{"id":2911,"date":"2016-11-25T11:57:00","date_gmt":"2016-11-25T16:57:00","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=2911"},"modified":"2025-09-20T19:17:21","modified_gmt":"2025-09-21T01:17:21","slug":"prospecting-antibiotics","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2016\/11\/25\/2911\/prospecting-antibiotics\/","title":{"rendered":"Prospecting for New Antibiotics"},"content":{"rendered":"

\"engine-qidp-blog\"<\/a><\/span><\/p>\n

The QIDP designation was introduced in 2012 to incentivize drug development in antiinfectives. QIDP came with several attractive features, such as prolongation of patent life, FDA\u00a0expedited review and more.\u00a0 In addition, FDA made it quite easy to garner the label.\u00a0 As you can see, there is really no downside to obtaining QIDP status. Therefore, it would seem logical that antibiotics in development with any degree of differentiation would clamber for recognition as QIDP drugs.<\/p>\n

There may be good reasons to request QIDP at a particular time in development: early on for external validation of a project, or at a later stage in order to attract funding or to \u2018dress up the bride\u2019 before that all-important outlicensing effort gets underway. \u00a0It is hard to think of a situation in which a company would want to forgo applying for QIDP status altogether unless the drug was moribund or about to become shelved.<\/p>\n

Right after its introduction, we saw\u00a0a flurry of QIDP announcements reflecting pent-up demand from an existing pipeline. After this initial wave, one would expect things to settle down to a steady state as new applicants backfilled the pipeline.\u00a0 Sadly, 2016 is shaping up to become a particularly dry harvest year (Table 1<\/strong>):<\/p>\n

\"table-1\"<\/a>
Table 1: Number of FDA designated QIDP antibiotics\u00a0by year<\/figcaption><\/figure>\n

After excluding antifungals and topical, inhalational, and non-absorbed compounds, we are left with the following tally of systemically active antibacterial drugs (Table 2<\/strong>):<\/p>\n

\"table-2\"<\/a>
Table 2: Number of FDA designated systemically active QIDP antibiotics per year<\/figcaption><\/figure>\n

We are now in the second year of single digit QIDP nominations, not a pretty picture, for sure. Those 5 new antibiotics that garnered QIDP status in 2016 are highlighted\u00a0below (Table 3<\/strong>):<\/p>\n

\"table-3\"<\/a>
Table 3: Systemically active QIDP drugs by Phase and Novel Class<\/figcaption><\/figure>\n

If one considers QIDP as a pull incentive, it has failed us: There is\u00a0only a very small number of preclinical and early compounds which can be swept off the roster rather quickly. In this fragile field, we found only 2 candidate drugs with a truly novel MoA: TXA-709, a drug directed against the bacterial FtsZ ring protein, a critical and validated cell division target, and GSK-2140944, a topoisomerase II\u00a0inhibitor that is different from the established fluoroquinolone class. Btw, the Entasis compound ETX-0914 falls into the same category.<\/p>\n

We are not sure whether MCB-3837, a quinolone linked to an oxazolidinone, should be listed as a new antibiotic class. Confusingly, this combination is being referred to as \u2018oxaquin\u2019 which happens to be a trade name for moxifloxacin in some parts of the world.<\/p>\n

Noticeably absent from this year\u2019s list are QIDP awards for some other new MoA drugs which should have matured by now. \u00a0We are thinking of the LpxC, FabI, PDF and tRNA synthase inhibitors, just to mention a few. Some of these have been in clinical development for a long\u00a0time already; the Chiron \/ Novartis LpxC inhibitor is no longer in development but Achaogen’s ACH-975, a perpetually preclinical LpxC inhibitor, is still on their pipeline chart. GSK really had bad luck with GSK-2251052, a tRNA synthase inhibitor from Anacor but Crestone\u00a0continues to work on a compound for topical use. The Affinium, now Debiopharm FabI, has been leading a life in the shadows for a very long time; it is time for all these projects to out themselves.<\/p>\n

As it stands, the QIDP engine is barely cranking and certainly not developing much torque. Nevertheless, in the spirit of Thanksgiving, let’s stay positive: We still have antibiotics that work. We will need to really start worrying about the pipeline once veterinarians stop using antibiotics in livestock because growth promotion no longer works.<\/p>\n","protected":false},"excerpt":{"rendered":"

