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zu VPHM... Cinryze entwickelt sich ganz gut ViroPharma Provides 2010 Cinryze(TM) (C1 Esterase Inhibitor [Human]) Outlook http://finance.yahoo.com/news/ViroPharma-Provides-2010-prnew… - Company Also Provides Update to U.S. Hereditary Angioedema (HAE) Peak Year Sales Estimates - EXTON, Pa., Jan. 11 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that Vincent Milano, president and chief executive officer of ViroPharma, will provide an overview of the company's business and present a financial update during the 28th Annual J.P. Morgan Healthcare Conference. As previously announced, this presentation will be webcast live at 11:00 A.M. ET (8:00 A.M. PT) on Wednesday, January 13, 2010 and may be accessed via the company's website at www.viropharma.com . The company expects to release full-year 2009 financial results and further discuss 2010 guidance later in the first quarter of 2010. "The ultimate reward for us in any given year is to achieve our goal of providing solutions for patients with serious diseases and unmet medical needs; 2009 was a remarkable year in that respect," stated Vincent Milano, ViroPharma's chief executive officer. "In 2009 we successfully launched Cinryze™ (C1 esterase inhibitor [human]), the first and only drug approved to prevent HAE attacks. Thanks to meticulous execution by our team, we were able to provide Cinryze during 2009 to over 400 patients who are now actively preventing their attacks. We are pleased to announce that for 2009, we expect our net Cinryze sales will be toward the high end of our previous guidance range of $90 to $95 million, placing Cinryze among the best ever launches of an ultra orphan drug product." Milano continued, "Our momentum into 2010 is also strong, as we announced this morning an agreement with our partner, Sanquin for the global rights to market and develop Cinryze, and as we continue our execution on our manufacturing scale up efforts to serve HAE patients including the hundreds who are now enrolled in CinryzeSolutions™. We are now producing Cinryze through our scaled-up parallel chromatography process, or PCP, which will begin to enter the trade in the second quarter of this year. Further, we recently conducted a successful meeting with the FDA on our industrial scale initiative where we were able to confirm our previous expectations of the path forward for this significantly expanded manufacturing process. As a result, we are announcing 2010 Cinryze net sales guidance of between $145 and $165 million, which represents tremendous revenue growth over 2009. Although we anticipate that we will be profitable in 2010, we will provide our full guidance later in the first quarter of this year. Finally, I am pleased to announce we have increased our projection of U.S. HAE peak year Cinryze sales to between $350 and $450 million. Our objective continues to be to ensure that every patient who can benefit from Cinryze will have access to this important drug." *********** ViroPharma expands licensing deal for angioedema drug Cinryze http://philadelphia.bizjournals.com/philadelphia/stories/201… ViroPharma Inc. said Monday it has expanded it global licensing deal for Cinryze with Sanquin Blood Supply Foundation in the Netherlands. The Exton, Pa., specialty pharmaceutical company said the revised agreement “significantly expands ViroPharma's rights to commercialize Cinryze in regions beyond the originally licensed territories of North America, most of the countries in South America, and Israel, and allows for development of potential new indications.” In October 2008, the Food and Drug Administration approved the use of Cinryze to prevent against angioedema attacks in adolescent and adult patients with hereditary angioedema or HAE. HAE is a rare, severely debilitating, and life-threatening genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein. The drug is only approved in the United States. “We have developed an outstanding relationship with Sanquin during the first year of the launch of Cinryze in the United States, and the expansion of our collaboration represents a significant step in our combined efforts to expand the potential markets in which we may commercialize Cinryze,” said Vincent Milano, ViroPharma's president and CEO. Milano said ViroPharma (NASDAQ:VPHM) will look to getting Cinryze approved in new territories and for other C1-mediated diseases. The company also plans to develop new forms of administration for the drug, which is now delivered intravenously. Under the terms of the expanded deal, which involved no upfront payments, ViroPharma agreed to modify the existing manufacturing fee, establish minimum purchase requirements, fund research efforts at Sanquin at the rate of 1 million Euros ($1.45 million) a year for five years, and provide an additional loan to Sanquin to fund capacity expansions. ViroPharma has been granted the exclusive right and license to research, develop, obtain regulatory approvals for and commercialize Cinryze in all countries in Europe and the rest of world, other than certain European and other territories in which Sanquin has existing relationships. ViroPharma also has been granted the right to develop Cinryze for all potential new indications. mfg ipollit |
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| aus der Diskussion: | Biotech Depot 2010 |
| Autor (Datum des Eintrages): | ipollit (12.01.10 00:17:13) |
| Beitrag: | 47 von 334 (ID:38713781) |
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