IHS Global Insight Perspective | |
Significance | Researchers from the Cedars-Sinai Medical Center (U.S.) said yesterday that Sanofi-Aventis's antiarrhythmic agent Multaq is less effective than older antiarrhythmic drug amiodarone, and without clearly demonstrating fewer side effects. Meanwhile, the French drug maker amended the terms of the agreement over its osteoporosis drug Actonel with Irish firm Warner Chilcott for the U.S. and Puerto Rican market. |
Implications | Under the amended agreement, Irish firm Warner Chilcott will assume full responsibility for the commercialisation and management of osteoporosis drug Actonel (risedronate) instead of sharing the costs with Sanofi. |
Outlook | The new Multaq review adds damaging arguments against the drug, on which Sanofi-Aventis was banking to bring in blockbuster revenues to its ageing portfolio. The negative data is likely to comfort healthcare authorities in their choice to refuse general reimbursement to the drug or to only back its use as a second- or third-line therapy. |
Amended Agreement over Osteoporosis Drug Actonel
French pharma company Sanofi-Aventis and Irish drug maker Warner Chilcott have agreed to amend their collaboration agreement regarding osteoporosis drug Actonel (risedronate) in the United States and Puerto Rico. Under the new agreement, Warner Chilcott will take full responsibility for the sales, marketing, distribution and local R&D decisions in exchange for paying royalties on net sales to Sanofi-Aventis until the agreement expires in December 2014. Warner Chilcott inherited the collaborative agreement from Procter & Gamble (U.S.) in October 2009, when it acquired the U.S company portfolio of branded pharmaceutical products (see United States: 26 August 2009: Warner Chilcott Acquires P&G's Prescription Drug Business). The deal between the two partners includes worldwide development and marketing rights for Actonel, except in Japan.
New Review Harms Multaq in Head-to-Head Study Versus Generics
Meanwhile, a review, published yesterday in the Journal of American College of Cardiology, has hit Sanofi-Aventis with uncertainties as the use of its touted drug Multaq (dronedarone) was once again challenged in the prevention of atrial fibrillation/flutter. Data gathered by researchers from the Cedars-Sinai Medical Center (U.S.), from existing clinical trials, have showed that the drug is only as half as effective as the older antiarrhythmic generic drug amiodarone, while bringing no clear advantage in terms of side effects, reports the Los Angeles Times.
The U.S. approval of Multaq to reduce the risk of cardiovascular hospitalisation in patients with atrial fibrillation or atrial flutter was based on the ATHENA trial which showed a reduction of 24% in the combined endpoint of cardiovascular hospitalisation or death from any cause versus placebo (see France: 12 February 2009: Sanofi-Aventis Claims ATHENA Trial Results Show Multaq Offers Clear Benefit in Atrial Fibrillation and France: 3 July 2009: Sanofi-Aventis Clinches Long-Awaited FDA Approval for Multaq). Based on the head-to-head study which assessed Multaq versus amiodarone, researchers from the Cedars-Sinai Medical Center concluded that Multaq should not be considered as first-line therapy in the treatment of AF. Dr Sanjay Kaul, director of the Vascular Physiology and Thrombosis Research Laboratory at the Cedars-Sinai Heart Institute and co-author of the report said "that dronedarone should only be used as a second-line or third-line agent in individuals that are not able to tolerate amiodarone or other first-line agents recommended by the guidelines".
Sanofi Scores Victory over Eloxatin Patent Lawsuit in U.S.
In a different press release, Sanofi-Aventis announced it has settled three additional patent lawsuits related to its colorectal cancer drug Eloxatin (oxaliplatin). The three generic drug makers in question are Mayne/Hospira (Australia/U.S.), Actavis (Iceland) and MN/Par (U.S.). The six generic producers concerned by the patent litigation—including Teva (Israel), Fresenius Kabi (Germany), Mayne/Hospira, Actavis, MN/Par and Sandoz (subsidiary of Novartis, Switzerland)—have all agreed to cease marketing copycat versions of Eloxatin in the U.S. market until 9 August 2012 (see United States: 1 April 2010: Sanofi-Aventis to Switch Activities Towards Biotech, Vaccines by 2014 in France, Settles Patent Lawsuits over Eloxatin in U.S.).
Outlook and Implications
The review comes as an additional blow to Sanofi-Aventis, which is gradually seeing its hopes to see Multaq become its future blockbuster vanish. Last week, the use of Sanofi-Aventis's Multaq was eventually backed by the U.K.'s National Institute for Health and Clinical Excellence (NICE), which however, only recommended its use as a first-choice therapeutic option in patients whose atrial fibrillation is not controlled by first-line therapy—including beta-blockers (see United Kingdom: 30 March 2010: NICE Backs Use of Sanofi-Aventis's Multaq in New Appraisal Consultation Document). The limited use in the United Kingdom came as positive news for Sanofi which risked receiving a complete refusal, after a first negative opinion issued several months earlier and a significant setback in Denmark where the Danish Medicines Agency estimated that an approval for general reimbursement would induce "a risk to see Multaq be used in patients as a first choice when this is not indicated" (see Denmark: 4 March 2010: Danish Medicines Agency Refuses to Grant General Reimbursement Status to Sanofi-Aventis' Multaq). The recommendation for a limited use of the heart drug is however seriously diminishing its commercial prospects in Europe where most countries will tend to copy the U.K. verdict. The situation appears as challenging in France where unofficial sources announced a negative reimbursement decision ahead of the official publication (see France: 22 March 2010: Sanofi Aventis' Multaq Receives Low Score from HAS).
Meanwhile, the collaboration with Warner Chilcott will allow Sanofi to further concentrate on its current strategic switch towards diversification while retaining royalties on sales of its osteoporosis drug Actonel (risedronate) in the United States and Puerto Rico (see France: 1 April 2010: Sanofi-Aventis to Switch Activities Towards Biotech, Vaccines by 2014 in France, Settles Patent Lawsuits over Eloxatin in U.S.). The new strategic plan outlined by the company will help to offset upcoming challenges, notably on the generic side which, despite its recent victory over generic versions of Eloxatin, will seriously drive its revenues down in future years.