MannKind Corporation announced that it has proposed to the United States Food and Drug Administration to use AFRESA as the trade name for its Technosphere Insulin System.
Afresa (pronounced uh-FRESS-uh) was unveiled by Alfred Mann, chairman and chief executive officer of MannKind, during a ceremony at the company's Danbury, Connecticut, location that marked the completion and dedication of a new facility for the commercial manufacture of the product.
The events in Danbury included a building dedication, a luncheon, and tours of the 263,900 sq ft production facility for invitees, who included investors, medical and industry professionals, scientists, employees, and government officials. The completion of the building phase of this project brings MannKind's investment in plant and equipment at the Danbury site to almost $200 million. The facility is now in the process of being qualified and readied for pre-approval inspection by the FDA.
Featuring state-of-the-art equipment and processes and redundant utilities, the new facility includes expansion space that will allow production capacity to be increased to meet expected demand over the next few years. The architect for the project was Kling Stubbins. The engineering firm was Clark Richardson Biskup and the construction manager was Torcon.
MannKind's facility expansion received the 2008 Bronze Vision Award in the Corporate Owner: Industrial/Manufacturing category at the Ninth Annual Constructech Vision Award ceremony, held in Chicago on August 21, 2008. The Constructech Vision Awards honour construction and engineering projects that have solved critical business issues through the use of innovative technology solutions. The award was presented to MannKind by Mike Carrozzo, chief editor of Constructech Magazine and accepted by Abigail Smith, MannKind's vice president of Engineering, and Stephen Hall, MannKind's senior director of Engineering.
"Today's event is a milestone in the history of MannKind," Mann said. "We are preparing to manufacture a unique and differentiated therapy for the treatment of diabetes on a commercial scale. This has been a busy week for MannKind. We announced collaboration with Pfizer that will allow certain Exubera patients with an urgent medical need for inhaled insulin to transition to Afresa on a compassionate use basis. In addition, we released some top-line results from the first of our three completed pivotal phase-3 clinical studies. In this trial of 565 patients with type-1 diabetes, we established that Afresa is non-inferior in A1C and superior in other objectives compared to present standard of care for prandial insulin needs, a rapid acting insulin analog. Later, we will report the results from our other two pivotal studies of Afresa before we enter the final stretch of our effort to submit a new drug application by year-end or shortly thereafter."
The large surface area of the lung provides unique access to the circulatory system. The pH-sensitive Afresa insulin's particles immediately dissolve upon contact with the lung surface, releasing insulin monomers that rapidly enter the bloodstream.
MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer.