DANBURY, Conn., Sept. 17 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) today 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 today by Alfred Mann, Chairman and Chief Executive Officer of MannKind, during a ceremony at the company's Danbury, Conn., 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 preapproval 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 is proud to note that its 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 honor 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," Mr. 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. Yesterday, we announced a 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 today's standard of care for prandial insulin needs, a rapid acting insulin analog. Later this Fall, 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 pharmacokinetic profile of AFRESA sets it apart from all other insulin products. The large surface area of the lung provides unique access to the circulatory system. The pH-sensitive AFRESA particles immediately dissolve upon contact with the lung surface, releasing insulin monomers that rapidly enter the bloodstream. As described in publications in the Journal of Diabetes Science and Technology, MannKind's AFRESA achieves peak insulin levels within 12-14 minutes of administration, effectively mimicking the release of meal-time insulin observed in healthy individuals, but which is absent from patients with diabetes. In a one-year Phase 3 clinical study of patients with type 1 diabetes, the meal-time use of AFRESA (in combination with an injected long-acting insulin) was associated with a statistically significant reduction of fasting blood glucose levels compared to the meal-time use of an injected rapid-acting insulin (also in combination with an injected long-acting insulin).
Additional Phase 3 data for AFRESA is scheduled to be disclosed later this year.
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its pipeline includes AFRESA, which has completed Phase 3 clinical trials, and MKC253, which is currently in phase 1 clinical trials. Both of these investigational products are being evaluated for their safety and efficacy in the treatment of diabetes. For more information on MannKind Corporation and its technology, visit http://www.mannkindcorp.com.
AFRESA and TECHNOSPHERE are trademarks of MannKind Corporation.
|SOURCE MannKind Corporation|
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