{"id":1105,"date":"2014-11-02T16:01:51","date_gmt":"2014-11-02T21:01:51","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=1105"},"modified":"2014-11-02T16:01:51","modified_gmt":"2014-11-02T21:01:51","slug":"dalbavancin-sale-to-actavis","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2014\/11\/02\/1105\/dalbavancin-sale-to-actavis\/","title":{"rendered":"Dalbavancin Sale to Actavis"},"content":{"rendered":"<p>When Pfizer bought dalbavancin and anidulofungin from Vicuron in 2005, it shelled out USD 1.9 billion for both Phase 3 drugs.\u00a0 One can argue whether each drugs had the same commercial value for Pfizer but it is safe to assume that dalbavancin was valued at approx. USD 1 billion at least.<\/p>\n<p>Now Actavis bought Durata and its sole asset, dalbavancin\/Dalvance, now an approved drug for a mere USD 675 mio.\u00a0 With QIDP status and a\u00a05-year patent extension the drug still has patent protection in the US until 2028\u00a0<a href=\"#_ftn1\" name=\"_ftnref1\">[1]<\/a>.\u00a0 Also, the need for a long-acting vancomycin replacement has not lost attractiveness over the years. \u00a0\u00a0So, at first glance, it may look like Durata sold for quite a bit under value.<\/p>\n<p>Neither the deal structure Durata had with Pfizer nor COGs can explain the low auction price. \u00a0From the perspective of a clinician (not a financial analyst), there are some obvious reasons the price tag has dropped off significantly, and it\u2019s not because of the drug per se but the changed market environment:<\/p>\n<ul>\n<li>Oritavancin\/Orbactiv development has caught up nicely with dalbavancin and the drugs were approved almost simultaneously this year. Hence, there is now a true competitor in the market.\u00a0 Compared to 2007 when dalbavancin could have hit the market as a unique product, it is now launched under less favorable circumstances.<\/li>\n<li>Oritavancin\u2019s one-time only dosing scheme is simpler and cleaner than the split dosing required for dalbavancin. FDA Ad Board members were concerned about patients not getting their 2<sup>nd<\/sup> dose, an issue for dalbavancin but not for oritavancin.\u00a0 By my standards, we could forget about the 2<sup>nd<\/sup> dose of dalbavancin as it adds nothing from a PK\/PD perspective, but that\u2019s not the approved label.<\/li>\n<li>Pricing for dalbavancin was set at USD 1490 for the 500 mg dose. Hence, a regular treatment course costs approx. USD 4500, i.e., significantly more than oritavancin which has a charge of USD 2900 for a single shot <a href=\"#_ftn2\" name=\"_ftnref2\">[2]<\/a>.\u00a0\u00a0 Again, by omitting the 2<sup>nd<\/sup> dalbavancin dose, the price difference disappears.<\/li>\n<\/ul>\n<p>FDA had some concerns about LFT abnormalities; however, the jury is still out on this.\u00a0 Once a few million patients have been treated, we should learn from the AERS system whether this is really of concern.\u00a0 So far there is no reason to believe that dalbavancin\u2019s efficacy and safety profile had anything to do with the low valuation.<\/p>\n<p>The perception about dalbavancin and its commercial prospects has clearly changed.\u00a0 At 66% above stock value, dalbavancin was not sold to Actavis for a pittance but at a downward corrected value due to changed times.<\/p>\n<p>This is still much of an uphill battle for Actavis.\u00a0 They will have their work cut out to even at this bargain price.\u00a0 As David Shaes wrote in a recent blog, Actavis is a newcomer to the antibiotic field and not all that experienced<a href=\"#_ftn3\" name=\"_ftnref3\">[3]<\/a>.\u00a0 They have recently acquired several antibiotics and have some tough portfolio decisions now.\u00a0 Maybe they felt that dalbavancin was a \u2018low hanging fruit\u2019 opportunistic investment they did not want to pass up.<\/p>\n<p>Unlike in 2005, there obviously was not much competition to drive the acquisition price up higher.<\/p>\n<p><strong>References:<\/strong><\/p>\n<p><a href=\"#_ftnref1\" name=\"_ftn1\">[1]<\/a> http:\/\/www.otcmarkets.com\/edgar\/GetFilingPdf?FilingID=9855751<br \/>\n<a href=\"#_ftnref2\" name=\"_ftn2\">[2]<\/a> JAMA Drugs for MRSA Skin and Soft-Tissue Infections\u00a0\u00a0 2014 Volume 312, 1583<br \/>\n<a href=\"#_ftnref3\" name=\"_ftn3\">[3]<\/a> D. Shlaes.\u00a0 Blog dated Oct 29, 2014 at http:\/\/antibiotics-theperfectstorm.blogspot.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>When Pfizer bought dalbavancin and anidulofungin from Vicuron in 2005, it shelled out USD 1.9 billion for both Phase 3 drugs.\u00a0 One can argue whether each drugs had the same commercial value for Pfizer but it is safe to assume that dalbavancin was valued at approx. USD 1 billion at <a class=\"more-link\" href=\"https:\/\/allphasepharma.com\/dir\/2014\/11\/02\/1105\/dalbavancin-sale-to-actavis\/\">Continue reading <span class=\"screen-reader-text\">  Dalbavancin Sale to Actavis<\/span><span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":1110,"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":[292,658,660,66,85,125,597,5,234,67,657,656,655,659],"class_list":["post-1105","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-qidp_antibiotic","category-the_news","category-the_viewpoint","tag-actavis","tag-aers","tag-cogs","tag-dalbavancin","tag-dalvance","tag-drug-price","tag-durata","tag-fda","tag-orbactiv","tag-oritavancin","tag-patent-extension","tag-patent-life","tag-pfizer","tag-vicuron"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/DalvanceActavis.jpg?fit=640%2C200&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-hP","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":1915,"url":"https:\/\/allphasepharma.com\/dir\/2015\/09\/07\/1915\/dalbavancin-approval-issues-a-case-of-much-ado-about-nothing\/","url_meta":{"origin":1105,"position":0},"title":"Dalbavancin Approval Issues: A Case of Much Ado About Nothing","author":"Harald","date":"September 7, 2015","format":false,"excerpt":"Dalbavancin has changed hands a few times in its development history, moving\u00a0from Lilly to Vicuron, then Pfizer and ultimately Durata. The original NDA for dalbavancin was submitted to FDA on Dec. 21, 2004.