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January 1, 2001 Amylin Pharmaceuticals Inc. (Nasdaq: AMLN) is planning to conduct additional clinical studies leading to the planned submission of an amendment to its new drug application for Symlin, a diabetes treatment. The company expects that information from these clinical studies will fulfill the FDA's request for additional clinical data as indicated in the approvable letter received in October 2001, and in subsequent discussions with the agency. "Following receipt of the approvable letter, we have continued our productive dialogue with the FDA to better understand their requests and to establish our plans for responding," says Joann L. Data, senior v.p. of regulatory affairs and quality assurance. "Our goal is to submit to the agency, in the second half of 2002, a Symlin NDA amendment which will satisfy the FDA's requirements." The approvable letter requested additional clinical and pharmacokinetic-pharmacology information. Amylin does not expect that additional extended studies in people with type 2 diabetes will be required prior to approval. To complete the planned submission, Amylin plans to conduct a placebo-controlled dose titration study focused on safety in about 250 people with type 1 diabetes actively trying to improve their glucose control. Patients will then be followed for six months at a Symlin steady-state dose with additional insulin adjustments allowed to examine effects that can be gained when physicians and patients are free to adjust insulin. The company will also conduct a few small, short-term pharmacokinetic-pharmacology studies to enhance suggested prescribing information. "We are pleased with the outcome of our discussions with the FDA, and experts in the diabetes community, regarding our proposed strategy," says Orville G. Kolterman, senior v.p. of clinical affairs. "We now have a clear action plan for Symlin, and our Symlin team is focused on initiating and executing the required clinical studies." Symlin is an analog of human amylin, a hormone secreted with insulin by the beta cells in the pancreas. Amylin submitted the original NDA package seeking approval to market Symlin as an adjunctive therapy to insulin for the treatment of people with type 1 or insulin-using type 2 diabetes in December of 2000. Amylin is engaged in the discovery and development of potential drug candidates for the treatment of diabetes and other metabolic disorders. Symlin, its lead drug candidate, is targeted as a treatment for people with diabetes who use insulin. Based in San Diego, it has about 220 employees. *** The Titan Corp.'s wholly-owned subsidiary, Titan System Corp., has been awarded a contract to design and execute complex, computer simulated wargames for advanced tactical training of the U.S. Navy's Pacific Fleet. With an initial base year award and four one-year options, if exercised, the contract has a potential value of more than $18 million. "Titan has been providing this computer simulation expertise to the Navy for the past 13 years," says Gene Ray, Titan's president, chairman, and CEO. "The work plays a vital role in preparing and training our forces for the wide variety of scenarios and uncertainties that they may have to face in today’s war time environment." Under this contract, Titan will execute more than 150 wargames each year to support a training curricula and pre-deployment work-up training for the ships, submarines, squadrons and Marine units of the Fleet. Titan will create, build, test, execute and analyze very complex and realistic scenarios that include all aspects of modern maritime operations including expeditionary warfare, anti-terror warfare, force protection, information warfare, and the traditional elements of modern fleet and joint operations across the globe. Players in these wargames are senior officers of the U.S. Navy, U.S. Marine Corps, other services and United States' allies in the Pacific Theater of Operations. Titan will use the Navy's Enhanced Naval Warfare Gaming System and the Marine Corps' Marine Air-Ground Task Force Tactical Warfare Simulation to provide a realistic simulation of the wargame's battle space. The work will be accomplished in San Diego and at other US Pacific Fleet locations as required. Headquartered in San Diego, The Titan Corp. creates, builds and launches technology-based businesses, offering innovative technical solutions. The company has 10,000 employees and annual sales of $1.3 billion. *** In other Titan System Corp. news, the company has been awarded a one-year GSA Master Agreement by the Department of Labor to provide all DOL organizations a broad range of information technology services. The agreement has a ceiling of $14 million with specific task orders being awarded to Titan Systems during the ordering period. DOL's Bureau of Labor Statistics already is placing purchase orders against the agreement for regional support. Key purchase order requirements include data collection; electronic data interchange analysis and software development; solicitation of survey participants and help desk management — all in support of various surveys conducted by the Bureau. These surveys provide critical economic information to public and private sectors. "We’re very pleased to continue of our relationship with the Bureau of Labor Statistics," says Ray. "This is Titan's fifth successive award of the BLS regional support work. For nearly a decade, Titan has been providing regional support to the bureau, and we are proud to be part of the bureau's success in generating statistics critical to the economic health of the nation." *** Paul K. Scripps, a sixth generation journalist who spent more than 30 years in the newspaper business, retired Dec. 31 as a newspaper division v.p. for Cincinnati-based The E. W. Scripps Co. (NYSE: SSP). Scripps, 56, will continue as a member of the Scripps board of directors and as a trustee of the Scripps Howard Foundation, the company’s philanthropic arm. Scripps began his newspaper career 30 years ago, continuing a family tradition that can be traced back to his great-great-great grandfather, William Arminger Scripps, who in 1803, became editor of the London (England) Daily News. Paul Scripps also is a great-grandson of Edward W. Scripps, the founder of The E.W. Scripps Co. Paul Scripps began his newspaper career in 1970 at the Ventura County Star-Free Press, which at the time was the largest of the JPSN newspapers. The newspaper, now the Ventura County Star, is one of 21 daily newspapers operated by The E. W. Scripps Co. After two years in Ventura, he was named editor and publisher of what at the time was JPSN's smallest weekly newspaper, the Morro Bay Sun. Within a year after he was assigned to Morro Bay the Sun merged with a competing weekly — the Morro Bay Bulletin — and was renamed the Central Coast Sun-Bulletin. In 1974, Scripps moved to JPSN headquarters in San Diego to coordinate a management training project for the newspaper group. In 1977 he was named associate editorial director for JPSN, and in 1986 advanced to editorial director. That year, JPSN merged with The E. W. Scripps Co. Scripps was named a v.p. for the Scripps newspaper group and for a time served as chairman of the board of John P. Scripps Newspapers before its consolidation with The E. W. Scripps Co. was complete. In addition to his role as a trustee of the Scripps Howard Foundation, he is a trustee of the Ellen Browning Scripps Foundation, the Ellen Browning Scripps Relief Trust and the Quest for Truth Foundation. He also is a member of the board of the Inter American Press Association and a member of the San Diego Chapter of the Society for Professional Journalists. He is a past president of the La Jolla Chapter of the International Wine & Food Society and is a member of other various clubs and associations, including the National Rifle Association, the San Diego Yacht Club, the San Diego Zoological Society and the San Diego Rest & Aspiration Society. |
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