New ETF Book by Larry Connors - Click here to read more
The approval covers Lipsovir's use in adults and children over 12 years of age for the early treatment of recurrent cold sores, to reduce the risk of cold sores, and to shorten the healing time for those which are not prevented. The drug is a combination of an anti-inflammatory agent hydrocortisone and acyclovir, an antiviral.
The FDA's approval of Lipsovir was based on the outcome of a Phase III program which comprised almost 3,000 patients in five studies and compared Lipsovir to the current gold-standard acyclovir, as well as placebo. The studies demonstrated that treatment with Lipsovir prevented the development of cold sores in 42% of patients in comparison to 35% in the acyclovir-only arm and 26% in the placebo arm.
Although the Lipsovir results were statistically significant, the drug appears to offer only a modest improvement over acyclovir in terms of prevention. That said, in those patients who nevertheless developed a cold sore, Lipsovir significantly reduced severity and reduced healing time by 1.5 days in comparison to placebo. Lipsovir was also well tolerated in all Phase III studies.
Medivir anticipates EU approval for Lipsovir in November or December 2009. However, the company lacks the infrastructure to successfully launch and market Lipsovir in the US by itself and is still seeking a suitable partner to facilitate commercialization. Medivir has stated that it will not launch Lipsovir until partnering efforts have been successful, aiming at a US launch in the first half of 2010. Datamonitor believes that while Lipsovir, which is available on prescription only, offers some improvements in terms of prevention and healing, the biggest threat for the drug will be the competition by generic acyclovir, which is well established and likely to be cheaper than Lipsovir.
http://www.datamonitor.com
Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon
More News:
Market Updates |
Stock Alerts |
All Trading News |
Stock Index
About TradingMarkets | Contact | Advertise | Careers | Link to Us | Site Map | Help | Terms & Conditions | Privacy Policy | Return Policy | Testimonials | Feedback
The Connors Group, Inc. ("Company") is not an investment advisory service, nor a registered investment advisor or broker-dealer and does not purport to tell or suggest which securities or currencies customers should buy or sell for themselves. The analysts and employees or affiliates of Company may hold positions in the stocks, currencies or industries discussed here. You understand and acknowledge that there is a very high degree of risk involved in trading securities and/or currencies. The Company, the authors, the publisher, and all affiliates of Company assume no responsibility or liability for your trading and investment results. Factual statements on the Company's website, or in its publications, are made as of the date stated and are subject to change without notice.
It should not be assumed that the methods, techniques, or indicators presented in these products will be profitable or that they will not result in losses. Past results of any individual trader or trading system published by Company are not indicative of future returns by that trader or system, and are not indicative of future returns which be realized by you. In addition, the indicators, strategies, columns, articles and all other features of Company's products (collectively, the "Information") are provided for informational and educational purposes only and should not be construed as investment advice. Examples presented on Company's website are for educational purposes only. Such set-ups are not solicitations of any order to buy or sell. Accordingly, you should not rely solely on the Information in making any investment. Rather, you should use the Information only as a starting point for doing additional independent research in order to allow you to form your own opinion regarding investments. You should always check with your licensed financial advisor and tax advisor to determine the suitability of any investment.
HYPOTHETICAL OR SIMULATED PERFORMANCE RESULTS HAVE CERTAIN INHERENT LIMITATIONS. UNLIKE AN ACTUAL PERFORMANCE RECORD, SIMULATED RESULTS DO NOT REPRESENT ACTUAL TRADING AND MAY NOT BE IMPACTED BY BROKERAGE AND OTHER SLIPPAGE FEES. ALSO, SINCE THE TRADES HAVE NOT ACTUALLY BEEN EXECUTED, THE RESULTS MAY HAVE UNDER- OR OVER-COMPENSATED FOR THE IMPACT, IF ANY, OF CERTAIN MARKET FACTORS, SUCH AS LACK OF LIQUIDITY. SIMULATED TRADING PROGRAMS IN GENERAL ARE ALSO SUBJECT TO THE FACT THAT THEY ARE DESIGNED WITH THE BENEFIT OF HINDSIGHT. NO REPRESENTATION IS BEING MADE THAT ANY ACCOUNT WILL OR IS LIKELY TO ACHIEVE PROFITS OR LOSSES SIMILAR TO THOSE SHOWN.
The Connors Group, Inc.
10 Exchange Place, Suite 1800
Jersey City, NJ 07302
© Copyright 2009 The Connors Group, Inc.
