LONDON, July 26 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 authorisation 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
Otsuka's new drug Delamanid for treating
multidrug-resistant tuberculosis, however, was not recommended
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