Nycomed, which is in the process of being acquired by Takeda, and Finland’s Orion Corp, are looking to co-market generics of two respiratory blockbusters – GlaxoSmithKline’s Advair and AstraZeneca’s Symbicort.
The firms have signed an agreement which covers Orion’s combination products for the treatment of asthma and chronic obstructive pulmonary disease, delivered by its new Easyhaler dry powder inhaler. In particular, Orion is developing copies of GSK’s Advair/Seretide (fluticasone/salmeterol) and AstraZeneca’s Symbicort (budesonide and formoterol).
The co-marketing deal covers the major European countries, except the Nordic countries, the UK and eastern Europe where Orion is currently promoting single-molecule Easyhaler products. Nycomed will have exclusive rights to the combos in the Middle East and North Africa region (MENA).
Guido Oelkers, head of commercial operations at Nycomed, said that “we see great potential in these high-quality Easyhaler products in major European countries and the MENA region”. He added that “they will significantly enhance Nycomed’s fast-growing respiratory portfolio”, which includes the COPD treatment Daxas (roflumilast), Alvesco (ciclesonide) for asthma, and Omnaris (also ciclesonide) for allergic rhinitis.
No financial details were given and the companies were coy as to when marketing authorisation applications will be made for the Advair and Symbicort copies. Presumably it will be pretty soon, considering that analysts have predicted that generics of the former could hit the market in the next year.
Only yesterday, the UK’s Vectura Group signed an agreement with “a US division of an undisclosed leading international pharmaceutical company” for VR315, a combination therapy also thought to be a generic version of Advair and Novartis’ Sandoz is developing that product in Europe.
GSK has previously said that it believes there will not be much competition to Advair because even though copycat versions containing the same active ingredients will be available, the inhaler device used for Advair means that competing products will not be fully substitutable, so regulators may be wary. It will be interesting to see how impressed the regulators will be with Easyhaler.
