{"id":445,"date":"2014-07-02T14:49:05","date_gmt":"2014-07-02T14:49:05","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=445"},"modified":"2014-11-10T22:29:56","modified_gmt":"2014-11-11T03:29:56","slug":"why-the-next-novel-antibiotic-will-cost-40k-or-more","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2014\/07\/02\/445\/why-the-next-novel-antibiotic-will-cost-40k-or-more\/","title":{"rendered":"Why The Next Novel Antibiotic Will Be A Blockbuster And Cost $40k"},"content":{"rendered":"
\"pills\"<\/a>
The Next Golden Bullet<\/figcaption><\/figure>\n

Looking at all antibiotics in the pipeline, I can\u2019t help but think that \u2013 by 2018 \u2013 there\u00a0will be\u00a0some blockbuster anti-infectives coming to the market. Why do I say this?\u00a0 What is going to generate this revenue stream for companies when the new crop of drugs will be restricted by label, by formularies, and probably by\u00a0a very limited activity spectrum? Because we have a convergence of several factor, all of which point to a great opportunity for companies willing to take on the risk, spend the money, and make the necessary development effort.<\/p>\n

Here is my rationale: Available antibiotics are already losing ground against pesky MDR pathogens and there will be an ever-increasing shortage of effective drugs as time goes on.\u00a0 Let\u2019s be realistic and assume that we can still handle most problem pathogens for another 5-10 years.\u00a0 The emphasis is on \u2018most\u2019: there will be a growing number of lethal XDR bugs that defy anything but surgery or fire. Any antibiotic \u2013 even narrow in spectrum \u2013 will be looked at as \u2018the savior\u2019 in these dismal cases.\u00a0 And rare cases can mean profitable business.<\/p>\n

Our colleagues in orphan drug development have shown that there is no segment too small for a life-saving drug to become a blockbuster. Look at Alexion or Genzyme. Would you have thought that drugs for\u00a0Paroxysmal Nocturnal Hematuria (PNH) or Gaucher\u2019s disease could be this profitable?<\/p>\n

Actually, we only remember\u00a0the price escalation brought about in the HCV area.\u00a0 For example, in 2007, a 48-wk treatment course of Peg-IFN plus ribavirin cost approx. $35k, made you feel pretty miserable, and gave you a 40-50% chance of cure. Compared to that, the new Gilead drug, sofosbuvir (Sovaldi\u00ae) with its $82k price tag is a bargain even in combination with other expensive drugs: the new Direct Acting Antivirals (DAA) can\u00a0achieve cure rates of 95%, are vastly better tolerated, and treatment is reduced to 24 weeks\u00a0or less.\u00a0 I consider that real progress.<\/p>\n

Looking over the fence at other therapeutic areas we see prices unheard of in the anti-infective arena.\u00a0 A cancer agent which only improve Progression-Free Survival (PFS) can cost $40k. By\u00a0contrast, a 2 week prescription of linezolid, one of the most innovative and expensive antibiotics, costs ~$1000.\u00a0 And daptomycin, our best MRSA drug so far, is to be had for ~$300 \/ day.<\/p>\n

The business model for ‘curative’ therapeutics like antibiotics is broken and needs to be changed. \u00a0This was the assessment and recommendation from the London School of Economics back in 2009 already (1).<\/p>\n

The next group of me-too drugs hitting the market will not ‘rock the boat’ of current pricing standards too much. \u00a0Although\u00a0some will bring significant improvements\u00a0in pharmacokinetics they offer\u00a0no quantum leap in efficacy profile.\u00a0 I am oversimplifying a bit here but these drugs cannot set prices without looking back\u00a0at linezolid, vancomycin, or penem antibiotics as references.<\/p>\n

Now, such backwards price point comparisons would not be meaningful for the next drug against, say, enterococci, acinetobacter, or what is known more broadly\u00a0the ESCAPE (2) pathogens. Think about it this way: \u00a0If you have an immunocompromised patient in the ICU who has XDR Klebsiella sepsis despite several courses of exotic antibiotic cocktails, you would want to have a Sovaldi-cillin or Sovaldi-mycin to give to that \u00a0patient.\u00a0 I know you would.\u00a0 And pay the sticker price that it comes with.<\/p>\n

\n

References:<\/strong><\/p>\n

(1)\u00a0Mossialos: http:\/\/www.lse.ac.uk\/LSEHealthAndSocialCare\/impacts\/LSEHealthNews\/News%20Attachments\/Policies%20and%20incentives%20report.pdf<\/p>\n

(2) ESKAPE =\u00a0Enterococcus faecium<\/em>,<\/span>Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumanii, Pseudomonas aeruginosa<\/em>, and\u00a0<\/span>Enterobacter<\/em>\u00a0species<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Looking at all antibiotics in the pipeline, I can\u2019t help but think that \u2013 by 2018 \u2013 there\u00a0will be\u00a0some blockbuster anti-infectives coming to the market. Why do I say this?\u00a0 What is going to generate this revenue stream for companies when the new crop of drugs will be restricted by Continue reading Why The Next Novel Antibiotic Will Be A Blockbuster And Cost $40k<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"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":[18],"tags":[238,242,403,235,92,228,236,240,239,126,72,181,83,25,137,48,241],"class_list":["post-445","post","type-post","status-publish","format-standard","hentry","category-the_viewpoint","tag-alexion","tag-antibiotic-blockbusters","tag-antibiotic-blog","tag-antibiotic-cost","tag-cubist","tag-daptomycin","tag-delafloxacin","tag-eskape","tag-genzyme","tag-gilead","tag-linezolid","tag-mdr","tag-mrsa","tag-sofosbuvir","tag-sovaldi","tag-vancomycin","tag-xdr"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-7b","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":2660,"url":"https:\/\/allphasepharma.com\/dir\/2016\/08\/27\/2660\/the-epipen-episode-an-epitaph-on-epinephrine-as-we-know-it-an-epilogue-and-an-epiphany\/","url_meta":{"origin":445,"position":0},"title":"The EpiPen Episode, an Epitaph on Epinephrine as we know it, an Epilogue and an Epiphany","author":"Harald","date":"August 27, 2016","format":false,"excerpt":"For a good long time, economists have been thinking about the reimbursement quandary for antibiotics, esp. antibacterials. 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