November 12, 2009 – LONDON -(Dow Jones)-

Among the main facts and positive opinions mentioned by the committee were the following:-

- Generic medications:

Sanofi-Aventis Deutschland GmbH with Leflunomide Winthrop, a treatment intended for active psoriatic arthritis and rheumatoid arthritis in adult patients.

- Extension of indication:

Eli Lilly Nederland B.V., with Adcirca (tadalafil), to change the indication to include pulmonary arterial hypertension. The Medicines Company U.K. Ltd., with Angiox (bivalirudin), to extend the indication to contain ST-segment myocardial infarction suffering patients, who also undergo primary percuteneous coronary intervention (PCI).

As a matter of fact, Angiox is an authorized medication for the treatment of acute coronary syndromes in adults (unstable angina/non-ST segment elevation myocardial infarction, also known as UA/NSTEMI) who must undergo an urgent or early surgical intervention.

Eli Lilly Nederland B.V. (developers of Cialis), with Cymbalta (duloxetine) and Boehringer Ingelheim International GmbH, with Xeristar (duloxetine), to extend the indication for these drugs to address the treatment of major depressive disorders.

Boehringer Ingelheim International GmbH, with Micardis (telmisartan) and Bayer Schering Pharma AG (developers of Levitra), with Pritor and Kinzalmo (telmisartan), to extend the indication to reflect their use as a reduction method of cardiovascular morbidity in patients with type 2 diabetes mellitus with detailed organ damage documentation or manifest atherothrombotic cardiovascular disease (coronary heart disease, peripheral arterial disease or stroke history).

- New medications:-

CIS bio international, with its radiopharmaceutical Scintimun, developed for its use in scintigraphic imaging, in combination with further appropiate imaging forms, in order to determine the place of infections or inflammations in peripheral bone in adult patients with possible osteomyelitis disorders.

EUSA Pharma SAS, with Zenas (amifampridine), a drug developed for use in the treatment of symptoms of the Lambert-Eaton Myasthenic Syndrome (LEMS) in adult patients, which is a uncommon neuromuscular transmission disorder due to impaired presynaptic loss of acetylcholine substances (Ach). The Zenas review started on 24 June 2008, which made an active review time of 197 days.

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