{"id":561,"date":"2014-07-10T12:14:20","date_gmt":"2014-07-10T16:14:20","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=561"},"modified":"2014-09-24T00:02:42","modified_gmt":"2014-09-24T04:02:42","slug":"the-difficult-transition-into-phase-3","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2014\/07\/10\/561\/the-difficult-transition-into-phase-3\/","title":{"rendered":"The Difficult Transition Into Phase 3"},"content":{"rendered":"
\"Hurdle\"<\/a>
The Hurdle Race to Phase 3<\/figcaption><\/figure>\n

Preclinical and early clinical development is expensive enough already for VC companies but it gets really expensive in Phase 3.\u00a0 Hence, not surprisingly, few small companies tackle Phase 3 programs on their own.\u00a0 Unless an ‘angel investor’ with deep pockets commits to the compound and assures continuity of development, the search for a partner is a necessity.\u00a0 This often becomes a drawn-out process and is likely to slow things down.\u00a0 Time is never on the side of the drug developers but raising funds can really become the overriding concern even for companies with very innovative promising compounds.<\/p>\n

But partnering with \u2018Big pharma\u2019 has its own downsides; it is not always a marriage made in heaven.\u00a0 Issues of control, layers of decision-making and strategic portfolio priorities can cause delays and create complexity for a VC company unaccustomed to being the junior partner at the table.\u00a0 A change, or a change in commitment, by senior management on either side may be all it takes to derail a program.<\/p>\n

Case in point:\u00a0 Nabriva probably hoped that its partnership with Forest would continue to fund their Phase 3 program for BC-3781, its most advanced pleuromutilin antibiotic.\u00a0 This was not to be. When it was announced in July 2013 that Forest had stopped its partnership with Nabriva it did not create big waves.\u00a0 \u00a0After all, this collaboration was meant to be a \u201812-month collaboration\u2019 from the start, providing development funds to Nabriva while in return giving Forest exclusive rights to acquire Nabriva.\u00a0 When the time was up, Forest and Nabriva issued a boilerplate statement indicating that the \u2018collaboration elapsed\u2019 without providing an specifics [1].<\/p>\n

So what made Forest lose interest and disengage?\u00a0 We don\u2019t know the\u00a0details and are not going to speculate here except to say that this decision had probably not much to do with BC-3781, Nabriva\u2019s lead compound. At the time of the initial \u2018engagement\u2019 in mid-2012, the Phase 2 program of BC-3781 had finished enrollment and results the Phase 2 ABSSSI trial were certainly already known internally.\u00a0 Indeed, all efficacy markers of interest compared favorably to vancomycin.\u00a0 Likewise, the safety results were positive and would support continued development at either BC-3781 dose tested [2].<\/p>\n

So, it stands to reason that Forest knew the data, liked what they saw and did not mind shelling out $25 mio for \u2018development activities\u2019 and an option to buy Nabriva. \u00a0Still, the stars were not aligned for the BC-3781 to propel it into Phase 3.<\/p>\n

Clearly, Forest has its hands full with other antibiotics closer to the market.\u00a0 Ceftazidime\/avibactam is in late phase development; it will compete in the market with Cubist\u2019s ceftolozane\/tazobactam and other newcomers.\u00a0 Very recently, Forest acquired Furiex which brought JNJ-2, an anti-MRSA fluoroquinolone and Phase 3 drug, to the company. That\u2019s quite a lot to lift, even with Actavis as a partner.<\/p>\n

Now the search is on at Nabriva to find a new partner for BC-3781.\u00a0 This should not be too difficult for a novel MoA drug with IV and PO formulations.\u00a0 Stay tuned.<\/p>\n

 <\/p>\n

\n

References:<\/strong> [1] http:\/\/www.evaluategroup.com\/Universal\/View.aspx?type=Story&id=482175
\n[2] Prince. \u00a0Antimicrob. Agents Chemother. 2013: 10.1128<\/p>\n","protected":false},"excerpt":{"rendered":"

Preclinical and early clinical development is expensive enough already for VC companies but it gets really expensive in Phase 3.\u00a0 Hence, not surprisingly, few small companies tackle Phase 3 programs on their own.\u00a0 Unless an ‘angel investor’ with deep pockets commits to the compound and assures continuity of development, the Continue reading The Difficult Transition Into Phase 3<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":914,"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":[81,292,286,403,244,288,344,92,8,287,253,290,291,245,284,117,9,285,48,283],"class_list":["post-561","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the_viewpoint","tag-absssi","tag-actavis","tag-angel-investor","tag-antibiotic-blog","tag-bc-3781","tag-ceftazidimeavibactam","tag-ceftolozanetazobactam","tag-cubist","tag-efficacy","tag-forest","tag-ivpo","tag-jnj-2","tag-mrsa-fluoroquinolone","tag-nabriva","tag-phase-3-costs","tag-pleuromutilin","tag-safety","tag-transition-to-phase-3","tag-vancomycin","tag-vc-companies"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/07\/DrugDevProcess.jpg?fit=640%2C200&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-93","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":1168,"url":"https:\/\/allphasepharma.com\/dir\/2014\/12\/15\/1168\/the-circuitous-route-to-phase-3-another-chapter-in-the-fitful-development-of-ptk-0796\/","url_meta":{"origin":561,"position":0},"title":"The Circuitous Route to Phase 3:\u00a0 Another Chapter in the Fitful Development of PTK-0796","author":"Harald","date":"December 15, 2014","format":false,"excerpt":"When antibiotics change hands, it can be a good thing.\u00a0 Small companies are often desperate to attract a partner with \u2018deep pockets\u2019 to help them finance an expensive late phase development but often have to give up control once\u00a0the honeymoon period is over.\u00a0 Such transitions can bring delays because new\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\/12\/PTK-slider-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\/12\/PTK-slider-copy.jpg?fit=640%2C200&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/12\/PTK-slider-copy.jpg?fit=640%2C200&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":2328,"url":"https:\/\/allphasepharma.com\/dir\/2016\/02\/26\/2328\/brincidofovir-another-drug-fails-in-phase-3\/","url_meta":{"origin":561,"position":1},"title":"Brincidofovir \u2013 Another Drug Fails in Phase 3","author":"Harald","date":"February 26, 2016","format":false,"excerpt":"It is sad to see a pivotal trial fail, and you have to wonder why we recently had several such late-stage \u2018mishaps\u2019. Take Tetraphase\u2019s eravacycline which failed in a Phase 3 cUTI trial. 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RG-7929 has not made it into www.clinicaltrials.gov yet, only POL7080 is listed. An uncontrolled open label study in \u201cpatients with non-CF acute exacerbation of bronchiectasis due to P. aeruginosa requiring IV treatment\u201d is enrolling. Well, good luck finding those patients! 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