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J Otaryngol Head Neck Surg 2008; 37(6): 836 43; 8 Ivani G, et al. Can J Anaesth 1999; 46(5): 467 469; 9 Pitimana aree S, et al. Reg Anesth Pain Med 2005; 30(5): 446 51; http://www.naropin us.com/about_benefits.php 2 Source: KOL interviews October 2013 Notes 1 1 2 3 7 5 KOL Feedback 2 The goal is to achieve sensory blockade without significant motor blockade.
Orthopedic Surgeon 1 Sources: Scott, et al. Anesth Analg 1989; 24: 514 518; Knudsen K, et al. Br J Anesth 1997 78; 507 514; Bertini, et al. Reg Anesth Pain Med 1999; 4 Chelly JE, et al. J Orthop Trauma 2003; Turner G, et al. Br J Anesth 1996; 76:606 610; 5 Writer WDR, et al. Br J Anaesth 1998; 81: 713 717. 6 McGlade, et al. Anaesth Intensive Care 1998;26:515 520; Arikan OK, et al.
Orthopedic Surgeon Safety Lower CV and CNS toxicity Overall better side effect profile Safety is where ropivacaine has a clear advantage. It is widely known in our institution that bupivacaine has more cardiovascular toxicity. Anesthesiologist MOA Ropivacaine has been shown to have shorter depth and duration of motor block compared to bupivacaine Clinical Flexibility Considered more clinically versatile by physicians Approved for use in children For all these reasons, a long acting bupivacaine is a hit but a long acting ropivacaine would be a home run .
HEC regimens account for ~20% (500K) of palonosetron administrations Of all HEC administrations, ~20% are given without concomitant IV 5 HT3 inconsistent with clinical guidelines HEC MEC LEC Minimal 200,000 400,000 600,000 800,000 1,000,000 1,200,000 1,400,000 1,600,000 200,000 400,000 600,000 800,000 1,000,000 1,200,000 Annual HEC administrations Untreated with IV 5HT3 Treated with generic IV 5HT3 Treated with Aloxi 497,256 1,463,558 451,490 111,696 2013.
Confidential. 4 Highlights Lead product candidate, SUSTOL (formerly known as APF530), is long acting, injectable product for chemotherapy induced nausea and vomiting (CINV) Incorporates widely used 5 HT3 antagonist granisetron (Kytril ) 5 day delivery profile Reduces both acute and delayed onset CINV with single injection Patent coverage into 2024; however, effective exclusivity actually longer due to polymer SUSTOL shown to be non inferior to market leader Aloxi 1,341 patient, randomized, controlled, Phase 3 study SUSTOL targets a large market opportunity, with approximately 7 million doses of chemotherapy annually in US alone* Recent competitive setbacks could enhance commercial uptake Could be second, long acting, injectable product on market Plans to leverage our Biochronomer drug delivery technology, development capacity and commercial expertise for other opportunities: Long acting anesthetic for post surgical pain Double and Triple combination for CINV is under evaluation Potential for several others *TDR August 2006 internal report 2013.