{"id":1314,"date":"2015-03-25T11:28:14","date_gmt":"2015-03-25T15:28:14","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=1314"},"modified":"2015-03-26T15:33:05","modified_gmt":"2015-03-26T19:33:05","slug":"aerosolized-antibiotics-selling-nebulizers","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2015\/03\/25\/1314\/aerosolized-antibiotics-selling-nebulizers\/","title":{"rendered":"Aerosolized Antibiotics & Selling Nebulizers"},"content":{"rendered":"

\u201cThe medicine comes for free, just pay us for the inhaler\u201d should be the marketing slogan for this group of therapeutics.\u00a0 Nebulizers are good business: hard to copy as a delivery system, they are a great opportunity to \u2018evergreen\u2019 off-patent antibiotics.<\/p>\n

The inhalational route to administer antibiotics is clearly attractive.\u00a0 The ease of delivery, the much reduced systemic exposure, and high local concentrations at the site of infection are major advantages over pills.\u00a0\u00a0 Remember the days when inhaled pentamidine was used for prophylaxis of P. carinii \u00a0(P. jiroveci) pneumonia?\u00a0 This otherwise toxic drug was reasonably well tolerated by the respiratory route, and with clear benefits to patients.<\/p>\n

Hence, there are good reasons to belief that antibiotics given by the pulmonary route will work for other pulmonary infections as well.\u00a0 Problems for developers are mainly related to local tolerability and the technical issues of controlling particle size, hygroscopicity, and dose-metering, not so much safety concerns.<\/p>\n

As it turns out, proving the efficacy of inhaled antibiotics is not a trivial pursuit.\u00a0 The precedent-setting TOBI (tobramycin PodHaler) for cystic fibrosis, has paved the way for the entire \u2018genre\u2019 of drugs now in the pipeline showing\u00a0 how functional improvement (FEV1) is the efficacy marker required for approval.\u00a0 Hence, it is FEV1 , not microbiologic eradication (which is not achievable) or reduction in CFU\/mL (which is achievable) that companies use as primary efficacy endpoint as far as I can tell.<\/p>\n

The commercial success of TOBI (approx. \u00a0USD 300-400 mio\/year) is quite impressive.\u00a0 Approved by FDA in 1997, it is just the right incentive for small companies to pursue respiratory delivery systems.\u00a0 Nonetheless, so far, only 1 other inhaled antibiotic has been approved in the US:\u00a0 In 2010, Cayston (inhaled aztreonam) was approved after a long gestation period at FDA and a bitterly fought battle between Gilead and regulators.<\/p>\n

Here the\u00a0inhalational drugs in development\u00a0\u00a0I was able to find:<\/p>\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t
Product Name<\/th>Drug<\/th>Company<\/th>Inhaler<\/th>Indication<\/th>\n<\/tr>\n<\/thead>\n
AeroVanc<\/td>Vancomycin<\/td>Savara Pharmaceuticals<\/td>proprietary DPI<\/td>CF with MRSA<\/td>\n<\/tr>\n
Amikacin Inhale<\/td>Amikacin<\/td>Bayer \/ Nektar<\/td>Nektar's Pulmonary Drug Delivery System (PDDS)<\/td>VAP adjunctive<\/td>\n<\/tr>\n
Arikayce<\/td>Amikacin \/ liposomal<\/td>Insmed Pharmaceuticals<\/td>Optimized PARI investigational eFlow\u00ae Nebulizer System<\/td>CF, NTM<\/td>\n<\/tr>\n
Ciprofloxacin DPI<\/td>Ciprofloxacin<\/td>Bayer HealthCare<\/td>Novartis' PulmoSphere\u2122 technology T-326 DPI<\/td>Non-Cystic Fibrosis Bronchiectasis<\/td>\n<\/tr>\n
N.N.<\/td>Amikacin + fosfomycin<\/td>Cardeas Pharma<\/td>PARI Investigational eFlow\u00ae Inline Nebulizer<\/td>VAP adjunctive<\/td>\n<\/tr>\n
Pulmaquin \/ Lipoquin<\/td>Ciprofloxacin \/ liposomal<\/td>Aradigm Pharmaceuticals<\/td>AERx inhaler<\/td>Bronchiectasis, CF, COPD, biodefense<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

As you will notice, these are not like your grandma\u2019s Ventolin inhalers any more: they are high-tech devices featuring breath-activated delivery and high efficiency reliable drug delivery.\u00a0 And some look pretty slick too.<\/p>\n

However, it is hard to\u00a0understand why all of them garnered QIDP status. \u00a0Should the next 10 quinolones and aminoglycosides all\u00a0get a patent extension just for doing a CF study,with a new inhaler of course?<\/p>\n

