AD 237 : An Inhaled Long-acting Anti-muscarinic for the Treatment of Chronic Obstructive Pulmonary Disease in Phase II
Apr 18, 2005 - 9:02:38 AM

Novartis announced that it has signed a global development and commercialization agreement with Vectura Group plc and Arakis Ltd. for AD 237, an inhaled, long-acting, anti-muscarinic agent for the treatment of chronic obstructive pulmonary disease (COPD).

Novartis will be responsible for further development of AD 237 both as 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 has been developed using Vectura's proprietary PowderHale® inhalation technology for delivering product to the lung and optimizing fine particle fraction delivery through a commercially available dry-powder inhaler device.

"With this agreement, our late stage pipeline now contains two promising bronchodilator drugs, QAB149 and AD 237 for the treatment of COPD," said Joerg Reinhardt, Head of Development, Novartis Pharma AG. "Both products have significant therapeutic potential, either as single agents or combination therapies. Respiratory disease is one of our key therapeutic areas of focus, and we are delighted to expand our franchise and provide patients with important new therapeutic solutions."

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 population in the USA, Europe and Japan, and that at least one in 15 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 receive an initial payment and additional milestone payments based upon the achievement of agreed clinical, regulatory and commercialisation targets. In addition, royalties on product sales will be paid for both the monotherapy and combination products. All payments by Novartis will be shared equally by Arakis and Vectura.

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