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11:27 AM 15 FEB 2013

(AGI) - Rome, Feb. 15. – Novartis "is collaborating fully" with the Antitrust, "in which it places the utmost trust, and reiterates that its work is constantly inspired by principles of transparency and correctness". The company specifies this with reference to the news that appeared in the press regarding the investigations underway by the Authority. Yesterday evening, the Antitrust announced the start of an investigation against the Roche and Novartis groups "to verify whether they have put in place an agreement restricting competition for the sale in Italy of drugs intended for the treatment of ophthalmic diseases" .

   As a result of the alleged cartel, explains the Antitrust, "according to the complaints received, the National Health System would have suffered an additional outlay of approximately 400 million euros a year". Novartis intends to reiterate what is already present in its 2012 management report: "the company holds 33.3% of the bearer shares which represent 6.4% of the total capital of Roche, which does not allow any influence on the strategies of the Roche group which is managed, administered and operates in a totally independent manner". Lucentis (ranibizumab) is a monoclonal antibody designed, developed and formulated specifically for intravitreal use and is characterized by a good tolerability profile. It is licensed in over 100 countries for the treatment of neovascular age-related macular degeneration and in over 80 countries for the treatment of vision impairment following DME (diabetic macular edema) and vision impairment following macular edema due to RVO ( retinal vein occlusion) both central and branch. In most countries, including Europe, ranibizumab has an individualized treatment regimen with the goal of maximizing vision outcomes while minimizing under- or over-treatment of patients. Ranibizumab has a well-characterized safety and tolerability profile that is monitored systematically and continuously for its licensed indications. The safety profile was confirmed in a clinical development program which enrolled over 10,000 patients across various indications. (AGI) .

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Antitrust: investigation opens on Novartis and Roche

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco