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October 2008

MannKind Dedicates Danbury Insulin Facility
Alexion's Soliris® Honored
Stem Cell Research Applications
National SBIR Conference
UConn Law Clinic Adds Expert
CURE Member News Digest
MannKind Opens New Danbury Insulin Manufacturing Facility
From the desk of Paul Pescatello, President and CEO of CURE

With the problems of Wall Street and Washington omnipresent in the news, it's a pleasure to report on a very positive development for the Connecticut economy.  MannKind Pharmaceuticals' decision to build a manufacturing facility in Danbury for the company's promising new insulin product is a vote of confidence in the bioscience cluster we've built in Connecticut.

Taking part in the September 17 ribbon cutting ceremony were Connecticut's Lieutenant Governor Michael Fedele and Danbury Mayor Mark Boughton, as well as State Representative and Deputy Speaker Bob Godfrey, State Representative Janice Giegler, and Ronald Angelo, Deputy Commissioner of the Department of Economic and Community Development.

Left to right: Ron Angelo, deputy commissioner, Connecticut Department of Economic and Community Development; Paul Pescatello, president and CEO of CURE; Lieutenant Governor Michael Fedele; State Representative Bob Godfrey; State Representative Janice Giegler; Alfred Mann, chairman and CEO of MannKind; Dr. Jay Skyler, diabetes expert at the University of Miami; Danbury Mayor Mark Boughton; and Abraham "Barry" Cohen of the MannKind Board of Directors

Alfred Mann, chairman and CEO of MannKind, unveiled the new logo for AFRESA™, which is the trade name the company has proposed to the FDA for marketing its Technosphere® Insulin System.

The company believes that the AFRESA™ product produces a profile of insulin levels in the bloodstream that approximates the insulin profile normally seen in healthy individuals immediately following a meal, but which is absent in patients with diabetes. Positive results from the first of several Phase 3 trials the company has underway became available the day before the dedication ceremony and support MannKind's expectations.

Al Mann, chairman and CEO of MannKind, unveils the news AFRESA™ logo
at a September 17 ceremony in Danbury

As part of the opening ceremonies, Dr. Jay Skyler of the University of Miami School of Medicine explained why AFRESA™ is so promising. Calling it the first super rapid-acting insulin, he said he had not seen such an advance in diabetes therapy in 40 years of research and practice.

In Danbury the company formulates AFRESA™ from recombinant human insulin and Technosphere® particles, then fills the AFRESA™ powder into plastic cartridges and packages them. Completion of the 263,900 sq. ft. production facility 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.

Acting as emcee in a tent erected next to the new building, Dr. Juergen Martens, corporate vice president and chief technical officer and resident Danbury executive, said he appreciated the strong and tangible support the company has received from local and state officials.

Lieutenant Governor Fedele, stating that bioscience was a cornerstone of Connecticut's new economy, pledged full cooperation from the state as MannKind continues to grow. He praised Connecticut's foresight in establishing a strong bioscience sector, and thanked the state officials who had worked so tirelessly to establish MannKind's presence in Danbury.

The company mentioned that Connecticut's unique R&D tax credit exchange program, which allows qualifying companies to exchange unused R&D tax credits for cash at 65 cents on the dollar, was a factor in their decision to invest in Danbury. They also cited the existence of a core bioscience industry in the state, including numerous pharmaceutical and biotechnology companies, a vibrant university sector, competitive real estate costs, the existence of a highly educated workforce well trained in bioscience, and the state's high quality of life.

The company still has important milestones ahead. First and foremost, MannKind must file for and win FDA approval for their new drug. To score commercial success, MannKind must develop and execute a successful strategy for marketing AFRESA™ to patients and the medical profession. All of this will occur in the next 18 months or so – with turbulence as background noise testing the resolve of MannKind's investors.

MannKind's Danbury manufacturing facility is tangible evidence of the value of Connecticut's effort to nurture bioscience research and development.  The long R&D road that has culminated in AFRESA™ means a better life for diabetes sufferers, good jobs for Danbury residents, and a broader tax base for all of Connecticut.

Paul R. Pescatello is President and CEO of CURE.

Copyright 2008 © Connecticut United for Research Excellence. All rights reserved.
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