* "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.
[The 10-5 vote against approval seems incompatible with votes by the same panel that Daxas was safe (9-6 in favor) and was effective (also 9-6 in favor). Methinks the way these panels are conducted is in need of some housekeeping work!
FRX licensed the US rights to Daxas from Nycomed, a private Swiss biotech company that tried to sell itself a year ago but evidently got no takers (#msg-36507247).]
SILVER SPRING, Md., April 7 (Reuters) - Forest Laboratories Inc <FRX.N> suffered a setback on Wednesday as a U.S. advisory panel voted against recommending approval of an experimental drug to treat a common and deadly lung disorder.
The committee voted 10-5 that Forest had not provided substantial evidence to support Food and Drug Administration approval of Daxas for chronic obstructive pulmonary disease (COPD).
Forest shares fell 8 percent in after-hours trading.
The company's shares had jumped 6.5 percent ahead of the market close after the advisory panel voted that Daxas was safe and effective in separate 9-6 votes.
In opposing approval, some panelists said the benefits of Daxas were small and did not outweigh risks.
"The benefit of this drug, although it's there, it's meager," said Dr. Richard Honsinger of Los Alamos Medical Center Clinic in New Mexico.
"The drug does have side effects," he added.
The fate of Daxas, a once-a-day pill, is key to Forest as the company tries to build its portfolio ahead of the 2012 patent expiration for its huge-selling antidepressant Lexapro.
Daxas was developed by Nycomed, a privately held Swiss drugmaker aiming for an initial public offering. Forest holds U.S. rights to the drug. Analysts have estimated peak annual sales could hit $500 million or more.
The FDA usually follows panel recommendations, and a decision is due in mid-May. Analysts said before the meeting they expected a delay as Forest recently modified the drug's proposed use from broad treatment of COPD to reducing exacerbations, or attacks that restrict breathing. The panel voted on the broader use. Forest may win approval for the narrower group of patients but not before the end of the year, said analyst Ira Loss of Washington Analysis.
"There's a lot of places the FDA could go here in getting the narrow indication," he said.
Collins Stewart analyst Louise Chen also said the panel outcome "doesn't mean the drug's not going to get approved."
She noted that the votes were mixed and said any weakness in Forest's share price will likely be short-lived.
"I think it will bounce back," Chen said.
COPD, or "smoker's lung," is a potentially fatal lung disease that causes breathing trouble and chronic coughing. An estimated 80 million people worldwide have moderate to severe COPD.
Forest said COPD patients needed new options as many still have symptoms despite treatment with current drugs. The company said studies in more than 7,000 patients showed Daxas reduced exacerbations.
FDA reviewers, however, said Daxas produced only a modest improvement in lung function. They urged the panel to weigh that against concerns about severe diarrhea, weight loss, cancer, psychiatric problems and suicides among people who took Daxas in studies. Three people killed themselves, and two attempted suicide.
Forest said there was no evidence that Daxas caused the suicides or raised the risk of cancer. The company said other risks were manageable.
Lawrence Olanoff, Forest's president and chief operating officer, said he was disappointed the panel did not recommend approval but said the company would continue talking with the FDA in light of the two positive votes.
"We believe there is still room for us to begin and go forward with negotiations with the agency," Olanoff told reporters.
Daxas, known generically as roflumilast, works by inhibiting an enzyme called PDE4 that is linked to inflammation. Nausea, diarrhea and weight loss are known side effects of the PDE4 inhibitors.‹
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