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Brief Marketplace Overview

3Q, 2005

Psychiatrists welcome new interventional alternatives, as existent medications often exhibit diminished efficacy in long-term patients.  New product comfort in the Psychiatry community is established with time and prescriptive experience, since trial results present a broad picture which is often less applicable to the individual patient.  Patient-specific response to antidepressant and antipsychotic medications can vary significantly, therefore requiring considerable clinician experience with the newly launched products in order to establish a comfort level. 

Lexapro, supported by Forest’s sizeable sales force and awaiting outcome of a patent challenge, has been prioritized with the agenda of converting Celexa patients.  Line extension to Adult and Pediatric Major Depressive Disorder is progressing.  Cymbalta, approved for Depression as well as Diabetic Peripheral Neuropathy, is supported by a smaller DTC budget with sufficient sales force detailing.  Zoloft, well supported by a diversified Pfizer sales force, although in transition, has a substantial 2005 budget allocation with reductions planned for 2006.  Wyeth has promoted Effexor as comparatively superior to Paxil regarding remission rate.  Detailing has been reduced overall, including the conversion of 750 sales force personnel to part-time status. 

Wyeth’s Desvenlafaxine (DVS 233) NDA filing is fast approaching, while DOV 21,947 and 216,303 remain in Phase II.  The DOV compounds, partnered with Merck for the Depression indication exclusively, are under reevaluation as to development priority and Merck’s interest in continuation.  DOV 102,677 progression to Phase II awaits Phase I results compilation.  YKP 10A has been licensed by SK to JNJ, and remains in Phase II.  Somerset/Mylan/Watson responded in May to the 1Q, 2004 approvable letter, and await a November 27th, 2005 PDUFA date. 

Elzasonan is currently in Phase II, while Sepracor’s SEP-225289 and SEP-227162 remain preclinical.  Abilify has initiated a Phase III clinical trial for Treatment Resistant Depression.  Corcept’s C 1073-07 development targets Depression with psychotic features.  Roche’s R673 awaits Phase II trial results compilation, which will determine Phase III progression.  PRX 00023, Desmethylsibutramine, Agomelatine, and Milnacipran have not exhibited Depression development progression in the US market, although Agomelatine has been filed with EMEA.  PRX 00023 has completed Phase IIa trials for Generalized Anxiety development.  Nemifitide, in the process of resolving associated adverse neurological findings in Beagle dogs, awaits trial resumption following FDA discussions.  Emsam, to be marketed by BMS, awaits an October 26th Advisory Committee Meeting for analysis of data collected since the issuance of the 2004 Approvable letter requesting 3 additional Phase IV and toxicology trials, including dietary related data pertaining to tyramine mediated effects.

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