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Danoprevir HCV Protease Roche China Deal
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EASL/2012: RAPID AND SUSTAINED ACHIEVEMENT OF UNDETECTABLE HCV RNA DURING TREATMENT WITH RITONAVIR-BOOSTED DANOPREVIR/PEG-IFNα-2A/RBV IN HCV GENOTYPE 1 OR 4 PATIENTS: DAUPHINE WEEK 36 INTERIM ANALYSIS...............
http://www.natap.org/2012/EASL/EASL_35.htm
EASL: RITONAVIR SUBSTANTIALLY REDUCES REACTIVE METABOLITE FORMATION OF THE HCV PROTEASE INHIBITOR DANOPREVIR BOTH IN VITRO AND IN VIVO - (04/21/12)
Roche, Ascletis to jointly develop investigational Hepatitis-C drug in China
http://contractresearch.pharmaceutical-business-review.com
16 April 2013
Roche and Ascletis have collaborated to develop and commercialize investigational Hepatitis-C drug danoprevir in China.
Roche's investigational protease inhibitor Danoprevir is a potent Hepatitis-C Virus (HCV) therapeutic active against HCV genotypes 1 and 4.
Roche Pharmaceuticals Asia Pacific head Luke Miels said, "The decision to develop danoprevir based on its promising profile in HCV Genotype 1b, and to do this via collaboration with our partner Ascletis represents another example of this strategy in action."
As per the terms of the deal, Ascletis will carry out danoprevir development, regulatory and manufacturing activities in greater China, including Taiwan, Hong Kong and Macau.
Both the companies will jointly carry out clinical development and the commercialization activities.
Roche will make certain development and commercial milestone payments in addition to royalties to Ascletis.
Ascletis president and CEO Jinzi Wu said presently there are no marketed direct antiviral agents (DAAs) available for hepatitis C in China.
"Roche is a global leader in the development of innovative Hepatitis C therapies, and we are pleased to be collaborating with Roche to develop and eventually commercialize this much needed medicine for Chinese patients," Wu added.
"Furthermore, we are very encouraged by the clinical data that have emerged to date and looking forward to bringing this novel DAA to patients in need."
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Roche taps local expertise for hep C drug in China
Partners with Chinese-American biotech company Ascletis
Roche has enlisted the aid of Chinese-American biotech company Ascletis to help bring its hepatitis C virus (HCV) therapy danoprevir to the market in China.
Under the terms of the deal, Ascletis will have responsibility for funding the development, registration and manufacturing of danoprevir in greater China - including Taiwan, Hong Kong and Macau - in return for payments on development and commercial milestones.
The two companies will share responsibility for clinical development and commercialisation of the drug under the deal, which also includes a royalty stream.
China is one of the largest markets for HCV infections worldwide, with 10 million people chronically infected with the virus. Many of these are infected with HCV genotype 1b, a strain which has proved "highly responsive" to danoprevir, according to Ascletis.
Danoprevir is a small-molecule NS3/4A protease inhibitor with a similar mode of action to two other directly-acting HCV drugs - Merck & Co's Victrelis (boceprevir) and Vertex Pharma/Janssen's Incivek (telaprevir) - which reached the market in 2011 but are not yet available in China.
Therapy for HCV relies on the use of interferon-alpha in combination - such as Roche's own Pegasys (peginterferon alfa-2a) - given alongside the oral drug ribavirin. Adding directly-acting antiviral agents to that background therapy has been shown to provide a significant boost to treatment efficacy in terms of achieving sustained virologic responses.
Commenting on the link-up with Ascletis, Luke Miels, head of Roche's Asia-Pacific pharma operations, said: "our strategy is based on bringing innovative, differentiated medicines to patients.
"The decision to develop danoprevir based on its promising profile in HCV genotype 1b patients, and to do this via a collaboration with our partner Ascletis represents another example of this strategy in action."
The agreement comes against a backdrop of increasing concern about HCV, particularly given that worldwide as few as 10 per cent of infected people receive treatment for the disease.
Last year, Roche said it had decided to focus the development of danoprevir as an add-on therapy to Pegasys in emerging markets after conceding it was lagging behind its rival in the protease inhibitor class.
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