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Genaera Corporation – developing genomics
and natural products to aid in the fight against
cancer, obesity, asthma and blindness

Healthcare
Biotechnology & Drugs
NASD: GENR

Genaera Corporation

5110 Campus Dr.
Plymouth Meeting, PA 19462

Kenneth J. Holroyd, M.D., MBA
Executive VP & Chief Business Officer

Interview conducted by:
Walter Banks, Co-Publisher

CEOCFOinterviews.com
September 2001

BIO of CBO:

Dr. Holroyd was appointed Executive Vice President and Chief Business Officer in November 2000. He joined the Company in February 1997, and has held various executive positions in Regulatory Affairs and Clinical Research, Respiratory Discovery Research, Product Development, and Business Development. Prior to joining Genaera, Dr. Holroyd was a faculty member and head of respiratory care services at Johns Hopkins University School of Medicine and Hospital.  Finally, he earned both his M.D. and MBA at Johns Hopkins University in Baltimore, Maryland.

About
Genaera Corporation

Genaera Corporation is a biopharmaceutical company committed to developing medicines for serious diseases from genomics and natural products. Research and development efforts are focused on anti-angiogenesis, obesity, infectious and respiratory diseases.

Their research and drug development efforts are focused on two technology platforms: host-defense drug discovery, and genomics and respiratory treatments.
 
Genaera was formed to engage in the research, development and commercialization of compounds derived from the host-defense systems of animals. The host-defense system is the complex of natural processes and mechanisms used by the body to protect itself against infection and certain cancers. The Company believes that certain classes of naturally occurring compounds, such as certain small molecules, known as aminosterols, are used by the host-defense system and may have activity against certain cancers.

Anti-Angiogenesis:
Squalamine, an anti-angiogenic agent, is currently in phase 2 clinical trials for the treatment of non-small cell lung cancer and advanced ovarian cancer.  Squalamine is the first clinical drug candidate in a class of naturally occurring, pharmacologically active, small molecules known as aminosterols. Discovered in the dogfish shark in 1992, squalamine is a synthetically produced molecule with a unique mechanism of action that directly blocks endothelial (blood vessel) cell activation, migration and proliferation by multiple growth factors. This intracellular mechanism contrasts to most other angiogenesis inhibitors that focus on a single growth factor or on a single stage of blood vessel recruitment.


Obesity:
Produlestan, Genaera's second aminosterol compound, has been shown to produce appetite suppression and weight loss in animals. Preclinical data on this compound demonstrate it is a potent appetite suppressant in numerous animal models of obesity. In these models, in additional to controlling weight, produlestan seems to normalize blood sugar, and hypercholesterolemia, as well as high blood cholesterol levels. Genaera researchers have shown efficacy with produlestan and demonstrated that animal food intake can be regulated in a reversible manner, leading to changes in body weight.


Genomics and Respiratory Treatments:
Genaera employs a comprehensive functional genomics approach to understand the genetic basis of disease and to develop potential drug leads. Through these efforts, they seek to identify appropriate targets for pharmaceutical intervention that aim to control the root cause of human disease. They believe that pharmaceuticals developed for use against these specific targets have the potential for greater effectiveness and fewer side effects than pharmaceuticals developed through more traditional processes.


Within the respiratory disease focus, Genaera has two genomics-based programs.  The Company has a collaboration with MedImmune, Inc. to co-develop an interleukin-9 (IL9) based antibody for asthma and other respiratory conditions. Genetic studies in both humans and animals have generated substantial support for IL9 as a major mediator of asthma, and functional genomic analyses have confirmed these findings. Genaera maintains a comprehensive research and development program to identify additional genes that may be implicated in respiratory disease.

Genaera’s second genomics-based program has led to the identification of several small molecules believed to inhibit the overproduction of mucin.  These so-called “mucoregulators” have the potential to yield novel therapeutics for mucus overproduction in a number of chronic respiratory diseases.  The Company initiated phase 1 mucoregulator clinical trials in August 2001.


CEOCFOinterviews -
Dr. Holroyd, can you give us a brief history of Genaera Corporation?

Dr. Holroyd: "The Company was founded in l987 and has been public since December 1991. Its initial focus was developing medicines for serious diseases from natural products.  In 1995, we added a genomics focus, related to respiratory diseases. Since then our focus has been on both genomics and natural products."

CEOCFOinterviews On which of the two do you put the most emphasis?

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