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`European Agency Approves Ventavis for Primary Pulmonary
`Hypertension
`BERLIN, Sept. 22 /PRNewswire-FirstCall/ -- Schering AG, Germany (NYSE: SHR; FSE: SCH) announced today that the
`European Commission in a Centralized Procedure approved Schering's new drug Ventavis(R) for marketing in all EU countries.
`Ventavis(R) is an inhalation treatment for patients with primary pulmonary hypertension. It is the only prostacyclin product that
`targets the pulmonary vessels more directly by inhalation.
`
`"Ventavis(R) improves the therapy for patients affected by severe symptoms and heart failure. It is a new, convenient treatment
`option for patients suffering from a life threatening disease," said Dr. Hubertus Erlen, CEO and Chairman of the Executive Board
`of Schering AG. "We will offer Ventavis(R) as soon as possible to doctors and patients in the EU countries."
`
`Schering plans to start marketing Ventavis(R) in the first EU countries in 2003 and to roll-out the product in Europe fully by 2004.
`Ventavis(R) was designated as an orphan medicinal product in December 2000 and will fall under orphan drug protection until
`2013.
`
`Additional information
`In May 2003, Schering received the positive opinion from the Committee of Proprietary Medicinal Products (CPMP). The CPMP is
`the scientific committee for human medicinal products of the European Agency for the Evaluation of Medicinal Products (EMEA)
`and its positive opinion a prerequisite of the EU decision.
`
`The active substance of Ventavis(R) is iloprost, a synthetic prostacyclin analogue. The pharmacological effects after inhalation of
`Ventavis(R) are direct vasodilatation of the pulmonary arterial bed with consecutive significant improvement of pulmonary artery
`pressure, pulmonary vascular resistance and cardiac output as well as mixed venous oxygen saturation.
`
`The benefits of Ventavis(R) include improvements in exercise capacity and symptoms. A randomized, double-blind, multi-center,
`placebo-controlled phase III trial has been conducted in 203 adult patients with stable pulmonary hypertension. Inhaled iloprost (or
`placebo) was added to patients' current therapy, which could include a combination of anticoagulants, vasodilators (e.g. calcium
`channel blockers), diuretics, oxygen, and digitalis, but not prostacyclin or its analogues.
`
`Source: Schering AG
`
`Date to go live:
`Monday, September 22, 2003
`
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`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1037, p. 5 of 5
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