\u00a0 Pfizer acquired dalbavancin\u00a0as a \u201cPhase 3 completed\u201d drug ready for world-wide marketing on June 15, 2005. The\u2026","rel":"","context":"In &quot;QIDP Antibiotics&quot;","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"Dalbavancin slider copy","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/09\/Dalbavancin-slider-copy.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/09\/Dalbavancin-slider-copy.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/09\/Dalbavancin-slider-copy.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":157,"url":"https:\/\/allphasepharma.com\/dir\/2014\/04\/22\/157\/antibiotics-with-qidp-designation\/","url_meta":{"origin":1105,"position":1},"title":"Antibiotics with QIDP Designation &#8211;   &#8211;    &#8211;  Updated 9-30-14","author":"Harald","date":"April 22, 2014","format":false,"excerpt":"For the latest QIDP listing, please click HERE \u00a0 Since\u00a0FDA issued the QIDP designation in 2012, many companies have requested this important 'label'. \u00a0Which should not come as a surprise: QIDP status confers significant benefits - and there is no downside. While an official FDA list of drugs that have\u2026","rel":"","context":"In &quot;QIDP Antibiotics&quot;","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":[]},{"id":1800,"url":"https:\/\/allphasepharma.com\/dir\/2015\/08\/01\/1800\/qidp-drugs-4th-edition\/","url_meta":{"origin":1105,"position":2},"title":"QIDP Drugs &#8211;  4th Edition","author":"Harald","date":"August 1, 2015","format":false,"excerpt":">>> For the latest QIDP list, please click HERE \u00a0<<< Since our\u00a0last QIDP blog from April 8, 2015, several new drugs have made the list which now includes 41 compounds. Below a table\u00a0which includes compound, sponsor\u00a0and development stage (Phase). It also indicates whether a drug has been\u00a0the topic of a\u2026","rel":"","context":"In &quot;Recent Literature&quot;","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"QIDP 4th edition","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/QIDP-4th-edition.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/QIDP-4th-edition.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/QIDP-4th-edition.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":1408,"url":"https:\/\/allphasepharma.com\/dir\/2015\/05\/07\/1408\/no-such-thing-as-a-free-ride\/","url_meta":{"origin":1105,"position":3},"title":"No Such Thing as a Free Ride\u2026","author":"Harald","date":"May 7, 2015","format":false,"excerpt":"..when it comes to FDA review of antibiotic NDAs.\u00a0 Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions.\u00a0 Many failed not because of lack of efficacy or a bad safety profile but because of changes in\u2026","rel":"","context":"In &quot;QIDP Antibiotics&quot;","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"theBMJ","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/05\/theBMJ.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":2205,"url":"https:\/\/allphasepharma.com\/dir\/2015\/12\/23\/2205\/qidp-antibiotics-2015-year-end-update\/","url_meta":{"origin":1105,"position":4},"title":"QIDP Antibiotics  &#8211;  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 &quot;QIDP Antibiotics&quot;","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":249,"url":"https:\/\/allphasepharma.com\/dir\/2014\/06\/05\/249\/here-they-are-dalbavancin-oritavancin-the-new-long-acting-lipoglycopeptides\/","url_meta":{"origin":1105,"position":5},"title":"Here They Are:  Dalbavancin and Oritavancin \u2013 The New Long-Acting Lipoglycopeptides","author":"Harald","date":"June 5, 2014","format":false,"excerpt":"The development history of glycopeptide drugs is anything but normal.\u00a0 Daptomycin (Cubicin\u00ae) was abandoned by Lilly but resurrected by Francis Tally at Cubist by adjusting the dosing schedule to once daily and careful uptitration.\u00a0 The drug did superbly in a landmark endocarditis trial and everything looked rosy.\u00a0 Then we learned\u2026","rel":"","context":"In &quot;The News&quot;","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]}],"jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/1105","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=1105"}],"version-history":[{"count":4,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/1105\/revisions"}],"predecessor-version":[{"id":1109,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/1105\/revisions\/1109"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media\/1110"}],"wp:attachment":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media?parent=1105"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/categories?post=1105"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/tags?post=1105"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}