being developed for the disease. The publication concluded that Retisert(TM) was "arguably superior" to other treatments for this condition. A copy of the report is attached and also available at www.psivida.com.
pSivida is a global bio-nanotech company committed to the biomedical sector and the development of drug delivery products. Retisert(TM) is FDA approved for the treatment of uveitis. Vitrasert(R) is FDA approved for the treatment of AIDS-related CMV Retinitis. The technologies underlying both of these products are licensed to Bausch & Lomb. The technology underlying Medidur(TM), a treatment for diabetic macular edema, is licensed to Alimera Sciences and is in Phase III clinical trials.
pSivida owns the rights to develop and commercialize a modified form of silicon (porosified or nano-structured silicon) known as BioSilicon(TM), which has applications in drug delivery, wound healing, orthopaedics, and tissue engineering. pSivida's subsidiary, AION Diagnostics Limited is developing diagnostic products and the subsidiary pSiNutria is developing food technology products both using BioSilicon(TM).
pSivida's intellectual property portfolio consists of 70 patent families, 74 granted patents and over 290 patent applications.
pSivida conducts its operations from offices and facilities near Boston in Massachusetts, Malvern in the United Kingdom, Perth in Western Australia and Singapore.
pSivida is listed on NASDAQ (PSDV), the Australian Stock Exchange (PSD) and in Germany on the Frankfurt Stock Exchange on the XETRA system (German Symbol: PSI. Securities Code (WKN) 358705). pSivida is a founding member of the NASDAQ Health Care Index and the Merrill Lynch Nanotechnology Index.
The Company's largest shareholder and a strategic partner is QinetiQ, a leading international defense, security and technology company, formed in July 2001 from the UK Government's Defence Evaluation & Research Agency (DERA). QinetiQ was instrumental in discovering BioSilicon(TM) and pSivida enjoys a strong relationship with it having access to its cutting edge research and development facilities. For more information visit www.QinetiQ.com
For more information, visit www.psivida.com
This document contains forward-looking statements that involve risks and uncertainties. The statements are indicated by the use of words such as "believes", "expects", "anticipates" and similar words and phrases. Although we believe that the expectations reflected in such forward-looking statements are reasonable at this time, we can give no assurance that such expectations will prove to be correct. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Actual results could differ materially from those anticipated in these forward-looking statements due to many important factors including: the failure of the results of the Retisert for DME trial to be a good indicator of the results of pSivida's ongoing Phase III Medidur(TM) for DME trial; failure of the Medidur(TM) trials in DME to show a very similar improvement in visual acuity and diabetic retinopathy severity score as Retisert(TM) for DME; inability to recruit patients for the Phase III Medidur(TM) for DME trial; our failure to develop applications for BioSilicon(TM) due to regulatory, scientific or other issues, our inability to successfully integrate CDS' operations and employees; the failure of the CDS' products to achieve expected revenues and the combined entity's inability to develop existing or proposed products; the failure of the Bausch & Lomb/Novartis co-promotion arrangement to provide faster royalty growth. Other reasons are contained in cautionary statements in the Registration Statement on Form 20-F filed with the U.S. Securities and Exchange Commission, including, without limitation, under Item 3.D, "Risk Factors" therein. We do not undertake to update any oral or written forward-looking statements that may be made by or on behalf of pSivida.