German drug delivery company Inamed has signed up the first partner for its computer-controlled AKITA inhaler, designed to improve respiratory treatment by tailoring drug delivery to each patient using a smart card system.
Bayer Biological Products has turned to Inamed's AKITA system to deliver its recombinant alpha-1 antitrypsin (AAT) protein - used in the treatment of hereditary emphysema caused by deficiency in the enzyme - that is currently administered intravenously. Bayer BP has marketed Prolastin (alpha1-proteinase inhibitor - human) as an IV treatment for the disease since 1988.
Bernhard Schaefer, vice president of global strategic marketing for Bayer BP said that the AKITA technology "represents a major advance in inhalation dosing."
The device is designed to provide full control over a patient's breathing pattern to improve deposition of the active drug in the parts of the lung where it most required. Inamed has developed it for dose-critical applications, including patients inhaling high-price drugs such as antibiotics, those inhaling for more than one hour a day and pharmaceutical dosing studies.
"With the AKITA device, patients no longer have to concentrate on the right breathing technique, because the device induces the optimum breathing pattern," said Inamed.
Under the terms of the deal, Bayer BP will have worldwide exclusive rights to the AKITA device and any other products developed by Inamed based on the same technology for clinical development and marketing of its inhaled AAT products.
Early developmental work on the aerosolised plasma-derived AAT has begun, according to Bayer BP. Research with the new AKITA device will include determinations of required doses and validation experiments required to register the device with regulatory authorities, and preclinical and toxicology studies are scheduled to begin in 2004, said the firm in a statement.