Germany's Merck sets out stall for respiratory sector
for generic respiratory medicines, revealing that it is the
previously unnamed company that has licensed UK inhaler company
Innovata's Clickhaler device in European markets.
Merck said it has been working with Innovata to develop respiratory medicines using the Clickhaler, a single-dose, dry-powder device, to deliver generic active pharmaceutical ingredients (APIs).
Merck Respiratory said it has already secured marketing approvals for Clickhaler versions of the corticosteroid budesonide and long-acting beta agonist formoterol for the treatment of asthma and COPD, in a number of European markets.
Further approvals in other major EU markets are anticipated in the coming months.
Under the terms of the agreement with Merck Generics, Innovata has received milestone payments totalling £6 million (€9m), and the above event triggers a further milestone payment.
Sales of comparable budesonide products in Europe total £200 million while the European market for comparable formoterol products is estimated at more than £100 million.
In addition to the Clickhaler development, Merck said that further applications to health authorities for approval of additional innovative inhaler devices are imminent.
The market for respiratory drugs is one of the fastest-growing therapeutic categories in the global drug market, according to IMS Health.
The latest report on the industry found respiratory medicines currently have a growth rate of around 8 per cent, higher than for cardiovascular and central nervous system drugs (6 per cent) and outstripping other big categories such as gastrointestinal medicines (3 per cent) and musculoskeletals (2 per cent).
One of the contributory factors is escalating rates of asthma and chronic obstructive pulmonary disease, as well as novel delivery devices that are bringing new diseases into the reach of inhaled treatment.
The number of patients with asthma in the seven largest pharmaceutical markets is set to rise from 51 million in 2003 to 62 million in 2013.
Datamonitor estimates that the market for asthma and COPD products will reach $18 billion by 2011.
Also coming under the Merck respiratory banner will be the company's North American subsidiary, Dey Inc, which sells a number of products for the treatment of respiratory diseases and respiratory related allergies.
The new respiratory unit will operate under the umbrella of Merck Generics, the world's third-largest generics company after Novartis subsidiary Sandoz and Teva Pharmaceutical Industries of Israel.
Merck's announcement was made at the European Respiratory Society's 15th Annual Congress, currently being held in Copenhagen, Denmark.
External links to companies or organisations mentioned in thisstory: Merck KGaA Innovata plc
