CHIPPENHAM and LITTLE CHESTERFORD, England, April 13
/PRNewswire-FirstCall/ -- Vectura Group plc and Arakis Ltd today announce that they have signed a global development and commercialisation agreement with Novartis for their collaborative product AD 237, a novel once daily, long acting antimuscarinic agent for the treatment of chronic obstructive pulmonary disease (COPD).
Novartis will be responsible for developing AD 237 both as a monotherapy and in combination with QAB149, its once daily, long acting beta2 agonist currently in Phase II clinical development.
Developed to date through a joint venture between Arakis and Vectura, AD 237 is a once-daily, long-acting muscarinic antagonist (LAMA) with a fast onset of action. The compound is in Phase II trials for the treatment of COPD and studies have thus far demonstrated that it is well-tolerated and effective over 24 hours after a single dose. AD 237 was originated by Arakis and has been developed using Vectura's proprietary PowderHale(R) inhalation technology for delivering product to the lung and optimizing fine particle fraction delivery through a commercially available dry-powder inhaler device.
Dr Chris Blackwell, Chief Executive of Vectura, said: "We believe that AD 237 will play a major role in the expansion of the COPD market which is underserved today but set for dramatic growth over the coming decade. Our objective is for AD 237 to be launched as a differentiated once-daily antimuscarinic having potential patient benefits over the competition, in this rapidly expanding market."
Dr Ken Cunningham, Chief Executive Officer of Arakis, said: "As one of the world's leading companies in the treatment of respiratory disease, Novartis is an ideal partner for AD 237. This collaboration is Arakis' first major out-licensing agreement and validates the Company's approach to low-risk drug development."
COPD, the world's fourth largest cause of death, is an irreversible and chronic obstruction of the airways which is caused primarily by smoking. It is estimated that the disease is prevalent in 4% of the populations of the USA, Europe and Japan and that at least one in fifteen smokers suffers from it. Symptoms include chronic bronchitis and emphysema or both conditions, which slowly progress and eventually lead to a largely irreversible loss of lung function. The current market for COPD drug therapy is estimated to be worth $4 billion per annum and is predicted to grow to $10 billion by 2010.
Under the terms of the agreement Arakis and Vectura will each receive an initial payment of $15 million. Clinical, regulatory and commercialisation payments to each of Arakis and Vectura will be payable upon the achievement of pre-agreed targets, which could total up to $172.5 million each for both the monotherapy and combination product. Such initial payment plus potential milestones thus total up to $375 million. In addition, royalties on product sales will be paid for the monotherapy and the combination product. If a third combination product is developed by Novartis, using AD 237, further milestones and royalties may be payable on that product.
Notes for Editors:
Vectura's principal focus is to combine its proprietary pulmonary formulation and device technologies with existing, off-patent drugs to develop inhaled drugs for the treatment of both lung diseases and conditions where delivery via the lungs can provide significant benefits, such as a rapid onset of action, improved efficacy and improved tolerability compared with current therapies.
The Company will seek 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. The Company has development collaborations with a number of companies, including GSK, Chiesi and Arakis. For further information, please visit Vectura's website at http://www.vectura.com/
Arakis is a private UK based biopharmaceutical company that discovers, develops and commercialises innovative medicinal products based on established drugs and drug templates. Its chosen therapeutic areas are inflammatory disease and oncology adjunctive therapy.
Arakis has four products in clinical development: AD 237 for chronic obstructive pulmonary disease (COPD) and AD 452 for rheumatoid arthritis (RA) which have completed Phase IIa trials and AD 337 for fibromyalgia syndrome and AD 923 for cancer breakthrough pain (CBP) are in Phase I. In addition, there is a preclinical pipeline of other opportunities, two of which are finishing proof-of-principle studies.
Arakis was founded in March 2000 and has raised over GBP49 million in three private equity funding rounds. The company is based at Chesterford Research Park, south of Cambridge, UK and currently has 38 employees. For further information about Arakis, please visit its website on http://www.arakis.com/
There will be a meeting and conference call for analysts at the offices of Financial Dynamics at 9.30am today (UK time), please contact Claire Rowell on +44-207-269-7285 for further information.
Lucy Briggs, Tel: +44-207-831-3113
Vectura Group plc and Arakis Ltd