{"id":1741,"date":"2015-07-17T04:42:09","date_gmt":"2015-07-17T08:42:09","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=1741"},"modified":"2015-07-17T05:31:05","modified_gmt":"2015-07-17T09:31:05","slug":"does-the-taxpayer-get-rewarded-for-funding-studies","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2015\/07\/17\/1741\/does-the-taxpayer-get-rewarded-for-funding-studies\/","title":{"rendered":"Does The Taxpayer Get Rewarded For Funding Such Studies?"},"content":{"rendered":"

\"LAP<\/a><\/p>\n

Cabotegravir (S-1265744) is an integrase inhibitor similar to dolutegravir. \u00a0When formulated as a long-acting drug using crystalline nanoparticle technology it is called GSK’744 LAP.\u00a0 When injected intramuscularly, ‘744 LAP it has a half-life of >1 month which makes it ideally suited for PrEP\u00a0of HIV for high-risk patients who nowadays are candidates for Truvada (tenofovir\/emtricitabine) prophylaxis.\u00a0 While the intracellular half-life of tenofovir (TFV) is several days, Truvada has to be taken once daily.<\/p>\n

\"cabotegravir\"<\/a>
Cabotegravir<\/figcaption><\/figure>\n
\"dolutegravir<\/a>
Dolutegravir<\/figcaption><\/figure>\n

Fig. 1+2:\u00a0 Both drugs are structurally almost identical.<\/span><\/p>\n

Compliance is a major issue in HIV therapy. \u00a0Hence, cabotegravir, injected every 3 months, would greatly improve adherence and therefore reduce the risk of HIV transmission.<\/p>\n

This is the rationale why HPTN (the HIV Prevention Trial Network) is actively supporting PrEP studies with long-acting agents like cabotegravir.<\/p>\n

According to an announcement from Feb 18, 2015, HPTN<\/a>\u00a0<\/span>has launched two new Phase 2 studies for long-acting prophylaxis drugs:
\n– Protocol 076: \u00a0TMC278 LA \/ rilpivirine – the NNRTI from Janssen
\n– Protocol 077: \u00a0GSK1265744 LAP \/ cabotegravir – developed by GSK and\u00a0ViiV<\/p>\n

Because of the public health importance of HIV and the non-profit nature of HPTN, these studies are\u00a0supported by 3 major grants from NIH and NIAID:
\n– Award # UM1AI068619 (HPTN Leadership &\u00a0Ops Center) –\u00a0$ 20,980,154<\/span>
\n<\/a><\/span>– Award # UM1AI068617 (HPTN Statistical &\u00a0Data Mgmt\u00a0Center) –\u00a0$ 9,184,867<\/span>
\n– Award # UM1AI068613 (HPTN Laboratory Center) –\u00a0$ 1,327,398<\/span><\/p>\n

It is good to see such generous funding\u00a0for worthwhile projects, and nothing said here should be construed to suggest that the goals of these trials are without merit or that NIH funding for HIV drug development is inappropriate.\u00a0 Just the opposite: Such studies are valuable, should be conducted, and executed expeditiously and with the best\u00a0available expertise .<\/p>\n

What seems unclear is the payback to the TAX PAYER: Who will reap the financial benefits when rilpivirine LA or cabotegravir LAP get approved?\u00a0 Does anyone want to guess?\u00a0 I venture to say that GSK and JNJ will be the sole beneficiaries, without consideration of the gracious support extended by NIH and NIAID. With $31 mio already granted for Phase 2 studies, I am curious about the price tag for the Phase 3 programs and how much more public funding\u00a0will NIH provide.<\/p>\n

It is good to see your tax dollars being used for anti-infective programs; we certainly need more MDR antibiotics, and these 2 long-acting HIV drugs will address an unmet need. However, both are\u00a0me-too drugs and\u00a0should not get federal funding without a decent ROI for the taxpayer as well. We are\u00a0not dealing with VC companies in need of a government hand-out: \u00a0NIH is\u00a0giving money to\u00a0the world\u2019s biggest of Big Pharma companies.<\/p>\n

Once on the market the price tag for either drug will make your eyes water \u2013 we are talking retail prices as\u00a0high as for HCV drugs. However, these long-acting HIV drugs are not just given for 12 weeks but …for life!<\/p>\n

Bottom line: This is the next great money-making opportunity for GSK and JNJ. It seems that – finally –\u00a0<\/span>HIV drugs beat oncology drugs as\u00a0revenue generators for ‘Ethical Pharma’.<\/span><\/p>\n

If taxpayer money is used in the development process, the price of the marketed drug should be considerably lower to the patient taxpayer who funded this research. My guess is that the monies from NIH \/ NIAIDS did not come with these strings attached.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Cabotegravir (S-1265744) is an integrase inhibitor similar to dolutegravir. \u00a0When formulated as a long-acting drug using crystalline nanoparticle technology it is called GSK’744 LAP.\u00a0 When injected intramuscularly, ‘744 LAP it has a half-life of >1 month which makes it ideally suited for PrEP\u00a0of HIV for high-risk patients who nowadays are Continue reading Does The Taxpayer Get Rewarded For Funding Such Studies?<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":1746,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[140,3,18],"tags":[403,1171,188,191,1069,1162,246,1172,1169,1167,1168,419,1165,943,1164,1163,204,1096,638,418,1070,1160,1173,200,1174,1080,1067,1166,1161,1068,1170],"class_list":["post-1741","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-interesting_facts","category-the_news","category-the_viewpoint","tag-antibiotic-blog","tag-cabotegravir","tag-dolutegravir","tag-edurant","tag-emtricitabine","tag-glaxo","tag-gsk","tag-hiv-pre-exposure-prophylaxis","tag-hiv-prevention-trial-network","tag-hiv-therapeutics","tag-hptn","tag-insti","tag-integrase-strand-transfer-inhibitor","tag-janssen","tag-jnj","tag-johnson-johnson","tag-mdr-pathogens","tag-niaid","tag-nih","tag-nnrti","tag-prep","tag-rilpivirine","tag-roi","tag-shionogi","tag-taxpayer","tag-tdf","tag-tenofovir","tag-tibotec","tag-tivicay","tag-truvada","tag-viiv"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/07\/LAP-HIV-Drugs-slider-copy.jpg?fit=640%2C119&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-s5","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":1590,"url":"https:\/\/allphasepharma.com\/dir\/2015\/06\/22\/1590\/tenofovir-bmd-and-monitoring-of-renal-function\/","url_meta":{"origin":1741,"position":0},"title":"Tenofovir, BMD and Monitoring of Renal Function","author":"Harald","date":"June 22, 2015","format":false,"excerpt":"The approved tenofovir \/ Viread label lists not only standard\u00a0nucleoside-class side effects but also\u00a0\u2013 since an update in 2012 \u2013 makes mention of diminished bone mineral density (BMD) in the Warnings \/ Precautions section. 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