EX-99.1 2 0002.txt PRESENTATION INFORMATION EXHIBIT 99.1 SHEFFIELD'S CURRENT PRODUCT PIPELINE
PRODUCT NON-CLINICAL CLINICAL ---------------------------------------------------------------------------------------------------------------------------------- FORMULATION PILOT STUDIES IND PHASEI/IIA PHASE IIB PHASE III ------------------ ----------------- ----- --------------- --------------- --------- Respiratory: MSI - albuterol ------------------------------------------------------------------------------------- (To begin Q2'01) MSI - ipratropium -------------------------------------------------------------------- (To begin Q1'01) MSI - cromolyn --------------------------------------------- (To begin Q1'01) MSI - Nano-steroid ------------------------------------- (To be filed Q1'01) Unit-dose-Nano-steroid ------------------------------------- (To be filed Q4'01) ADDS - Nano-steroid ------------------------------------- (To be filed Q1'01) ADDS - respiratory ------------------------------------- (To be filed product Q1'01) Systemic: MSI - morphine -------------------------------------- (To be outlicensed in FY2001) ADDS - ergotamine -------------------------------------- (To be outlicensed in FY2001)
UPCOMING PRODUCT DEVELOPMENT MILESTONES REMAINDER OF 2000 FIRST HALF OF 2001 ----------------- ------------------ . Conduct MSI-albuterol (adult) End of . Initiate MSI-albuterol Phase III Phase II Meeting with FDA adult trial . Complete MSI-albuterol Phase I/IIa . Complete MSI-ipratropium Phase IIb pediatric trial trial . File IND for Unit Dose-nanosteroid . File IND and complete MSI-cromolyn Phase I/IIa trial . File IND and complete MSI- nanosteroid Phase I/IIa trial . Complete Unit Dose-nanosteroid Phase I/IIa trial . File IND and complete ADDS-patent extension respiratory product Phase I/IIa trial OTHER UPCOMING MILESTONES REMAINDER OF 2000 2001 ----------------- ---- . Initiate program for development of new . Initiate program for development ADDS-respiratory product of macromolecule/protein delivery . Initiate program for development of . Acquire access to complementary additional systemic compound delivery technologies