{"success":true,"data":{"_id":261556795,"filings":[{"Organization":{"Hours":[0],"Total Compensation":[0],"Direct compensation":[0],"Other compensation":[0]},"Basic":{"mission":"The international medica foundation is committed to the development of safe and cost effective healthcare products for families in need in neglected populations around the world. All activities of the foundation are in the field of medical research related to the development of vaccines and related products, services, therapeutics, diagnostics and drug delivery methods for diseases affecting the world population with particularly catastrophic effects on the lives of families in the developing world.","primary_activities":"The primary purpose of intl-medica is the development and delivery of an oral rotavirus vaccine for the prevention of rotavirus-related morbidity and deaths in the developing world. Globally, infections from rotavirus account for an estimated 125 million cases of diarrhea each year, resulting in the deaths of approximately 500,000 infants annually from a disease that is highly preventable with an oral vaccine. Worldwide, rotavirus infects every child in the world in their first few years of life and sends 1 child in every 5 to 8 to a clinic for treatment, 1 in every 58 to a hospital, and 1 in 250-300 die from dehydrating diarrhea. Rotavirus is the cause of 30% to 40% of the hospitalizations for diarrhea in children less than five years of age and results in over 1,600 deaths each day in developing countries where medical care is limited and malnutrition is prevalent. Rotavirus vaccine activities. Brief history: the rotavirus vaccine, known as rotashield, was invented and initially developed by the national institutes of health of the united states (nih). From its inception in december 2007 and continuing currently, international medica personnel have been working extensively alongside the nih and a vaccine manufacturer to complete a finalized vaccine product ultimately for use in the neglected populations of the world. Vaccine manufactured for clinical trials was tested to ensure it met all potency standards and all regulatory requirements prior to being released for use. International medica, working with the nih, actively participated in the ongoing development of the manufacturing process, ensuring that any changes to the manufacturing process met all regulatory requirements. Phase ii clinical trial: working with a number of groups internationally, the foundation conducted a phase ii clinical trial the purpose of which was to allow international medica to determine if the rotashield vaccine, when given in the neonatal delivery regimen, stimulates the immune response of infants to provide an adequate protection against the rotavirus. Giving the vaccine to neonates would allow more children to receive the vaccine, as children in developing countries are most likely to have interaction with health care providers in the first days immediately after birth. Starting immunizations at or near birth would also protect infants earlier in life.in early 2nd quarter of 2009, manufacture of the final rotashield vaccine was completed and ready for the clinical trial. This phase ii clinical trial ultimately screened approximately 1,051 children for the trial with multi-arm end-points. A total of 949 infants completed the study and pursuant to the trial design were followed for one-year to monitor for any safety issues. The last infant follow-up visit was completed in early december 2010. After a year of following the infants, there was then a data lock on the clinical trial information in june of 2011 followed by the final clinical study report in december of 2011. Neo-natal dosing: a key aspect of intl-medica development of rotashield was the change of dosing for rotavirus vaccines to a neonatal dosing schedule, ie providing the first dose within the first 29 days birthed life and a second dose before 60 days of age. The vaccine was originally developed where the first dose would be administered to infants at 2 months of age, in a three dose regimen. To increase the effectiveness of the vaccine with fewer doses, and to increase the likelihood of access of children to health professionals in the developing world, international medica did extensive review into the previous data and established a protocol to determine the effectiveness of rotashield when given in this two-dose, neonatal delivery regime. Neonatal dosing has become a practice of great interest in the pediatric vaccine fields since a significant number of infants die from vaccine preventable diseases within the first few months of life; and in the developing world, most infants come in contact with medical/health workers during the neonatal period.further, as all rotavirus vaccines have some concern of correlation with intussusception after receiving the vaccine, providing the vaccine prior to the age where intussusception is to occur could minimize if not eliminate the risk of intussusception. This could lead to rotashield actually being the safest rotavirus vaccine on the market.new rights: consistent with our neonatal delivery strategy, intl-medica, working with the nih, amended our license to add the intellectual property that the nih has developed concerning neo-natal delivery of rotashield. In essence, the clinical trial conducted by intl-medica proved the patented ideas of the nih of neonatal dosing.phase ii trial conclusion: intl-medica working with kendle research inc. (now inc research), went through a detailed analysis of the voluminous data generated by this trial and characterized the data into workable formats. This involved analyzing the data and putting much of the data into readable tables. The final clinical study report was finalized in december of 2011. Based on a review by experts in the rotavirus field, the results of the trial are impressive. Rotashield, with only two doses appears to have produced efficacy results approximately equivalent to three doses of a rotavirus vaccine currently on the market and provided protection several months earlier in life than the existing vaccine did in a previous (separate) study in ghana.clinical trial results/ publication: intl-medica assembled a team of the worlds leading experts in the field of rotavirus disease and vaccinations to write a manuscript for publication of the results. The manuscript has been accepted for publication in a major scientific journal in the july 2013 issue.phase iii clinical trial planning / ema: based on the positive phase ii clinical trial results, intl-medica has developed a strategic plan for a phase iii clinical trial for rotashield, and the foundation began preparing for a scientific advice meeting with the european medicines agency (ema) to conduct a phase iii trial with parts of the trial to be conducted in the eu and other portions in various regions around the world. The foundation working with quintiles (a contract research organization) drafted a voluminous submission concerning primarily the size of the trial needed to indicate efficacy and safety of rotashield. A preliminary meeting with the ema occurred in november of 2012 in london and the final meeting occurred in january 2013 again in london. A determination by the ema will be received by the foundation in 1st qtr of 2013.summary: concluding this large phase ii clinical trial was a major achievement for intl-medica, especially considering that this was a major undertaking for a foundation considering its small size. The publication concerning the results of our trial will also be of great importance to the foundation in the next fiscal year as will be the report of the ema on the foundations strategy for conducting a phase iii clinical trial.\n\nInternational medica has been working with the national institute of allergy and infectious diseases (niaid) national institutes of health (nih), and idt biologika gmbh, its vaccine manufacturer in germany, on a new, proprietary, liquid, heat-stable formulation of rotashield.a major constraint in achieving high immunization rates in less-developed countries is the requirement for a cold chain -- maintaining proper refrigeration of the vaccine product to ensure its effectiveness. This new rotashield liquid formulation has the potential to eliminate the need for a cold chain, which would significantly reduce the distribution and storage costs of the vaccine. All of the currently marketed rotavirus vaccines require refrigeration. Elimination of the need for the cold-chain for vaccines is also of great interest to the vaccine community worldwide, especially in the developing world.a typical liquid rotavirus suspension would generally lose its effectiveness after approximately one week of storage at 37 degrees celsius (98.6 degrees fahrenheit), whereas the new rotashield liquid formulation has shown stability for 6 months at this temperature even when an antacid is present. This same proprietary technology may be adaptable for use with other oral vaccines. The foundation has been actively seeking intellectual property protection of its advanced formulation.intl-medica expanded its patent protection of its new formulation and filed for extensive world-wide patent protection of its formulation. The foundation also began discussions with numerous groups who are interested in a license of this technology to ultimately utilize this technology in vaccine delivery.\n\nThe foundation has continued to engage in discussions with researchers at the national institute of health (nih) in bethesda, maryland, the infectious disease research institute (idri) in seattle, washington and the mayo clinic in rochester, minnesota, with regard to potential vaccines to be developed and other possible global disease issues to be addressed. The foundation is actively examining the possibilities of licensing and developing a vaccine for dengue.","year":2011,"name":"INTERNATIONAL MEDICA FOUNDATION","phone":"5072064380","website":"WWW.INTL-MEDICA.ORG","type":"990","principal_officer":"DR LEONARD RUIZ","year_formation":2007,"state_legal_domicile":"MN","total_volunteers":11,"tax_period_begin":"2011-12-01T00:00:00","tax_period_end":"2012-11-30T00:00:00","address":"421 1ST AVENUE SW NO 304, ROCHESTER, MN, 55902, USA","city":"ROCHESTER","state":"MN","country":"USA","zip_code":"55902"},"Governance":{"501c3 determination":true,"Number of voting members":7,"Number of independent voting members":5,"Number of employees total":2,"Total Gross UBI":0,"Net unrelated business taxable income":0,"Number of employees":2,"Prohibited tax shelter transactions":false,"Taxable party notification":false,"Funds to pay premiums":false,"Premiums Paid":false,"Family or business relationship":false,"Delegation of management duties":false,"Conflict of interest policy":true,"Whistle blower policy":false,"Compensation process for CEO":true,"Compensation process for other employees":true,"Changes to organizing documents":false,"Material diversion or misuse":false,"Members or stockholders":false,"Election of board members":false,"Decisions subject to approval":false,"Minutes of governing body":true,"Local chapters":false,"Form 990 provided to governing body":true,"Document retention policy":false,"Investment in joint venture":false,"Independent audit financial statements":false,"Consolidated audit financial statements":false,"Accountant compile or review":false,"Financial statements audited by independent accountant":false,"Federal grant audit required":false,"Political activities":false,"Donor advised funds":false,"Conservation easements":false,"Collections of art":false,"School":false,"Hospital":false,"Foreign activities":false,"Foreign office":false,"Gaming":false,"Fundraising activities":false,"Professional fundraising":false,"Loan to officer or DQP":true,"Grant to related person":false,"Business relationship through family member":false,"Business relationship with organization":false,"Transfers to exempt non-charitable organization":false},"Revenues":{"value":-5414,"Contributions":{"value":0},"Program revenue":{"value":0,"Unrelated business revenue":0},"Investment income":{"value":-5414,"Investment income total":-79,"Net investment gain":-5335},"Other revenues":{"value":0}},"Expenses":{"value":724928,"Grant expense":{"value":0},"Total professional fundraising expense":{"value":0},"Benefits paid to members":{"value":0},"Salaries":{"value":467692,"Current officers":405000,"Other employee benefits":43167,"Payroll taxes":19525},"Other expenses":{"value":257236,"Legal":19872,"Accounting":6382,"Other services":25000,"Office expenses":8144,"Occupancy":7032,"Travel":21513,"Conferences and meetings":35,"Depreciation and depletion":497,"Insurance":2226,"Itemized Expenses":{"value":166535,"VARIOUS":166535}}},"Assets":{"value":518547,"Non-interest bearing cash":3256,"Savings and temp cash investments":515043,"Accounts receivable":0,"Land, building, equipment":248,"Investments publicly traded":0},"Liabilities":{"value":500000,"Loans from officers, directors":500000},"Fund balance":{"value":18547},"Form990Details":{"program_service_accomplishments":[{"description":"THE PRIMARY PURPOSE OF INTL-MEDICA IS THE DEVELOPMENT AND DELIVERY OF AN ORAL ROTAVIRUS VACCINE FOR THE PREVENTION OF ROTAVIRUS-RELATED MORBIDITY AND DEATHS IN THE DEVELOPING WORLD. GLOBALLY, INFECTIONS FROM ROTAVIRUS ACCOUNT FOR AN ESTIMATED 125 MILLION CASES OF DIARRHEA EACH YEAR, RESULTING IN THE DEATHS OF APPROXIMATELY 500,000 INFANTS ANNUALLY FROM A DISEASE THAT IS HIGHLY PREVENTABLE WITH AN ORAL VACCINE. WORLDWIDE, ROTAVIRUS INFECTS EVERY CHILD IN THE WORLD IN THEIR FIRST FEW YEARS OF LIFE AND SENDS 1 CHILD IN EVERY 5 TO 8 TO A CLINIC FOR TREATMENT, 1 IN EVERY 58 TO A HOSPITAL, AND 1 IN 250-300 DIE FROM DEHYDRATING DIARRHEA. ROTAVIRUS IS THE CAUSE OF 30% TO 40% OF THE HOSPITALIZATIONS FOR DIARRHEA IN CHILDREN LESS THAN FIVE YEARS OF AGE AND RESULTS IN OVER 1,600 DEATHS EACH DAY IN DEVELOPING COUNTRIES WHERE MEDICAL CARE IS LIMITED AND MALNUTRITION IS PREVALENT. ROTAVIRUS VACCINE ACTIVITIES. BRIEF HISTORY: THE ROTAVIRUS VACCINE, KNOWN AS ROTASHIELD, WAS INVENTED AND INITIALLY DEVELOPED BY THE NATIONAL INSTITUTES OF HEALTH OF THE UNITED STATES (NIH). FROM ITS INCEPTION IN DECEMBER 2007 AND CONTINUING CURRENTLY, INTERNATIONAL MEDICA PERSONNEL HAVE BEEN WORKING EXTENSIVELY ALONGSIDE THE NIH AND A VACCINE MANUFACTURER TO COMPLETE A FINALIZED VACCINE PRODUCT ULTIMATELY FOR USE IN THE NEGLECTED POPULATIONS OF THE WORLD. VACCINE MANUFACTURED FOR CLINICAL TRIALS WAS TESTED TO ENSURE IT MET ALL POTENCY STANDARDS AND ALL REGULATORY REQUIREMENTS PRIOR TO BEING RELEASED FOR USE. INTERNATIONAL MEDICA, WORKING WITH THE NIH, ACTIVELY PARTICIPATED IN THE ONGOING DEVELOPMENT OF THE MANUFACTURING PROCESS, ENSURING THAT ANY CHANGES TO THE MANUFACTURING PROCESS MET ALL REGULATORY REQUIREMENTS. PHASE II CLINICAL TRIAL: WORKING WITH A NUMBER OF GROUPS INTERNATIONALLY, THE FOUNDATION CONDUCTED A PHASE II CLINICAL TRIAL THE PURPOSE OF WHICH WAS TO ALLOW INTERNATIONAL MEDICA TO DETERMINE IF THE ROTASHIELD VACCINE, WHEN GIVEN IN THE NEONATAL DELIVERY REGIMEN, STIMULATES THE IMMUNE RESPONSE OF INFANTS TO PROVIDE AN ADEQUATE PROTECTION AGAINST THE ROTAVIRUS. GIVING THE VACCINE TO NEONATES WOULD ALLOW MORE CHILDREN TO RECEIVE THE VACCINE, AS CHILDREN IN DEVELOPING COUNTRIES ARE MOST LIKELY TO HAVE INTERACTION WITH HEALTH CARE PROVIDERS IN THE FIRST DAYS IMMEDIATELY AFTER BIRTH. STARTING IMMUNIZATIONS AT OR NEAR BIRTH WOULD ALSO PROTECT INFANTS EARLIER IN LIFE.IN EARLY 2ND QUARTER OF 2009, MANUFACTURE OF THE FINAL ROTASHIELD VACCINE WAS COMPLETED AND READY FOR THE CLINICAL TRIAL. THIS PHASE II CLINICAL TRIAL ULTIMATELY SCREENED APPROXIMATELY 1,051 CHILDREN FOR THE TRIAL WITH MULTI-ARM END-POINTS. A TOTAL OF 949 INFANTS COMPLETED THE STUDY AND PURSUANT TO THE TRIAL DESIGN WERE FOLLOWED FOR ONE-YEAR TO MONITOR FOR ANY SAFETY ISSUES. THE LAST INFANT FOLLOW-UP VISIT WAS COMPLETED IN EARLY DECEMBER 2010. AFTER A YEAR OF FOLLOWING THE INFANTS, THERE WAS THEN A DATA LOCK ON THE CLINICAL TRIAL INFORMATION IN JUNE OF 2011 FOLLOWED BY THE FINAL CLINICAL STUDY REPORT IN DECEMBER OF 2011. NEO-NATAL DOSING: A KEY ASPECT OF INTL-MEDICA DEVELOPMENT OF ROTASHIELD WAS THE CHANGE OF DOSING FOR ROTAVIRUS VACCINES TO A NEONATAL DOSING SCHEDULE, IE PROVIDING THE FIRST DOSE WITHIN THE FIRST 29 DAYS BIRTHED LIFE AND A SECOND DOSE BEFORE 60 DAYS OF AGE. THE VACCINE WAS ORIGINALLY DEVELOPED WHERE THE FIRST DOSE WOULD BE ADMINISTERED TO INFANTS AT 2 MONTHS OF AGE, IN A THREE DOSE REGIMEN. TO INCREASE THE EFFECTIVENESS OF THE VACCINE WITH FEWER DOSES, AND TO INCREASE THE LIKELIHOOD OF ACCESS OF CHILDREN TO HEALTH PROFESSIONALS IN THE DEVELOPING WORLD, INTERNATIONAL MEDICA DID EXTENSIVE REVIEW INTO THE PREVIOUS DATA AND ESTABLISHED A PROTOCOL TO DETERMINE THE EFFECTIVENESS OF ROTASHIELD WHEN GIVEN IN THIS TWO-DOSE, NEONATAL DELIVERY REGIME. NEONATAL DOSING HAS BECOME A PRACTICE OF GREAT INTEREST IN THE PEDIATRIC VACCINE FIELDS SINCE A SIGNIFICANT NUMBER OF INFANTS DIE FROM VACCINE PREVENTABLE DISEASES WITHIN THE FIRST FEW MONTHS OF LIFE; AND IN THE DEVELOPING WORLD, MOST INFANTS COME IN CONTACT WITH MEDICAL/HEALTH WORKERS DURING THE NEONATAL PERIOD.FURTHER, AS ALL ROTAVIRUS VACCINES HAVE SOME CONCERN OF CORRELATION WITH INTUSSUSCEPTION AFTER RECEIVING THE VACCINE, PROVIDING THE VACCINE PRIOR TO THE AGE WHERE INTUSSUSCEPTION IS TO OCCUR COULD MINIMIZE IF NOT ELIMINATE THE RISK OF INTUSSUSCEPTION. THIS COULD LEAD TO ROTASHIELD ACTUALLY BEING THE SAFEST ROTAVIRUS VACCINE ON THE MARKET.NEW RIGHTS: CONSISTENT WITH OUR NEONATAL DELIVERY STRATEGY, INTL-MEDICA, WORKING WITH THE NIH, AMENDED OUR LICENSE TO ADD THE INTELLECTUAL PROPERTY THAT THE NIH HAS DEVELOPED CONCERNING NEO-NATAL DELIVERY OF ROTASHIELD. IN ESSENCE, THE CLINICAL TRIAL CONDUCTED BY INTL-MEDICA PROVED THE PATENTED IDEAS OF THE NIH OF NEONATAL DOSING.PHASE II TRIAL CONCLUSION: INTL-MEDICA WORKING WITH KENDLE RESEARCH INC. (NOW INC RESEARCH), WENT THROUGH A DETAILED ANALYSIS OF THE VOLUMINOUS DATA GENERATED BY THIS TRIAL AND CHARACTERIZED THE DATA INTO WORKABLE FORMATS. THIS INVOLVED ANALYZING THE DATA AND PUTTING MUCH OF THE DATA INTO READABLE TABLES. THE FINAL CLINICAL STUDY REPORT WAS FINALIZED IN DECEMBER OF 2011. BASED ON A REVIEW BY EXPERTS IN THE ROTAVIRUS FIELD, THE RESULTS OF THE TRIAL ARE IMPRESSIVE. ROTASHIELD, WITH ONLY TWO DOSES APPEARS TO HAVE PRODUCED EFFICACY RESULTS APPROXIMATELY EQUIVALENT TO THREE DOSES OF A ROTAVIRUS VACCINE CURRENTLY ON THE MARKET AND PROVIDED PROTECTION SEVERAL MONTHS EARLIER IN LIFE THAN THE EXISTING VACCINE DID IN A PREVIOUS (SEPARATE) STUDY IN GHANA.CLINICAL TRIAL RESULTS/ PUBLICATION: INTL-MEDICA ASSEMBLED A TEAM OF THE WORLDS LEADING EXPERTS IN THE FIELD OF ROTAVIRUS DISEASE AND VACCINATIONS TO WRITE A MANUSCRIPT FOR PUBLICATION OF THE RESULTS. THE MANUSCRIPT HAS BEEN ACCEPTED FOR PUBLICATION IN A MAJOR SCIENTIFIC JOURNAL IN THE JULY 2013 ISSUE.PHASE III CLINICAL TRIAL PLANNING / EMA: BASED ON THE POSITIVE PHASE II CLINICAL TRIAL RESULTS, INTL-MEDICA HAS DEVELOPED A STRATEGIC PLAN FOR A PHASE III CLINICAL TRIAL FOR ROTASHIELD, AND THE FOUNDATION BEGAN PREPARING FOR A SCIENTIFIC ADVICE MEETING WITH THE EUROPEAN MEDICINES AGENCY (EMA) TO CONDUCT A PHASE III TRIAL WITH PARTS OF THE TRIAL TO BE CONDUCTED IN THE EU AND OTHER PORTIONS IN VARIOUS REGIONS AROUND THE WORLD. THE FOUNDATION WORKING WITH QUINTILES (A CONTRACT RESEARCH ORGANIZATION) DRAFTED A VOLUMINOUS SUBMISSION CONCERNING PRIMARILY THE SIZE OF THE TRIAL NEEDED TO INDICATE EFFICACY AND SAFETY OF ROTASHIELD. A PRELIMINARY MEETING WITH THE EMA OCCURRED IN NOVEMBER OF 2012 IN LONDON AND THE FINAL MEETING OCCURRED IN JANUARY 2013 AGAIN IN LONDON. A DETERMINATION BY THE EMA WILL BE RECEIVED BY THE FOUNDATION IN 1ST QTR OF 2013.SUMMARY: CONCLUDING THIS LARGE PHASE II CLINICAL TRIAL WAS A MAJOR ACHIEVEMENT FOR INTL-MEDICA, ESPECIALLY CONSIDERING THAT THIS WAS A MAJOR UNDERTAKING FOR A FOUNDATION CONSIDERING ITS SMALL SIZE. THE PUBLICATION CONCERNING THE RESULTS OF OUR TRIAL WILL ALSO BE OF GREAT IMPORTANCE TO THE FOUNDATION IN THE NEXT FISCAL YEAR AS WILL BE THE REPORT OF THE EMA ON THE FOUNDATIONS STRATEGY FOR CONDUCTING A PHASE III CLINICAL TRIAL.","expense":497136},{"description":"INTERNATIONAL MEDICA HAS BEEN WORKING WITH THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) NATIONAL INSTITUTES OF HEALTH (NIH), AND IDT BIOLOGIKA GMBH, ITS VACCINE MANUFACTURER IN GERMANY, ON A NEW, PROPRIETARY, LIQUID, HEAT-STABLE FORMULATION OF ROTASHIELD.A MAJOR CONSTRAINT IN ACHIEVING HIGH IMMUNIZATION RATES IN LESS-DEVELOPED COUNTRIES IS THE REQUIREMENT FOR A COLD CHAIN -- MAINTAINING PROPER REFRIGERATION OF THE VACCINE PRODUCT TO ENSURE ITS EFFECTIVENESS. THIS NEW ROTASHIELD LIQUID FORMULATION HAS THE POTENTIAL TO ELIMINATE THE NEED FOR A COLD CHAIN, WHICH WOULD SIGNIFICANTLY REDUCE THE DISTRIBUTION AND STORAGE COSTS OF THE VACCINE. ALL OF THE CURRENTLY MARKETED ROTAVIRUS VACCINES REQUIRE REFRIGERATION. ELIMINATION OF THE NEED FOR THE COLD-CHAIN FOR VACCINES IS ALSO OF GREAT INTEREST TO THE VACCINE COMMUNITY WORLDWIDE, ESPECIALLY IN THE DEVELOPING WORLD.A TYPICAL LIQUID ROTAVIRUS SUSPENSION WOULD GENERALLY LOSE ITS EFFECTIVENESS AFTER APPROXIMATELY ONE WEEK OF STORAGE AT 37 DEGREES CELSIUS (98.6 DEGREES FAHRENHEIT), WHEREAS THE NEW ROTASHIELD LIQUID FORMULATION HAS SHOWN STABILITY FOR 6 MONTHS AT THIS TEMPERATURE EVEN WHEN AN ANTACID IS PRESENT. THIS SAME PROPRIETARY TECHNOLOGY MAY BE ADAPTABLE FOR USE WITH OTHER ORAL VACCINES. THE FOUNDATION HAS BEEN ACTIVELY SEEKING INTELLECTUAL PROPERTY PROTECTION OF ITS ADVANCED FORMULATION.INTL-MEDICA EXPANDED ITS PATENT PROTECTION OF ITS NEW FORMULATION AND FILED FOR EXTENSIVE WORLD-WIDE PATENT PROTECTION OF ITS FORMULATION. THE FOUNDATION ALSO BEGAN DISCUSSIONS WITH NUMEROUS GROUPS WHO ARE INTERESTED IN A LICENSE OF THIS TECHNOLOGY TO ULTIMATELY UTILIZE THIS TECHNOLOGY IN VACCINE DELIVERY.","expense":108087},{"description":"THE FOUNDATION HAS CONTINUED TO ENGAGE IN DISCUSSIONS WITH RESEARCHERS AT THE NATIONAL INSTITUTE OF HEALTH (NIH) IN BETHESDA, MARYLAND, THE INFECTIOUS DISEASE RESEARCH INSTITUTE (IDRI) IN SEATTLE, WASHINGTON AND THE MAYO CLINIC IN ROCHESTER, MINNESOTA, WITH REGARD TO POTENTIAL VACCINES TO BE DEVELOPED AND OTHER POSSIBLE GLOBAL DISEASE ISSUES TO BE ADDRESSED. THE FOUNDATION IS ACTIVELY EXAMINING THE POSSIBILITIES OF LICENSING AND DEVELOPING A VACCINE FOR DENGUE.","expense":21617}],"functional_expense_allocations":{"current_officers_directors":{"program_services":336000,"management_and_general":69000,"total":405000},"other_employee_benefits":{"program_services":35872,"management_and_general":7295,"total":43167},"payroll_taxes":{"program_services":16135,"management_and_general":3390,"total":19525},"legal_fees":{"program_services":17124,"management_and_general":2748,"total":19872},"accounting_fees":{"management_and_general":6382,"total":6382},"other_service_fees":{"program_services":25000,"total":25000},"office_expenses":{"program_services":4072,"management_and_general":4072,"total":8144},"occupancy":{"program_services":7032,"total":7032},"travel":{"program_services":19462,"management_and_general":2051,"total":21513},"conferences_meetings":{"management_and_general":35,"total":35},"depreciation_depletion":{"management_and_general":497,"total":497},"insurance":{"management_and_general":2226,"total":2226}},"tax_and_disclosure_flags":{"activities_conducted_through_partnership":false,"foreign_financial_account":false,"employment_tax_returns_filed":true,"lobbying_activities":false,"deductible_non_cash_contributions":false,"deductible_contributions_of_art":false,"method_of_accounting_accrual":true,"schedule_o_part_iii":true,"schedule_o_part_vi":true},"principal_officer_detail":{"person_name":"DR 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Rotavirus Vaccine Activities. The primary purpose and main exempt function activity of Intl-Medica is the development and delivery of a rotavirus vaccine for the prevention of rotavirus-related morbidity and deaths in the developing world. Globally, infections from the rotavirus account for an estimated 125 million cases of diarrhea each year, resulting in the deaths of approximately 600,000 infants annually from a disease that is highly preventable with an oral vaccine. Worldwide, rotavirus infects every child in the world in their first few years of life and sends 1 child in every 5 to 8 to a clinic for treatment, 1 in every 58 to a hospital, and 1 in 250-300 die from dehydrating diarrhea. Rotavirus is the cause of 30% to 40% of the hospitalizations for diarrhea in children less than five years of age and results in approximately 1,600 deaths each day in developing countries where medical care is limited and malnutrition is prevalent. The rotavirus vaccine, known as Rotashield, was invented and initially developed by the National Institutes of Health of the United States (\"NIH\"). From its inception in December 2007 and continuing currently, International Medica personnel have been working extensively alongside the NIH and a vaccine manufacturer to complete a finalized vaccine product for use in clinical trials. While in the manufacturing process, the vaccine was constantly tested to insure proper viral growth. International Medica, working with the NIH, actively participated in the ongoing development of the manufacturing process, making many critical changes to the manufacturing process. In early 2nd Quarter of 2009 the final RotaShield vaccine was completed and ready for the clinical trial. The Foundation has conducted detailed evaluation and research into using the vaccine in a neonatal dosing (within 29 days of birth) schedule and in a two-dose regimen. The first dose of the vaccine was previously provided to children at 6 to 12 weeks of age in a three dose regimen. To increase the effectiveness of the vaccine with fewer doses, and to increase the likelihood of access of children to health professionals in the developing world, International Medica did extensive review into the previous data and established a protocol to determine the effectiveness of Rotashield when given in this two-dose, neonatal delivery regimen.Working with a number of groups internationally, the Foundation initiated a highly scientific clinical trial which will allow International Medica to determine if the Rotashield vaccine, when given in the neonatal delivery regimen, stimulates the immune response of infants to provide an adequate protection against rotavirus. Giving the vaccine to neonates will allow more children to receive the vaccine, as children in developing countries are most likely to have interaction with health care providers in the first days immediately after birth. This Phase II clinical trial screened approximately 1,051 children for the trial with multi-arm endpoints. The trial ended up with 949 infants having completed the study and pursuant to the trial design was followed for one-year to monitor for any safety issues. The last infant follow-up visit was completed in early December 2010.For this trial, Intl-Medica established a Data Safety Monitoring Board, comprised of world experts in rotavirus vaccine trials. This Board, with active participation by Intl-Medica, monitored the Serious Adverse Events (\"SAEs\") that occurred during the Trial. This involved continuous monitoring and review by Intl-Medica staff and was formally reviewed in periodic Data Safety Monitoring Board (\"DSMB\") meetings. There were no concerns that the SAEs were related to the vaccine. In fact, there were far fewer deaths statisticlly for this cohort under the trial then the standard death rate for infants in Northern Ghana. Monitoring and reviewing the many SAEs, which are common for clinical trials in Africa, constituted a major activity for the Foundation with this Clinical Trial during this fiscal year.Intl-Medica has also put together some of the leaders in the rotavirus community to analyze and publish the results of the trial. Further, Intl-Medica is also developing a strategy to publicize the results of the trial to the world health community. The Foundation also put together a detailed plan for a Phase III trial, which would be a multi-site and significantly larger trial than the Phase II clinical trial. Largely concluding this large Phase II clinical trial was a major achievement for Intl-Medica, especially considering that this was a major undertaking for a Foundation of its small size.A significant development in the rotavirus vaccine area this past year was the presence in other rotavirus vaccines of the porcine circovirus. Due to concerns that RotaShield could also have porcine circovirus contaminants, Intl-Medica had an analysis done by the Federal Research institute for Animal health in Germany. Their analysis indicated that RotaShield is free of both PCV1 and PCV2. This accomplishment is also very important to the re-introduction of RotaShield into the developing world as a safe and effective vaccine.