- Data Includes a Late-breaking Oral Presentation of 24-Week Interim Data of the TMC435 phase 2b PILLAR Study -
HUDDINGE, Sweden, Oct 29, 2010 (BUSINESS WIRE) -- Regulatory News:Medivir AB (omx:MVIR), a research-based specialty pharmaceutical company focused on infectious diseases will hold a conference call for analysts and investors and a breakfast meeting in Boston, USA, for US based investors, analysts and media on Tuesday 2nd November 2010. Both events will discuss Medivir's lead development product TMC435, a once-daily hepatitis C protease inhibitor in phase 2b development, which is being jointly developed by Medivir and Tibotec Pharmaceuticals.
Hosts, Rein Piir (CFO/IR), Bertil Samuelsson, (CSO) and Asa Rosenquist, (Director Medicinal Chemistry) will provide an update on the development of TMC435, which is the subject of four posters and one oral presentation being presented at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place from 29 October to 2 November 2010 in Boston, USA.
The details are as follows:
Conference Call For Analysts and Investors:
Tuesday, November 2, 2010 at 6.30am EDT / 10.30am GMT / 11.30am CET Please register for the conference call online at: http://invite.taylor-rafferty.com/_Medivir/ConferenceCall
You will receive the dial-in and replay numbers for the conference call following your online registration.
Breakfast Meeting for US based Analysts, Investors and Media
Tuesday November 2, 2010 at 7:00am -- 8.30am EDT (breakfast will be served between 7:00am -- 7.30am EDT) Venue: Colonnade Hotel, Braemore & Kenmore Room 120 Huntington Avenue, Boston Please confirm your participation by registering on-line: http://invite.taylor-rafferty.com/_Medivir/Breakfast/default.htm
For enquiries please contact: Lindsey Neville at M:Communications on +44 (0)20 7920 2333 or Jason Marshall on +1 212 889 4350 or email Neville@mcomgroup.com
Accepted titles for Abstracts to be presented at the 2010 AASLD meeting are as follows:
Late Breaker Oral Presentation for presentation at Monday 1 Nov. 17:45 (EST): LB-5. "Efficacy and safety of TMC435 in combination with peginterferon a-2a and ribavirin in treatment-naive genotype-1 HCV patients: 24-week interim results from the PILLAR study."
Poster Presentations:
278. "In vitro studies investigating the mechanism of interaction between TMC435 and hepatic transporters." To be presented: Saturday 30 Oct, 14:00 (EST)
812. "Virologic analysis of genotype-1-infected patients treated with once-daily TMC435 during the Optimal Protease inhibitor Enhancement of Response to Therapy (OPERA)-1 study." To be presented: Sunday 31 Oct, 08:00 (EST)
895. "A Phase IIa, open-label study to assess the antiviral activity of TMC435 monotherapy in patients infected with HCV genotypes 2--6." To be presented: Sunday 31 Oct, 08:00 (EST)
1873. "Pharmacokinetic-pharmacodynamic analyses of TMC435 in patients infected with Hepatitis C Virus (HCV) genotypes 2 to 6." To be presented: Tuesday 2 Nov, 07:00 (EST).
About Medivir
Medivir is a research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development. Medivir has a strong R&D portfolio and has recently launched its first product Xerese(TM)/Xerclear(R). Medivir's key pipeline asset, TMC435, a protease inhibitor, is in phase 2b clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.
Xerese(TM)/Xerclear(R) is an innovative treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GSK to be sold OTC in Europe and Russia and with Meda in North America. Medivir has retained the Rx rights for Xerclear(R) in Sweden and Finland.
For more information about Medivir, please visit the Company's website: http://www.medivir.se/.
About TMC435 clinical trial programs
TMC435 is a once daily protease inhibitor jointly developed by Medivir and Tibotec Pharmaceuticals to treat hepatitis C virus infections. TMC435 is currently being studied in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in genotype 1 (G1) treatment-naive and in G1 patients that failed previous IFN-based treatment. TMC435 is planned to enter phase 3 studies early 2011.
PILLAR Study (TMC435-C205)
TMC435-C205 is an ongoing randomized double-blind global phase 2b study in 386 genotype-1 treatment-naive patients. It evaluates once daily treatment of TMC435 with different doses and durations given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.
ASPIRE Study (TMC435-C206)
TMC435-C206 is an ongoing randomized double-blind global phase 2b study in 463 genotype-1 treatment-experienced patients. It evaluates once daily treatment of TMC435 in with different doses of given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.
TMC435-C215
TMC435-C215 is an ongoing Japanese phase 2b study in 92 genotype-1 treatment-naive patients. It evaluates once daily treatment of TMC435 with different doses and durations given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.
Opera-2 (TMC435-C202)
TMC435-C202 is a completed phase 2a study in treatment-naive genotype 2 to 6 HCV patients. It is a once daily treatment of TMC435 during seven days, at 200 mg. Subsequently, patients could continue with Standard of Care treatment consisting of pegylated interferon and ribavirin upon agreement with the study doctor.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
This information was brought to you by Cision http://www.cisionwire.com/
SOURCE: Medivir
Medivir
CFO & VP Investor Relations Office:
Rein Piir, +46 8 546 831 23
Mobile: +46 708 537 292
http://www.medivir.seor/
M:Communications
Europe:
Mary-Jane Elliott/Emma Thompson/Amber Bielecka, +44(0)20 7920 2330
or
USA:
Jason Marshall, +1 212 897 5497
Medivir@mcomgroup.com
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