AEROCOUNT® Dose Indicator integrated with the Alvesco® (ciclesonide) Inhalation Aerosol for the U.S. Market
London, Canada (7-May-08) - Trudell Medical International is pleased to announce the FDA approval of Alvesco® (ciclesonide) inhalation aerosol in combination with the AEROCOUNT® Dose Indicator. Alvesco, a novel inhaled corticosteroid, will be distributed in the U.S. by Sepracor Inc. under an agreement with Nycomed based in Europe.
The approval of Alvesco with the AEROCOUNT Dose Indicator marks a significant milestone for respiratory patients. AEROCOUNT Dose Counters and Indicators are designed to address the 2003 FDA guidance calling for the integration of dose counters for metered-dose inhalers (MDI) used to deliver medication to the lungs. The AEROCOUNT Dose Indicator customized for Alvesco numerically displays the number of doses left in a patient’s inhaler, and as they approach a low medication level, the indicator displays a warning in red. The use of color helps to send a strong visual reminder to patients to renew their prescription.
“We are very pleased to partner with Nycomed to integrate the AEROCOUNT Dose Indicator as part of the Alvesco MDI. The FDA approval is a validation of Trudell’s dose counting technology and our commitment to excellence in medical aerosol delivery devices and systems,” said Mark Pickard, Vice-President and General Manager of Trudell Medical International.
With the first patent dating back to January 1998, Trudell Medical International had an early start towards building an intellectual property base in dose counting consisting of 50 issued patents and patents pending. Leveraging over a decade of development and commercialization effort in dose counting solutions, Trudell Medical International is able to provide pharmaceutical partners with a turnkey solution.
About Trudell Medical International
Trudell Medical International has a 25 year history in creating innovative aerosol drug delivery products that are distributed in over 90 countries around the world. In addition to the AEROCOUNT (www.aerocount.com) Dose Counters and Indicators, Trudell Medical International produces the AEROCHAMBER® Brand of Valved Holding Chambers, AEROECLIPSE® II Breath Actuated Nebulizer and a range of other devices for respiratory disease management. For more information visit www.trudellmed.com
Nycomed is a privately owned pharmaceutical company that is active in a range of therapeutic areas. Its key products are aimed at gastroenterology, pain management, osteoporosis, respiratory diseases and tissue management. Operating throughout Europe and in fast-growing markets such as Latin America, Russia/CIS and the Asia-Pacific region Nycomed has a presence in about 50 markets worldwide. The combined group employs over 11,500 people. In 2007, it had annual sales of € 3.5 billion and an adjusted EBITDA of € 1.2 billion.
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Currently marketed products include LUNESTA® brand eszopiclone, XOPENEX® brand levalbuterol HCl Inhalation Solution, XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol and BROVANA® brand arformoterol tartrate Inhalation Solution. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.