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HomeMy WebLinkAbout11-15-95 ECONOMIC DEVELOPMENT COMMITTEE AGENDA - Wednesday,November 15, 1995 8:00 a.m. Army Reserve Center 4655 North Lexington Avenue 1. Call to Order. 2. Approve minutes from October 18, 1995 3. Monthly Report 4. Unfinished and New Business A. Election of new Chair B. Recruitment of new members and direction for Committee 5. Staff Comments 6. Council Comments 7. Miscellaneous 8. Adjournment If you are unable to attend this meeting, then please contact Julie at 633-5676. Economic Development Committee Meeting Minutes Wednesday, October 18, 1995 8:00 a.m. Army Reserve Center 1. Call to Order The meeting was called to order at 8:03 AM. 2. Attendance Present were: Arnold Lindberg, Dan McCallum, and Raymond McGraw, City Administrator Brian Fritsinger, and Community Development Director Kevin Ringwald. Absent were: Rob Carlson - Chair, Steve Friemuth, Tom Goblirsch, and Terry Nagle. 3. Approval of Minutes Minutes of the August 16, 1995 regular meeting were approved. 4. Monthly RWort Staff briefed the Committee on its activities over the past month. Discussion took place on the status of the CPI Guidant expansion and the State of Minnesota proposal to CPI Guidant. 5. Gateway Business District/TCAAP Updates Staff briefed the Committee on the status of the GBD and TCAAP. Staff outlined the anticipated development scenarios for the GBD and the Phase II planning/implementation process for TCAAP. 6. Miscellaneous The Staff presented the Committee with the resignation letter of Committee Chair Rob Carlson. 7. Council Comments None. 8. Adjournment The meeting adjourned at 9:06 AM. Economic Development Committee Meeting Minutes - Wednesday, October 18, 1995 8:00 a.m. Army Reserve Center 1. Call to Order The meeting was called to order at 8:03 AM. 2. Attendance Present were: Arnold Lindberg, Dan McCallum, and Raymond McGraw, City Administrator Brian Fritsinger, and Community Development Director Kevin Ringwald. Absent were: Rob Carlson- Chair, Steve Friemuth, Tom Goblirsch, and Terry Nagle. 3. Approval of Minutes Minutes of the August 16, 1995 regular meeting were approved. 4. Monthly Report Staff briefed the Committee on its activities over the past month. Discussion took place on the status of the CPI Guidant expansion and the State of Minnesota proposal to CPI Guidant. 5. Gateway Business District/TCAAP Updates Staff briefed the Committee on the status of the GBD and TCAAP. Staff outlined the anticipated development scenarios for the GBD and the Phase II planning/implementation process for TCAAP. 6. Miscellaneous The Staff presented the Committee with the resignation letter of Committee Chair Rob Carlson. 7. Council Comments None. 8. Adjournment The meeting adjourned at 9:06 AM. • CITY OF ARDEN HILLS ' MEMORANDUM DATE: November 15, 1995 TO: Economic Development Committee FROM: Kevin Ringwald, Community Development Director i SUBJECT: Monthly Report The following is a brief list of Staff contact over the past several weeks. 1. GalaGen, Inc. GalaGen is an spin-off company of Land O'Lakes. The company is currently located at the Land O'Lakes facility in Arden Hills, where they are conducting research and development activities. GalaGen is a Biopharmaceutical company making products derived from dairy milk to fight gastrointestinal diseases. GalaGen is hoping to receive approval from the Food and Drug Administration(FDA) in early 1996 for their first production drug. If production and commercial acceptance of this drug is successful, then GalaGen would be looking at expanding their operations. The Staff is working with GalaGen on this eventuality and particularly with respect to the GBD. Attached you will find a Corporate Overview of GalaGen for your information (Exhibit A). 2. CPI Guidant The Staff is continuing to work with CPI Guidant on their consolidation and expansion in Arden Hills. Staff has provided the State of Minnesota with the Phase I application for the Minnesota Economic Recovery Fund grant(Exhibit B). The Staff and CPI Guidant are now working on the Phase II application it is anticipated that the Phase II application will be presented to the State by December 1, 1995. The State has informed CPI Guidant that they can expect to receive a grant(forgivable loan) of$250,000 to $300,000. The Staff will keep the Committee informed on their activities as it relates to this matter. PXA I b i GaIaGen Inc. NOV o ; �9G� A� rr7V n A Corporate Overview Biopharmaceuticals Derived from Milk for Gastrointestinal Diseases August 1995 Z�� y Executive Summary Technology Platform + GalaGen is a unique biopharmaceutical company with a technology platform that enables rapid discovery and development of a broad range of milk-derived products for diseases of the human gastrointestinal tract. These products contain specific polyclonal antibodies,or immunoglobulins, that target individual pathogens and are processed from the milk and colostrum of dairy cows. The immunoglobulins are taken orally, either in a solid oral dosage form or as a dry powder reconstituted in liquid, and they act locally within the gastrointestinal tract to provide passive immunity, or immunity transferred from one individual to another. The products have potential utility for both treating and preventing infections. Product Portfolio GalaGen's products target complications of immunocom promised patients, including Cryptosporidium parvum-associated diarrhea and yeast infections of the mouth and esophagus caused by Candida albicans (thrush); ulcers and or caused by Helicobacter pylori; antibiotic-associated diarrhea caused by Clostridium difficile; and traveler's diarrhea caused by Shigella flexneri and enterotoxic E. coli. Benefits of Milk-derived Antibodies Because these antibody products are derived from milk, they are likely to be well tolerated, with minimal side effects. This safety profile should significantly reduce the regulatory burden, leading to faster and less expensive clinical development programs as compared to new chemical entities. In addition,the use of antibody products to treat gastrointestinal pathogens is expected to have certain key advantages over classical anti-infectives, including better specificity resulting in fewer side effects, less resistance due to the multiple mechanisms of attack these polyclonal antibodies possess, and applicability for a broader target group, including bacteria and their toxins, protozoa, viruses and fungi. Production System GalaGen immunizes pregnant cows, using in many cases proprietary immunization agents and regimens, collects and processes the colostrum, the antibody-rich milk obtained from the first six milkings after calving, using techniques that purify and preserve the activity of the antibodies. GalaGen's formal relationship with Land O'Lakes, the large midwestern dairy cooperative, provides access to colostrum from over 250,000 cows. This supply relationship takes advantage of the existing infrastructure of the cooperative members' Grade A dairy farms and the supply is expected to exceed the worldwide requirements for all the above mentioned products. Development Strategy GalaGen's strategy is first to demonstrate the safety and efficacy of these antibody products as therapeutic biopharmaceuticals, and later to exploit the technology's value for disease prevention. Because of the speed with which GalaGen can develop products, the low cost of manufacturing, and the safety of the products, GalaGen is demonstrating that it can bring a new therapeutic antibody product to market for a fraction of the cost of a traditional biopharmaceutical product. This makes it possible to develop products for small, orphan product indications as well as large markets. 3/) %4 Technology Overview GalaGen's technology platform enables it to produce large quantities of pathogen-specific antibodies in the milk of dairy cows. Antibodies are infection-fighting proteins produced by lymphocytes,or white blood cells, and are directed against a wide array of pathogens that the body encounters throughout its life. While antibodies circulate in the bloodstream, they also are found in other body fluids, including milk, saliva and other secretions. Antibodies are normal constituents of milk, yogurt and other dairy foods; however, the pasteurization process inactivates most antibodies so they are either not functional in dairy foods or are present in quantities too low be effective. GalaGen's proprietary technology produces far more antibodies than are available in standard dairy foods, especially antibodies that are directed against specific human diseases, and preserves their biologic activity. There are three major components of this technology: Antibody-rich colostrum as a raw material. GalaGen uses the first milk produced during a cow's lactation, called colostrum, that is well tolerated and much richer in antibodies than milk produced later in lactation. The mother cow transfers antibodies into the colostrum from the bloodstream just prior to birth of the calf.These antibodies, active against a range of infections encountered by the mother during her lifetime, provide the initial critical line of defense for the calf during the first month of life. Immunization technology. GalaGen's proprietary technology enhances the cow's natural production of antibodies by immunizing the cow against human pathogens. The components of GalaGen's immunization regimens are proprietary and have been demonstrated to yield high levels of antibodies that attack the specific human pathogen of interest. These antibodies are transferred into the colostrum. Manufacturing technology. GalaGen uses proprietary production methods to concentrate the colostrum very gently so that maximal antibody activity is preserved. The resulting concentrate is dried to a stable powder that is similar in appearance to non-fat dried skim milk. II �II r AN Product Portfolio GalaGen's lead products in development target serious human gastrointestinal diseases. Natural beneficiaries of several of these products include AIDS and oncology patients with compromised immune systems. • SPORIDIN-GTE' AIDS diarrhea, caused by Cryptosporidium parvum • CANDISTAT-GTM Yeast infections of the mouth and esophagus caused by Candida albicans(thrush) • HELISTAT-G Ulcers and gastritis caused by Helicobacter pylori GalaGen has a full product pipeline. Products at earlier stages in development are directed at antibiotic-associated diarrhea caused by Clostridium drfficile, and traveler's diarrhea caused by Shigella flexneri and enterotoxic E. coli. In addition to these products, GalaGen can generate new products in an accelerated way with a minimum of early stage preclinical research and at relatively low cost. Once a pathogen target has been identified and immunizing materials obtained, GalaGen can produce clinical trial quantities of the antibody product in less than six months. Safety The safety of GalaGen's products is unique for drugs in development. The burden of proof for any new pharmaceutical is safety and efficacy. Many new products drop out of development due to safety concerns, even though they hold high promise for efficacy. GalaGen's products consist of common milk proteins and their safety profile should be similar to milk itself. They should be appropriate for administration to all age groups, with the exception of those individuals who cannot tolerate drinking dairy products due to an allergy or severe lactose intolerance. The Company has demonstrated that no measurable antibody reaches the systemic circulation. The probability of bringing one of GalaGen's bovine antibody products to market should be increased substantially by these safety features, especially when compared to a new chemical entity or biopharmaceutical. Activity Bovine antibodies represent a new class of oral therapeutics. While antibodies have been used for decades to prevent or treat human infections —such as gamma globulin shots for hepatitis—antibodies have not been typically administered orally to treat gastrointestinal infections. Bovine antibodies are uniquely structured to resist digestion in the upper gastrointestinal tract and bind with and kill or inhibit pathogens throughout the gastrointestinal system. In addition to their safety, bovine antibodies are: • active against all major classes of human pathogens: bacteria, viruses, fungi and parasites. • target individual pathogens without destroying beneficial bacteria. • polyclonal, meaning that they target many individual features of a pathogen and therefore diminish the likelihood that a pathogen will develop resistance to the product. Lead Products: SPORIDIN-GTM for AIDS Diarrhea The Disease SPORIMN-G, produced from bovine colostrum with high titers of anti-Cryptosporidium parvum antibodies, is designed to mitigate the symptoms due to infections by the parasite Cryptosporidium parvum. Cryptosporidium parvum is an intestinal parasite, infecting both humans and animals. Healthy individuals recover after a week of discomfort and diarrhea; AIDS patients develop a lingering, debilitating diarrhea. Cryptosporidium parvum has been in the headlines a number of times recently, both due to its causing of diarrhea in AIDS patients and also for the epidemic it caused when it infected Milwaukee's water supply in March 1993 producing diarrheal illness in over 400,000 individuals and tragically death in at least 50 AIDS patients. The Market Opportunity It is estimated that 10 percent of AIDS patients in the U.S. have cryptosporidiosis, with higher percentages reported in developing countries. In addition, diarrhea is associated with malnutrition, wasting, decreased quality of life and early death. It is expensive, adding more than$10,000 in annual medical costs. Most cases respond poorly to existing therapies and no drug is currently approved for this indication. GalaGen believes that the medical need and market opportunity for SPORIDIN-G is substantial. Development Status Patients have received SPORIMN-G under a compassionate-use protocol. Many have had serious disease j that was unresponsive to other available, but unapproved therapies. About half of the 28 patients treated with SPORIDIN-G received clinical benefit in the form of parasite eradication,diarrheal symptom reduction, or more general clinical improvement, including weight gain and improved appetite. A Phase I/II clinical trial in adult AIDS patients was initiated in December 1994 at San Francisco General Hospital. The study is exploring the efficacy of SPORIDIN-G in several different populations. Preliminary results in the group with C.parvum as their sole infection appear to confirm the clinical benefits seen in the compassionate use program. A pivotal clinical trial planned to begin in October 1995 may be the final trial required to submit for regulatory approval in the U.S. This pivotal Phase II/III trial has been discussed with the FDA and a study design incorporating their suggestions will be submitted in August 1995. SPORIDIN-G received approval for orphan drug status in March 1994. New Adjuvant Technology In March 1995 GalaGen licensed proprietary adjuvant technology from Chiron Corporation for the immunization regimen that produces SPORIDIN-G. The adjuvant, MF59-0, increases specific anti- Cryptosporidium parvum antibody levels four-fold. SPORID[N-G produced with MF59-0 has shown superior efficacy versus non-MF59-0 product in both in vitro and animal models. GalaGen has worldwide, exclusive rights to the use of MF59-0 for producing bovine antibody products intended for Cryptosporidium parvum and will use the adjuvant for product used in pivotal clinical trials. I i Lead Products: CANDISTAT-GTM for Thrush in AIDS, Cancer and . Transplant Patients The Disease CANDISTAT-G is specifically targeted to prevent or eliminate oral and esophageal yeast infections, also known as thrush, caused by the yeast Candida albicans. Thrush affects nearly all end-stage AIDS patients, as well as cancer and transplant patients. It causes whitish patches in the mouth and esophagus that are extremely painful, impair eating and swallowing, and can lead to malnutrition. The Market Opportunity In severely immunocompromised individuals, thrush is poorly controlled by systemic antibiotics. Therapy with front-line antifungal agents often fails and relapse after successful therapy is almost universal. There have been reports of drug resistant strains or emergence of secondary pathogenic strains associated with use of a leading antifungal agent. Another systemic antifungal agent is toxic in large doses and is generally reserved for deep systemic infections. A specific oral agent with minimal side effects and no antibiotic resistance would be extremely valuable for this patient population, and GalaGen's product CANDISTAT-G offers this profile. Sales of the leading anti-fungal agent will exceed $700 million in 1995 and patients at risk in the U.S., including cancer chemotherapy patients, bone marrow and solid organ transplant patients, and AIDS patients total more than 350,000 individuals. Development Status CANDISTAT-G is earlier in its development than SPORIDIN-G. Preclinical studies demonstrate potent inhibition of the yeast cells' ability to bind to human cheek cells. A pilot clinical trial at the Karolinska Institute in Sweden is expected to begin in the second half of 1995. A clinical trial in AIDS patients in the U.S. is anticipated to begin in early 1996. • i Lead Products: Helicobacter pylori Antibody Product The Disease In March 1995 GalaGen signed an agreement with Chiron Corporation to develop jointly a bovine antibody product for the treatment of Helicobacter pylori,the pathogen associated with most duodenal ulcers and gastritis. The Market Opportunity The prevalence of duodenal ulcers in the United States is estimated at 3.5 million cases. Each year there are estimated to be 250,000 new cases of duodenal ulcers and 3.2 million recurrences. The U.S. market for existing ulcer drugs is estimated at$3.2 billion annually. The term "ulcer"describes an erosive opening in the internal surface of the stomach or duodenum with inflammation and bleeding at the site. The accepted standard treatment for ulcers focuses on gastric acid hypersecretion, for example, via antacids which neutralize the acid or drugs which inhibit acid secretion or coat the ulcerated tissue to protect against the acid. Because relapse rates are significant,many physicians also prescribe maintenance therapy. Since the discovery that an infection by the bacterium H.pylori is associated with most duodenal ulcers and gastritis and is likely the cause of relapse after conventional ulcer therapies, a major trend in the development of duodenal ulcer therapy has been the increased use of antibacterial"Triple Therapy" (a combination of several antibiotics and bismuth) instead of or in addition to conventional ulcer therapies. Development Status GalaGen's bovine antibody product in development is intended to eradicate H.pylori from the gastrointestinal tract, targeting those patients who would be treated with antibiotic "Triple Therapy." GalaGen's initial laboratory studies with the product have successfully demonstrated neutralizing antibody activity against a key feature of H.pylori. Preclinical studies are being conducted with Institut Pasteur, University of Minnesota and Chiron Corporation's Biocine division. Chiron recently published a mouse infection model that mimics the pathology that develops in humans infected with H.pylori. This model will provide a rapid screening system for evaluating and optimizing new antibodies prior to testing them in the clinic. Phase II clinical trials are expected to begin in the second half of 1996. Development and Marketing Partner GalaGen and Chiron have cross-licensed proprietary immunizing technology and will collaborate on ZZ further development of the product. GalaGen has granted Chiron an option to the exclusive worldwide marketing rights for H.pylori products emerging from the collaboration. • 8 .� Manufacturing Raw Material Procurement and Processing GalaGen produces its antibodies through a highly efficient system that links local veterinarians, dairy farmers and Land O'Lakes transportation systems with the GalaGen technical operations center. All such dairy farmers are members of the Land O'Lakes cooperative system and their farms are certified Grade A dairy producers and meet a set of rigorous standards defined by the FDA. Local veterinarians are trained to immunize dairy cows at regular intervals during their"dry period"—the end of their pregnancy when they are no longer producing milk. Colostrum is collected under special conditions from the first six milkings after the calf is born. After giving the calf all it can consume, the dairy farmer delivers the remainder to GalaGen, where it is screened for quality and processed. The end product is a spray dried powder that is stable for several years at room temperature and that can be formulated into final medication, e.g. capsules, tablets or powders. Quality Control Systems GalaGen's procurement system is a critical element in the regulatory approval process for pharmaceutical uses of colostrum. Because this procurement system is rigorously controlled and documented, and each participant in the process is highly trained, every batch of GalaGen antibody products can be traced back to the individual cows that provided the starting materials. i Source of Raw Material Supply The Land O'Lakes system provides a tremendous reservoir of raw materials. A cow calves yearly and produces over a pound of antibody in the first several milkings after the calf is born. Cooperative member farms comprise over 250,000 cows and provide the potential for producing more than 150 tons of GalaGen's finished product per year. GalaGen's long-term supply contract with Land O'Lakes will ensure raw material supply well into the next century. Immunization Technology for Optimal Specific Antibody Yield Modern dairy cows, which have been bred for high milk production, also produce large quantities of colostrum, and, therefore, antibodies. These same attributes result in highly efficient production of antibodies in colostrum and milk, compared with far more costly systems developed for producing therapeutic antibodies, such as monoclonal antibodies. GalaGen's immunization technology maximizes the antibody yield from each cow. Colostrum naturally contains antibodies active against a broad spectrum of pathogens, including the human pathogens that GalaGen is interested in treating. Antibody levels for specific pathogens can be increased through the use of booster immunizations,just as tetanus booster shots remind our immune systems to be vigilant against tetanus. GalaGen's proprietary technology includes immunization regimens which provide economically important increases in specific antibody levels. For example, a single dose of one of GalaGen's products provides about a thousand times more antibodies for the targeted disease than a glass of milk purchased from the dairy case at the supermarket. Using new technology introduced over the past three years, GalaGen has been able to increase antibody levels in colostrum against the parasite Cryptosporidium parvum more than thirty times . higher than the level typically seen in dairy cows as a result of their natural exposure. * - Barriers to Competition While commercial antibodies have been produced in animals for decades, and the processes for this are well known and not patentable, GalaGen intends to protect its business opportunities in several ways. Trade Secrets GalaGen maintains a host of trade secrets related to its procurement and manufacturing system. Biologic Drug Development Regulations The biologics drug development pathway provides considerable protection, because for this class of drug products, there can be no generic products approved for marketing. This means that each competitor must proceed through the same laborious, painstaking pathway that GalaGen will have used to receive FDA approval. Patents GalaGen has filed several in a series of planned narrow and strong patents to protect various aspects of its immunization regimens and the use of antibodies for specific disease targets. In-Licensing Novel Technology GalaGen also intends to in-license unique and proprietary technology wherever possible, and has licensed product components from Institut Pasteur in Paris, France, the United States Department of Agriculture, MicroCarb, in Gaithersburg, MD, and Chiron Corporation, in Emeryville, CA. Patents either have been issued or are pending for these licensed components. Strategic Alliances and Technology Licensing Agreements GalaGen has entered into a series of important strategic alliances and technology licensing agreements. Land O'Lakes GalaGen's agreements with Land O'Lakes provides for access to raw materials and the license of Land O'Lakes' technology developed prior to GalaGen's formation. Nestle Nestle has granted GalaGen a license to its technology relating to the production and use of bovine anti- rotavirus and anti-E. coli antibodies for therapeutic and prophylactic indications. The license includes Nestle's clinical data and foreign patents and also gives GalaGen the right to grant sublicenses. The license is exclusive in North America and semi-exclusive in the rest of the world. Chiron Corporation In March 1995 GalaGen and Chiron Corporation entered into a License and Collaboration Agreement, involving the licensing of Chiron adjuvant technology and a collaboration to research and develop passive immune therapies, using bovine antibodies, against H.pylori. Institut Pasteur Institut Pasteur granted GalaGen an exclusive license for an H.pylori antigen candidate. GalaGen has also entered into a collaborative research agreement that gives GalaGen rights to future technology emerging from the collaboration that relate to passive immunotherapy. United States Department of Agriculture The USDA granted GalaGen an exclusive license for a Cryptosporidium parvum antigen candidate, for both human and animal health applications. The license was granted for technology developed under a Cooperative Research and Development Agreement with the U.S.D.A. that was sponsored by GalaGen. i Management GalaGen's management team is comprised of individuals who formed the nucleus of the technical development team when the company was still part of Land O'Lakes and individuals experienced in the pharmaceutical and nutrition products industries. The Company also uses external resources to augment its skills for regulatory issues and special technical tasks. The Company has 20 employees and has leveraged its association with Land O'Lakes for economical office, laboratory and manufacturing facilities. Members of the management team are as follows: Robert A. Hoerr, M.D., Ph.D. President and Chief Executive Officer Dr. Hoerr was named President and Chief Executive Officer in September 1994. He joined GalaGen as Vice President, Medical and Regulatory Affairs in January 1993 and thereafter served as Senior Vice President and President and Chief Operating Officer. Dr. Hoerr was Director of Medical Affairs for Sandoz Nutrition Corporation, Minneapolis, Minnesota from 1990 to 1993, and Dr. Hoerr was Research Scientist and Assistant Program Director at the Clinical Research Center, Massachusetts Institute of Technology, Cambridge, Massachusetts from 1987 to 1990. Dr. Hoerr received his A.B. in Biology from Indiana University, his M.D. from Indiana University School of Medicine and his Ph.D. in Nutritional Biochemistry and Metabolism from M.I.T. Gregg A. Waldon Chief Financial Officer Mr. Waldon was named Chief Financial Officer in November 1994. He joined GalaGen in July 1992 as Controller was elected Treasurer in September 1992, Secretary in March 1993, and Vice President in December 1993. Mr. Waldon has seven years of experience in public accounting and is a CPA. From 1989 to 1992, he served as an Audit Manager with Price Waterhouse in its Middle Market and Emerging Growth Practice in Minneapolis, Minnesota and was Senior/Staff accountant with Price Waterhouse prior to that time. Peter N. Gray, Ph.D. Vice President, Research & Development Dr. Gray joined the Company in March 1995. He is a scientific business leader experienced in all phases of research and product development,technology strategy, licensing and management. Dr. Gray has earned his B.S. degree from the University of Delaware,his M.S. degree from Northwestern University Medical School and his Ph.D. from The University of Texas M.D. Anderson Tumor Institute. Dr. Gray has served a Fortune 300 pharmaceutical company,IMCERA Group, as Vice President of Research and also Technology Development. Dr. Gray has provided consulting expertise in the fields of control of biological infestation. Dr. Gray was a founder of the Biotechnology Research and Development Corporation and managed the formation of American Gene Therapy. Prior to joining industry, Dr. Gray was head of the department of biochemistry and molecular biology at The University of Oklahoma College of Medicine. Christopher J. Searcy, Pharm. D., M.B.A. Vice President, Business Development Dr. Searcy was named Vice President, Business Development of the Company in April 1995. Dr. Searcy was Director, Licensing and Development for Pfizer Inc.,New York, from 1991 until 1995. In that function, he was responsible for worldwide pharmaceutical licensing including evaluation of early and late stage products as well as strategic alliances from small, medium and large companies primarily based in the U.S. and Europe. Prior to that and since 1985, he held three different positions in Pfizer International's Pharmaceutical Group including responsibilities in regulatory affairs, clinical research and marketing with a focus on anti-infectives. In particular,he worked extensively on both medical and marketing programs for fluconazole, Diflucan®, Pfizer's novel antifungal which is now the number one , product in that therapeutic category. Prior to Pfizer, he was on the faculty of the University of Illinois College of Pharmacy from 1979 to 1984. Dr. Searcy received his B.S. in Pharmacy and Pharm. D. from the University of Minnesota and his Masters of Business Administration from the University of Pennsylvania's Wharton School. Michael E. Cady, M.B.A. Vice President, Manufacturing and Engineering Mr. Cady has served as Vice President, Manufacturing and Engineering of the Company since July 1992, and was a founder and Director of Operations for Procor since its inception. Prior to that time,Mr. Cady held several engineering and planning positions within three operating groups of Land O'Lakes. Mr. Cady was a member of the Land O'Lakes group that initially evaluated the oral immunoglobulin technology and its commercial applications prior to the formation of Procor in 1987. Mr. Cady received his B.S. in Engineering from the University of Iowa and his M.B.A. from the University of St. Thomas. Eileen F. Bostwick, Ph.D. Director, Research & Development Dr. Bostwick has been Director of Research and Development for the Company since October 1993 and Manager of Research and Development since July 1992. She joined Procor in 1988 as Immunology Group Leader. Before joining Procor, Dr. Bostwick was a Senior Immunologist in the Biotechnology Section at Minnesota Mining & Manufacturing where she directed preclinical medical device testing and immunoassay development. Dr. Bostwick received her B.S. and M.S. degrees from Michigan State University in Dairy Science, and her Ph.D. in immunology and physiology from the University of Minnesota. Scientific Advisory Council The Company has organized a group of scientific advisors(the"Scientific Advisory Council"),currently consisting of eight individuals, who advise the Company on matters relating to its research and development. The Advisors meet from time to time and do not actively participate in the Company's activities or in the development of the Company's technology. Gerald E. Gaull, M.D Chairman Research Professor of Pediatrics and Director at the Center for Food and Nutrition Policy at Georgetown University Medical School. Prior to this appointment, he served as Vice President for Nutritional Science at NutraSweet Company since 1984. He is the author of more than 200 published works on metabolism, nutrition and human development, including more than 100 original research articles. John Gill Bartlett, M.D. Professor of Medicine at Johns Hopkins University School of Medicine. He is currently Chief, Division of Infectious Diseases at The Johns Hopkins Hospital and John Hopkins University School of Medicine, and Stanhope Bayne Jones Professor of Medicine, Johns Hopkins University School of Medicine. He also has a joint appointment at the Department of Epidemiology, Johns Hopkins School of Hygiene and Public Health. He has published numerous scientific and medical articles and is regarded as a worldwide authority on infectious diseases of the GI tract. Robert J. Desnick, Ph.D., M.D. Professor and Chairman of the Department of Human Genetics at Mount Sinai School of Medicine. His research areas include molecular,biochemical, somatic cell and clinical genetics. He has over 300 research publications and has edited six books on topics in genetics. He is a member of the Board of Directors of the American Board of Medical Genetics ("ABMG")and serves as Chairman of the ABMG Molecular Genetics Subcommittee. Lars A. Hanson, M.D., Ph.D. Professor and Chairman of the Department of Clinical Immunology at Goteborg Universitet, Goteborg, Sweden. He is a specialist in Pediatrics and in Clinical Immunology. He is one of the world's leading authorities on infant formula and perinatal nutrition. Dr. Hanson has published numerous scientific papers in immunology, pediatrics and bacteriology and is author/editor of 15 books. Henri C. Isliker, Ph.D. Founder and former head of the Swiss Institute for Experimental Cancer Research in Lausanne, Switzerland. His pioneering work in the 1950s and 1960s in protein chemistry and molecular immunology laid the scientific foundation for modern passive immunotherapy. He was an advisor to Nestle during the early stages of its bovine antibody program development. Dr. Isliker is the founder of the World Health Organization's("WHO")Center for Immunology and a scientific advisor to the WHO Director General. Arthur Kornberg, M.D. Professor of the Department of Biochemistry at Stanford University's School of Medicine,which he founded and organized in 1959 and served as its Chairman until 1969. His research focused on the mechanisms of replication of DNA, which made possible the discovery of recombinant DNA and the advent of genetic engineering. His discoveries in molecular biology earned him the Nobel Prize in Medicine and Physiology in 1959 and numerous other distinctions(including the National Medal of Science in 1979). Peter Palese, Ph.D. Professor and Chairman of the Department of Microbiology at Mount Sinai School of Medicine. His major research interests relate to the study of respiratory RNA viruses, including influenza viruses. In addition,Dr. Palese has been involved in research on the development of antiviral agents and novel vaccines. Among his major accomplishments have been the establishment of genetic maps for influenza viruses,the elucidation of the function of viral proteins such as the influenza virus neuraminidase,and,most recently,the introduction of synthetic RNAs into the genome of infectious influenza viruses. Thomas E. Wagner, Ph.D. Professor of Molecular Biology and Director of Edison Biotechnology Center at Ohio University, the biotechnology Consortium in Ohio focused on animal biotechnology. Dr. Wagner is known as the leader of the research group which in 1980 transferred a functioning gene into a mouse, producing the world's first transgenic animal. Since 1980 he and his research group have been involved in the introduction of genes into both laboratory and livestock animals and have produced over 200 different lines of transgenic animals. a FXJ41.61-t C3 l 5 CITY OF ARDEN HILLS V" M-dAm 14 50 WEST HIGHWAY 96 ARDEN HILLS, NIN 55112-5794 October 10, 1995 Minnesota Department of Trade and Economic Development Attn: Cheryl Johnson 500 Metro Square 121 Seventh Place East Saint Paul, Minnesota 55101 Re: CPI Guidant - Minnesota Economic Recovery Fund Dear Cheryl: Pursuant to the Minnesota Department of Trade and Economic Development (DTED) proposal to CPI Guidant (CPI), dated August 21, 1995, the City of Arden Hills respectfully submits its Part I grant application for the Minnesota Economic Recovery • Fund (ERF) on behalf of CPI in the amount of 5500,000. Attached to this letter you will find the Part I application and its related exhibits. The exhibits are: DTED's proposal to CPI (Exhibit A); Lease ageement between CPI and Control Data Corporation(Exhibit B); CPI's preliminary project costs (Exhibit C); and CPI's employee/recruitment information (Exhibit D). The City is also continuing to work with CPI and Metro East Development Partnership on job training, work force recruitment, asbestos abatement, and telecommunication issues. If you should have any questions or comments, please feel free to contact me at 6" 5676. Sincerely, Kevin Ringwald, P Community Dev lopment Director cc: Brian Fritsinger, City Administrator Dave Reimer, CPI Guidant Deborah Barkley, Metro East Patricia Neuman, DTED PHONE: (6121 633-5676 FAX (6121 633-7839 2/S Business and Community Development Application Part I Applicant Information Section I (for State use only) Section II: See instruction for completion on the reverse side of this form. Applicant: City of Arden Hills On behalf of: CPI Guidant Communities served: City of Arden Hills Region: Metro Leg.: 53A Cong.: 4 Init. Fund: Metro County: Ramsey • Section III Contact Person Name: Kevin Ringwald, AICP Title: Community Development Director Address: 1450 West Highway 96 Arden Hills, Minnesota 55112 Phone: (612) 633-5676 Fax: (612) 633-7339 IA 3/5 Business and Community Development Application • Part I Community Needs Statement I Name of Community/Applicant City of Arden Hills The City of Arden Hills is a second ring suburb and is located in the Northern sector of the Twin Cities Metropolitan Area. Arden Hills encompasses approximately 9.4 square miles within Ramsey County. The City of Arden Hills is approximately 10 miles North of the downtowns of Saint Paul and Minneapolis and 13 miles North of the Minneapolis-Saint Paul International Airport. The City of Arden Hills is within 15 miles of over 18 colleges and universities and 50 technical and business schools. The current population of Arden Hills is estimated to be 9,426 persons (Metropolitan Council, April of 1994). The Northerly 2,370 acres of the City is the Twin Cities Army Ammunition Plant (TCA_AP). The City of Arden Hills, but for TCAAP, is approximately 95 percent fully developed. CPI is located on 48.85 acres, in a corporate campus setting, with no visibility from Interstate 694, Lexington Avenue, or Hamlin Avenue. CPI is the largest employer in the City of Arden . Hills, with 1,777 employees (DIED, Community Profile). CPI constitutes 6.98 percent of the City's total tax capacity, 12.32 percent of the City's CommerciaUIndustrial tax capacity, and 2.85 percent of the City's water utility fund. CPI is currently experiencing difficulty in recruiting qualified employees for its manufacturing workforce. If CPI were to relocate significant amounts of their employees to their other facilities rather than consolidating and expanding their operations in Arden Hills, then the City would face a significant economic impact. Also, it would be safe to assume that future consolidations would not occur in Arden Hills, which would have a long term negative impact on the viability of the Arden Hills campus. Given the limited nature of and the competitive nature for corporate users, Arden Hills would face extreme difficulty in attracting a new tenant for this facility. The City of Arden Hills is committed to protecting and enhancing the viability of its corporate campus community. The accomplishment of this goal will require additional resources from a variety of sources. To that end, the City of Arden Hills requests the assistance of DIED in retaining and expanding the operations of CPI. Lastly, the City of Arden Hills considered the use of Tax Increment Financing (TIF) for this project. However, the increase in value to the Control Data building was not of a sufficient amount to warrant the use of TIF in this phase of the project. The City of Arden Hills will consider the use of TIF for qualifying improvements in future phases of this project. 2A 4/5- Business and Community Development Application Part l Project Purpose Name of Community/Applicant: City of Arden Hills Project 41: CPI Guidant (CPI) is a world leader in the medical device and diagnostics industry, specifically cardiac rhythm management. In7une of 1995, CPI received approval from the Food and Drug Administration (FDA) for the market release of their VIGOR DR and SR pacemaker systems. The VIGOR DR and SR pacemaker systems use an advanced accelerometer technology to morutor the patient's physical activity and provide rate modulation to meet the patient's needs. The market release of VIGOR DR and SR brings the total of new CPI products introduced into the United States market to nine (9), since the start of 1995. In August of 1995, CPI approached the City of Arden Hills requesting assistance in retaining up to 450 jobs and then expanding their operations in Arden Hills. CPI currently owns a 315,000 square foot facility in Arden Hills and leases an additional 119,000 square feet in Arden Hills • and Shoreview. Additionally, CPI currently owns 954,000 square feet of facilities in: Dorado, Puerto Rico; Santa Clara, California; and Temecula, California. CPI was considering relocating 70 to 90 professionals to their Temecula operation and 350 to 450 manufacturing jobs to their Dorado, Puerto Rico facility. Also, in August of 1995, the Minnesota Department of Trade and Economic Development (DTED), with the assistance of the City of Arden Hills and the Metro East Development Partnership (Metro East) prepared a proposal to CPI to retain these jobs and requested them to expand their operations in Minnesota, and specifically Arden Hills (Exhibit A). CPI concurred, and is in the process of consolidating their operations in Arden Hills. CPI is leasing 94,462 square feet, with an option for an additional 35,317 square feet (Exhibit B), from Control Data Corporation (CDC) which has a facility directly adjacent to CPI's Arden Hills campus. It is currently estimated, by CPI, that the consolidation and expansion costs will be approximately S 14,550,000 to S 16,550,000 through June of 1996 (Exhibit Q. The consolidation and expansion costs include: Architectural and Engineering design (550,000); Demolition (5200,000); Renovation (51,200,000); Telecommunications (5800,000); Moving (5300,000); and Equipment (S12,000,000 to S14,000,000). 3A • 5/s The consolidation and expansion of CPI's operation into the CDC facility has retained approximately 450 well paid manufacturing jobs. The base salary for CPI's manufacturing jobs. is S 12.97 per hour, with a bonu51benefit of 29 percent of base salary for CPI's employees (Exhibit D). The consolidation and expansion of CPI's operation into the CDC facility has retained approximately 90 well paid professional jobs. The base salary for CPI's professional jobs is S 17.81 per hour, with a bonus benefit of 29 percent of base salary for CPI's employees (Exhibit D). The consolidation and expansion of CPI's operation into the CDC facility will create approximately 50 manufacturing and 50 professional jobs between September of 1995 and January of 1996 (Exhibit D). The consolidation and expansion of CPI's operation into the CDC facility will create approximately 200 new jobs between January of 1996 and January of 1998 (Exhibit D). If it is assumed that the last 200 jobs will have a 50-50 split between manufacturing and professional, then the consolidation and expansion of CPI's operation would have retained or created 600 manufacturing and 240 professional jobs. 4A • CITY OF ARDEN HILLS " MEMORANDUM DATE: November 15, 1995 TO: Economic Development Committee FROM: Kevin Ringwald, Community Development Director SUBJECT: Election of a new Chair The Economic Development Committee (EDC) Chair Rob Carlson resigned from the EDC effective October 15, 1995 (Exhibit A). Therefore, it would be appropriate that the EDC recommend a new Chair to the City Council for their consideration. It may be beneficial in your deliberation and for the City Council deliberation if the members who wish to serve on the EDC in 1996 make their request known. • C 6-11 V)r-)o V2jT 4 Rob Carlson 7-1 3377 3377 Snelling Ave. N. St. Paul, MN 55112 612-639-9466 `�rS October 15, 1995 H Mr. Brian Fritsinger City Administrator City of Arden Hills 1450 W. Highway 96 Arden Hills, MN 55112 Dear Brian, I apologize for missing the last several meetings and not fulfilling my obligations as the chair of the Arden Hills Economic Development Committee. In April of this this year I was accepted Into an accelerated medical school program to begin training as a Physicians Assistant. This Is a dramatic turn around from my previous business background and one that is filled with new challenges and opportunities. It also requires a significant commitment of my time and energy. As a result, I find it necessary to resign my position on the Economic Development Committee. I believe this committee should play a vital role in development issues facing the city. It al• requires a Chairperson who is able to attend all pertinent meetings and devote additional time to addressing the many opportunities that exist with TCAP and the Planning Committee and City Council issues concerning the cities business climate. My current classroom and upcoming clinical rotations do not leave me with the time necessary to devote to these issues. Therefore, I feel it necessary to resign and open the position up to someone who is able to address these issues. If you have any questions, please feel free to call me. Sincerely, Rob Carlson • CITY OF ARDEN HILLS • MEMORANDUM DATE: November, 15, 1995 TO: Economic Development Committee FROM: Kevin Ringwald, Community Development Director SUBJECT: Recruitment of neNv members and direction for Committee The Staff wishes to discuss with the Economic Development Committee (EDC) recruitment issues for the EDC. Obviously, the effectiveness of the EDC can only be fully realized with a full spectrum of participation. Currently, there exists two (2) vacancies on the EDC one of those being the Chair. Staff would like to brain-storm with the EDC on this issue. The City Council is requesting the attendance of the EDC or its representatives, at their worksession on Thursday, December 21, 1995 at 4:30 p.m. in the Public Works lunchroom. The City Council wishes to discuss the activities of the EDC in 1995 and the goals for 1996. Your input on these matters would be beneficial to this discussion. • The Staff will discuss these items with the EDC at the meeting in greater detail. •