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United Therapeutics Completes European Mutual Recognition for Remodulin(R)
Remodulin to be Approved in 22 Additional European Union Countries with Resubmissions to be made in Three Countries
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Aug. 10 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR - News) announced today that the European Union Mutual Recognition Procedure (MRP) has been completed for Remodulin (treprostinil sodium) Injection for the subcutaneous treatment of NYHA Class III Primary Pulmonary Hypertension patients.
"Our pursuit of the European approvals and resubmissions demonstrates our commitment to making Remodulin available as widely as practical," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and CEO. "We appreciate the opportunity to work with the European authorities on subcutaneous Remodulin currently, on intravenous Remodulin in the near-term and, subject to the outcome of pending studies, on inhaled and oral formulations as well," concluded Dr. Rothblatt.
France was the Reference Member State for the MRP as France was the first European Union nation to approve Remodulin in February 2005. At the completion of the MRP, the following countries endorsed the mutually-agreed summary of product characteristics for Remodulin: Austria, Belgium, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, and Sweden. With French approval already completed, formal action letters must be issued by the 22 other countries and pricing approvals must be issued by each country before commercial sales and marketing activities for Remodulin may commence in each country. (Remodulin currently is reimbursed in a number of European countries on a non-marketed individual patient basis). Applications in Ireland, Spain and the United Kingdom were withdrawn by United Therapeutics with regulatory discussions underway concerning the timing of resubmission in these three countries. There can be no assurances as to the timing of the receipt of the formal action letters and pricing approvals and the completion of discussions and resubmissions in the remaining three countries.
"We are pleased to have received national approvals in 22 additional countries of the European Union," said Dean Bunce, Sr., Vice President of Regulatory Affairs for United Therapeutics. "Refilings in Ireland, Spain and the United Kingdom will be bolstered by interim data from the United States Phase IV Flolan® transition trial. We look forward to presenting complete Remodulin data to regulators in these three European nations."
On August 2, 2005, United Therapeutics announced that the results of the interim assessment from the Phase IV trial were positive (p = 0.0006). Specifically, 13 of 14 patients (93%) in the Remodulin arm were able to successfully transition from Flolan and complete the study without the need to institute rescue therapy, compared to only 1 of 7 patients (14%) in the placebo arm.
United Therapeutics is a biotechnology company focused on the development and commercialization of unique products for patients with chronic and life- threatening cardiovascular, cancer and infectious diseases.
In addition to historical information, this press release contains forward-looking statements about expectations regarding the commencement of commercial sales and marketing activities of Remodulin in Europe, the timing of the receipt of the formal action letters and pricing approvals, the resubmission of Remodulin marketing authorization applications in Ireland, Spain and the United Kingdom and discussions with regulators in these three countries that are based on United Therapeutics' current beliefs and expectations as to future outcomes. These expectations are subject to risks and uncertainties such as those described in United Therapeutics' periodic reports filed with the Securities and Exchange Commission which may cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in United Therapeutics' periodic reports and documents filed with the Securities and Exchange Commission, including the company's most recent Form 10-K and Form 10-Q. United Therapeutics is providing this information as of August 10, 2005 and undertakes no obligation to publicly update or revise the information contained in this press release whether as a result of new information, future events or any other reason.
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Source: United Therapeutics Corporation
Four Utah women win suit against drug maker
Wyeth's weight-loss medicine Pondimin, once part of the fen-phen combination, damaged the heart valves of four Utah women who deserve a total of $392,200 to cover future medical costs, a Philadelphia jury ruled Thursday.
Sharon Thacker, 64, Ernestine Vigil, 62, Jorie Williams, 46, and Suzan Talbot, 40, sued Wyeth in Philadelphia Court of Common Pleas in 2004, claiming their injuries might require open-heart surgery.
Doctors wrote more than 6 million prescriptions for the diet-drug combination, which included Wyeth's Pondimin or Redux, along with the generic phentermine. Wyeth pulled the drugs in 1997 after researchers linked them to heart and lung problems.
Wyeth set aside $21 billion to resolve thousands of fen-phen lawsuits. Utahns have had mixed success suing the company.