\n\nThe Foundation has engaged in discussions with researchers at the National Institute of Health (NIH) in Bethesda, Maryland, the Infectious Disease Research Institute (IDRI) in Seattle, Washington, the Center for Biopharmaceutical Research and Production, North Dakota State university, and the Mayo Clinic in Rochester, Minnesota, with regard to potential vaccines to be developed and other possible global disease issues to be addressed. The Foundation is actively examining the possibilities of licensing and developing a vaccine for Dengue.\n\nIntl-medica has also begun work on a liquid, shelf stable formulation for the rotashield vaccine to allow rotashield, and certain other vaccines to maintain stability without the need for cold storage of the vaccines.infectious diseases kill millions of people every year and children under the age of five, especially those in developing countries, are particularly vulnerable. While significant progress has been made through global immunization campaigns to protect against many of these diseases, the delivery of vaccines to target populations is costly and requires considerable logistical support.many vaccines currently used to treat the many diseases that affect the world population require cold storage (between 2 and 8 degrees celsius) to remain stable and viable. This can increase significantly the cost per dose of these vaccines as there needs to be an infrastructure of refigeration and/or freezers to be established to store the vaccines. This infrastructure is very difficult to establish in many parts of the world, especially those places that do not have electricity. This lack of infrastructure also makes it difficult to distribute widely in the developing world and as a result there can be significant vaccine wastage arising from breaks in the cold chain.","year":2009,"name":"INTERNATIONAL MEDICA FOUNDATION","phone":"5072064380","website":"WWW.INTL-MEDICA.ORG","type":"990","principal_officer":"DR LEONARD RUIZ","year_formation":2007,"state_legal_domicile":"MN","total_volunteers":10,"tax_period_begin":"2009-12-01T00:00:00","tax_period_end":"2010-11-30T00:00:00","address":"421 1ST AVE SW No 304, ROCHESTER, MN, 55902, USA","city":"ROCHESTER","state":"MN","country":"USA","zip_code":"55902"},"Governance":{"501c determination":true,"Number of voting members":6,"Number of independent voting members":4,"Number of employees total":2,"Total Gross UBI":0,"Net unrelated business taxable income":0,"Number of employees":2,"Prohibited tax shelter transactions":false,"Taxable party notification":false,"Funds to pay premiums":false,"Premiums Paid":false,"Family or business relationship":false,"Delegation of management duties":false,"Conflict of interest policy":true,"Whistle blower policy":false,"Compensation process for CEO":true,"Compensation process for other employees":true,"Changes to organizing documents":false,"Material diversion or misuse":false,"Members or stockholders":false,"Election of board members":false,"Decisions subject to approval":false,"Minutes of governing body":true,"Local chapters":false,"Form 990 provided to governing body":true,"Document retention policy":false,"Investment in joint venture":false,"Independent audit financial statements":false,"Consolidated audit financial statements":false,"Accountant compile or review":false,"Financial statements audited by independent accountant":false,"Federal grant audit required":false,"Political activities":false,"Donor advised funds":false,"Conservation easements":false,"Collections of art":false,"School":false,"Hospital":false,"Foreign activities":false,"Foreign office":false,"Gaming":false,"Fundraising activities":false,"Professional fundraising":false,"Loan to officer or DQP":false,"Grant to related person":false,"Business relationship through family member":false,"Business relationship with organization":false,"Transfers to exempt non-charitable organization":false},"Revenues":{"value":-1753860,"Contributions":{"value":0},"Program revenue":{"value":0,"Unrelated business revenue":0},"Investment income":{"value":-1753860,"Investment income total":40317,"Net investment gain":-1794177},"Other revenues":{"value":0}},"Expenses":{"value":3321321,"Grant expense":{"value":0},"Total professional fundraising expense":{"value":0},"Benefits paid to members":{"value":0},"Salaries":{"value":436514,"Current officers":416815,"Payroll taxes":19699},"Other expenses":{"value":2884807,"Legal":29800,"Accounting":8235,"Other services":7037,"Office expenses":8496,"Occupancy":6880,"Travel":17251,"Conferences and meetings":2212,"Depreciation and depletion":1806,"Insurance":106964,"Itemized Expenses":{"value":2696126,"VARIOUS":2696126}}},"Assets":{"value":1961849,"Non-interest bearing cash":3928,"Savings and temp cash investments":1552866,"Accounts receivable":129095,"Land, building, equipment":2581,"Investments publicly traded":273379,"Other assets":0},"Liabilities":{"value":0},"Fund balance":{"value":1961849},"Form990Details":{"program_service_accomplishments":[{"description":"1. Rotavirus Vaccine Activities. The primary purpose and main exempt function activity of Intl-Medica is the development and delivery of a rotavirus vaccine for the prevention of rotavirus-related morbidity and deaths in the developing world. Globally, infections from the rotavirus account for an estimated 125 million cases of diarrhea each year, resulting in the deaths of approximately 600,000 infants annually from a disease that is highly preventable with an oral vaccine. Worldwide, rotavirus infects every child in the world in their first few years of life and sends 1 child in every 5 to 8 to a clinic for treatment, 1 in every 58 to a hospital, and 1 in 250-300 die from dehydrating diarrhea. Rotavirus is the cause of 30% to 40% of the hospitalizations for diarrhea in children less than five years of age and results in approximately 1,600 deaths each day in developing countries where medical care is limited and malnutrition is prevalent. 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Giving the vaccine to neonates will allow more children to receive the vaccine, as children in developing countries are most likely to have interaction with health care providers in the first days immediately after birth. This Phase II clinical trial screened approximately 1,051 children for the trial with multi-arm endpoints. The trial ended up with 949 infants having completed the study and pursuant to the trial design was followed for one-year to monitor for any safety issues. The last infant follow-up visit was completed in early December 2010.For this trial, Intl-Medica established a Data Safety Monitoring Board, comprised of world experts in rotavirus vaccine trials. This Board, with active participation by Intl-Medica, monitored the Serious Adverse Events (\"SAEs\") that occurred during the Trial. This involved continuous monitoring and review by Intl-Medica staff and was formally reviewed in periodic Data Safety Monitoring Board (\"DSMB\") meetings. 