pSivida Reports Retisert(TM) Approved for Full US Medicare Rebate.PERTH, Australia -- Global bio-nanotech company pSivida Limited (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :PSDV PSDV Process Shut Down Valve (oil & gas) , ASX ASX See: Australian Stock Exchange :PSD (tool) PSD - Portable Scheme Debugger. , Xetra:PSI) today announced that the Centers for Medicare & Medicaid Services in the United States has designated the single-indication orphan drug Retisert(TM) as eligible for Medicare pass-through payment under the Hospital Outpatient Prospective Payment System (OPPS OPPS Outpatient Prospective Payment System (hospital/medical) ) effective 1 October 2005. This week, pSivida entered into a definitive merger agreement to acquire Control Delivery Systems (CDS), a private US drug delivery company located in the Boston, Massachusetts area. Retisert(TM) was developed by CDS and global eye care health company, Bausch & Lomb commenced marketing the product in the US in June. The acquisition of CDS is expected to close in the fourth quarter of 2005 and is subject to Australian regulatory and pSivida shareholder approvals, as well as other customary closing conditions. Retisert(TM) for Uveitis uveitis Inflammation of the uvea, the middle coat of the eyeball. Anterior uveitis, involving the iris or ciliary body (containing the muscle that adjusts the lens) or both, can lead to glaucoma and blindness. Bausch & Lomb's Retisert(TM)is the world's first intravireal drug implant for the treatment of this condition that affects an estimated 175,000 people in the United States and an estimated 800,000 people worldwide. The product received FDA fast track Fast Track is a designation of the Food and Drug Administration that accelerates the approval of experimental drugs, such as experimental cancer treatments, that treat a serious or life-threatening medical condition for which no other drug either exists or works as well. status, designed to allow for priority review of novel therapies for serious diseases for which there is an unmet medical need. It also received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. orphan drug designation for this indication. Control Delivery Systems anticipates receiving royalties from Bausch & Lomb from this product this year and is presently priced at US$18,250 for a treatment period of 30 months. A copy of the Bausch & Lomb media release is attached. CDS Revenues Control Delivery Systems had unaudited revenues of US$8 million for the year ended 30th June 2005 which does not include Retisert(TM) royalties as marketing of that product has only recently commenced by Bausch & Lomb. NOTES TO EDITORS: pSivida Limited pSivida is a global bio-nanotech company committed to the biomedical sector and the development of products in healthcare. The company's focus is the development and commercialization of a modified form of silicon (porosified or nano-structured silicon) known as BioSilicon(TM). pSivida owns the intellectual property pertaining to BioSilicon(TM) for use in or on humans and animals. The IP portfolio consists of 29 patent families, 34 granted patents and over 80 patent applications. The core patent, which recognizes BioSilicon(TM) as a biomaterial was granted in the UK in 2000 and in the US in 2001. pSivida is listed on NASDAQ (PSDV), the Australian Stock Exchange Australian Stock Exchange (ASX) Australia's major securities market, formed when the six state stock exchanges (Adelaide, Brisbane, Hobart, Melbourne, Perth, and Sydney stock exchanges) were merged in 1987. (PSD) and in Germany on the Frankfurt Stock Exchange Frankfurt Stock Exchange The largest of Germany's eight securities exchanges, operated by Deutsche Borse AS. on the XETRA system (German Symbol: PSI. Securities Code (WKN WKN Wertpapier-Kenn-Nummer (identifying number assigned to securities traded in Germany) WKN Warrior Knowledge Network (US Army) ) 358705). pSivida's shares also trade in the United Kingdom on the OFEX OFEX Off Exchange (Over-The-Counter Market established in 1995, Specialising in Smaller Companies) International Market Service (IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. ) under the ticker symbol PSD. pSivida is a founding member of the NASDAQ Health Care Index and the Merrill Lynch Nanotechnology Index. The Company's strategic partner and largest shareholder is the QinetiQ group, the largest science and technology company in Europe. QinetiQ is the former UK government Defence Evaluation Research Agency and was instrumental in discovering BioSilicon(TM). pSivida enjoys a strong relationship with QinetiQ having access to its cutting edge research and development facilities. For more information on QinetiQ visit www.qinetiq.com. For more information visit www.psivida.com This announcement does not constitute an offer of any securities for sale or the solicitation of an offer to buy any securities. Any securities offered may not be or have not been registered under the US Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements." This document contains forward-looking statements that involve risks and uncertainties. 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: our failure to develop applications for BioSilicon(TM) due to regulatory, scientific or other issues, our inability to negotiate and consummate the proposed acquisition, our inability to successfully integrate the CDS's operations and employees; the failure of the CDS's products to achieve expected revenues and the combined entity's inability to develop existing or proposed products. 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. Bausch & Lomb Announces Medicare Reimbursement Terms for Retisert(TM) 10/6/2005 8:01:00 AM EST EST electroshock therapy. EST abbr. electroshock therapy Bausch & Lomb announced today that the Centers for Medicare & Medicaid Services has designated the single-indication orphan drug Retisert(TM) (fluocinolone acetonide intravitreal implant), 0.59 mg, as eligible for Medicare pass-through payment under the Hospital Outpatient Prospective Payment System (OPPS) effective October 1. The payment rate to hospitals billing for Retisert using HCPCS HCPCS Healthcare Common Procedure Coding System code C9225 is set at $19,345, as reported in the October 2005 update of OPPS Addendum A on the CMS (1) See content management system and color management system. (2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system. website, http://www.cms.hhs.gov/providers/hopps. The payment methodology is based upon 106 percent of wholesale acquisition cost (WAC WAC (Women's Army Corps), U.S. army organization created (1942) during World War II to enlist women as auxiliaries for noncombatant duty in the U.S. army. Before 1943 it was known as the Women's Auxiliary Army Corps (WAAC). Its first director was Oveta Culp Hobby. ). Coding and payment amounts for non-Medicare procedures vary by insurer. Retisert was approved as a single-indication orphan drug by the U.S. Food and Drug Administration in April for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye, a sight-threatening inflammatory disease. Bausch & Lomb launched Retisert in the U.S. in June. The most common adverse events - which are anticipated given the nature of the disease and the type of drug used - include cataract progression, which is managed by standard cataract surgery; increased intraocular pressure, which is managed with the use of IOP-lowering eye drops or filtering surgery; and procedural complications and eye pain. Bausch & Lomb is the eye health company, dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Founded in 1853, the Company is headquartered in Rochester, New York This article is about the city of Rochester in Monroe County. For the town in Ulster County, see Rochester, Ulster County, New York. Rochester, once known as The Flour City, and more recently as The Flower City or . Bausch & Lomb's 2004 revenues were $2.2 billion; it employs approximately 12,400 people worldwide and its products are available in more than 100 countries. More information about the Company can be found on the Bausch & Lomb Web site at www.bausch.com. Copyright Bausch & Lomb Incorporated. TM/(R) denote trademarks of Bausch & Lomb Incorporated |
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