Novartis forms COPD alliance
Group and Arakis to develop and commercialise AD 237, a novel, long
acting, antimuscarinic agent, for the treatment of chronic
obstructive pulmonary disease (COPD).
Under the terms of the agreement, Novartis will be responsible for developing AD237 both as a monotherapy and in combination with QB149, its once daily, long acting beta2 agonist currently in Phase II clinical 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 per cent 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.
"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," said Dr Chris Blackwell, chief executive of Vectura.
"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," he added.
According to Datamonitor, the world market for asthma/COPD drugs is valued at $13.3 billion (€10.4 billion) in 2003, forecast to grow to $19.0 billion (€14.8 billion) by 2009. Such is the pace of the market and the rising incidences in children, annual growth rates of 10-15 per cent have been reported.
AD 237 is a long-acting muscarinic antagonist (LAMA) with a fast onset of action. The compound is in Phase II trials for the treatment of COPD and has demonstrated that it is well-tolerated and effective over 24 hours after a single dose.
The agreement will also see Arakis and Vectura receiving initial payments 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.
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.
The agreement by Novartis comes late in the game after a whole host of large pharmaceutical companies have formed alliances with the specific intention of treating COPD and related respiratory illnesses. At the start of this year, Pfizer and Rigel Pharmaceuticals entered into a collaboration to develop a novel class of compounds for the treatment of allergic asthma and other respiratory diseases.
Additionally, Novartis announced last summer that the US Food and Drug Administration (FDA) had approved the novel IgE-blocker Xolair (Omalizumab) for the treatment of moderate-to-severe persistent asthma in adults and adolescents.
At the same time Merck Sharp & Dohme announced that they have agreed to fund Amrad with an upfront payment of $7.4 million (€5.6 million), and potentially up to $167 million (€128 million) plus royalties, to advance its early-stage biological treatment for asthma.
