{"id":15925,"date":"2011-12-01T12:18:15","date_gmt":"2011-12-01T12:18:15","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=15925"},"modified":"2013-09-30T06:49:28","modified_gmt":"2013-09-30T06:49:28","slug":"new-formulations-acquisitions-and-company-announcements","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/15925","title":{"rendered":"New formulations, acquisitions and company announcements"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/strong><\/p>\n

The last two months have been a lively time for pharmaceutical industry announcements concerning Fixed Dose Combinations (FDCs) and new compounds in the HIV and hepatitis pipelines.<\/strong><\/p>\n

Integrase FDC Quad submitted to the FDA<\/h2>\n

At the end of October, Gilead submitted a new drug application (NDA) to the US regulatory agency (FDA) for its four-drug formulation of elvitegravir, cobicistat, tenofovir and FTC (Quad). This is based on 48-week data from two Phase 3 studies.<\/p>\n

Three weeks later Quad was also filed with the European Medicines Agency (EMA).<\/p>\n

If these applications are given a fast track review a decision will be made by both agencies within six months.<\/p>\n

Reference: Gilead press release: Gilead submits new drug application to U.S. FDA for once-daily, single-tablet ‘Quad’ HIV regimen (27 October 2011).<\/p>\n

Planned co-formulations of cobicistat with atazanavir, darunavir and darunavir\/FTC\/GS7340<\/h2>\n

On 26 October, Bristol-Myers Squibb (BMS) announced that it has entered an agreement to develop and market an FDC of its protease inhibitor atazanavir (Reyataz) with a pharmacokinetic booster cobicistat, currently in development with Gilead. [1]<\/p>\n

Phase 2 and 3 studies of atazanavir using cobicistat boosting are ongoing in treatment-naive patients.<\/p>\n

Cobicistat has a similar inhibitory impact on cytochrome P450 3A (CYP3A) and similar side effect profile to ritonavir.<\/p>\n

Earlier this year a similar agreement was reached between Gilead and Tibotec to produce an FDC of darunavir with cobicistat. [2]<\/p>\n

The press release also referred a further collaborate to produce an FDC of darunavir plus FTC together with cobicistat plus the new tenofovir prodrug (GS7340).<\/p>\n

Reference:<\/p>\n

    \n
  1. Press release: Bristol-Myers Squibb and Gilead Sciences announce licensing agreement for development and commercialisation of new Fixed Dose Combination pill for People Living with HIV. (26 October 2011).<\/li>\n
  2. Press release: Gilead Sciences announces agreement with Tibotec Pharmaceuticals to develop and commercialise a new fixed-dose combination of cobicistat and darunavir (Prezista). (28 June 2011).<\/li>\n<\/ol>\n

    Gilead license integrase inhibitor compounds from Boehringer Ingelheim<\/h2>\n

    Gilead acquired a license for exclusive worldwide rights for the research, development and commercialisation of its novel non-catalytic site integrase inhibitors (NCINIs) for HIV. This includes the lead compound BI 224436, which has been evaluated in a Phase 1a dose-escalation study to assess bioavailability and pharmacokinetics in healthy volunteers.<\/p>\n

    NCINIs inhibit HIV integrase by binding to a novel site, distinct from the catalytic site used by the current class of integrase inhibitors, and therefore may possess a differentiated resistance profile from raltegravir or elvitegravir.<\/p>\n

    Reference:
    \nPress statement: Gilead and Boehringer Ingelheim sign license agreement for novel HIV non-catalytic integrase inhibitors. (05 October 2011).<\/p>\n

    Gilead spends $11 billion to buy Pharmasset<\/h2>\n

    Finally, on 21 November 2011, Gilead announced that it would acquire Pharmasset for the not insignificant cost of $11 billion from “cash on hand, bank debt and senior unsecured notes”.<\/p>\n

    Pharmasset currently has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials in various populations.<\/p>\n

      \n
    • The lead product compound, PSI-7977, an unpartnered uracil nucleotide analogue, has recently been advanced into two Phase 3 studies in genotype 2 and 3 patients. Both studies use 12 weeks of treatment with PSI-7977 in combination with ribavirin. Comparitor arms include pegylated : ?interferon\/ribavirin in treatment-na? patients, and placebo in interferon- intolerant\/ineligible patients. A third Phase 3 study in genotype 1 patients will be initiated in the second half of 2012.<\/li>\n
    • PSI-938, an unpartnered guanosine nucleotide analogue, is being tested in a Phase 2b interferon-free trial as monotherapy and in combination with PSI-7977 in subjects with HCV of all viral genotypes.<\/li>\n
    • Mericitabine (RG7128), a cytidine nucleoside analogue, is partnered with Roche and is being evaluated in three Phase 2b trials. Roche is responsible for all aspects of the development of mericitabine.<\/li>\n<\/ul>\n

      Reference:
      \nPress statement: Gilead Sciences to acquire Parmasset Inc for $11 billion. (21 November 2011).<\/p>\n

      Abbott to separate treatment from medicinal products in company split<\/h2>\n

      Abbott, the research-based company responsible for developing lopinavir\/ritonavir (Kaletra) and ritonavir (Norvir) which has a annual revenue close to $18 billion dollars announced that it plans to divide into two separate companies: one focused on research and treatment and the other on diversified medical products.<\/p>\n

      The press statement listed immunology, Multiple Sclerosis, chronic kidney disease, Hepatitis C, women’s health and oncology, but not HIV, as future research priorities.<\/p>\n

      Reference:
      \nPress statement: Abbott to Separate into Two Leading Companies in Diversified Medical Products and Research-Based Pharmaceuticals. (19 October 2011).<\/p>\n","protected":false},"excerpt":{"rendered":"

      Simon Collins, HIV i-Base The last two months have been a lively time for pharmaceutical industry announcements concerning Fixed Dose Combinations (FDCs) and new compounds in the HIV and hepatitis pipelines. Integrase FDC Quad submitted to the FDA At the …<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-15925","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15925","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=15925"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15925\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=15925"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=15925"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=15925"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}