joint venture products
Inhaled Insulin product summary
Diabetes is a chronic health condition where the body is unable to produce or adequately use insulin. Diabetes is broadly grouped into two types – Type I and Type 2. Type 2 diabetics make up approximately 90% of all diabetics and the incidence of Type 2 diabetes is growing rapidly. According to the World Health Organization, diabetes is reaching epidemic proportions. Approximately 194 million people worldwide suffer from the disease, and it is estimated that the number of people with diabetes will more than double by 2030. Predictions are that one in three children in the U.S. born five years ago will develop diabetes.
Direct healthcare costs from diabetes are estimated to be as high as $286 billion worldwide. It is widely accepted that early intervention for Type 2 diabetics by treatment with insulin improves outcomes. However, as Type 2 diabetics are reluctant to inject insulin the introduction of non-invasive insulin delivery formats, such as inhalable insulin, is likely to have a positive impact on outcomes. In 2005, the global market for therapies to treat Type I and Type II diabetes represented approximately $17 billion in annual worldwide sales and is predicted to grow to nearly $33 billion by the year 2010.
about the Inhaled Insulin product
Through extensive analysis of diabetic user-needs and market research, MicroDose, through its joint venture with Vectura Group plc, QDose Limited, has designed and developed a highly efficient, rapid acting, insulin inhaler, based upon MicroDose’s proprietary electronic inhaler technology and Vectura’s dry powder insulin formulation. The QDose inhaled insulin product offers dose titration capability over a broad range of dose strengths, in a single inhalation. The inhaler also provides active dose feedbacks to the patient in an easy to use, pocket-sized device. The product has demonstrated a faster onset of action than subcutaneous insulin and a relative bioavailability of approximately 18% in the first three hours which exceeds that of most other inhaled insulin products that have been studied in the clinic.
In excess of $30 million has been invested to date by both QDose and Bristol-Myers Squibb (BMS) during its sponsorship of the program between 2003 and 2005. QDose owns all the rights to its inhaled insulin product, using Vectura’s formulation and MicroDose’s inhaler. QDose performed pre-clinical studies and a Phase I clinical trial in 2001 and successfully completed a Phase I glucose clamp study in April 2007 under a U.S. IND, which confirmed the high relative bioavailability, and demonstrated dose proportionality and dose titration capability.
In the aftermath of Pfizer’s Exubera failure, and the subsequent termination of development activities by both Lilly/Alkermes and NovoNordisk the future for inhaled insulin is uncertain and as a result development is currently suspended. The company, however, remains confident in the potential of this product and awaits the re-invigoration of the inhaled insulin market by other players still pursuing this space.
QDose, originally formed in 1999 between MicroDose and what was then Quadrant Drug Delivery plc, is now a 50/50 joint venture between MicroDose and Vectura plc, a publicly traded British specialty pharmaceuticals company. The rapid acting inhaled insulin product discussed here is the only product contained in the QDose joint venture.