Novartis drug investigated after 11 deaths

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LONDON (AP) — A European agency is investigating a multiple sclerosis drug made by industry giant Novartis to determine whether the medicine played any role in the deaths at least 11 patients.

The drug, Gilenya, was licensed last year in the European Union to treat a severe type of multiple sclerosis. It can cause a slow heart rate when first taken and doctors closely monitor patients after the first dose.

The European Medicines Agency, which is now investigating the drug, said it isn't clear if it caused the deaths. One of the fatalities occurred in the United States, where a patient died within 24 hours of taking the first dose.

The European agency said it didn't know where the other 10 deaths occurred, but that they were reported to its drug database, which monitors side effects from medicines in the European Union.

Novartis said not all the deaths were heart related.

A spokeswoman at the U.S. Food and Drug Administration said it also is conducting a data analysis but has not made any definitive conclusions and does not know when its review will be complete.

More than 30,000 patients have taken Gilenya worldwide.

The European Medicines Agency advised doctors to increase their monitoring of patients after the first dose of the medicine. The agency said the risk of a slow heart rate after the first dose of Gilenya was known when it was approved.

Novartis AG said it was advising doctors of new recommendations on using Gilenya. They had previously said all patients should be monitored for six hours after their first dose, but are now tightening that to include continuous heart monitoring using electrocardiograms and measuring blood pressure and heart rate every hour. In certain patients, that monitoring should be extended, the drug maker said in a statement.

This new guidance applies only to patients taking their first dose, Novartis said in a statement.

The EU drug regulator hopes to finish its review of the drug by March.

___

Online:

www.ema.europa.eu

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Novartis seeks approval for new smoker's cough drug

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By Aaron Gray-Block

AMSTERDAM | Tue Sep 27, 2011 1:30am EDT

AMSTERDAM (Reuters) - Swiss drugmaker Novartis said it has applied to start selling its experimental drug to treat smoker's cough -- which afflicts 80 million people worldwide -- after tests showed that it helped patients breathe more easily.

Novartis has carried out late-stage trials for the drug, known as NVA237, because it wants to tap into the lucrative market for respiratory drugs at a time when it is facing increasing competition for its top-selling products from generic rivals.

Analysts say Novartis could earn billions of dollars if its treatments for chronic obstructive pulmonary disease (COPD), commonly known as smoker's cough, win regulatory approval. NVA237 alone could potentially add $500 million in annual sales.

On Tuesday Novartis said NVA237, used once a day, significantly increased the functioning of lungs in patients compared with a placebo and that the first dose produced a fast response. NVA237 also enabled patients to exercise longer, it added.

Dave Morris, global development head at the Respiratory unit, said Novartis applied to the European Medicines Agency for approval at the end of August and expects a final decision from authorities some time in 2012. The drug will be marketed in the European Union as Seebri Breezhaler.

In a presentation at the European Respiratory Society annual meeting in Amsterdam, Novartis said NVA237 prolonged the time before patients suffered their first moderate to severe relapse and reduced the number of hospitalizations.

In June a separate study showed NVA237, or glycopyrronium bromide, helps patients with smoker's cough -- which causes breathing trouble and chronic coughing and is sometimes fatal, in a similar way to a rival drug from Pfizer and Boehringer Ingelheim.

Novartis wants to combine NVA237 with an inhalation powder indacaterol to treat the disease as it races British drugmaker GlaxoSmithKline to be the first company to sell a two-in-one medicine. The combined treatment is being developed under the name QVA149.

Data unveiled in Amsterdam also showed a 150 mcg and 300 mcg dose of Novartis' indacaterol drug significantly improved lung function among patients after using it for six months compared with patients who were treated with a placebo.

Earlier this year, U.S. authorities approved a 75 mcg dose, but Novartis failed to win backing for its higher 150 mcg dose, a setback for Novartis in its development of QVA149.

Deutsche Bank analyst Richard Parkes estimates that NVA237 could generate annual sales of $500m by 2018, while the combined treatment could add more than $2 billion to that figure.

NVA237 was licensed to Novartis in 2005 by Vectura and its co-development partner Sosei.

Until recently, Novartis was not on the radar as a major force in lung drugs, which are more difficult to make because of the inhaler devices needed.

The field is now becoming increasingly important to Novartis as it develops new drugs and cheap generic versions of older products such as Glaxo's Advair.

(Additional reporting by Katie Reid in Zurich)

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Novartis drug may help older breast cancer patients

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By Kate Kelland

STOCKHOLM | Sun Sep 25, 2011 11:20am EDT

STOCKHOLM (Reuters) - Novartis's bone drug Zometa extended survival in older breast cancer patients but failed to improve disease-free survival among younger women patients in a large-scale clinical trial, researchers said on Sunday.

Detailed data presented at the European Multidisciplinary Cancer Congress (EMCC) in Stockholm showed that Zometa, a bisphosphonate drug known generically as zoledronic acid, only improved overall survival rates in patients who had undergone the menopause at least five years earlier.

Researchers said the effect was likely to be linked to levels of reproductive hormones, which are lower in women who have been through the menopause.

"This is not a treatment for ever woman with breast cancer," said Robert Coleman of Britain's Sheffield University, who led the study. But for women with low levels of female hormones, either due to aging or specific treatments to induce menopause, Zometa "appears very promising."

An analysis of the subset of older patients showed that at a the five-year follow-up, there was a 26 percent reduction in recurrence of tumors, Coleman said, as well as a 26 percent reduction in the risk of an early death.

These strong results could lead to "a major new treatment approach" for post-menopausal patients, he said.

Zometa, which generated sales of $2.1 billion for Novartis in 2010, is an intravenous drug from a widely used class of osteoporosis medicines called bisphosphonates.

It is increasingly being prescribed to help reduce or delay fractures and other skeletal complications in a variety of cancers that have spread to the bones. From 65 to 75 percent of breast cancer recurrences occur in the bones.

This trial, called AZURE and also published in the New England Journal of Medicine on Sunday, involved 3,360 women with early-stage breast cancer from 174 centers in Britain, Australia, Spain, Ireland, Portugal, Taiwan and Thailand.

Patients randomly allocated receive standard chemotherapy and/or hormone therapy, either with or without the addition of Zometa, a drug that works by inhibiting the cells that break down bone, called osteoclasts.

The results showed that looking across all trial participants, there was no significant difference in disease-free survival or overall survival between patients who received Zometa and those who didn't. But in a subset of older patients, the addition of the Novartis drug did bring clear benefits.

These women, who had at least five years since their last period, had an overall survival rate at five years of 85 percent on Zometa compared with 79 percent for those not on the drug. For all other patients, overall five-year survival was similar, at 86 percent in the Zometa group and 85 percent in the control group.

Investigators said that most surprising among the findings was the drug's effect on the rate at which the cancer recurred outside the bone. The relative risk for developing metastases, or secondary tumors, outside bone during treatment with Zometa was approximately halved in the postmenopausal women compared with the younger patients.

Coleman said the results shed new light on the role bones may play in the progress of the disease.

"The effects on metastasis and recurrence outside bone suggests that the bone marrow is an important sanctuary for tumor cells which can be activated after, sometimes, many years of dormancy," he said. "With help from bone marrow stem cells, they may then spread via the blood stream to set up metastases at other sites."

(Editing by Will Waterman)

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