`
`P&T COMMUNITY
`
`Register
`
`Sign in
`
`
`
`HOME
`
`NEWS
`
`P&T
`
`P&T TV
`
`AUTHORS
`
`ABOUT
`
`CONTACT US
`
`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
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1037, p. 1 of 5
`
`
`
`More Headlines
`What to Expect in Senate’s Health Care Bill
`GOP leaders pursue moderate votes
`
`White House Task Force Echoes Pharma Proposals
`Industry influences working group’s deliberations, report contends
`
`FDA Readying Regulatory Plan for Digital Health Devices
`Novel “post-market approach” expected this fall
`
`FDA Approves Darzalex in Combination with Pomalidomide and Dexamethasone for Patients With
`Multiple Myeloma
`New approval augments previous myeloma indications
`
`FDA Expands Dysport Label to Include Lower-Limb Spasticity in Adults
`Botulinum toxin product carries boxed warning
`
`State Attorneys General Probe Opioid Drug Companies
`Officials suspect marketing scheme to promote chronic opioid use
`
`Cleveland Clinic Jumps Into Insurance Business
`Move blurs line between payer and provider
`
`C-Suite Survey: Health Care Leaders Use Generics, Tighter Formularies, Physician Education to Control
`Drug Spending
`Most respondents anticipate increased drug expenses over the next five years
`
`FDA Approves EpiPen Rival
`Symjepi provides two single-dose syringes of epinephrine
`
`
`
`STAY IN TOUCH!
`NEWSLETTERS AVAILABLE:
`P&T and drug management daily news
`P&T table of contents (monthly)
`
`USEFUL LINKS
`
`About P&T
`2017 Media kit
`2017 Space and materials due dates
`Terms and conditions for using this site
`Masthead
`Guidelines for authors
`
`INDUSTRY ANNOUNCEMENTS
`Affimed Presents Data on First-in-Class BCMA-Targeting
`Immune Cell Engager AFM26 at ASCO Annual Meeting
`2017
`
`Share buy-back week 22/2017
`
`Novartis drug Tasigna receives EU approval for inclusion of
`Treatment-free Remission (TFR) data in product label
`
`Basilea announces presentation of interim phase 1/2a clinical
`data with anticancer drug candidate BAL101553 at ASCO
`meeting
`
`Targovax presents further positive clinical data from TG01
`phase I/II trial at 2017 ASCO annual meeting
`
`Addex Annual General Meeting Scheduled for 22 June 2017
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1037, p. 2 of 5
`
`
`
`VALNEVA to Present at Jefferies 2017 Global Healthcare
`Conference in New York
`
`Targovax announces formal agenda for 2017 Capital Markets
`Updates in Oslo and London
`
`Lundbeck obtains rights to breakthrough research in
`Alzheimer’s disease
`
`Veloxis Pharmaceuticals A/S Announces Agreement with
`Chiesi Farmaceutici S.p.A. to Commercialize Envarsus XR in
`China
`
`More from Globe NewsWire
`
`Editorial board
`Subscribe
`Renew your subscription
`Update your subscription
`Subscription customer service
`BPA statement
`RSS feed
`Contact webmaster
`
`CONTACT US
`
`Editorial: J. Stephen McIver, Editor
`Advertising:
`Maureen Dwyer Liberti, Vice President, Group Publisher
`Production: Dawn Flook, Director of Production Services
`Circulation: Jackie Ott, Circulation Manager
`Webmaster: Webmaster
`
`From the PharmD Corner
`Beyond the pills: Accountable
`Health Communities highlight
`social comorbidities that affect our
`health
`Mimi Chen, PharmD
`
`CURRENT ISSUE OF P&T
`
`June 2017
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1037, p. 3 of 5
`
`
`
`NEWS CENTER
`Approvals, Launches, & New Indications
`
`Pipeline Plus
`
`Research News
`
`Industry Trends
`
`Safety Issues
`
`Agency Actions
`
`Health Care Reform
`
`Guidelines
`
`Clinical Trials
`
`Drug Forecast
`
`NAVIGATION
`
`Popular content
`Search
`Site map
`Managed Care magazine
`
`USER LOGIN
`Username *
`
`Password *
`
`Create new account
`Request new password
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1037, p. 4 of 5
`
`
`
`Terms and Conditions for Using this Site
`© 2017 MediMedia, an ICON Plc company.
`All Rights Reserved.
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1037, p. 5 of 5
`
`