Nonetheless,\u00a0I am glad to see vancomycin and fosfomycin on the list of inhaled antibiotics undergoing development.\u00a0 Maybe other drug classes will join the list as well.\u00a0 I am thinking of antifungals (like amphotericin for pulmonary aspergillosis), or the new antivirals (for RSV bronchiolitis). \u00a0There certainly are markets for these indications,\u00a0bundled with a new inhaler, of course.<\/p>\n

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

\u201cThe medicine comes for free, just pay us for the inhaler\u201d should be the marketing slogan for this group of therapeutics.\u00a0 Nebulizers are good business: hard to copy as a delivery system, they are a great opportunity to \u2018evergreen\u2019 off-patent antibiotics. The inhalational route to administer antibiotics is clearly attractive.\u00a0 Continue reading Aerosolized Antibiotics & Selling Nebulizers<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":1320,"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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[19,3,18],"tags":[893,403,594,897,888,336,220,892,890,596,885,42,891,901,5,904,898,889,598,213,896,174,902,895,894,900,500,903,886,887,48,899],"class_list":["post-1314","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-qidp_antibiotic","category-the_news","category-the_viewpoint","tag-aerovanc","tag-antibiotic-blog","tag-aradigm","tag-arikayce","tag-aspergillosis","tag-aztreonam","tag-bayer","tag-bronchiectasis","tag-bronchiolitis","tag-cardeas","tag-cayston","tag-ciprofloxacin","tag-cystic-fibrosis","tag-dpi","tag-fda","tag-fev1","tag-fosfomycin","tag-inhaled-antibiotics","tag-insmed","tag-levofloxacin","tag-nektar","tag-novartis","tag-pari-eflow-nebulizer","tag-pentamidine","tag-podhaler","tag-pulmosphere","tag-rsv","tag-sawara","tag-tobi","tag-tobramycin","tag-vancomycin","tag-ventolin"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/03\/Inhaler-slider-copy.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-lc","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":2942,"url":"https:\/\/allphasepharma.com\/dir\/2016\/12\/15\/2942\/antibiotic-inhalers-galore-part-1-more-combinations-permutations-rubiks-cube\/","url_meta":{"origin":1314,"position":0},"title":"Antibiotic Inhalers Galore (Part 1): \u00a0More Combinations and Permutations than a Rubik\u2019s Cube","author":"Harald","date":"December 15, 2016","format":false,"excerpt":"There is much interest in inhaled antibiotics these days.\u00a0 Prima facie, the logic for this approach is compelling: Getting the antibiotic (and a lot of it) directly to the site of infection, while avoiding systemic toxicity, sounds like optimized efficacy plus optimized safety combined.\u00a0 However, some high-profile failures were published\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\/2016\/12\/Inhalational-Abx-slider.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/12\/Inhalational-Abx-slider.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/12\/Inhalational-Abx-slider.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":2205,"url":"https:\/\/allphasepharma.com\/dir\/2015\/12\/23\/2205\/qidp-antibiotics-2015-year-end-update\/","url_meta":{"origin":1314,"position":1},"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":3174,"url":"https:\/\/allphasepharma.com\/dir\/2017\/02\/20\/3174\/google-news-week-antibiotics\/","url_meta":{"origin":1314,"position":2},"title":"Google Search for News on “Antibiotics”","author":"Harald","date":"February 20, 2017","format":false,"excerpt":"The top-line news articles that come up on a Google search when one enters the term \u201cantibiotics\u201d is truly an eclectic bunch. Here is Page 1 of search results after eliminating some duplications. We have a few comments on these headlines for \u201cBreaking News\u201d. Antibiotics, not surgery, could treat appendicitis\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\/2017\/02\/Google-Slider-blog.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/02\/Google-Slider-blog.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/02\/Google-Slider-blog.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":846,"url":"https:\/\/allphasepharma.com\/dir\/2014\/09\/07\/846\/growth-promotion-now-called-prophylaxis-the-logic-of-chicks\/","url_meta":{"origin":1314,"position":3},"title":"Growth Promotion Now Called Prophylaxis \u2013 The Logic of Chicks","author":"Harald","date":"September 7, 2014","format":false,"excerpt":"California is getting rid of a time-honored justification for antibiotic use in veterinary medicine [1].\u00a0 No longer will it be acceptable to prescribe them for \u00a0\u201dgrowth promotion\u201d, but rather only for \u201cprophylaxis\u201d.\u00a0 Just like in humans, so it is argued, does prudent use of antibiotics have a place in prevention,\u2026","rel":"","context":"In "The News"","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"Broiler Battery","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/09\/Indiapoultry.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":2911,"url":"https:\/\/allphasepharma.com\/dir\/2016\/11\/25\/2911\/prospecting-antibiotics\/","url_meta":{"origin":1314,"position":4},"title":"Prospecting for New Antibiotics","author":"Harald","date":"November 25, 2016","format":false,"excerpt":"The QIDP designation was introduced in 2012 to incentivize drug development in antiinfectives. 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