The QIDP designation was introduced in 2012 to incentivize drug development in antiinfectives. QIDP came with several attractive features, such as prolongation of patent life, FDA\u00a0expedited review and more.\u00a0 In addition, FDA made it quite easy to garner the label.\u00a0 As you can see, there is really no downside to Continue reading Prospecting for New Antibiotics<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":2912,"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":true,"_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":[140,19,3,18],"tags":[1820,1825,1829,1271,403,1515,585,175,1623,1826,1306,1222,578,5,1833,246,1636,1827,1583,183,1821,1807,1822,1809,47,174,1362,1835,1823,115,1832,1834,1371,1830,1831,1629,1828,1819],"class_list":["post-2911","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-interesting_facts","category-qidp_antibiotic","category-the_news","category-the_viewpoint","tag-aai-101","tag-ach-975","tag-affinium","tag-allphase-pharma-consulting","tag-antibiotic-blog","tag-antibiotic-pipeline","tag-astrazeneca","tag-chiron","tag-crestone","tag-debiopharm","tag-entasis","tag-etx-0914","tag-fabi","tag-fda","tag-ftsz","tag-gsk","tag-gsk-2140944","tag-gsk-2251052","tag-harald-reinhart","tag-lpxc-inhibitor","tag-mat-2501","tag-matinas","tag-mcb-3837","tag-morphochem","tag-moxifloxacin","tag-novartis","tag-novel-moa","tag-novel-moa-antibiotics","tag-oxaquin","tag-pdf-inhibitor","tag-pull-incentive","tag-push-pull-incentive","tag-qidp","tag-systemically-active-qidp-antibiotics","tag-taxis-pharma","tag-topoisomerase-ii-inhibitor","tag-trna-synthase-inhibitor","tag-txa-709"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/11\/Engine-QIDP-blog.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-KX","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":2205,"url":"https:\/\/allphasepharma.com\/dir\/2015\/12\/23\/2205\/qidp-antibiotics-2015-year-end-update\/","url_meta":{"origin":2911,"position":0},"title":"QIDP Antibiotics – 2015 Year-End Update","author":"Harald","date":"December 23, 2015","format":false,"excerpt":"Here an updated listing of all QIDP drugs we are aware of as of 12\/24\/2015. Today just\u00a0facts and numbers; we will provide an interpretation of the current landscape in upcoming blogs. There are\u00a058 drugs which garnered QIDP status and these are listed in the Main Table below. With the recent\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/12\/QIDP-slider.jpg?fit=640%2C200&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/12\/QIDP-slider.jpg?fit=640%2C200&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/12\/QIDP-slider.jpg?fit=640%2C200&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":2817,"url":"https:\/\/allphasepharma.com\/dir\/2016\/10\/24\/2817\/qidp-drug-update-part-2-categories-of-interest\/","url_meta":{"origin":2911,"position":1},"title":"QIDP Drug Update \u2013 Part 2: \u00a0Categories of Interest","author":"Harald","date":"October 24, 2016","format":false,"excerpt":"According to Janet Woodcock, 63 drugs have been given the \u201cQIDP\u201d designation so far. Our inofficial list has 61 drugs, of which we believe only 57 are still in active clinical development.\u00a0 So we are in fairly close agreement. That may seem like an impressive record but it is also\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"qidp-part2-slider","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/10\/QIDP-Part2-slider.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/10\/QIDP-Part2-slider.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/10\/QIDP-Part2-slider.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":3211,"url":"https:\/\/allphasepharma.com\/dir\/2017\/03\/05\/3211\/qidp-liberal-hand-out-fda\/","url_meta":{"origin":2911,"position":2},"title":"QIDP, a Liberal Hand-Out from FDA","author":"Harald","date":"March 5, 2017","format":false,"excerpt":"On our blog site, \u2018QIDP\u2019 stands for \u201cQualified Infectious Diseases Product\u201d but when you look up \u2018QIDP\u2019 on the internet, you will find that it also stands for \u201cQualified Intellectual Disabilities Professional\u201d. Looking at the more recent crop of ID products that garnered QIDP status, you wonder whether there is\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/03\/Great-Heist-slider.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/03\/Great-Heist-slider.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/03\/Great-Heist-slider.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":1332,"url":"https:\/\/allphasepharma.com\/dir\/2015\/03\/28\/1332\/drugs-with-qidp-designation-update-3282015\/","url_meta":{"origin":2911,"position":3},"title":"Drugs with QIDP Designation \u2013 Update 4\/8\/2015","author":"Harald","date":"March 28, 2015","format":false,"excerpt":"For the latest QIDP listing, please click HERE Our latest internet search came up with 37 drugs that garnered QIDP status.\u00a0 They are listed in the Table below (if I missed a compound, please leave a comment!!). \u00a0The\u00a0table is searchable so you should be able to massage the data to\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"APPC + QIDP copy","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/10\/APPC-QIDP-copy.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/10\/APPC-QIDP-copy.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/10\/APPC-QIDP-copy.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":2802,"url":"https:\/\/allphasepharma.com\/dir\/2016\/10\/18\/2802\/qidp-drug-update-part-1-an-updated-who-is-who\/","url_meta":{"origin":2911,"position":4},"title":"QIDP Drug Update \u2013 Part 1: An Updated Who Is Who","author":"Harald","date":"October 18, 2016","format":false,"excerpt":"It is time for a new look at the field of QIDP drugs. 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While an official FDA list of drugs that have\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/04\/FDA-GAIN-LPAD-banner-copy.jpg?fit=640%2C200&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/04\/FDA-GAIN-LPAD-banner-copy.jpg?fit=640%2C200&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/04\/FDA-GAIN-LPAD-banner-copy.jpg?fit=640%2C200&ssl=1&resize=525%2C300 1.5x"},"classes":[]}],"jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/2911","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/comments?post=2911"}],"version-history":[{"count":13,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/2911\/revisions"}],"predecessor-version":[{"id":2931,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/2911\/revisions\/2931"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media\/2912"}],"wp:attachment":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media?parent=2911"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/categories?post=2911"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/tags?post=2911"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}