Healthcare Industry News:  MedImmune 

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 News Release - February 26, 2007

Artisan Pharma, Inc. Hires Senior Clinical and Regulatory Management

FRAMINGHAM, Mass.--(HSMN NewsFeed)--Artisan Pharma, Inc. today announced that it has completed hiring the senior management team of its clinical, regulatory and quality compliance group, with the addition of David Gelmont, M.D., as Chief Medical Officer, Robin Wallace, B.S.N., as Director of Clinical Operations and Nita U. Patel, Ph.D., as Senior Vice President, Regulatory Affairs and Quality Compliance. Artisan's business strategy is to in-license development-stage pharmaceutical and biopharmaceutical products for critical care and hospital-based markets.



Commenting on the hires, Jeffrey D. Wager, M.D., President and CEO of Artisan, said, "The additions of David, Nita and Robin complete one of the most important tasks in building Artisan: the creation of the core clinical, regulatory and quality compliance group that will drive the development of ART 123, a promising new self-regulating treatment for disseminated intravascular coagulation (DIC) in sepsis that is awaiting approval in Japan, and eventually of other products that we plan to acquire. Their combined expertise in critical care, clinical trial management, regulatory affairs and quality compliance is exceptionally well targeted to our needs as we now gear up to launch our Phase 2b trial in DIC in sepsis. The ability of Artisan to attract such a seasoned and highly qualified team is testimony to the attractiveness of ART 123's potential, the quality of our investors and the strength of our alliance with Asahi Kasei Pharma Corporation."

Dr. Gelmont headed the critical care and pulmonary therapeutic area in the clinical R&D organization at Baxter Healthcare prior to joining Artisan. He has also been in charge of critical care services at the Department of Medicine at the University of Southern California (USC); Director of the medical intensive care unit at Cornell Medical College; and Medical Director of the intensive care unit at a USC affiliate hospital, where he acted as a Principal Investigator in multiple industry-sponsored trials in sepsis and other critical care studies.

Prior to joining Artisan, Dr. Patel served as the Vice President of Regulatory Affairs and Clinical Quality Assurance at GenVec; Senior Director, Regulatory Affairs at Baxter Healthcare Corporation; Vice President of Regulatory Affairs and Quality at Novovax; and in various senior regulatory affairs positions at MedImmune, where she was responsible for global regulatory and quality strategy of both investigational and licensed products, life-cycle management, ensuring regulatory and quality compliance, multiple IND and license filings and communications with regulatory agencies around the world. She currently also serves as an adjunct professor of Regulatory Affairs and Biotechnology at Montgomery College in Maryland and has over 25 years of academic experience and over 15 years of industry experience.

Before joining Artisan, Ms. Wallace was the Director of Clinical Operations at Clinical Assistance Programs, LLC, a boutique contract product development company; Director of Project Management for Averion, a contract research organization; and Senior Clinical Monitoring Manager for Clinical Operations at Sepracor. She has also served as a Staff Nurse on the Coronary Critical Care Step Down Unit and CICU of Albert Einstein Medical Center in Philadelphia and trained at the Children's Hospital of Philadelphia on the Cardiac Step Down unit for medical and surgical patients.

About ART 123

ART 123 is a novel, recombinant, soluble thrombomodulin for the treatment of DIC (disseminated intravascular coagulation) in sepsis. ART 123 uniquely targets both anti-coagulant and systemic anti-inflammatory pathways, and holds great promise as a self-regulating treatment of DIC in sepsis. ART 123 has finished Phase 3 studies in Japan for DIC and Asahi has recently filed a Japanese NDA. Artisan plans on initiating Phase 2b studies of ART 123 in sepsis/DIC in the U.S. early this year.

About DIC in Sepsis

Approximately 1.8 million patients in the United States and Europe suffer from sepsis annually, with approximately 30% of them developing DIC. For those that do, prognosis is poor. DIC is a severe condition in which widespread microthrombi formation ultimately causes organ dysfunction and death. This market is estimated at over $2 billion and is increasing due to the growing incidence of sepsis in the industrialized world.

About Artisan Pharma, Inc.

Artisan Pharma is a biopharmaceutical company dedicated to bringing best-in-class critical care and hospital-based therapeutics to patients. Artisan's strategy is to acquire clinical stage or marketed drugs and develop them for markets with clear unmet medical needs. www.artisanpharma.net


Source: Artisan Pharma

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