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Medicines Company -MDCO 216 (ApoA-I Milano)

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samenvoegen....

[Posted 02/09/2012]

ISSUE: FDA notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together.

A drug interaction study showed that taking boceprevir (Victrelis) with ritonavir (Norvir) in combination with atazanavir (Reyataz) or darunavir (Prezista), or with Kaletra (lopinavir/ritonavir) reduced the blood levels of the HIV medicines and boceprevir in the body (see Data Summary below). FDA will be updating the Victrelis drug label to include information about these drug interactions.

BACKGROUND: Victrelis is a hepatitis C virus (HCV) protease inhibitor used with the medicines pegiBACKGROUND: Victrelis is a hepatitis C virus (HCV) protease inhibitor used with the medicines peginterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C infection in adults. HIV protease inhibitors are a class of anti-viral drugs used to treat HIV infection. Ritonavir is an HIV protease inhibitor used to “boost” other HIV protease inhibitors, increasing their levels in the blood and making them more effective.

RECOMMENDATION: Patients should not stop taking any of their medicines without talking to their healthcare professional. Patients should contact their healthcare professional if they have any questions or concerns.

Healthcare professionals who have started patients infected with both chronic HCV and HIV on Victrelis and antiretroviral therapy containing a ritonavir-boosted protease inhibitor should closely monitor patients for HCV treatment response and for potential HCV and HIV virologic rebound.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
nterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C infection in adults. HIV protease inhibitors are a class of anti-viral drugs used to treat HIV infection. Ritonavir is an HIV protease inhibitor used to “boost” other HIV protease inhibitors, increasing their levels in the blood and making them more effective.
patient
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MDCO-216 (formerly referred to as apoA-I Milano): MDCO-216 is a naturally occurring variant of a
protein found in human high-density lipoprotein (HDL) that has the potential to reverse atherosclerotic
plaque development and reduce the risk of coronary events in patients with ACS. The company
exclusively licensed MDCO-216 from Pfizer Inc. in December 2009. As per the terms of the agreement,
Pfizer received an up-front payment of $10 million and will receive additional payments upon the
achievement of certain clinical, regulatory, and sales milestones up to a total of $410 million. Pfizer will
also be eligible to receive single-digit royalty payments on worldwide net sales of MDCO-216. The
company received the transfer of technology and know-how from Pfizer in 2Q10. The company expects
to submit an IND and commence a phase I study in 2H12.

www.zacks.com/ZER/rd_get_pdf.php?r=MDCO
wiegveld
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Heel lang van de radar, maar nu groot nieuws. Ik verwacht dat de koers die al ver is opgelopen de afgelopen dagen verder stijgt als de studie geheel openbaar wordt of in beste geval in aanloop daarvan stijgt.

www.fiercepharma.com/marketing/amgen-...
wiegveld
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Na enkele dagen licht dalende koers en vandaag Wall Street op slot wordt vanavond de inclirisan studie gepresenteerd.

54% daling slecht cholesterol met halfjaarlijkse toediening en niet meer bijwerkingen dan placebo. Klinkt te mooi om waar te zijn. Slecht nieuws voor Amgen en Sanofi met hun PCKS 9 remmers. Morgen verwacht ik daling van die twee en forse stijging van dit bedrijf.

www.themedicinescompany.com/investor/...
wiegveld
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Mooie koerssprong op dieprode beurs. Naar $ 47 en meer vandaag na goede resultaten.
Verkopen gaf binnen 1 week ruim 10% winst!
Wacht op pull back en in derde kwartaal komen er meer resultaten.
Succes
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