Sanofi-Aventis Begins Study Of Heart Drug Multaq In 10,000 Patients For Expanded Use

Pharmaceutical company Sanofi-Aventis Wednesday said it has initiated a Phase IIIb trial of Multaq in over 10 thousand patients with permanent atrial fibrillation or abnormal heart rhythm. The Paris, France-based company’s study is focused on assessing the potential clinical benefit of the drug in reducing major adverse cardiovascular events, and it expects first patient enrollment to begin in the third quarter of 2010.

Multaq, or dronedarone, an antiarrhythmic drug, has completed clinical trials in more than 7,000 patients and has met the primary endpoint by reducing cardiovascular hospitalization or death by 24%. The company added that the incidence of atrial fibrillation is growing worldwide in relation to aging populations, increasing the risk of stroke up to five-fold, worsening the prognosis of patients with cardiovascular risk factors and doubling the risk of mortality.

The Phase IIIb study, dubbed PALLAS, is conducted primarily to demonstrate a reduction in major cardiovascular events like stroke, systemic arterial embolism, myocardial infarction or cardiovascular death. In addition, the study aims to lessen cardiovascular hospitalization or death from any cause among patients with permanent atrial fibrillation and additional risk factors.

The company said the secondary objectives are to evaluate the efficacy of Multaq in preventing cardiovascular death and to check whether the drug is well-tolerated in this patient population.

Stuart Connolly, MD, Division of Cardiology, McMaster University, Hamilton, Canada, one of the trial’s principal investigators commented, “This is a trial of major significance since no anti-arrhythmic drug has ever been shown to reduce major morbidity and mortality in permanent AF patients in a large scale clinical trial. We designed the PALLAS trial to further assess the role of Multaq(R) to reduce cardiovascular outcomes in patients with AF.”

Sanofi-Aventis elaborated that PALLAS is a multinational, randomized, double-blind, parallel-group, placebo-controlled, multicenter trial comparing the efficacy of Multaq 400mg twice-daily with placebo in permanent atrial fibrillation patients. The study of Multaq is expected to be conducted on 10,800 patients enrolled in 43 countries at 700 sites.

Multaq, discovered and developed by sanofi-aventis, was granted marketing authorization by the European Commission in November last year to treat adult clinically stable patients with a history of, or current non-permanent atrial fibrillation to prevent recurrence of atrial fibrillation or to lower ventricular rate.

Multaq is currently available in the U.S., Canada, Switzerland, Germany, Denmark, Ireland, Norway, Finland and the UK and is also being launched in most European countries in 2010.

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Sanofi has winning cancer drug, but short patent

Sanofi-Aventis may have bagged a winning cancer drug when it agreed to buy privately held BiPar Sciences for up to $500 million in April, but a short patent could limit the French group's scope to cash in on sales.

BiPar's BSI-201 has emerged as one of the most promising new products at this year's ASCO cancer conference in Orlando, Florida, with positive mid-stage trial results helping lift Sanofi shares by more than 3 percent on Monday.

But there is a fly in the ointment. A Sanofi spokesman said on Monday that the main U.S. composition patent on the medicine was valid only until 2013, though this could be extended by five years.

In Europe, the patent runs to 2014 and Sanofi will have 10 years data exclusivity after approval.
"These facts probably explain the relatively modest agreed price for the BiPar deal," analysts at Morgan Stanley said in a research note.

They estimate BSI-201 could sell between $1 billion and $4 billion a year to Sanofi's 2016 revenues, with a U.S. launch as possible by late 2010.

On the face of it, that makes the price Sanofi's new chief executive, Chris Viehbacher, paid for BiPar seem a bargain. The problem is the medicine could face generic competition in the world's biggest pharmaceuticals market from 2018.

BSI-201 belongs to a new class of drugs that block a cell repair enzyme known as PARP.

It impressed doctors at the annual meeting of the American Society of Clinical Oncology (ASCO) on Sunday by improving survival by 60 percent compared with chemotherapy alone for women with tough-to-treat "triple negative breast cancer."

Patients with triple negative metastatic breast cancer have tumors that do not express the hormones oestrogen or progesterone, as well as the protein HER-2.

These women, who account for 15 to 20 percent of breast cancer patients, have a very aggressive form of disease and there are currently no treatments other than chemotherapy.

Citigroup analyst Mark Dainty said the data for BSI-201 was significantly better than the results with Roche's Avastin in triple negative patients and the new drug could put 20 to 25 percent of Avastin sales forecasts at risk.

Citi currently forecasts 2011 Avastin breast cancer sales at 1.7 billion Swiss francs ($1.6 billion) and losing 20 percent of this would slice some 2 percent off Roche's 2011 earnings per shares.

AstraZeneca also has an experimental PARP inhibitor called olaparib that is further behind in development.

Source : www.reuters.com

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