Posted on April 12, 2004 at 3:09 p.m.

BIRMINGHAM, AL — The University of Alabama at Birmingham (UAB) Research Foundation and Aegis Therapeutics Inc. of San Diego have entered into an exclusive license agreement allowing Aegis to commercialize novel, cutting-edge drug delivery technology for non-invasive administration of peptide and non-peptide drugs.

The technology for which UAB holds two U.S. patents, has demonstrated superior performance in administering a number of pharmacologically active protein drugs, including calcitonin (osteoporosis), insulin (diabetes), glucagon (diabetes), leptin (diabetes and obesity) and somatropin (human growth hormone). The technologies were developed and patented at UAB through Dennis Pillion, Ph.D., UAB associate professor of pharmacology, and Elias Meezan, Ph.D., UAB professor of pharmacology and toxicology. Aegis has exclusive rights to further develop and commercialize the basic technology as well as certain related programs conducted by these UAB scientists and related to the patents.

The Intravail™ delivery enhancement agents facilitate the efficient passage of therapeutic proteins, peptides and other macromolecules across nasal membranes into the circulatory system. These well-tolerated and safe delivery agents do not react with, inactivate, precipitate or chemically modify the drugs with which they are formulated. The delivery agents are uncharged, completely biodegradable and are compatible with and applicable to the nasal delivery of large- and small-molecule drugs.

“Our Intravail™ intranasal drug delivery technology offers a number of advantages for our clients and ultimately the patient,” said Donald W. Grimm, executive chairman of Aegis. “Intravail™ will facilitate the rapid development and introduction of new drug formulations and significantly enhance the clinical usefulness of many peptide and protein therapeutics currently on the market.”

“These more effective drugs and drug delivery agents will make our clients more competitive; for patients it potentially means more potent, faster-acting medicines and shorter recovery times. And in the case of many drugs going from needle delivery to nasal delivery means less stress for patients, especially children.”

Through the agreement with the UAB Research Foundation, Aegis obtained exclusive licenses to U.S. Patent Number 5,661,130 “Absorption Enhancers for Drug Administration” and U.S. Patent Number 5,384,128 “Method of and Compounds for the Treatment of Cystic Fibrosis.”

“When looking for a partner for UAB’s technologies, one goal is to develop relationships with companies that demonstrate strong business ethics and proven capabilities in the commercialization of products,” said Lucy Hicks, director of the UAB Research Foundation. “In Aegis we found these qualities, as well as a uniquely qualified team of business and scientific leaders to take this technology to the marketplace.”

“We look forward to a long and mutually rewarding and expanding relationship,” added Alane Barnes, licensing associate for this relationship.

AEGIS THERAPEUTICS

Aegis Therapeutics is a biopharmaceutical company developing advanced intranasal delivery of therapeutic proteins, peptides, and other macromolecules posing special delivery challenges with respect to bioavailability, ease of administration, patient convenience, and stability. Intranasal drug delivery eliminates the need for injections and therefore offers patients reduced physical discomfort, greater convenience, reduced likelihood of infection and a higher likelihood of compliance.

THE UNIVERSITY OF ALABAMA AT BIRMINGHAM

UAB is a 35-year-old comprehensive, urban university and medical center that encompasses 82 city blocks and has a student enrollment of 16,000. UAB also is home to a large graduate school, a world-renowned health care complex and more than 70 research centers, focusing on such diverse issues as AIDS vaccines and aging to the environment, urban affairs, and telecommunications.

Research funding has doubled every decade at UAB. Today, UAB and its Southern Research Institute (SRI) affiliate receive more than $470 million in grants and contracts, up from $389 million a year ago. In funding from the National Institutes of Health (NIH), UAB ranks 21 overall with five schools in the Top 20: Health Related Professions (No.2), Optometry (No. 3), Public Health (No. 11), Nursing (No. 16) and Medicine (No. 17).

THE UAB RESEARCH FOUNDATION

The UAB Research Foundation (RF) was formed in 1987 as a non-profit corporation with a mission to identify, assess, and market commercially viable technology developed at The University of Alabama at Birmingham (UAB). The RF is the assignee of all intellectual property developed at UAB and is responsible for reviewing all invention disclosures submitted.

UAB’s Research Foundation’s commercialization of faculty discoveries has since 1986 created more than $20.7 million in royalty and license fees, 1,402 invention disclosures, 294 patents, and over 360 license and other agreements. RF holds stock in 29 spin-off companies.