BioPharm Insight's September Catalyst Monitor Highlights Blockbuster Competition for Likely New Approvals Tivozanib and Ruconset

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Tivozanib and Ruconset to face challenges in already crowded markets.

BioPharm Insight’s Catalyst Monitor analyzes the most material events in the sector during the upcoming month. The Catalyst Monitor tracks upcoming binary events such as: FDA approvals, clinical trial outcomes and expected key results.

Blockbuster drugs will contribute to difficulties for a few candidates within the approval pipeline for September. AVEO’s Tivozanib for kidney cancer and Santarus’ Ruconest for HAE will both likely see FDA approvals but will struggle with gaining market share in already crowded markets.

On the data release front, Sunesis plans on reporting Phase III VALOR interim data for vosaroxin in acute myeloid leukemia (AML). In March 2012, Sunesis entered into a licensing agreement with Royalty Pharma. The deal structure is based on completion of interim analysis from the VALOR study. The Phase III will likely have to expand patient enrollment to meet the primary endpoint in OS target

Additional developments for September include:

  •     Salix’s Crofelemer for secretory diarrhea in HIV/AIDS patients - unmet need warrants approval
  •     Ironwood’s Linaclotide for IBS-C and CC has edge of competition
  •     Navidea’s Lymphoseek - request for additional CMC data
  •     Bayer/Regeneron’s Eylea - label expansion likely with ap¬proval in RVO
  •     Cornerstone’s lixivaptan – good chance for Phase III success and approval in hyponatremia

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Kristopher Sarajian
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