Shares in Spain's Faes Farma leapt on the news that its antihistamine bilastine has been given the green light in Europe.
The German health agency (BfARm), which was acting as the European Medicines Agency rapporteur for bilastine, has approved the drug for allergic rhinoconjunctivitis and urticaria. The remainder of the European states are expected to ratify the decision.
The Bilbao-headquartered group said the efficacy of bilastine has been demonstrated by 28 clinical trials involving more than 5,000 patients. Now Fae's partner Menarini, which has the rights to the drug in 51 countries, including the EU, will start planning launches as will Pierre Fabre which has a deal in place to co-market bilastine in France and Belgium. Vianex will sell the treatment in Greece.
In the last couple of years, Faes has assembled an impressive list of marketing partners for other territories. Merck Serono is signed up to sell the drug in India and agreements are also in place with Pfizer (Mexico), Nycomed (Brazil), Hikma (Middle East) and Yuhan (South Korea).
Faes concluded by saying that the world antihistamine market is worth 4.2 billion euros and Europe makes up a quarter of that. The firm is hoping for a 20% share of the latter market.
Last week, Faes announced that it has signed a co-marketing deal with Merck & Co to sell the latter's diabetes drugs Januvia (sitagliptin) and Janumet (sitagliptine/metformin) in Spain.
Fast-track for Zeltia brain disorder drug
Staying in Spain, Zeltia's Noscira unit has announced that the US Food and Drug Administration has granted fast-track status to its neuroprotector drug Zentylor (tideglusib) to treat progressive supranuclear palsy, a fast-advancing fatal degenerative brain disorder. The drug is in Phase II.