17th Jan 2008 12:29
Vectura Group plc17 January 2008 VECTURA GROUP PLC: INTERIM MANAGEMENT STATEMENT 3 MONTHS ENDED 31 DECEMBER 2007 Chippenham, UK - January 17 2008: Vectura Group plc (LSE: VEC) ("Vectura"), thepulmonary product development company focused on lung and neurological diseases,is today issuing its Interim Management Statement ("IMS"). This IMS relates tothe three month period from 1 October 2007 to 31 December 2007 and containsinformation up to the publication of this IMS ("the period"). Highlights: • Milestone from collaboration with Boehringer Ingelheim (€10 million cash payment and a €5 million equity investment received in December 2007) • Milestone (€3 million received in October 2007) on VR315 (Vectura's generic combination product in development for asthma and COPD with an undisclosed partner) • Progress on development of NVA237 and QVA149 for COPD (licensed to Novartis), with initiation of two QVA149 Phase II clinical studies. Novartis announced today that they expect to file NDA submissions for both NVA237 and QVA149 in 2011. • Announced in December 2007 an agreement to develop VR632, a second combination product for asthma, with our European collaboration partner for VR315 • Announced successful outcome of Phase II clinical study on VR040 for Parkinson's disease in October 2007 Financial outlook: • Cash generative in the third quarter with cash balances at 31 March 2008 expected to be in excess of £75 million • Revenues for third quarter in line with expectations with full year revenues expected to be at least 70% ahead of previous year's total of £14 million Dr Chris Blackwell, Chief Executive of Vectura, commented: "Vectura continues to build its position in the rapidly growing respiratorymarket. Two significant milestones have been received during the past quarterand we have added an important new late-stage product to the pipeline with theintroduction of our new, partnered combination asthma therapy, VR632. Ourbusiness focus is to generate sustainable cash flow and this is reflected in theprioritisation and focus of our resources to deliver the progress we have seenin our pipeline." Enquiries:Vectura Group plc + 44 +44 (0)1249 667700Chris Blackwell, Chief ExecutiveAnne Hyland, Chief Financial OfficerJulia Wilson, Director of Investor Relations & CorporateCommunications Financial Dynamics +44 (0)20 7831 3113David YatesSanjeev PandyaSusan Quigley Notes for Editors: About Vectura Vectura Group plc is a pulmonary product development company focused principallyon the development of a range of inhaled therapies for the treatment ofrespiratory and neurological diseases. Vectura develops products to treatrespiratory diseases such asthma, chronic obstructive pulmonary disease (COPD)and cystic fibrosis, the market for which is forecast to achieve sales of $32billion by 2011. Vectura also develops products for non-respiratory diseaseswhere optimised delivery via the lungs into the blood stream can providesignificant benefits, such as a rapid onset of action, improved efficacy andimproved tolerability 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 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 several pharmaceutical companiesincluding Boehringer Ingelheim, Novartis and Chiesi. The acquisition of Innovatain January 2007 brought established alliances with a number of additionalcompanies, such as Baxter, GlaxoSmithKline (GSK), Merck Generics (part of MylanInc), UCB and Otsuka, as well as providing revenue streams, complementaryproducts and critical mass. For further information, please visit Vectura's website at www.vectura.com Forward-Looking Statements This press release contains "forward-looking statement", 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 programmes; failure to obtain patent protectionfor inventions; commercial limitations imposed by patents owned or controlled bythird 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. INTERIM MANAGEMENT STATEMENT PIPELINE UPDATE Boehringer Ingelheim collaboration We announced on 26 November 2007 that we had achieved a pre-agreed milestoneunder our collaboration with Boehringer Ingelheim to develop a new dry powderinhaler (DPI). Vectura received a cash payment of €10 million and a €5 millionequity investment. In April 2006, Vectura entered a worldwide collaboration, development andlicence agreement with Boehringer Ingelheim to develop a DPI as a tailoredBoehringer Ingelheim device to deliver a range of their proprietary respiratoryproducts, primarily for treating asthma and COPD. Boehringer Ingelheimultimately will be responsible for further development, manufacturing andclinical trial use of the DPI with their proprietary compounds, and thecommercialisation of these products. Vectura will receive development milestonesand royalties on sales of each product that uses the device. The non-exclusivenature of the agreement with Boehringer Ingelheim provides Vectura with anexcellent opportunity to deliver further value from our inhaled therapytechnologies. NVA237 and QVA149 for COPD NVA237 is a once-daily, rapid onset, long-acting muscarinic antagonist (LAMA),which Novartis intends to launch as a as a once-daily treatment for COPD.QVA149 comprises the combination of NVA237 with Novartis's once-daily,long-acting beta agonist (LABA), indacaterol (or QAB149), which is currently inPhase III development. Novartis announced in September 2007 that it expected to initiate Phase IIItrials in 2008, with an expectation to file NDAs (New Drug Applications) in2010. Today, Novartis updated their expected filing dates for both products to2011. The start of the Phase III programme will trigger a substantial milestonepayment to Vectura. VR315 for asthma VR315 is an inhaled combination therapy for asthma that is being developed as ageneric product using Vectura's GyroHaler(R) as the delivery device. Vecturalicensed the European rights for VR315 to an undisclosed leading internationalpharmaceutical company in March 2006. The US rights were licensed to anundisclosed leading international pharmaceutical company in December 2006. Vectura received €3 million in cash from its European partner in October 2007and the Directors expect VR315 to enter clinical registration studies in 2008. VR632 for asthma On 18 December 2007, Vectura announced that its undisclosed Europeancollaboration partner for VR315 had exercised an option to license VR632, asecond combination asthma therapy. VR632 will be developed as a genericcombination product using GyroHaler(R). This agreement follows the March 2006agreement with the same European partner for VR315. Vectura will receive up to €15.5 million in milestones and development fundingprior to launch of VR632, and will earn royalties on all product sales, as wella margin on the commercial manufacture and supply of GyroHaler(R). VR040 treatment for Parkinson's disease (PD) VR040 is an inhaled, systemically acting product for treating "off" episodesassociated with advanced PD that do not respond to oral treatment. In October 2007 Vectura announced successful completion of a second Phase IIclinical study for VR040 in patients with PD. The study demonstrated that VR040was safe, well tolerated, and successfully recovered patients from an induced "off" episode with a rapid onset of action that was also durable. Importantly,the novel delivery via inhalation could offer patients an improved alternativeto the currently available formulations of apomorphine. GUIDANCE AND OUTLOOK Following the receipt of the milestones payments from Boehringer Ingelheim andour VR315 partner, Vectura was cash generative in the third quarter of 2007 andwe expect cash balances at 31 March 2008 to be in excess of £75 million. We expect our revenues for our year to March 2008, which will include elementsof the above milestones, to be around 70% higher than the £14 million reportedin the previous year, with the majority of this increase resulting from the fullyear revenue contribution from the acquired Innovata business. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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