GSK lung drug Anoro recommended for European approval
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Anoro, a GlaxoSmithKline (NYSE: GSK) respiratory drug pegged to succeed GSK blockbuster drug Advair, has been recommended for approval by regulators in Europe.
Britain-based GSK, which operates U.S. headquarters in Research Triangle Park, said the European Medicines Agency recommended Anoro as a once-daily treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease, the London-based company said in a statement today. Anoro was approved in the U.S. in December.
Anoro may help Glaxo protect its respiratory business, which made up 42 percent of its total pharmaceutical sales last year. The company’s top-selling product, Advair for smokers’ cough and asthma, is facing increasing competition from a newly approved generic in Europe and cheaper options in the U.S. Glaxo also won approval last year for Breo, a separate drug for COPD.
Anoro, a once-daily dry powder inhaler, may generate $1.25 billion in sales in 2016, according to the average of seven analysts’ estimates compiled by Bloomberg. COPD is a disease often caused by smoking, that makes it difficult to breathe.
Anoro will compete with Novartis AG’s Ultibro Breezhaler, which works in a similar way. Novartis has also been winning approval for AirFluSal, a generic form of Advair, since December in European markets such as Germany and Denmark through a decentralized country-by-country process.
COPD kills a person every 10 seconds and will become the third leading cause of death worldwide by 2030, according to the World Health Organization and Glaxo. Conditions known as chronic bronchitis and emphysema are both included in the COPD diagnosis. While asthma affects more people globally, it doesn’t kill on the scale of COPD, according to the WHO.
The market for COPD medicines may rise to $14 billion in 2018 from $10 billion this year, Citigroup Inc. analysts estimate. Including asthma, the respiratory market will total more than $30 billion, according to Bloomberg Industries.
In other GSK news
GlaxoSmithKline Plc is pushing for more stringent regulation of electronic cigarettes, which compete with its Nicorette gum and other smoking cessation products, according to e-mails from a company executive.
Europe should follow the lead of the U.K., which plans to to require all nicotine-containing products including e- cigarettes to be licensed as medicines, wrote Sophie Crousse, the Brussels-based vice president of European public affairs for Glaxo’s consumer health-care division.
“We believe in responsible and proportionate regulation for all nicotine-containing products as medicinal products,” Crousse said in an e-mail dated Oct. 30. The message and other documents were made public last week through a freedom of information request made to the health and consumer affairs division of the European Commission.
The commission is revising the Tobacco Products Directive to regulate products such as e-cigarettes that don’t contain tobacco, yet are linked to tobacco use. E-cigarettes, which Euromonitor International Plc estimates will generate $7 billion in sales by the end of this year, compete with quit-smoking products sold by pharmaceutical companies including Glaxo, Johnson & Johnson and Novartis AG.
Glaxo is also seeking assurances that the revised directive will apply to e-cigarettes already on the market and ensure a ban on advertising, according to company comments included in a draft of Article 18 of the tobacco directive.
“Safety is our number one priority and we support the smoker’s right to choose from a selection of products that have well established safety and efficacy profile in helping them quit smoking,” Simon Steel, a spokesman for London-based Glaxo, said in an e-mailed statement. “All nicotine-containing products including e-cigarettes should be reviewed and regulated to the same standard of safety.”
Novartis, the Basel, Switzerland-based company that markets Nicotinell gums, lozenges and patches, didn’t immediately provide a comment.
J&J, which markets the Nicorette line of products in all markets outside the U.S., is also “strongly in favor of” regulating all non-tobacco nicotine products, including e- cigarettes, as medicines, Caroline Almeida, a spokeswoman for the New Brunswick, New Jersey-based company, said in an e-mailed statement.
“This is the best way to ensure all non-tobacco nicotine products are advancing public health by means of effective, high-quality and safe products,” Almeida said.
The primary components of e-cigarette cartridges and vapor are propylene glycol, glycerine and nicotine. Smokers are harmed by the deadly tar and toxins in tobacco smoke.
In the U.K., the Medicines and Healthcare products Regulatory Agency will require manufacturers to present data on the quality of their products, on how they deliver the addictive drug nicotine to the body and on how they compare with existing nicotine-replacement products.
Research commissioned by the U.K. agency has shown that nicotine levels in some e-cigarettes can be considerably different from the level stated on the label, according to Jeremy Mean, an official in the MHRA unit in charge of vigilance risk management of medicines.
British American Tobacco Plc started a digital and television advertising campaign for the Vype e-cigarette brand, the company said this week.
(Bloomberg News contributed to this report)
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