2nd Aug 2007 07:02
Vectura Group plc02 August 2007 Vectura Announces Positive Results from the QDose Inhaled Insulin Glucose Clamp Study 2 August 2007, Chippenham, UK. Vectura Group plc (LSE: VEC), the pulmonaryproduct development company focused on respiratory and neurological diseases,today announces headline results from a glucose clamp study of the QDose inhaledinsulin product. Vectura, through its joint venture with MicroDose TechnologiesInc., QDose Limited, has developed a rapid acting, dry powder, insulinformulation designed to give highly efficient delivery from the MicroDoseElectronic Inhaler. The study employed the widely used and validated glucose clamp technique, andresults demonstrated that: • The inhaled insulin formulation was safe and effective • Peak levels of insulin activity were achieved more quickly followingthe 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 forthe currently marketed product • Administration of the same total dose of inhaled insulin from either asingle blister or two "half strength" blisters led to equivalent activity; anadvantage over the currently marketed product The study was a randomised, crossover, open-label glucose clamp study, designedto confirm the high relative bioavailability of the QDose insulin formulationpreviously observed, and to demonstrate the product's dose titration capability.The results confirmed the faster onset of action seen with the QDose inhaledformulation compared with subcutaneous insulin. The relative bioavailabilityobserved in this study compares favourably with available information oncompetitor inhaled insulin programmes. The study was conducted in the UnitedStates at Profil Institute for Clinical Research Inc (Profil) in San Diego, with14 healthy male volunteers, using a glucose clamp technique. Profil is thelargest unit in the world for euglycaemic, hyperglycaemic and hypoglycaemicglucose clamps. Dr Chris Blackwell, Chief Executive of Vectura, commented: "The disease, as well as the complications associated with diabetes, places atremendous burden on healthcare systems throughout the world. There are anumber of companies working on inhaled insulin therapies, but we believe we havea number of competitive advantages which will make our programme attractive tolicensing partners. We are therefore currently seeking a licensing partnerprior to the programme entering later stage clinical trials." - Ends - Enquiries: Vectura Group plc +44 (0)1249 667 600Dr Chris BlackwellAnne HylandJulia Wilson Financial Dynamics +44 (0)20 7831 3113David YatesJohn Gilbert About Vectura Vectura is a pulmonary drug development company focused principally on thedevelopment of a range of inhaled therapies for the treatment of respiratory andneurological diseases. The respiratory market is forecast to achieve sales of$32 billion by 2011. Vectura develops products to treat respiratory diseasessuch asthma, COPD and cystic fibrosis. Vectura also develops products whereoptimised delivery via the lungs into the blood stream can provide significantbenefits, such as a rapid onset of action, improved efficacy and improvedtolerability compared with current therapies. Vectura has eight marketed products and a portfolio of drugs in clinical andpre-clinical development, some of which have been licensed to majorpharmaceutical companies. The Company also seeks to develop certain programmesfurther through development to optimise value at a later licensing stage.Vectura also offers its formulation and inhalation technologies to otherpharmaceutical companies on a licensing basis where this complements Vectura'sbusiness strategy. Vectura has development collaborations with a broad range of pharmaceuticalcompanies including Boehringer Ingelheim, Novartis, and Chiesi. The acquisitionof Innovata in January 2007 brought established alliances with a number ofadditional companies, such as Baxter, GSK, Merck KGaA, UCB and Otsuka as wellproviding revenue streams, complementary products and critical mass. For further information, please visit Vectura's website at www.vectura.com About QDose QDose, a 50/50 joint venture between Vectura and MicroDose, was formed in 1999,and completed its first Phase I study in 2001. About Diabetes Diabetes is a chronic health condition where the body is unable to produce oradequately use insulin. Diabetes is broadly grouped into two types - Type I andType 2. Type 2 diabetics make up approximately 90% of all diabetics and theincidence of Type 2 diabetes is growing rapidly. According to the World HealthOrganization, diabetes is reaching epidemic proportions. Approximately 194million people worldwide have the disease, and it is estimated that the numberof people with diabetes will more than double by 2030. Predictions are that onein three children in the U.S. born five years ago will develop diabetes. Directhealthcare costs may be as much as $286 billion worldwide. It is widelyaccepted that early intervention for Type 2 diabetics by treatment with insulinimproves outcomes. However, as Type 2 diabetics are reluctant to inject insulinthe introduction of non-invasive insulin delivery formats, such as inhalableinsulin, is likely to have greater impact on outcomes and become the preferredmeans for delivering insulin for Type 2 diabetics. The first inhalable insulin product, Pfizer's EXUBERA(R), was approved by theEuropean Commission on January 26th 2006 and by the FDA on January 27th 2006.Following the launch of EXUBERA(R) inhaled insulin will become available fordiabetics and the way will be paved for next generation products. About Glucose Clamp Technique Glucose clamp technique is a technique that maintains a constant blood glucoselevel in human subjects by perfusion or infusion with glucose; the technique isused in studies to obtain evidence of the effectiveness and bioavailability ofpreparations of insulin in healthy human volunteers, and patients who sufferfrom diabetes. Glucose clamp techniques represent the gold standard for pharmacodynamic andpharmacokinetic studies to describe the time-action profiles of glucose-loweringdrugs; the effects of these drugs administered by various routes ofadministration can be studied individually, and then compared. For example, theeffects of inhaled versus subcutaneous insulin. The European regulatory authority EMEA expressly refers to the glucose clamptechnique in an EMEA/ CPMP Note for Guidance. This press release contains "forward-looking statements," including statementsabout the discovery, development and commercialisation of products. Variousrisks may cause Vectura's actual results to differ materially from thoseexpressed or implied by the forward-looking statements, including adverseresults in clinical development programs; failure to obtain patent protectionfor discoveries; commercial limitations imposed by patents owned or controlledby third parties; dependence upon strategic alliance partners to develop andcommercialise products and services; difficulties or delays in obtainingregulatory approvals to market products and services resulting from developmentefforts; the requirement for substantial funding to conduct research anddevelopment and to expand commercialisation activities; and product initiativesby competitors. As a result of these factors, prospective investors arecautioned not to rely on any forward-looking statement. We disclaim anyintention or obligation to update or revise any forward-looking statements,whether as a result of new information, future events or otherwise. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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