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Chippenham, UK, 18 January 2006: Vectura Group plc ("Vectura", LSE: VEC), the drug development company, announces today that it has received notification from the European Medicines Agency (EMEA) that VR040, its inhaled apomorphine product, has been granted orphan drug designation for the treatment of "off episodes" in patients with Parkinson's disease (PD) who do not respond to oral treatments.
Patients with advanced stage PD often experience unpredictable "off episodes" of sudden onset that severely compromise their ability to perform routine daily activities and negatively impact their quality of life. These "off episodes" can occur 3-5 times per day resulting in patients suffering lack of co-ordination, inability to move or communicate coherently, muscle cramps, musculoskeletal pain, and associated cognitive slowing.
Apomorphine has been used for over half a century, primarily in the treatment of advanced PD, but administered subcutaneously. Vectura's VR040 product has the potential to reduce the therapeutic dose required, and in so doing, may reduce the incidence of unwanted side-effects when compared with other ways of delivering apomorphine. With its expected rapid benefit within minutes of inhalation and non-invasive route of administration, VR040 may also allow more patients to self-administer treatment, in contrast to current treatment options.
Vectura will be starting clinical development of its proprietary formulation, delivered with its Aspirair® device, early in 2006. The first clinical study will be a Phase IIa proof-of-concept study in approximately 24 patients.
Orphan drug designation provides 10 years of potential market exclusivity upon marketing approval in the EU, regulatory assistance in preparing the marketing application, free protocol assistance to optimise clinical development, reduced regulatory fees associated with applying for marketing approval and direct access to the centralised procedure for Marketing Authorisation Application through the EMEA.
Vectura's Chief Executive, Dr Chris Blackwell, said: "We are delighted that we can now pursue a rapid development programme and utilise advice from the EMEA to make our inhaled apomorphine product available to patients as quickly as possible."
Enquiries:
Vectura Group plc
Chris Blackwell, Chief Executive
+44 (0) 1249 667 700
Financial Dynamics
David Yates/Sarah MacLeod/John Gilbert
+44 (0) 207 831 3113
Notes to Editors:
About Vectura
Vectura's principal focus is the development of a range of inhaled drugs for the treatment of both lung diseases and other conditions where optimised delivery via the lungs can provide significant benefits, such as a rapid onset of action, improved efficacy and improved tolerability compared with current therapies.
Vectura's strategy is to combine its proprietary, innovative, pulmonary formulation and device technologies (PowderHale®, Aspirair® and GyroHaler®) with existing, off-patent drugs either for use in new indications or to provide inhalation as an improved route of administration.
The Company seeks to license its lead products to pharmaceutical companies with established sales and marketing infrastructures for the later stages of development and for commercialisation, typically prior to Phase III clinical development.
In addition to its own pharmaceutical products, Vectura operates a well established Pharmaceutical Development Services business that undertakes contract development work for other pharmaceutical companies.
Vectura has also licensed some of its technologies in certain fields to other pharmaceutical companies. These activities generate positive cash flows that are available for investment in Vectura's own development projects. These activities also demonstrate Vectura's acknowledged expertise in applying pulmonary technologies to the creation of innovative pharmaceutical products.
The Company has development collaborations with a number of companies, including Novartis, GSK, SkyePharma and Chiesi.
About Parkinson's Disease
Parkinson's disease (PD) is an age related, chronic, progressive neurodegenerative disorder that affects movement, cognitive function, emotion and autonomic function and has a mean duration of 15 years. Disease severity varies widely with some tremor-dominant patients being only slightly disabled 20 years after diagnosis whereas patients with younger onset and akinetic-rigid forms may be considerably disabled after 10 years. The mortality for elderly people with PD is approximately 1.5 times that of age-matched controls.
Clinical experience indicates that an increasing proportion of patients develop motor fluctuations after 5 to 10 years of first line oral therapy. These fluctuations can take the form of predictable end-of-dose motor deterioration (wearing-off effect) or sudden loss of mobility at random intervals ("on-off" effect).
Despite a number of therapeutic strategies, patients continue to experience unpredictable, disabling "off" states of sudden onset that severely compromise their ability to perform routine daily activities and negatively impact upon their quality of life.
Apomorphine has been used as a pharmacological agent for over a century and has primarily been used in the treatment of advanced Parkinson's disease. Apomorphine is marketed as APO-go® and APOKYNTM throughout the European Union and in the United States respectively. Both products employ the subcutaneous route of administration and are usually prescribed to provide additional or alternative benefit for those people who have had PD for some time and who are experiencing sudden and unpredictable "on-off" fluctuations.
About VR040
The pulmonary system, with an estimated surface area of ~200 m2, facilitates the rapid and efficient exchange of inhaled materials.
Vectura has validated this concept for inhaled apomorphine through clinical pharmacokinetic (PK) studies. PK data demonstrated the rapid attainment of maximum plasma concentrations within 1-3 minutes of inhalation of doses.
Vectura therefore believes that inhalation of apomorphine using its VR040 product will provide a rapid, efficient and predictable benefit through non-invasive delivery that may allow more patients to self-administer treatment.
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