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Ukraine's Fast-Emerging Healthcare and Pharmaceuticals Market Is Open For Business

Ukraine's fast-growing healthcare and pharmaceuticals market (20%+ growth in 2006-2007) took center stage at the "21st Century Pharmaceutical Production and Health Care Research & Delivery in the Commonwealth of Independent States" symposium on May 28, 2008. Held at the Ritz-Carlton Hotel in downtown Washington, D.C., this first annual international conference explored the many medical and pharmaceutical business opportunities now emerging in the Commonwealth of Independent States (CIS).

MaxWell USA, LLC organized and hosted the all-day event. MaxWell USA is the chief American subsidiary of MaxWell Biocorporation, an international medical and pharmaceutical company based in Washington, D.C. MaxWell is dedicated to increasing the life expectancy and improving the quality of life in Ukraine and other underserved emerging healthcare markets in the former Soviet Union.

 The MaxWell symposium featured concurrent research and business tracks and a keynote address by former Member of Congress and veteran Ukraine proponent Curt Weldon. It drew nearly 150 attendees and speakers from the medical, business, legal, and NGO communities in the United States, Ukraine, and Russia.

"Given the acumen and enthusiasm of the many scientists and business professionals who contributed to our symposium, I am optimistic that our work in Ukraine and beyond will progress rapidly," said MaxWell Biocorporation founder, President and CEO Dr. Kenneth Alibek. "As we work to increase life expectancy and improve quality of life across Ukraine and the CIS, the dedication of these and many other professionals, who are also fine humanitarians, will add a priceless component to these efforts."

Dr. Alibek highlighted the substantive knowledge sharing between the United States and Ukraine seen since Ukrainian independence in 1991. He also forecast significant opportunities for U.S. companies and healthcare institutions to expand manufacturing facilities in Ukraine, home to a motivated and educated workforce, and for the U.S. to provide direction for and training on clinical care programs.

Paul Dyck, deputy assistant secretary for Europe at the U.S. Department of Commerce, emphasized the U.S. government's commitment to helping American companies successfully contribute to Ukraine's public health and economic development through strategic investment. Current U.S. investment in Ukraine totals $1.4 billion. "American involvement will help bring innovation, best practices, intellectual property protection, and new technology to underserved areas of the former Soviet Union," Dyck said.

Oleh Shamshur, Ukraine's ambassador to the United States, discussed the importance of healthcare investment in the Ukraine, citing the social and economic returns. "With Ukraine's accession to membership in the World Trade Organization (WTO) and MaxWell's new state-of-the-art pharmaceutical production facility in Ukraine, there is a swelling tide of medical, research, and business cooperation between the U.S. and Ukraine," he said.

William Taylor, U.S. ambassador to Ukraine, noted in his video greeting to the symposium that MaxWell's investment in Ukraine is the largest single high-technology American investment in Ukraine to date, and enjoys the strong support of the Embassy. MaxWell currently operates the only U.S.-owned pharmaceutical production facility in Ukraine. Opened in March 2008 in the town of Boryspil, MaxWell's 150,000-square-foot facility was built in only 12 months, impressive for a plant of such size.

Business Track Highlights International Information Exchange

During the symposium business track, presenters offered insights on how business is done in Ukraine, and emphasized MaxWell's capacity for facilitating market entry and guiding partners through Ukraine's often-challenging regulatory environment, both key to successful project development. Highlights include:

-- Many healthcare institutions have pledged to share knowledge and provide training to Ukrainian physicians. One such cooperative education program for Ukrainian physicians is sponsored by the West Virginia University School of Medicine.

-- Representatives from three global corporations - ThermoFisher Scientific, Becton Dickinson Med/Pharma Systems, and Optima Group Pharma - noted MaxWell's drive and focus as a significant factor in the success of their own Ukrainian operations. Speakers discussed successfully meeting the business, regulatory, and security challenges of sourcing active pharmaceutical ingredients (API) on the global market. Specifically, one panel member discussed the specific role of freeze dryer technology in pharmaceutical research and production and the myriad regulations and standards that govern such technologies. Another discussed the role pre-fillable syringes will play in MaxWell's pharmaceutical production and healthcare delivery initiatives in Ukraine.

-- Panelists from Gaithersburg, Md-based AFG Biosolutions, Inc., discussed the many challenges of making protein biologics, including the extreme operating ranges involved and the heavy demands placed on raw materials, equipment, processes, and people; and how quality control systems rely on documentation to ensure regulatory compliance and contribute to the critical quality assurance function of the laboratory.

-- Representatives from Baker Hostetler, Squire Sanders & Dempsey, and the Russian-Ukrainian Legal Group spoke about successfully conducting business in Ukraine, including cross-border tax issues, corporate income tax, transfer pricing, and strategies for addressing double taxation; harmonization of Ukrainian law with European Union law and WTO requirements; and strategies for mitigating business risk.

"These insightful panelists discussed some of the most pressing business issues," said Dr. Peter Leitner, president of MaxWell USA.

Medical Track Illustrates Dramatic Need for Advanced Clinical Care and Openness to Variety of Training Methods

The symposium's medical track showcased the high rate of morbidity and mortality in Ukraine versus other countries, prospects for turning around these staggering statistics, and how clinical trial execution in Ukraine is contributing to state-of-the-art clinical care delivery in the country, as well as contributing to the greater good of advancing medicine.

-- In Ukraine, the average life expectancy for men is 59 years, far lower than in Western or Central Europe. Ukraine has only about half the number of physicians per 100,000 people as Italy - 300 versus 618. Doctors are rapidly leaving rural Ukrainian areas because there is no modern housing, minimal transportation, deplorable conditions and no modern equipment in the regional hospitals.

-- National Institutes of Health technologies related to temperature stabilization, rapid induction that requires fewer doses, and alternative non-needle delivery systems via patch, self-administration, and intranasal are moving from the lab to commercial development, and will be shared with Ukraine to help them provide advanced clinical care. These technologies will make it easier to administer treatment and help to reduce cost.

-- Since Ukraine became independent in 1991, the city of Dnepropetrovsk has worked to overcome deteriorating health climate and high rate of cancer diagnoses by participating in clinical trials. To date, 750 randomized patients have participated in 57 trials sponsored by 24 companies. The clinical trial experience has built a knowledge base; led to process efficiencies with healthcare professional training programs, lab interactions and a referral network; and provided state-of-the art treatment for patients who traditionally have received far less.

About MaxWell

MaxWell Biocorporation is a U.S.-based international medical and pharmaceutical company with wholly owned subsidiaries and affiliates in the United States and Ukraine dedicated to increasing life expectancy and improving the quality of life of people in Ukraine and other underserved emerging healthcare markets in the former Soviet Union. MaxWell targets oncological, cardiological, chronic infectious and autoimmune disorders and diseases through the development, production, and introduction into clinical practice of sophisticated, high quality, and affordable off-patent generic biopharmaceutical and chemopharmaceutical medicines and the latest diagnostic and therapeutic methods. MaxWell = "Maximum Wellness."


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