18th Jan 2006 10:19
Vectura Group PLC18 January 2006 Vectura Announces EMEA Orphan Drug Designation for its Inhaled Product for Parkinson's Disease Chippenham, UK, 18 January 2006: - Vectura Group plc ("Vectura", LSE: VEC), thedrug development company, announces today that it has received notification fromthe European Medicines Agency (EMEA) that VR040, its inhaled apomorphineproduct, has been granted orphan drug designation for the treatment of "offepisodes" in patients with Parkinson's disease (PD) who do not respond to oraltreatments. Patients with advanced stage PD often experience unpredictable "off episodes" ofsudden onset that severely compromise their ability to perform routine dailyactivities and negatively impact their quality of life. These "off episodes"can occur 3-5 times per day resulting in patients suffering lack ofco-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 ofadvanced PD, but administered subcutaneously. Vectura's VR040 product has thepotential to reduce the therapeutic dose required, and in so doing, may reducethe incidence of unwanted side-effects when compared with other ways ofdelivering apomorphine. With its expected rapid benefit within minutes ofinhalation and non-invasive route of administration, VR040 may also allow morepatients to self-administer treatment, in contrast to current treatment options. Vectura will be starting clinical development of its proprietary formulation,delivered with its Aspirair(R) device, early in 2006. The first clinical studywill be a Phase IIa proof-of-concept study in approximately 24 patients. Orphan drug designation provides 10 years of potential market exclusivity uponmarketing approval in the EU, regulatory assistance in preparing the marketingapplication, free protocol assistance to optimise clinical development, reducedregulatory fees associated with applying for marketing approval and directaccess to the centralised procedure for Marketing Authorisation Applicationthrough the EMEA. Vectura's Chief Executive, Dr Chris Blackwell, said: "We are delighted that wecan now pursue a rapid development programme and utilise advice from the EMEA tomake our inhaled apomorphine product available to patients as quickly aspossible." Enquiries: Vectura Group plcChris Blackwell, Chief Executive +44 (0) 1249 667 700 Financial DynamicsDavid 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 thetreatment of both lung diseases and other conditions where optimised deliveryvia 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, pulmonaryformulation and device technologies (PowderHale(R), Aspirair(R) and GyroHaler(R)) with existing, off-patent drugs either for use in new indications or toprovide inhalation as an improved route of administration. The Company seeks to license its lead products to pharmaceutical companies withestablished sales and marketing infrastructures for the later stages ofdevelopment and for commercialisation, typically prior to Phase III clinicaldevelopment. In addition to its own pharmaceutical products, Vectura operates a wellestablished Pharmaceutical Development Services business that undertakescontract development work for other pharmaceutical companies. Vectura has also licensed some of its technologies in certain fields to otherpharmaceutical companies. These activities generate positive cash flows that areavailable for investment in Vectura's own development projects. These activitiesalso demonstrate Vectura's acknowledged expertise in applying pulmonarytechnologies to the creation of innovative pharmaceutical products. The Company has development collaborations with a number of companies, includingNovartis, GSK, SkyePharma and Chiesi. About Parkinson's Disease Parkinson's disease (PD) is an age related, chronic, progressiveneurodegenerative disorder that affects movement, cognitive function, emotionand autonomic function and has a mean duration of 15 years. Disease severityvaries widely with some tremor-dominant patients being only slightly disabled 20years after diagnosis whereas patients with younger onset and akinetic-rigidforms may be considerably disabled after 10 years. The mortality for elderlypeople with PD is approximately 1.5 times that of age-matched controls. Clinical experience indicates that an increasing proportion of patients developmotor fluctuations after 5 to 10 years of first line oral therapy. Thesefluctuations 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 experienceunpredictable, disabling "off" states of sudden onset that severely compromisetheir ability to perform routine daily activities and negatively impact upontheir quality of life. Apomorphine has been used as a pharmacological agent for over a century and hasprimarily been used in the treatment of advanced Parkinson's disease.Apomorphine is marketed as APO-go(R) and APOKYNTM throughout the European Unionand in the United States respectively. Both products employ the subcutaneousroute of administration and are usually prescribed to provide additional oralternative benefit for those people who have had PD for some time and who areexperiencing sudden and unpredictable "on-off" fluctuations. About VR040 The pulmonary system, with an estimated surface area of 200 m2, facilitates therapid and efficient exchange of inhaled materials. Vectura has validated this concept for inhaled apomorphine through clinicalpharmacokinetic (PK) studies. PK data demonstrated the rapid attainment ofmaximum plasma concentrations within 1-3 minutes of inhalation of doses. Vectura therefore believes that inhalation of apomorphine using its VR040product will provide a rapid, efficient and predictable benefit throughnon-invasive delivery that may allow more patients to self-administer treatment. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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