LONDON Swiss drugmaker Novartis won an important endorsement of its new inhaled medicine for chronic lung disease on Friday when European regulators recommended approval of Ultibro Breezhaler.
Also known as QVA149, the once-daily medicine belongs to a new type of dual-action treatments that are expected by analysts to become major sellers and is the first in the class to win such a green light.
The green light from the European Medicines Agency (EMA) paves the way for full marketing authorization in the next two or three months. Approval in the key U.S. market remains some way off, since the drug will not be filed there until late 2014.
The new product contains two bronchodilators - indacaterol, a long-acting beta2-adrenergic agonist (LABA), and glycopyrronium, a long-acting muscarinic antagonist (LAMA).
Glycopyrronium was licensed from Vectura, entitling the British firm to milestone payments and royalties on sales. Shares in Ventura rose 7 percent on Friday's news.
Other companies including GlaxoSmithKline are also working to develop such LABA/LAMA combinations.
Novartis is banking on new drugs, including QVA149, to fill the gap left by the loss of exclusivity on its blockbuster blood pressure pill Diovan. It also has high hopes for Serelaxin, a treatment for acute heart failure and psoriasis drug AIN457.
QVA149 is designed to treat chronic obstructive pulmonary disease (COPD), a disease that causes breathing trouble and chronic coughing, and is sometimes fatal. It affects an estimated 210 million people worldwide.
Analysts at Berenberg said Ultibro could achieve annual sales of around $2.3 billion by 2021, of which $1.7 billion could be generated outside the United States.
HIV DRUG GREEN LIGHT
The EMA said it had also recommended a new HIV medicine from Gilead Sciences called Tybost, or cobicistat, a drug that does not itself fight the virus that causes AIDS but boosts the function of other HIV medicines.
The European recommendation contrasts with a rebuff for the Gilead product from U.S. regulators in April.
In addition, the EMA issued a positive opinion for Gentium's drug Defitelio for use in patients undergoing blood stem-cell transplantation, and Boehringer Ingelheim's lung cancer drug Giotrif.
GSK's Revolade was recommended for wider use in patients with thrombocytopenia associated with chronic hepatitis C infection, while Bayer's Eylea was backed for wider use in eye disease. Regeneron is Bayer's partner on Eylea.
Otsuka's new drug Delamanid for treating multidrug-resistant tuberculosis, however, was not recommended for approval.
Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.
(Reporting by Ben Hirschler and Caroline Copley.; editing by Keith Weir and Patrick Graham)