Biotech Values

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COPD - NVS' QD LABA

Novartis lung drug beneficial in late stage study

http://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20&%20Specialty/idUSLE16644120090915

* Improved lung function, reduced breathlessness

* "Smoker's lung" affects 210 million people worldwide

* Company confident on drug unit's performance

* Shares flat, outperform peers

(Adds Vectura data, shares)

By Sam Cage

ZURICH, Sept 15 (Reuters) - Swiss drugmaker Novartis (NOVN.VX: Quote, Profile, Research, Stock Buzz) said a respiratory medicine improved lung function and significantly reduced breathlessness in a late stage trial.

The once-daily QAB149 drug, which treats chronic obstructive pulmonary disease (COPD), improved a key measure of lung function at both 12 and 26 weeks of treatment compared with bronchiodilator tiotropium, also known as Spiriva.

The outcome added to data suggesting QAB149 will challenge blockbusters like Pfizer's (PFE.N: Quote, Profile, Research, Stock Buzz) Spiriva and GlaxoSmithKline's (GSK.L: Quote, Profile, Research, Stock Buzz) Advair, giving Novartis an edge in one of the industry's most lucrative therapeutic areas. [ID:nLM109152]

"We believe there is significant upside to our $1 billion sales forecast in COPD," said Helvea analyst Karl-Heinz Koch, who expects the drug to hit the market at the end of 2009.

Spiriva, marketed by Pfizer and Boehringer Ingelheim, is currently considered the gold standard treatment for COPD, or "smoker's lung", commonly caused by cigarette smoke and other harmful fumes and characterised by a persistent obstruction of airflow in the lungs which results in breathlessness.

Novartis plans to use QAB149 both on its own and as the base of combination treatments with other lung medicines, including QVA149, a mix with Vectura's (VEC.L: Quote, Profile, Research, Stock Buzz) NVA237. It is being reviewed for approval in Europe and the United States.

Vectura said on Tuesday the QVA149 combination had shown promising results in mid stage trials and was safe and well tolerated. [ID:nWLA3399]

The franchise is a key plank in Novartis's strategy to overcome the loss of exclusivity on top-selling blood pressure drug Diovan, which loses patent protection in 2012.

Novartis shares were flat at 49.42 Swiss francs by 1402 GMT, against a 0.8 percent drop in the European healthcare sector and helped by a sell-side event hosted late on Monday in which the group explained its focus on improving efficiency. Vectura shares were up 1.5 percent.

EFFICIENCY

At that event, Novartis drugs chief Joe Jimenez suggested impressive first-half growth was continuing in the third quarter and was confident the buy of a majority stake in Alcon (ACL.N: Quote, Profile, Research, Stock Buzz) would go through soon, said Vontobel analyst Andrew Weiss.

Novartis, which already holds 25 percent of the eye care company, has a deal to buy Swiss food group Nestle's (NESN.VX: Quote, Profile, Research, Stock Buzz) 52 percent stake between January 2010 and July 2011.

"We reckon, however, that Novartis will need to gain full control, if it wants to start extracting synergies by combining business units," Weiss said.

Data on QAB149, which would be the first such medicine to be given once rather than twice a day, were presented this week at a European Respiratory Society meeting in Vienna and add to results presented to the American Thoracic Society this year.

Smoker's lung is a debilitating and progressive respiratory disease that affects 210 million people worldwide, according to Novartis.