Vectura Announces Positive Results from the QDose Inhaled Insulin Glucose Clamp Study
02 August 2007
2 August 2007, Chippenham, UK. Vectura Group plc (LSE: VEC), the pulmonary product development company focused on respiratory and neurological diseases, today announces headline results from a glucose clamp study of the QDose inhaled insulin product. Vectura, through its joint venture with MicroDose Technologies Inc., QDose Limited, has developed a rapid acting, dry powder, insulin formulation designed to give highly efficient delivery from the MicroDose Electronic Inhaler.
The study employed the widely used and validated glucose clamp technique, and results demonstrated that:
· The inhaled insulin formulation was safe and effective
· Peak levels of insulin activity were achieved more quickly following the inhaled insulin than those from the subcutaneous insulin injection
· Relative bioavailability of inhaled insulin was approximately 18% during the 3 hour period following dosing; higher than the published values for the currently marketed product
· Administration of the same total dose of inhaled insulin from either a single blister or two “half strength” blisters led to equivalent activity; an advantage over the currently marketed product
The study was a randomised, crossover, open-label glucose clamp study, designed to confirm the high relative bioavailability of the QDose insulin formulation previously observed, and to demonstrate the product’s dose titration capability. The results confirmed the faster onset of action seen with the QDose inhaled formulation compared with subcutaneous insulin. The relative bioavailability observed in this study compares favourably with available information on competitor inhaled insulin programmes. The study was conducted in the United States at Profil Institute for Clinical Research Inc (Profil) in San Diego, with 14 healthy male volunteers, using a glucose clamp technique. Profil has research facilities in the US and Germany and is the largest unit in the world for euglycaemic, hyperglycaemic and hypoglycaemic glucose clamps.
Dr Chris Blackwell, Chief Executive of Vectura, commented:
“The disease, as well as the complications associated with diabetes, places a tremendous burden on healthcare systems throughout the world. There are a number of companies working on inhaled insulin therapies, but we believe we have a number of competitive advantages which will make our programme attractive to licensing partners. We are therefore currently seeking a licensing partner prior to the programme entering later stage clinical trials.”
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Enquiries:
Vectura Group plc +44 (0)1249 667 600
Dr Chris Blackwell
Anne Hyland
Julia Wilson
Financial Dynamics +44 (0)20 7831 3113
David Yates
John Gilbert
Notes for Editors:
About Diabetes
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 have 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 may be as much 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 greater impact on outcomes and become the preferred means for delivering insulin for Type 2 diabetics.
The first inhalable insulin product, Pfizer’s EXUBERA®, was approved by the European Commission on January 26th 2006 and by the FDA on January 27th 2006. Following the launch of EXUBERA® inhaled insulin has become available for diabetics and the way is being paved for next generation products.
About Glucose Clamp Technique
Glucose clamp technique is a technique that maintains a constant blood glucose level in human subjects by perfusion or infusion with glucose; the technique is used in studies to obtain evidence of the effectiveness and bioavailability of preparations of insulin in healthy human volunteers, and patients who suffer from diabetes.
Glucose clamp techniques represent the gold standard for pharmacodynamic and pharmacokinetic studies to describe the time-action profiles of glucose-lowering drugs; the effects of these drugs administered by various routes of administration can be studied individually, and then compared. For example, the effects of inhaled versus subcutaneous insulin.
The European regulatory authority EMEA expressly refers to the glucose clamp technique in an EMEA/ CPMP Note for Guidance.
About Vectura
Vectura is a pulmonary drug development company focused principally on the development of a range of inhaled therapies for the treatment of respiratory and neurological diseases. The respiratory market is forecast to achieve sales of $32 billion by 2011. Vectura develops products to treat respiratory diseases such asthma, COPD and cystic fibrosis. Vectura also develops products where optimised delivery via the lungs into the blood stream can provide significant benefits, such as a rapid onset of action, improved efficacy and improved tolerability compared with current therapies.
Vectura has eight marketed products and a portfolio of drugs in clinical and pre-clinical development, some of which have been licensed to major pharmaceutical companies. The Company also seeks to develop certain programmes further through development to optimise value at a later licensing stage. Vectura also offers its formulation and inhalation technologies to other pharmaceutical companies on a licensing basis where this complements Vectura’s business strategy.
Vectura has development collaborations with a broad range of pharmaceutical companies including Boehringer Ingelheim, Novartis, and Chiesi. The acquisition of Innovata in January 2007 brought established alliances with a number of additional companies, such as Baxter, GSK, Merck KGaA, UCB and Otsuka as well providing revenue streams, complementary products and critical mass. For further information, please visit Vectura’s website at www.vectura.com
This press release contains “forward-looking statements,” including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura’s actual results to differ materially from those expressed or implied by the forward-looking statements, including adverse results in clinical development programs; failure to obtain patent protection for discoveries; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statement. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
