{"id":2289,"date":"2016-02-10T07:08:59","date_gmt":"2016-02-10T12:08:59","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=2289"},"modified":"2025-06-03T08:33:43","modified_gmt":"2025-06-03T14:33:43","slug":"the-10-x-20-goal-are-we-on-track","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2016\/02\/10\/2289\/the-10-x-20-goal-are-we-on-track\/","title":{"rendered":"The 10 x \u201920 Goal \u2013 Are We On Track?"},"content":{"rendered":"

\"10x20<\/a><\/p>\n

In the last decade (2000-2010), we saw the number of new antibiotic approvals drop successively each year; FDA changed the rules of the approval process without providing public guidance; many antibiotic companies fled the therapeutic area; investments were redirected to oncology projects which had a much better ROI.<\/p>\n

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

The IDSA 10 x \u201920 initiative was meant to reverse the trend and set the goal of 10 new antibiotics by 2020. With resistant pathogens popping up everywhere, MRSA had already become a household name. The campaign for renewed antibiotic development was highly publicized, and frequent news about drug resistance, the \u2018end of the antibiotic era\u2019 and other gloomy stories added support for the message that we need a new generation of antibiotics soon. The existing\u00a0armamentarium of antibiotics was coming to the end of its useful lifespan.\u00a0 There was hope that \u2013 with\u00a0some regulatory hurdles removed \u2013 companies would re-engage.<\/p>\n

Where do we stand now, in Year 6 of this 10-Year productivity plan? For sure, most\u00a0companies that once had focused\u00a0on antibacterial R&D have not returned (Bayer, Novartis, Roche, Pfizer, AZ) and the effort at GSK and Merck seems\u00a0rather minimalistic\/opportunistic relying mostly\u00a0on IMI and government \/ BARDA funding to support their in-house ID programs.<\/p>\n

We have to thank the many small and mid-size companies for carrying the torch. \u00a0Regarding approvals, the glass is more than half-full. It looks as if we were – at least quantitatively – on track meeting the 10 x \u201920 IDSA objective, as the list shows:<\/p>\n

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

Of course there were some other noteworthy advances and antibiotic approvals. Sirturo (bedaquiline) was approved (somewhat surprisingly given the imbalance in mortality) for the treatment of MDR tuberculosis in December 2012, and \u00a0Dificid (fidaxomicin) made quite a splash with very good data (fewer recurrent infections) when it was approved in May 2011. \u00a0Additional indications were garnered by several drugs during this time frame; telavancin\u2019s approval for HABP\/VABP caused by S. aureus in 2013 stands as an example for several others.<\/p>\n

But let\u2019s face it: most of the energy and excitement in the last 5 years came from the HCV arena where break-through drugs created all the excitement (and industry interest).<\/p>\n

Looking back at our list of systemic antibacterials above, we can take comfort in the numerical progress made. ID folks have a tendency to complain a lot: first, they wanted more Gram-positive drugs for MRSA, when they materialized, they complained about the lack of Gram-negative drugs. Industry actually heeded the call otherwise we’d be much worse off.<\/p>\n

Looking forward, the list of Phase 3 candidates nearing NDA and approval status is a mixed bunch of drugs providing at best incremental improvements in spectrum. \u00a0There is at least 1 more avibactam combination in development (aztreonam\/avibactam) but all other drugs in late-stage development are from well-known classes (see our recently updated QIDP<\/a> list). What is still lacking is significant qualitative differentiation. The field of Phase 2 drugs is a bit more diversified and has some outstanding candidates but most are without big company backing and are moving forward at a snail’s pace.<\/p>\n

There has been progress and there is a good chance that the goals of the 10 x ’20 initiative can be met. \u00a0So far, so good: 6 new antibiotics in 6 years is quite an achievement given the circumstances. Let’s hope the trend continues as the current pipeline is still quite empty. We lack depth in the candidate field: If one fails, there is just no fast-follower to replace a failed front-runner.<\/p>\n

Let’s keep fingers crossed…<\/p>\n

General Reference:
\n<\/strong>H Boucher.\u00a010 \u00d7 \u201920 Progress –\u00a0Development of New Drugs\u00a0Active Against Gram-Negative Bacilli: An\u00a0Update From the Infectious Diseases Society of\u00a0America. Clin Infect Dis 2013 –\u00a0DOI: 10.1093\/cid\/cit152<\/p>\n","protected":false},"excerpt":{"rendered":"

In the last decade (2000-2010), we saw the number of new antibiotic approvals drop successively each year; FDA changed the rules of the approval process without providing public guidance; many antibiotic companies fled the therapeutic area; investments were redirected to oncology projects which had a much better ROI. The IDSA Continue reading The 10 x \u201920 Goal \u2013 Are We On Track?<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":2296,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_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},"jetpack_post_was_ever_published":false},"categories":[3,18],"tags":[1271,403,1515,585,974,1468,595,220,1516,828,288,344,66,85,1520,236,89,425,717,1517,1583,1514,588,433,234,67,434,655,923,173,184,200,1518,462,7,1519,435,86,728,1470],"class_list":["post-2289","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the_news","category-the_viewpoint","tag-allphase-pharma-consulting","tag-antibiotic-blog","tag-antibiotic-pipeline","tag-astrazeneca","tag-avycaz","tag-aztreonamavibactam","tag-basilea","tag-bayer","tag-bedaquiline","tag-ceftaroline","tag-ceftazidimeavibactam","tag-ceftolozanetazobactam","tag-dalbavancin","tag-dalvance","tag-defensin","tag-delafloxacin","tag-dificid","tag-eravacycline","tag-fabi-inhibitor","tag-fidoxamicin","tag-harald-reinhart","tag-mdr-drugs","tag-merck","tag-omadacycline","tag-orbactiv","tag-oritavancin","tag-paratek","tag-pfizer","tag-pol7080","tag-polyphor","tag-roche","tag-shionogi","tag-sirturo","tag-sivextro","tag-tedizolid","tag-televancin","tag-tetraphase","tag-vibativ","tag-zerbaxa","tag-zinforo"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/02\/10x20-blog-slider-copy-e1455107451132.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-AV","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":5040,"url":"https:\/\/allphasepharma.com\/dir\/2025\/08\/21\/5040\/an-intro-to-emblaveo-aztreonam-avibactam\/","url_meta":{"origin":2289,"position":0},"title":"An Intro to Emblaveo (aztreonam + avibactam)","author":"Harald","date":"August 21, 2025","format":false,"excerpt":"The FDA web site usually provides label and review documents for approved drugs.[1]\u00a0 Emblaveo, the combination of aztreonam and avibactam, was approved in February 2025, almost \u00bd year ago, but clinical review documents are still not posted at the site.[2]\u00a0 Hence, we do not know how Regulators felt about the\u2026","rel":"","context":"In "Recent Literature"","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/08\/avibactam-Stick-Model.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/08\/avibactam-Stick-Model.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/08\/avibactam-Stick-Model.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/08\/avibactam-Stick-Model.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/08\/avibactam-Stick-Model.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/08\/avibactam-Stick-Model.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":972,"url":"https:\/\/allphasepharma.com\/dir\/2014\/09\/29\/972\/perusing-the-literature\/","url_meta":{"origin":2289,"position":1},"title":"Perusing the Literature","author":"Harald","date":"September 29, 2014","format":false,"excerpt":"Inhibitor\u00a0of the\u00a0NDM\u00a0Enzyme Aspergillomarasmine (AMA) was identified as an inhibitor of the New Delhi metallo-betalactamase (NDM) enzyme. 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