[e-med] Nouvelles associations antirétrovirales

["ReMeD" <c.bruneton@remed.org>]

[on n'arrête plus le progrès... au nord comme au sud!CB]

* Bristol-Myers Squibb Gilead Sciences And Merck Sharp &
Dohme Limited demande une AMM à l'EMEA pour l'Atripla° : efavirenz 600
mg/emtricitabine 200 mg/ fumarate de tenofovir disoproxil 300 mg

* Cipla annonce l'arrivée de sa nouvelle trithérapie, Viraday°: Efavirenz
600 mg, Tenofovir Disoproxil Fumarate 300 mg et Emtricitabine 200 mg

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BRISTOL-MYERS SQUIBB, GILEAD SCIENCES ET MERCK & CO PRÉSENTENT UNE DEMANDE
D'AUTORISATION DE COMMERCIALISATION POUR L'ATRIPLA° ( EFAVIRENZ 600 MG /
EMTRICITABINE 200 MG / FUMARATE DE TENOFOVIR DISOPROXIL 300 MG) À L'AGENCE
EUROPÉENNE
http://www.itnews.it
Bristol-Myers Squibb Company (NYSE : BMY), Gilead Sciences, Inc. (Nasdaq
:GILD) et Merck & Co., Inc. (NYSE : MRK) ont annoncé aujourd'hui la
présentation à l'Agence européenne des médicaments d'une demande
d'autorisation de commercialisation (DAC) pour l'ATRIPLA(MC) (efavirenz 600
mg/emtricitabine 200 mg/ fumarate de tenofovir disoproxil 300 mg) dans
l'Union Européenne. La DAC fera l'objet d'un examen par le Comité des
médicaments à usage humain (CHMP), sous réserve de validation par l'EMEA.La
DAC pour l'ATRIPLA dans l'Union Européenne a été remplie conjointement par
les trois sociétés, par le truchement d'une nouvelle coentreprise tripartite
sise en Irlande, Bristol-Myers Squibb Gilead Sciences And Merck Sharp &
Dohme Limited. L'EMEA examinera la DAC en vertu de sa procédure de licence
centralisée qui, une fois achevée, accordera une autorisation de
commercialisation dans tous les États membres de l'Union Européenne. Les
pourparlers entre les trois sociétés concernant des ententes de fabrication,
de commercialisation et de distribution de l'ATRIPLA dans l'Union Européenne
sont en cours.L'ATRIPLA est une posologie à comprimé quotidien unique,
approuvée aux États-Unis pour le traitement des infections au VIH-1 chez les
adultes.
http://www.itnews.it/risorse/EuroNews,Zj0xNDQ4NDc2

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[Cipla annonce l'arrivée de sa nouvelle association de 3 ARV, Viraday°:
Efavirenz 600 mg,
Tenofovir Disoproxil Fumarate 300 mg et Emtricitabine 200 mg]

Press Release

Breakthrough one-pill-a-day
HIV treatment is here from Cipla
This is possibly the brightest news since the scourge of HIV/AIDS began
spreading its darkness across the world in the late 1980s.
Cipla announces the launch of Viraday, a breakthrough combination of
anti-HIV drugs in a single pill, which can be taken just once a day.
Viraday is a combination of three anti-HIV drugs: Efavirenz 600 mg,
Tenofovir Disoproxil Fumarate 300 mg and Emtricitabine 200 mg. Cipla is the
first company to manufacture all the three active ingredients indigenously,
and the first to make the formulation in India. Cipla's achievement is
remarkable in terms of speed - the combination became available in the
international market just a few weeks ago; and in terms of cost - Cipla
offers Viraday at retail price of Rs. 5,200 a month, a fraction of the
wholesale international price of approximately US$ 1,100 (approximately Rs.
52,800) a month.
The medical fraternity has waited a long time for such a breakthrough. It
gives a big boost to dosage adherence and makes it easier for patients to
comply with drug regimentation as advised by the doctor. This is a vital
issue in HIV treatment. If patients do not correctly adhere to treatment it
can result in lowering the immune system and also developing resistance to
the drugs used.
The number of medicines, the number of times in a day they have to be taken,
and their side effects - all these affect adherence. On all these counts,
Viraday is very patient-friendly.
Just one pill a day and freedom from the side effects and resistance to some
other anti-HIV drugs.
Cipla has been a forerunner in harnessing its R & D efforts to reduce the
"pill burden" for patients on anti-HIV treatment. The company was the first
to introduce innovative treatment kits and the three-in-one (twice a day)
pills that have gone a long way to promote adherence and ease of use.
Viraday with its convenient one-pill-a-day dosage and accessibility is
Cipla's
most significant achievement yet.
Cipla has repeatedly reduced the prices of various anti-HIV drugs in recent
years, and has been at the forefront of initiatives to make them available
at affordable prices for patients in more than 130 countries. "In our own
way, we make living easier for those affected by HIV, regardless of their
circumstances," said a Cipla spokesperson. "Viraday is another milestone
achievement in our mission, that none should  be denied."
Other breakthrough anti-HIV drugs are in Cipla's pipeline as well.