Almirall has received a positive recommendation from seven European regulators for Actikerall, its new treatment for precancerous growths on the skin.
The Spanish drugmaker says that the regulatory authorities in Germany, the UK, Austria, Luxemburg, Poland, Czech Republic and Slovakia have recommended approval of Actikerall (flourouracil/salicylic acid) for the treatment of "palpable and/or moderately thick hyperkeratotic actinic keratosis" in adults.
The topical solution has shown good clinical efficacy data and in studies involving 168 people, 72% experienced histological clearance of lesions after treatment and sustained clinical benefit of 85.8% lesion clearance after 12 months post-treatment. The tolerability profile was good and, "as expected, only site application events of mild to moderate intensity were reported", Almirall noted.
Once product packaging and related documents have been completed, national marketing approvals can be granted in each of the respective countries. First launches are expected in the Germany and the UK in mid-2011.
Actinic keratosis (also known as solar keratosis) is a condition of thick, scaly, or crusty patches of skin. More common in fair-skinned people, it is associated with those who are frequently exposed to the sun and untreated lesions have up to a 20% risk of progression to squamous cell carcinoma.
Spanish price cuts hit earnings
Meantime, Almirall has posted financials for the first quarter which show that sales were down 12.3% to 212.7 million euros, hit by healthcare reforms in Spain that have reduced prices. Net income was down 40.0% to 30.6 million euros.
Chief financial officer Eduardo Sanchiz noted that 2011 should see filings for aclidinium bromide for chronic obstructive pulmonary disease and linaclotide for irritable bowel syndrome with constipation. Sales will also be boosted by the roll out of Sativex (delta-9-tetrahydrocannabinol and cannabidiol), an add-on therapy for the treatment of moderate to severe spasticity in multiple sclerosis patients (licensed from GW Pharmaceuticals), and Nycomed's once-daily COPD tablet Daxas (roflumilast); Almirall will be exclusively promoting a second brand of the phosphodiesterase 4 enzyme inhibitor in Spain.