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Largely concluding this large Phase II clinical trial was a major achievement for Intl-Medica, especially considering that this was a major undertaking for a Foundation of its small size.A significant development in the rotavirus vaccine area this past year was the presence in other rotavirus vaccines of the porcine circovirus. Due to concerns that RotaShield could also have porcine circovirus contaminants, Intl-Medica had an analysis done by the Federal Research institute for Animal health in Germany. Their analysis indicated that RotaShield is free of both PCV1 and PCV2. This accomplishment is also very important to the re-introduction of RotaShield into the developing world as a safe and effective vaccine.","expense":3132812},{"description":"The Foundation has engaged in discussions with researchers at the National Institute of Health (NIH) in Bethesda, Maryland, the Infectious Disease Research Institute (IDRI) in Seattle, Washington, the Center for Biopharmaceutical Research and Production, North Dakota State university, and the Mayo Clinic in Rochester, Minnesota, with regard to potential vaccines to be developed and other possible global disease issues to be addressed. The Foundation is actively examining the possibilities of licensing and developing a vaccine for Dengue.","expense":40000},{"description":"INTL-MEDICA HAS ALSO BEGUN WORK ON A LIQUID, SHELF STABLE FORMULATION FOR THE ROTASHIELD VACCINE TO ALLOW ROTASHIELD, AND CERTAIN OTHER VACCINES TO MAINTAIN STABILITY WITHOUT THE NEED FOR COLD STORAGE OF THE VACCINES.INFECTIOUS DISEASES KILL MILLIONS OF PEOPLE EVERY YEAR AND CHILDREN UNDER THE AGE OF FIVE, ESPECIALLY THOSE IN DEVELOPING COUNTRIES, ARE PARTICULARLY VULNERABLE. WHILE SIGNIFICANT PROGRESS HAS BEEN MADE THROUGH GLOBAL IMMUNIZATION CAMPAIGNS TO PROTECT AGAINST MANY OF THESE DISEASES, THE DELIVERY OF VACCINES TO TARGET POPULATIONS IS COSTLY AND REQUIRES CONSIDERABLE LOGISTICAL SUPPORT.MANY VACCINES CURRENTLY USED TO TREAT THE MANY DISEASES THAT AFFECT THE WORLD POPULATION REQUIRE COLD STORAGE (BETWEEN 2 AND 8 DEGREES CELSIUS) TO REMAIN STABLE AND VIABLE. THIS CAN INCREASE SIGNIFICANTLY THE COST PER DOSE OF THESE VACCINES AS THERE NEEDS TO BE AN INFRASTRUCTURE OF REFIGERATION AND/OR FREEZERS TO BE ESTABLISHED TO STORE THE VACCINES. THIS INFRASTRUCTURE IS VERY DIFFICULT TO ESTABLISH IN MANY PARTS OF THE WORLD, ESPECIALLY THOSE PLACES THAT DO NOT HAVE ELECTRICITY. THIS LACK OF INFRASTRUCTURE ALSO MAKES IT DIFFICULT TO DISTRIBUTE WIDELY IN THE DEVELOPING WORLD AND AS A RESULT THERE CAN BE SIGNIFICANT VACCINE WASTAGE ARISING FROM BREAKS IN THE COLD 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Rotavirus vaccine activities. The primary purpose of intl-medica is the development and delivery of a rotavirus vaccine for the prevention of rotavirus-related morbidity and deaths in the developing world. Globally, infections from rotavirus account for an estimated 125 million cases of diarrhea each year, resulting in the deaths of approximately 500,000 infants annually from a disease that is highly preventable with an oral vaccine. Worldwide, rotavirus infects every child in the world in their first few years of life and sends 1 child in every 5 to 8 to a clinic for treatment, 1 in every 58 to a hospital, and 1 in 250-300 die from dehydrating diarrhea. Rotavirus is the cause of 30% to 40% of the hospitalizations for diarrhea in children less than five years of age and results in approximately 1,600 deaths each day in developing countries where medical care is limited and malnutrition is prevalent. The rotavirus vaccine, known as rotashield, was invented and initially developed by the national institutes of health of the united states (\"nih\"). From its inception in december 2007 and continuing currently, international medica personnel have been working extensively alongside the nih and a vaccine manufacturer to complete a finalized vaccine product ultimately for use in the neglected populations of the world. While in the manufacturing process, the vaccine was constantly tested to insure proper viral growth. International medica, working with the nih, actively participated in the ongoing development of the manufacturing process, ensuring that any changes to the manufacturing process met all regulatory requirements. The foundation conducted detailed evaluation and research into using the vaccine in a neonatal dosing (first dose between 0 to 29 days) and in a two-dose regimen where the second dose is given before 60 days of age. This was the first time that a rotavirus vaccine had been tested in neonates in a clinical trail measuring efficacy. The vaccine was originally developed where the first dose would be administered to infants at 2 months of age, in a three-dose regimen. To increase the effectiveness of the vaccine with fewer doses, and to increase the likelihood of access of children to health professionals in the developing world, international medica did extensive review into the previous data and established a protocol to determine the effectiveness of rotashield when given in this two-dose, neonatal delivery regimen.working with a number of groups internationally, the foundation initiated a clinical trial which will allow international medica to determine if the rotashield vaccine, when given in the neonatal delivery regimen, stimulates the immune response of infants to provide an adequate protection against rotavirus. Giving the vaccine to neonates will allow more children to receive the vaccine, as children in developing countries are most likely to have interaction with health care providers in the first days immediately after birth. Starting immunizations at or near birth would also protect infants earlier in life.in early 2nd quarter of 2009, manufacture of the final rotashield vaccine was completed and ready for the clinical trial. This phase ii clinical trial ultimately screened approximately 1,051 children for the trial with multi-arm end-points. The trial ended up with 949 infants having completed the study and pursuant to the trial design was followed for one-year to monitor for any safety issues. The last infant follow-up visit was completed in early december 2010. After a year of following the infants, there was then a data lock on the clinical trial information in june of 2011 followed by the final clinical study report in december of 2011.intl-medica working with kendle research inc. (now inc research), went through a detailed analysis of the voluminous data generated by this trial and characterized the data into workable formats. This involved analyzing the data and putting much of the data into readable tables. The final clinical study report was finalized in december of 2011.based on a review by experts in the rotavirus field, the results of the trial are impressive. Rotashield, with only two doses has produced efficacy results approximately equivalent to three doses of a rotavirus vaccine currently on the market and provided protection several months earlier in life than the existing vaccine did in a previous (separate) study in ghana.intl-medica has assembled a team of the world's leading experts in the field of rotavirus disease and vaccinations to write a manuscript for publication of the results. Two of the authors are on the intl-medica scientific advisory board, two were on the dsmb, one author was the primary investigator of the trial; and dr. Kapikian of the nih and the inventor of rotashield is also an author. The lead author of this paper is dr. Robert jacobson, the immediate past chair of the department of pediatrics at the mayo clinic. It is anticipated that this paper will be published in a major scientific journal in the summer of 2012.based on these results, intl-medica has developed a strategic plan for a phase iii trial for rotashield, which would be a multi-site and significantly larger trial than the phase ii clinical trial. The foundation is examining several funding options for this phase iii trial. The foundation also continued to actively promote the efficacy and safety of rotashield through press releases and attendance at major vaccine conferences.concluding this large phase ii clinical trial was a major achievement for intl-medica, especially considering that this was a major undertaking for a foundation of its small size.\n\nInternational medica has been working with the national institute of allergy and infectious diseases (niaid) national institutes of health (nih), and idt biologika gmbh, its vaccine manufacturer in germany, on a new, proprietary, liquid, heat-stable formulation of rotashield.a major constraint in achieving high immunization rates in less-developed countries is the requirement for a \"cold chain\" -- maintaining proper refrigeration of the vaccine product to ensure its effectiveness. This new rotashield liquid formulation has the potential to eliminate the need for a cold chain, which would significantly reduce the distribution and storage costs of the vaccine. All of the currently marketed rotavirus vaccines require refrigeration. Elimination of the need for the cold-chain for vaccines is also of great interest to the vaccine community worldwide, especially in the developing world.a typical liquid rotavirus suspension would generally lose its effectiveness after approximately one week of storage at 37 degrees celsius (98.6 degrees fahrenheit), whereas the new rotashield liquid formulation has shown stability for 6 months at this temperature even when an antacid is present. This same proprietary technology may be adaptable for use with other oral vaccines. The foundation has been actively seeking intellectual property protection of its advanced formulation.\n\nThe foundation has continued to engage in discussions with researchers at the national institute of health (nih) in bethesda, maryland, the infectious disease research institute (idri) in seattle, washington, the center for biopharmaceutical research and production, north dakota state university, and the mayo clinic in rochester, minnesota, with regard to potential vaccines to be developed and other possible global disease issues to be addressed. The foundation is actively examining the possibilities of licensing and developing a vaccine for dengue.","year":2010,"name":"INTERNATIONAL MEDICA FOUNDATION","phone":"5072064380","website":"WWW.INTL-MEDICA.ORG","type":"990","principal_officer":"DR LEONARD RUIZ","year_formation":2007,"state_legal_domicile":"MN","total_volunteers":11,"tax_period_begin":"2010-12-01T00:00:00","tax_period_end":"2011-11-30T00:00:00","address":"421 1ST AVE SW NO 304, ROCHESTER, MN, 55903, USA","city":"ROCHESTER","state":"MN","country":"USA","zip_code":"55903"},"Governance":{"501c3 determination":true,"Number of voting members":7,"Number of independent voting members":5,"Number of employees total":2,"Total Gross UBI":0,"Net unrelated business taxable income":0,"Number of employees":2,"Prohibited tax shelter transactions":false,"Taxable party notification":false,"Funds to pay premiums":false,"Premiums Paid":false,"Family or business relationship":false,"Delegation of management duties":false,"Conflict of interest policy":true,"Whistle blower policy":false,"Compensation process for CEO":true,"Compensation process for other employees":true,"Changes to organizing documents":false,"Material diversion or misuse":false,"Members or stockholders":false,"Election of board members":false,"Decisions subject to approval":false,"Minutes of governing body":true,"Local chapters":false,"Form 990 provided to governing body":true,"Document retention policy":false,"Investment in joint venture":false,"Independent audit financial statements":false,"Consolidated audit financial statements":false,"Accountant compile or review":false,"Financial statements audited by independent accountant":false,"Federal grant audit required":false,"Political activities":false,"Donor advised funds":false,"Conservation easements":false,"Collections of art":false,"School":false,"Hospital":false,"Foreign activities":false,"Foreign office":false,"Gaming":false,"Fundraising activities":false,"Professional fundraising":false,"Loan to officer or DQP":false,"Grant to related person":false,"Business relationship through family member":false,"Business relationship with organization":false,"Transfers to exempt non-charitable organization":false},"Revenues":{"value":383167,"Contributions":{"value":500000,"Other contributions":500000},"Program revenue":{"value":0,"Unrelated business revenue":0},"Investment income":{"value":-116833,"Investment income total":563,"Net investment gain":-117396},"Other revenues":{"value":0}},"Expenses":{"value":1529787,"Grant expense":{"value":0},"Total professional fundraising expense":{"value":0},"Benefits paid to members":{"value":0},"Salaries":{"value":465649,"Current officers":445950,"Payroll taxes":19699},"Other expenses":{"value":1064138,"Legal":25479,"Accounting":6192,"Office expenses":8267,"Occupancy":7008,"Travel":18366,"Conferences and meetings":4624,"Depreciation and depletion":1835,"Insurance":4696,"Itemized Expenses":{"value":987671,"VARIOUS":987671}}},"Assets":{"value":748889,"Non-interest bearing cash":3329,"Savings and temp cash investments":127323,"Accounts receivable":129095,"Land, building, equipment":746,"Investments publicly traded":488396},"Liabilities":{"value":0},"Fund balance":{"value":748889},"Form990Details":{"program_service_accomplishments":[{"description":"1. ROTAVIRUS VACCINE ACTIVITIES. THE PRIMARY PURPOSE OF INTL-MEDICA IS THE DEVELOPMENT AND DELIVERY OF A ROTAVIRUS VACCINE FOR THE PREVENTION OF ROTAVIRUS-RELATED MORBIDITY AND DEATHS IN THE DEVELOPING WORLD. GLOBALLY, INFECTIONS FROM ROTAVIRUS ACCOUNT FOR AN ESTIMATED 125 MILLION CASES OF DIARRHEA EACH YEAR, RESULTING IN THE DEATHS OF APPROXIMATELY 500,000 INFANTS ANNUALLY FROM A DISEASE THAT IS HIGHLY PREVENTABLE WITH AN ORAL VACCINE. WORLDWIDE, ROTAVIRUS INFECTS EVERY CHILD IN THE WORLD IN THEIR FIRST FEW YEARS OF LIFE AND SENDS 1 CHILD IN EVERY 5 TO 8 TO A CLINIC FOR TREATMENT, 1 IN EVERY 58 TO A HOSPITAL, AND 1 IN 250-300 DIE FROM DEHYDRATING DIARRHEA. ROTAVIRUS IS THE CAUSE OF 30% TO 40% OF THE HOSPITALIZATIONS FOR DIARRHEA IN CHILDREN LESS THAN FIVE YEARS OF AGE AND RESULTS IN APPROXIMATELY 1,600 DEATHS EACH DAY IN DEVELOPING COUNTRIES WHERE MEDICAL CARE IS LIMITED AND MALNUTRITION IS PREVALENT. THE ROTAVIRUS VACCINE, KNOWN AS ROTASHIELD, WAS INVENTED AND INITIALLY DEVELOPED BY THE NATIONAL INSTITUTES OF HEALTH OF THE UNITED STATES (\"NIH\"). FROM ITS INCEPTION IN DECEMBER 2007 AND CONTINUING CURRENTLY, INTERNATIONAL MEDICA PERSONNEL HAVE BEEN WORKING EXTENSIVELY ALONGSIDE THE NIH AND A VACCINE MANUFACTURER TO COMPLETE A FINALIZED VACCINE PRODUCT ULTIMATELY FOR USE IN THE NEGLECTED POPULATIONS OF THE WORLD. WHILE IN THE MANUFACTURING PROCESS, THE VACCINE WAS CONSTANTLY TESTED TO INSURE PROPER VIRAL GROWTH. INTERNATIONAL MEDICA, WORKING WITH THE NIH, ACTIVELY PARTICIPATED IN THE ONGOING DEVELOPMENT OF THE MANUFACTURING PROCESS, ENSURING THAT ANY CHANGES TO THE MANUFACTURING PROCESS MET ALL REGULATORY REQUIREMENTS. THE FOUNDATION CONDUCTED DETAILED EVALUATION AND RESEARCH INTO USING THE VACCINE IN A NEONATAL DOSING (FIRST DOSE BETWEEN 0 TO 29 DAYS) AND IN A TWO-DOSE REGIMEN WHERE THE SECOND DOSE IS GIVEN BEFORE 60 DAYS OF AGE. THIS WAS THE FIRST TIME THAT A ROTAVIRUS VACCINE HAD BEEN TESTED IN NEONATES IN A CLINICAL TRAIL MEASURING EFFICACY. THE VACCINE WAS ORIGINALLY DEVELOPED WHERE THE FIRST DOSE WOULD BE ADMINISTERED TO INFANTS AT 2 MONTHS OF AGE, IN A THREE-DOSE REGIMEN. TO INCREASE THE EFFECTIVENESS OF THE VACCINE WITH FEWER DOSES, AND TO INCREASE THE LIKELIHOOD OF ACCESS OF CHILDREN TO HEALTH PROFESSIONALS IN THE DEVELOPING WORLD, INTERNATIONAL MEDICA DID EXTENSIVE REVIEW INTO THE PREVIOUS DATA AND ESTABLISHED A PROTOCOL TO DETERMINE THE EFFECTIVENESS OF ROTASHIELD WHEN GIVEN IN THIS TWO-DOSE, NEONATAL DELIVERY REGIMEN.WORKING WITH A NUMBER OF GROUPS INTERNATIONALLY, THE FOUNDATION INITIATED A CLINICAL TRIAL WHICH WILL ALLOW INTERNATIONAL MEDICA TO DETERMINE IF THE ROTASHIELD VACCINE, WHEN GIVEN IN THE NEONATAL DELIVERY REGIMEN, STIMULATES THE IMMUNE RESPONSE OF INFANTS TO PROVIDE AN ADEQUATE PROTECTION AGAINST ROTAVIRUS. GIVING THE VACCINE TO NEONATES WILL ALLOW MORE CHILDREN TO RECEIVE THE VACCINE, AS CHILDREN IN DEVELOPING COUNTRIES ARE MOST LIKELY TO HAVE INTERACTION WITH HEALTH CARE PROVIDERS IN THE FIRST DAYS IMMEDIATELY AFTER BIRTH. STARTING IMMUNIZATIONS AT OR NEAR BIRTH WOULD ALSO PROTECT INFANTS EARLIER IN LIFE.IN EARLY 2ND QUARTER OF 2009, MANUFACTURE OF THE FINAL ROTASHIELD VACCINE WAS COMPLETED AND READY FOR THE CLINICAL TRIAL. THIS PHASE II CLINICAL TRIAL ULTIMATELY SCREENED APPROXIMATELY 1,051 CHILDREN FOR THE TRIAL WITH MULTI-ARM END-POINTS. THE TRIAL ENDED UP WITH 949 INFANTS HAVING COMPLETED THE STUDY AND PURSUANT TO THE TRIAL DESIGN WAS FOLLOWED FOR ONE-YEAR TO MONITOR FOR ANY SAFETY ISSUES. THE LAST INFANT FOLLOW-UP VISIT WAS COMPLETED IN EARLY DECEMBER 2010. AFTER A YEAR OF FOLLOWING THE INFANTS, THERE WAS THEN A DATA LOCK ON THE CLINICAL TRIAL INFORMATION IN JUNE OF 2011 FOLLOWED BY THE FINAL CLINICAL STUDY REPORT IN DECEMBER OF 2011.INTL-MEDICA WORKING WITH KENDLE RESEARCH INC. (NOW INC RESEARCH), WENT THROUGH A DETAILED ANALYSIS OF THE VOLUMINOUS DATA GENERATED BY THIS TRIAL AND CHARACTERIZED THE DATA INTO WORKABLE FORMATS. THIS INVOLVED ANALYZING THE DATA AND PUTTING MUCH OF THE DATA INTO READABLE TABLES. THE FINAL CLINICAL STUDY REPORT WAS FINALIZED IN DECEMBER OF 2011.BASED ON A REVIEW BY EXPERTS IN THE ROTAVIRUS FIELD, THE RESULTS OF THE TRIAL ARE IMPRESSIVE. ROTASHIELD, WITH ONLY TWO DOSES HAS PRODUCED EFFICACY RESULTS APPROXIMATELY EQUIVALENT TO THREE DOSES OF A ROTAVIRUS VACCINE CURRENTLY ON THE MARKET AND PROVIDED PROTECTION SEVERAL MONTHS EARLIER IN LIFE THAN THE EXISTING VACCINE DID IN A PREVIOUS (SEPARATE) STUDY IN GHANA.INTL-MEDICA HAS ASSEMBLED A TEAM OF THE WORLD'S LEADING EXPERTS IN THE FIELD OF ROTAVIRUS DISEASE AND VACCINATIONS TO WRITE A MANUSCRIPT FOR PUBLICATION OF THE RESULTS. TWO OF THE AUTHORS ARE ON THE INTL-MEDICA SCIENTIFIC ADVISORY BOARD, TWO WERE ON THE DSMB, ONE AUTHOR WAS THE PRIMARY INVESTIGATOR OF THE TRIAL; AND DR. KAPIKIAN OF THE NIH AND THE INVENTOR OF ROTASHIELD IS ALSO AN AUTHOR. THE LEAD AUTHOR OF THIS PAPER IS DR. ROBERT JACOBSON, THE IMMEDIATE PAST CHAIR OF THE DEPARTMENT OF PEDIATRICS AT THE MAYO CLINIC. IT IS ANTICIPATED THAT THIS PAPER WILL BE PUBLISHED IN A MAJOR SCIENTIFIC JOURNAL IN THE SUMMER OF 2012.BASED ON THESE RESULTS, INTL-MEDICA HAS DEVELOPED A STRATEGIC PLAN FOR A PHASE III TRIAL FOR ROTASHIELD, WHICH WOULD BE A MULTI-SITE AND SIGNIFICANTLY LARGER TRIAL THAN THE PHASE II CLINICAL TRIAL. THE FOUNDATION IS EXAMINING SEVERAL FUNDING OPTIONS FOR THIS PHASE III TRIAL. THE FOUNDATION ALSO CONTINUED TO ACTIVELY PROMOTE THE EFFICACY AND SAFETY OF ROTASHIELD THROUGH PRESS RELEASES AND ATTENDANCE AT MAJOR VACCINE CONFERENCES.CONCLUDING THIS LARGE PHASE II CLINICAL TRIAL WAS A MAJOR ACHIEVEMENT FOR INTL-MEDICA, ESPECIALLY CONSIDERING THAT THIS WAS A MAJOR UNDERTAKING FOR A FOUNDATION OF ITS SMALL SIZE.","expense":1308832},{"description":"INTERNATIONAL MEDICA HAS BEEN WORKING WITH THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) NATIONAL INSTITUTES OF HEALTH (NIH), AND IDT BIOLOGIKA GMBH, ITS VACCINE MANUFACTURER IN GERMANY, ON A NEW, PROPRIETARY, LIQUID, HEAT-STABLE FORMULATION OF ROTASHIELD.A MAJOR CONSTRAINT IN ACHIEVING HIGH IMMUNIZATION RATES IN LESS-DEVELOPED COUNTRIES IS THE REQUIREMENT FOR A \"COLD CHAIN\" -- MAINTAINING PROPER REFRIGERATION OF THE VACCINE PRODUCT TO ENSURE ITS EFFECTIVENESS. THIS NEW ROTASHIELD LIQUID FORMULATION HAS THE POTENTIAL TO ELIMINATE THE NEED FOR A COLD CHAIN, WHICH WOULD SIGNIFICANTLY REDUCE THE DISTRIBUTION AND STORAGE COSTS OF THE VACCINE. ALL OF THE CURRENTLY MARKETED ROTAVIRUS VACCINES REQUIRE