title: Exubera. Inhale therapeutic systems.
abstract: Inhale, in colaboration with Pfizer and Aventis Pharma (formerly Hoechst Marion Roussel; HMR), is developing an insulin formulation utilizing its pulmonary delivery technology for macromolecules for the potential treatment of type I and II diabetes. By July 2001, the phase III program had been completed and the companies had begun to assemble data for MAA and NDA filings; however, it was already clear at this time that additional data might be required for filing. By December 2001, it had been decided that the NDA should include an increased level of controlled, long-term pulmonary safety data in diabetic patients and a major study was planned to be completed in 2002, with the NDA filed thereafter (during 2002). US-05997848 was issued to Inhale Therapeutic Systems in December 1999, and corresponds to WO-09524183, filed in February 1995. Equivalent applications have appeared to date in Australia, Brazil, Canada, China, Czech Republic, Europe, Finland, Hungary, Japan, Norway, New Zealand, Poland and South Africa. This family of applications is specific to pulmonary delivery of insulin. In February 1999, Lehman Brothers gave this inhaled insulin a 60% probability of reaching market, with a possible launch date of 2001. The analysts estimated peak sales at $3 billion in 2011. In May 2000, Aventis predicted that estimated peak sales would be in excess of $1 billion. In February 2000, Merrill Lynch expected product launch in 2002 and predicted that it would be a multibillion-dollar product. Analysts Merril Lynch predicted, in September and November 2000, that the product would be launched by 2002, with sales in that year of e75 million, rising to euro 500 million in 2004. In April 2001, Merrill Lynch predicted that filing for this drug would occur in 2001. Following the report of the potential delay in regulatory filing, issued in July 2001, Deutsche Banc Alex Brown predicted a filing would take place in the fourth quarter of 2002 and launch would take place in the first quarter of 2003. In August 2001, Lehman Brothers predicted that launch would take place in the first half of 2002 and that the product would make sales of $475 million in 2003, rising to $875 million in 2004. In the same month, Deutsche Bank predicted that there would be worldwide sales of $50 million in 2003, rising to $400 million in 2005. At this time, analysts at Credit Suisse predicted a launch of the product in 2003, with sales of $70 million in that year, rising to $550 million in 2005. By October 2001, Deutsche Bank predicted sales of $50 million in 2004 and $250 million in 2005. In September 2001, Morgan Stanley predicted sales of $500 million in 2002, rising to $1250 million in 2006.
authors.affiliation: University of Vermont College of Medicine, Department of Medicine, Burlington 05405, USA.
authors.forename: Sanjit
authors.initials: S
authors.lastname: Bindra
authors.forename: William T
authors.initials: WT
authors.lastname: Cefalu
mesh_terms: D000280:Administration, Inhalation; D000818:Animals; D002986:Clinical Trials as Topic; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D004333:Drug Administration Routes; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D009330:Nebulizers and Vaporizers; D013329:Structure-Activity Relationship
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin