Trudell Medical International is pleased to announce the FDA approval of Alvesco(R) (ciclesonide) inhalation aerosol in combination with the AEROCOUNT(R) 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.
LONDON, Ontario (Business Wire EON) May 7, 2008 --
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
About Nycomed
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.
About Sepracor
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.
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