* Plans Selincro launch in mid-2013
* Earnings guidance unchanged (Adds detail, background)
COPENHAGEN, Feb 28 (Reuters) - Danish drugmaker Lundbeck has received European Union approval for Selincro, its innovative drug to fight alcohol dependency, a small boost in its fight against falling sales and heavy investment in new products.
The EU decision, which follows a positive recommendation from the European Medicines Agency in December, will allow Lundbeck to launch the drug on the market in mid-2013, the company said on Thursday.
“Lundbeck will provide Selincro as part of a novel treatment concept that includes continuous psychosocial support focused on the reduction of alcohol consumption,” the company said.
The drug has been developed as a one-a-day tablet to be taken as required on days when the patient feels he or she is at risk of drinking.
Selincro, which blocks the action of opioid receptors in the brain, was licensed to Lundbeck from Finland’s Biotie Therapies .
Lundbeck added that sales predictions for the drug are unusually difficult because Selincro is unlike usual products, adding that the drug’s EU approval would not alter the company’s earnings guidance.
The company’s shares fell to their lowest level in more than 12 years in December after it cut revenue and profit guidance for the coming years, owing to generic competition and product development costs.
But the shares, considered undersold given promising developments, have climbed 16 percent since the start of the year and traded up 1.6 percent at 1042 GMT on Thursday, against a 0.4 percent rise in the Copenhagen stock exchange’s benchmark index. (Reporting by Balazs Koranyi; Editing by David Goodman)