REFRIGERATION. ELIMINATION OF THE NEED FOR THE COLD-CHAIN FOR VACCINES IS ALSO OF GREAT INTEREST TO THE VACCINE COMMUNITY WORLDWIDE, ESPECIALLY IN THE DEVELOPING WORLD.A TYPICAL LIQUID ROTAVIRUS SUSPENSION WOULD GENERALLY LOSE ITS EFFECTIVENESS AFTER APPROXIMATELY ONE WEEK OF STORAGE AT 37 DEGREES CELSIUS (98.6 DEGREES FAHRENHEIT), WHEREAS THE NEW ROTASHIELD LIQUID FORMULATION HAS SHOWN STABILITY FOR 6 MONTHS AT THIS TEMPERATURE EVEN WHEN AN ANTACID IS PRESENT. THIS SAME PROPRIETARY TECHNOLOGY MAY BE ADAPTABLE FOR USE WITH OTHER ORAL VACCINES. THE FOUNDATION HAS BEEN ACTIVELY SEEKING INTELLECTUAL PROPERTY PROTECTION OF ITS ADVANCED FORMULATION.","expense":60000},{"description":"THE FOUNDATION HAS CONTINUED TO ENGAGE IN DISCUSSIONS WITH RESEARCHERS AT THE NATIONAL INSTITUTE OF HEALTH (NIH) IN BETHESDA, MARYLAND, THE INFECTIOUS DISEASE RESEARCH INSTITUTE (IDRI) IN SEATTLE, WASHINGTON, THE CENTER FOR BIOPHARMACEUTICAL RESEARCH AND PRODUCTION, NORTH DAKOTA STATE UNIVERSITY, AND THE MAYO CLINIC IN ROCHESTER, MINNESOTA, WITH REGARD TO POTENTIAL VACCINES TO BE DEVELOPED AND OTHER POSSIBLE GLOBAL DISEASE ISSUES TO BE ADDRESSED. THE FOUNDATION IS ACTIVELY EXAMINING THE POSSIBILITIES OF LICENSING AND DEVELOPING A VACCINE FOR DENGUE.","expense":60000}],"functional_expense_allocations":{"current_officers_directors":{"program_services":369937,"management_and_general":76013,"total":445950},"payroll_taxes":{"program_services":16252,"management_and_general":3447,"total":19699},"legal_fees":{"program_services":22023,"management_and_general":3456,"total":25479},"accounting_fees":{"management_and_general":6192,"total":6192},"office_expenses":{"program_services":4134,"management_and_general":4133,"total":8267},"occupancy":{"program_services":7008,"total":7008},"travel":{"program_services":17670,"management_and_general":696,"total":18366},"conferences_meetings":{"program_services":4529,"management_and_general":95,"total":4624},"depreciation_depletion":{"management_and_general":1835,"total":1835},"insurance":{"management_and_general":4696,"total":4696}},"tax_and_disclosure_flags":{"activities_conducted_through_partnership":false,"foreign_financial_account":false,"employment_tax_returns_filed":true,"lobbying_activities":false,"deductible_non_cash_contributions":false,"deductible_contributions_of_art":false,"method_of_accounting_accrual":true,"schedule_o_part_iii":true,"schedule_o_part_vi":true,"schedule_o_part_xi":true},"principal_officer_detail":{"person_name":"DR 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ROSENOW","base_compensation_filing_org":190000,"bonus_filing_org":0,"bonus_related_orgs":0,"compensation_based_on_related_orgs":0,"comp_report_prior_990_filing_org":0,"comp_report_prior_990_related_orgs":0,"deferred_compensation_filing_org":19000,"deferred_compensation_related_orgs":0,"nontaxable_benefits_filing_org":450,"nontaxable_benefits_related_orgs":0,"other_compensation_filing_org":0,"other_compensation_related_orgs":0,"total_compensation_filing_org":209450,"total_compensation_related_orgs":0,"name":"SCOTT ROSENOW"}]},"source_xml":"201241079349300404_public.xml"}],"Latest":{"Organization":{"Hours":[0],"Total Compensation":[0],"Direct compensation":[0],"Other compensation":[0]},"Basic":{"mission":"The international medica foundation is committed to the development of safe and cost effective healthcare products for families in need in neglected populations around the world. All activities of the foundation are in the field of medical research related to the development of vaccines and related products, services, therapeutics, diagnostics and drug delivery methods for diseases affecting the world population with particularly catastrophic effects on the lives of families in the developing world.","primary_activities":"The primary purpose of intl-medica is the development and delivery of an oral rotavirus vaccine for the prevention of rotavirus-related morbidity and deaths in the developing world. Globally, infections from rotavirus account for an estimated 125 million cases of diarrhea each year, resulting in the deaths of approximately 500,000 infants annually from a disease that is highly preventable with an oral vaccine. Worldwide, rotavirus infects every child in the world in their first few years of life and sends 1 child in every 5 to 8 to a clinic for treatment, 1 in every 58 to a hospital, and 1 in 250-300 die from dehydrating diarrhea. Rotavirus is the cause of 30% to 40% of the hospitalizations for diarrhea in children less than five years of age and results in over 1,600 deaths each day in developing countries where medical care is limited and malnutrition is prevalent. Rotavirus vaccine activities. Brief history: the rotavirus vaccine, known as rotashield, was invented and initially developed by the national institutes of health of the united states (nih). From its inception in december 2007 and continuing currently, international medica personnel have been working extensively alongside the nih and a vaccine manufacturer to complete a finalized vaccine product ultimately for use in the neglected populations of the world. Vaccine manufactured for clinical trials was tested to ensure it met all potency standards and all regulatory requirements prior to being released for use. International medica, working with the nih, actively participated in the ongoing development of the manufacturing process, ensuring that any changes to the manufacturing process met all regulatory requirements. Phase ii clinical trial: working with a number of groups internationally, the foundation conducted a phase ii clinical trial the purpose of which was to allow international medica to determine if the rotashield vaccine, when given in the neonatal delivery regimen, stimulates the immune response of infants to provide an adequate protection against the rotavirus. Giving the vaccine to neonates would allow more children to receive the vaccine, as children in developing countries are most likely to have interaction with health care providers in the first days immediately after birth. Starting immunizations at or near birth would also protect infants earlier in life.in early 2nd quarter of 2009, manufacture of the final rotashield vaccine was completed and ready for the clinical trial. This phase ii clinical trial ultimately screened approximately 1,051 children for the trial with multi-arm end-points. A total of 949 infants completed the study and pursuant to the trial design were followed for one-year to monitor for any safety issues. The last infant follow-up visit was completed in early december 2010. After a year of following the infants, there was then a data lock on the clinical trial information in june of 2011 followed by the final clinical study report in december of 2011. Neo-natal dosing: a key aspect of intl-medica development of rotashield was the change of dosing for rotavirus vaccines to a neonatal dosing schedule, ie providing the first dose within the first 29 days birthed life and a second dose before 60 days of age. The vaccine was originally developed where the first dose would be administered to infants at 2 months of age, in a three dose regimen. To increase the effectiveness of the vaccine with fewer doses, and to increase the likelihood of access of children to health professionals in the developing world, international medica did extensive review into the previous data and established a protocol to determine the effectiveness of rotashield when given in this two-dose, neonatal delivery regime. Neonatal dosing has become a practice of great interest in the pediatric vaccine fields since a significant number of infants die from vaccine preventable diseases within the first few months of life; and in the developing world, most infants come in contact with medical/health workers during the neonatal period.further, as all rotavirus vaccines have some concern of correlation with intussusception after receiving the vaccine, providing the vaccine prior to the age where intussusception is to occur could minimize if not eliminate the risk of intussusception. This could lead to rotashield actually being the safest rotavirus vaccine on the market.new rights: consistent with our neonatal delivery strategy, intl-medica, working with the nih, amended our license to add the intellectual property that the nih has developed concerning neo-natal delivery of rotashield. In essence, the clinical trial conducted by intl-medica proved the patented ideas of the nih of neonatal dosing.phase ii trial conclusion: intl-medica working with kendle research inc. (now inc research), went through a detailed analysis of the voluminous data generated by this trial and characterized the data into workable formats. This involved analyzing the data and putting much of the data into readable tables. The final clinical study report was finalized in december of 2011. Based on a review by experts in the rotavirus field, the results of the trial are impressive. Rotashield, with only two doses appears to have produced efficacy results approximately equivalent to three doses of a rotavirus vaccine currently on the market and provided protection several months earlier in life than the existing vaccine did in a previous (separate) study in ghana.clinical trial results/ publication: intl-medica assembled a team of the worlds