In August 2004, a Philadelphia jury sided with five Utah women who claimed fen-phen caused their heart-valve damage, but awarded them just $4,000. Three months later, a jury awarded $2.1 million to four Utah women for similar claims. But last November, a jury rejected claims by Lee Ann Brunson, 55, Colleen Rondas, 62, and Lonnie Zimmerman, 55, three other Utah women after a seven-day trial.
mondoBIOTECH completes patient enrollment and treatment in the Phase II AVISARCO trial
October 12, 2006 - BASEL, Switzerland - mondoBIOTECH AG announced today the completion of patient enrollment and treatment in the AVISARCO trial, a Phase II clinical trial of inhaled Aviptadil in patients with severe pulmonary sarcoidosis.
AVISARCO is an open, uncontrolled clinical Phase II study designed to evaluate the effects of inhaled Aviptadil on the immunologic activity of alveolar macrophages and lymphocytes in patients with severe pulmonary sarcoidosis. Ten patients were enrolled and treated at the Medical University Hospital Freiburg, Germany, inhaling Aviptadil for a period of 4 weeks. Patients received 200 micrograms of Aviptadil daily using the ultrasonic OPTINEB®-ir device.
"AVISARCO is an important study to determine the beneficial effects of inhaled Aviptadil in patients with pulmonary sarcoidosis," said Dorian Bevec, Chief Scientific Officer of mondoBIOTECH. "An increased CD4/CD8 lymphocyte ratio and raised cytokine levels, particularly of Tumor Necrosis Factor alpha (TNF-?) in bronchoalveolar lavage fluid are characteristic pathophysiological hallmarks of pulmonary sarcoidosis. Our data suggest that Aviptadil strongly down-regulates both disease parameters. The final report of this study is awaited soon and will be the basis for pivotal clinical trials in pulmonary sarcoidosis, a rare lung disease for which there is currently no regulatory approved treatment available."
"The completion of patient enrollment and treatment in AVISARCO marks an important milestone for our company, and we thank the clinicians and patients who made this accomplishment possible," stated Fabio Cavalli, Chief Executive Officer of mondoBIOTECH. "Our commitment to deliver innovative medicines for patients who suffer from rare lung diseases remains firm, as we continue to make progress with Aviptadil in pulmonary sarcoidosis. This is the third rare lung disease after pulmonary arterial hypertension and acute lung injury, where Aviptadil is being successfully tested."
About pulmonary sarcoidosis
Pulmonary sarcoidosis is a rare lung disease in which the inflammatory process involves the alveoli (air sacs), small bronchi, and small blood vessels. As sarcoidosis progresses, small lumps, or granulomas, appear in the affected tissues which tend to remain inflamed and become scarred (fibrotic). Granulomas are structured masses composed of activated immunological cells (macrophages, lymphocytes, mast cells and fibroblasts). Many sarcoidosis patients are left with permanent lung damage as they undergo a chronic course where complications such as pulmonary fibrosis are common and irreversible. Currently no regulatory approved medicaments exist to treat sarcoidosis.
About Aviptadil
Aviptadil is a synthetically produced version of the endogenous human peptide Vasoactive Intestinal Peptide (VIP). Its biological role has been widely researched in a variety of diseases and in healthy situations. Aviptadil is produced by neurons, by endocrine cells, as well as by cells of the immune system. In scientific literature, Aviptadil is considered as one of the body’s ‘Molecules that Protect’. Aviptadil received Orphan Medicinal Product Designation status for Pulmonary Arterial Hypertension and Acute Lung Injury in the European Union, and for Pulmonary Arterial Hypertension and Acute Respiratory Distress Syndrome in the USA.
About mondoBIOTECH
mondoBIOTECH AG, a private Swiss breathing swiss air™ biotech company headquartered in Basel is focused on development of treatment options for fatal and rare lung diseases. For more information, please visit: www.mondoBIOTECH.com.
For further information please contact:
mondoBIOTECH Science Contact:
Dorian Bevec, Chief Scientific Officer
T. +41 840 200 030
F. +41 840 200 028
dorian.bevec@mondobiotech.com
mondoBIOTECH Corporate Contact:
mondoBIOTECH AG
Hardstrasse 52
4052 Basel
Switzerland
T. +41 840 200 010
F. +41 840 200 028
info@mondobiotech.com
www.mondoBIOTECH.com
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