1: the FDA is due, at any time, to rule on Pfizer's inhaled insulin product Exubera - a world first. approval would be a boost to IOV who have regained the rights to its own inhaled insulin formulation (in collaboration with MicroDose). a positive FDA outcome would boost IOV's negotiating hand with potential licencees;
2: i wonder whether Alpharen will remain core? as a disposal candidate this could raise upwards of c£5M - a figure that is NOT accounted for in the recent CODE note ie. a disposal of this nature would raise 06 eps by 1p plus; i have a feeling we may hear news on this front soon;
3: results in january will provide the company with a good opportunity to updates the market on Budesoinde & Formetoral lanches, with roll-out expected in 06;
4: the long-awaited ADEPT licensing news - and US approval - could come at any time;
5: 2006 possble japanese approval of Advate (submission in Oct 2004)
6: potential for licensind deals on the S2 Multidoe inhaler - apparnetly even more commercially lucrative than the c200
we are in for an interesting, and profitable, 2006 !
FDA panel OKs inhalable insulin
Vote by advisory panel could help Pfizer's Exubera win approval.
September 8, 2005: 5:42 PM EDT
By Aaron Smith, CNN/Money staff writer
NEW YORK (CNN/Money) - A panel of experts advising the FDA voted Thursday in favor of Exubera, the first form of inhalable insulin, a step that could lead to approval by the regulatory agency.
Exubera, developed by Pfizer Inc. (up $0.21 to $26.51, Research), Sanofi-Aventis (down $0.58 to $41.37, Research) and Nektar Therapeutics (unchanged at $19.14, Research), is a new way of delivering insulin for diabetics. Diabetics can use the Exubera inhaler to breathe a dry, powdered form of insulin through the lungs.
The advisory panel voted 7-2 in favor of using Exubera in type 1 and 2 diabetes. The Food and Drug Administration usually follows the recommendation of its advisory panels.
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