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Diabetes Marketplace
Brief Marketplace Overview

4Q, 2004


Significant metamorphosis has ensued in the Diabetes marketplace during 2004, with further dynamic transformation forthcoming in 2005.  Merck’s MK-0431 continues along with LAF237, as the two most significant DPP-IV inhibitor competitive threats, defined by similar chronology in the quest for first-to-market position.  Efficacy issues necessitated Phase III protocol expansion encompassing Metformin and Pioglitazone combination therapy.  Slow enrollment and a recurring carcinogenesis undercurrent, as yet publicly unconfirmed, remain as potential concerns.  Increasing Street pressure resulting from recent events augments the importance of enacting an accelerated timeline, despite the reality of elusive success probability.
   
Bristol-Myers Squibb continues to progress 477118 in the pipeline, with Phase III trials initiating.  GlaxoSmithKline, in earlier Phase development, has prioritized their DPP-IV inhibitor compound.  OSI established UK based Prosidion in 2004, acquiring the DPP-IV inhibitor PSN9301 (formerly Probiodrug’s P93/01), currently in Phase II development.
   
Recent FDA regulations originated as a result of the MK-767 failure in conjunction with variably evident class characteristics..  The current requirement of 2 years PPAR animal carcinogenicity data prior to proceeding with clinical trials of greater than 6 months duration has transformed the PPAR landscape considerably.  Naveglitazar, as a result, is stalled between Phase II and III, while Galida has experienced significant filing timeline prolongation.  Takeda appears to be ramping up their TAK-559 Phase III trial, while recently filing their Actoplus Met NDA.  Bristol-Myers Squibb/Merck is planning to file their Muraglitazar NDA prior to 2004 year end.
   
Exenatide is in Preregistration after Lilly/Amylin’s NDA filing in June, 2004, while Exenatide LAR will enter Phase IIb trials 1Q, 2005.  Novo Nordisk’s Liraglutide, an active pipeline participant, has emerged as a more apparent competitive threat after positive data presentation at the 2004 ADA.  Conjuchem’s CJC-1131 is progressing in development, as is AVE-0010 and BLX-1002.  BIM 51077 remains in early development at Roche.
   
Exubera, despite surmounting the pulmonary function issue, has experienced delays with the EMEA.  Efficacy issues and potential hypoglycemia may have contributed to regulatory hesitation.  Novo Nordisk/Aradigm’s AERx, Eli Lilly/Alkermes’ HIIP, and Technosphere’s Inhaled Insulin are nearing late Phase pipeline development.  Oralin, currently in Phase IIb trials, will highlight the advantages of buccal mucosal absorption, bypassing pulmonary function and first-pass metabolism concerns.

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