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ViiV与杨森合作开发HIV药物Tivicay/Edurant复方片

来源:生物谷 2014-06-12 19:08

2014年6月12日讯 /生物谷BIOON/ --葛兰素史克(GSK)和辉瑞(Pfizer)合资公司ViiV Healthcare 6月12日宣布,与强生(JNJ)旗下杨森(Janssen)签署了一项合作协议,开发和商业化含dolutegravir(商品名Tivicay)和rilpivirine(商品名Edurant)的复方片剂。此次合作,也代表着ViiV的首个外部合作。

Tivicay(dolutegravir)是一种HIV整合酶抑制剂,该药为每日一次的口服药物,已获FDA、欧盟、加拿大批准,与其他抗逆转录病毒制剂联合用于既往已治疗过、或初治HIV-1成人和12岁及以上青少年感染者的治疗。

Edurant(rilpivirine)为高活性的抗逆转录病毒治疗(HAART)药物之一,属于非核苷类逆转录酶抑制剂(NNRTI),通过阻断HIV复制来发挥作用,该药已获批与其他抗逆转录病毒药物联合用于初治HIV-1成人感染者的治疗。

作为协议的一部分,双方将调查dolutegravir/rilpivirine单一片剂的潜力,以扩大HIV患者的治疗选择。新的开发项目预计将于2015年第一季度启动,同时,双方还将进一步探索固定剂量组合dolutegravir/rilpivirine用于儿科患者的开发潜力。

如果获批,这种dolutegravir/rilpivirine固定剂量组合疗法将有望为HIV感染者提供一种选择,一旦稳定抑制病毒载量后,可从当前标准的3种药物组合疗法转向dolutegravir/rilpivirine固定剂量组合疗法。(生物谷Bioon.com)

英文原文:ViiV Healthcare announces new collaboration with Janssen to investigate single-tablet regimen for maintenance treatment of HIV-1

Agreement is ViiV Healthcare’s first external collaboration for development of a two drug single-tablet combining dolutegravir and rilpivirine

ViiV Healthcare today announced that they have entered into an agreement with Janssen R&D Ireland Ltd (Janssen) for the development and commercialisation of a single-tablet combining dolutegravir (Tivicay®) and Janssen’s non-nucleoside reverse transcriptase inhibitor rilpivirine (Edurant®[1]). This represents ViiV Healthcare’s first external collaboration to develop a single-tablet regimen with another company’s branded product and builds on ViiV Healthcare’s strategy to expand its portfolio of dolutegravir-based regimens, which started with the approval of dolutegravir for use in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs) in the US, and HIV infected adults and adolescents above 12 years of age in Europe.

As part of this agreement, the two companies will investigate the potential of combining dolutegravir and rilpivirine into a single-tablet in order to expand the treatment options available to people living with HIV.  Studies included in the new development programme are expected to begin by Q1 2015 and will investigate the two drug combination regimen as an HIV maintenance therapy for patients already virally suppressed on a three drug regimen. The companies will further investigate the development of paediatric fixed-dose formulations which combine dolutegravir and rilpivirine.

“New options that advance current therapies are increasingly important as patients and clinicians consider HIV care over the long term,” said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. “Through this collaboration with Janssen we aim to develop a new combination therapy that meets the needs of patients, and adds to our scientific understanding of dolutegravir.”

If approved by regulatory authorities, the two drug fixed-dose combination therapy being developed by ViiV Healthcare and Janssen could offer people living with HIV an option to switch from a standard three drug therapy to a two drug nucleoside reverse transcriptase inhibitors (NRTI)-sparing combination, once a stable suppressed viral load has been achieved.

 “ViiV Healthcare’s foundation was a novel business model, established to focus on pursuing the most effective outcomes for all people living with HIV. This collaboration builds on our mission to continually develop innovative new solutions to provide people living with HIV new treatment options,” said Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare.

Paediatric licence: The companies will further investigate the development of paediatric fixed-dose combinations of dolutegravir and rilpivirine. There are about 3.3 million children living with HIV worldwide; approximately 66% of those needing treatment do not have access to appropriate care and medicines. Among several barriers preventing further scale up of the numbers of children on treatment is the lack of medicines that are palatable and acceptable for use by children[i].

Since the company’s founding, ViiV Healthcare has been committed to improving scientific understanding and treatment options for infants and children living with HIV. This includes a broad range of initiatives supported through a £10 million Paediatric Innovation Seed Fund, which aims to improve paediatric HIV research, care and treatment in resource-limited settings, and the Positive Action for Children Fund which supports 150 organisations across 30 countries to deliver programmes designed to prevent mother-to-child transmission of HIV.

Important Information about Tivicay® (dolutegravir)

FDA Indication and Usage in the US:  TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children aged 12 years and older and weighing at least 40 kg. The following should be considered prior to initiating TIVICAY: poor virologic response was observed in subjects treated with TIVICAY 50 mg twice daily with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including L74I/M, E138A/D/K/T, G140A/S, Y143H/R, E157Q, G163E/K/Q/R/S, or G193E/R.

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