leading experts in the field of rotavirus disease and vaccinations to write a manuscript for publication of the results. The manuscript has been accepted for publication in a major scientific journal in the july 2013 issue.phase iii clinical trial planning / ema: based on the positive phase ii clinical trial results, intl-medica has developed a strategic plan for a phase iii clinical trial for rotashield, and the foundation began preparing for a scientific advice meeting with the european medicines agency (ema) to conduct a phase iii trial with parts of the trial to be conducted in the eu and other portions in various regions around the world. The foundation working with quintiles (a contract research organization) drafted a voluminous submission concerning primarily the size of the trial needed to indicate efficacy and safety of rotashield. A preliminary meeting with the ema occurred in november of 2012 in london and the final meeting occurred in january 2013 again in london. A determination by the ema will be received by the foundation in 1st qtr of 2013.summary: concluding this large phase ii clinical trial was a major achievement for intl-medica, especially considering that this was a major undertaking for a foundation considering its small size. The publication concerning the results of our trial will also be of great importance to the foundation in the next fiscal year as will be the report of the ema on the foundations strategy for conducting a phase iii clinical trial.\n\nInternational medica has been working with the national institute of allergy and infectious diseases (niaid) national institutes of health (nih), and idt biologika gmbh, its vaccine manufacturer in germany, on a new, proprietary, liquid, heat-stable formulation of rotashield.a major constraint in achieving high immunization rates in less-developed countries is the requirement for a cold chain -- maintaining proper refrigeration of the vaccine product to ensure its effectiveness. This new rotashield liquid formulation has the potential to eliminate the need for a cold chain, which would significantly reduce the distribution and storage costs of the vaccine. All of the currently marketed rotavirus vaccines require refrigeration. Elimination of the need for the cold-chain for vaccines is also of great interest to the vaccine community worldwide, especially in the developing world.a typical liquid rotavirus suspension would generally lose its effectiveness after approximately one week of storage at 37 degrees celsius (98.6 degrees fahrenheit), whereas the new rotashield liquid formulation has shown stability for 6 months at this temperature even when an antacid is present. This same proprietary technology may be adaptable for use with other oral vaccines. The foundation has been actively seeking intellectual property protection of its advanced formulation.intl-medica expanded its patent protection of its new formulation and filed for extensive world-wide patent protection of its formulation. The foundation also began discussions with numerous groups who are interested in a license of this technology to ultimately utilize this technology in vaccine delivery.\n\nThe foundation has continued to engage in discussions with researchers at the national institute of health (nih) in bethesda, maryland, the infectious disease research institute (idri) in seattle, washington and the mayo clinic in rochester, minnesota, with regard to potential vaccines to be developed and other possible global disease issues to be addressed. The foundation is actively examining the possibilities of licensing and developing a vaccine for dengue.","year":2011,"name":"INTERNATIONAL MEDICA FOUNDATION","phone":"5072064380","website":"WWW.INTL-MEDICA.ORG","type":"990","principal_officer":"DR LEONARD RUIZ","year_formation":2007,"state_legal_domicile":"MN","total_volunteers":11,"tax_period_begin":"2011-12-01T00:00:00","tax_period_end":"2012-11-30T00:00:00","address":"421 1ST AVENUE SW NO 304, ROCHESTER, MN, 55902, USA","city":"ROCHESTER","state":"MN","country":"USA","zip_code":"55902"},"Governance":{"501c3 determination":true,"Number of voting members":7,"Number of independent voting members":5,"Number of employees total":2,"Total Gross UBI":0,"Net unrelated business taxable income":0,"Number of employees":2,"Prohibited tax shelter transactions":false,"Taxable party notification":false,"Funds to pay premiums":false,"Premiums Paid":false,"Family or business relationship":false,"Delegation of management duties":false,"Conflict of interest policy":true,"Whistle blower policy":false,"Compensation process for CEO":true,"Compensation process for other employees":true,"Changes to organizing documents":false,"Material diversion or misuse":false,"Members or stockholders":false,"Election of board members":false,"Decisions subject to approval":false,"Minutes of governing body":true,"Local chapters":false,"Form 990 provided to governing body":true,"Document retention policy":false,"Investment in joint venture":false,"Independent audit financial statements":false,"Consolidated audit financial statements":false,"Accountant compile or review":false,"Financial statements audited by independent accountant":false,"Federal grant audit required":false,"Political activities":false,"Donor advised funds":false,"Conservation easements":false,"Collections of art":false,"School":false,"Hospital":false,"Foreign activities":false,"Foreign office":false,"Gaming":false,"Fundraising activities":false,"Professional fundraising":false,"Loan to officer or DQP":true,"Grant to related person":false,"Business relationship through family member":false,"Business relationship with organization":false,"Transfers to exempt non-charitable organization":false},"Revenues":{"value":-5414,"Contributions":{"value":0},"Program revenue":{"value":0,"Unrelated business revenue":0},"Investment income":{"value":-5414,"Investment income total":-79,"Net investment gain":-5335},"Other revenues":{"value":0}},"Expenses":{"value":724928,"Grant expense":{"value":0},"Total professional fundraising expense":{"value":0},"Benefits paid to members":{"value":0},"Salaries":{"value":467692,"Current officers":405000,"Other employee benefits":43167,"Payroll taxes":19525},"Other expenses":{"value":257236,"Legal":19872,"Accounting":6382,"Other services":25000,"Office expenses":8144,"Occupancy":7032,"Travel":21513,"Conferences and meetings":35,"Depreciation and depletion":497,"Insurance":2226,"Itemized Expenses":{"value":166535,"VARIOUS":166535}}},"Assets":{"value":518547,"Non-interest bearing cash":3256,"Savings and temp cash investments":515043,"Accounts receivable":0,"Land, building, equipment":248,"Investments publicly traded":0},"Liabilities":{"value":500000,"Loans from officers, directors":500000},"Fund balance":{"value":18547},"Form990Details":{"program_service_accomplishments":[{"description":"THE PRIMARY PURPOSE OF INTL-MEDICA IS THE DEVELOPMENT AND DELIVERY OF AN ORAL ROTAVIRUS VACCINE FOR THE PREVENTION OF ROTAVIRUS-RELATED MORBIDITY AND DEATHS IN THE DEVELOPING WORLD. GLOBALLY, INFECTIONS FROM ROTAVIRUS ACCOUNT FOR AN ESTIMATED 125 MILLION CASES OF DIARRHEA EACH YEAR, RESULTING IN THE DEATHS OF APPROXIMATELY 500,000 INFANTS ANNUALLY FROM A DISEASE THAT IS HIGHLY PREVENTABLE WITH AN ORAL VACCINE. WORLDWIDE, ROTAVIRUS INFECTS EVERY CHILD IN THE WORLD IN THEIR FIRST FEW YEARS OF LIFE AND SENDS 1 CHILD IN EVERY 5 TO 8 TO A CLINIC FOR TREATMENT, 1 IN EVERY 58 TO A HOSPITAL, AND 1 IN 250-300 DIE FROM DEHYDRATING DIARRHEA. ROTAVIRUS IS THE CAUSE OF 30% TO 40% OF THE HOSPITALIZATIONS FOR DIARRHEA IN CHILDREN LESS THAN FIVE YEARS OF AGE AND RESULTS IN OVER 1,600 DEATHS EACH DAY IN DEVELOPING COUNTRIES WHERE MEDICAL CARE IS LIMITED AND MALNUTRITION IS PREVALENT. ROTAVIRUS VACCINE ACTIVITIES. BRIEF HISTORY: THE ROTAVIRUS VACCINE, KNOWN AS ROTASHIELD, WAS INVENTED AND INITIALLY DEVELOPED BY THE NATIONAL INSTITUTES OF HEALTH OF THE UNITED STATES (NIH). FROM ITS INCEPTION IN DECEMBER 2007 AND CONTINUING CURRENTLY, INTERNATIONAL MEDICA PERSONNEL HAVE BEEN WORKING EXTENSIVELY ALONGSIDE THE NIH AND A VACCINE MANUFACTURER TO COMPLETE A FINALIZED VACCINE PRODUCT ULTIMATELY FOR USE IN THE NEGLECTED POPULATIONS OF THE WORLD. VACCINE MANUFACTURED FOR CLINICAL TRIALS WAS TESTED TO ENSURE IT MET ALL POTENCY STANDARDS AND ALL REGULATORY REQUIREMENTS PRIOR TO BEING RELEASED FOR USE. INTERNATIONAL MEDICA, WORKING WITH THE NIH, ACTIVELY PARTICIPATED IN THE ONGOING DEVELOPMENT OF THE MANUFACTURING PROCESS, ENSURING THAT ANY CHANGES TO THE MANUFACTURING PROCESS MET ALL REGULATORY REQUIREMENTS. PHASE II CLINICAL TRIAL: WORKING WITH A NUMBER OF GROUPS INTERNATIONALLY, THE FOUNDATION CONDUCTED A PHASE II CLINICAL TRIAL THE PURPOSE OF WHICH WAS TO ALLOW INTERNATIONAL MEDICA TO DETERMINE IF THE ROTASHIELD VACCINE, WHEN GIVEN IN THE NEONATAL DELIVERY REGIMEN, STIMULATES THE IMMUNE RESPONSE OF INFANTS TO PROVIDE AN ADEQUATE PROTECTION AGAINST THE ROTAVIRUS. GIVING THE VACCINE TO NEONATES WOULD ALLOW MORE CHILDREN TO RECEIVE THE VACCINE, AS CHILDREN IN DEVELOPING COUNTRIES ARE MOST LIKELY TO HAVE INTERACTION WITH HEALTH CARE PROVIDERS IN THE FIRST DAYS IMMEDIATELY AFTER BIRTH. STARTING IMMUNIZATIONS AT OR NEAR BIRTH WOULD ALSO PROTECT INFANTS EARLIER IN LIFE.IN EARLY 2ND QUARTER OF 2009, MANUFACTURE OF THE FINAL ROTASHIELD VACCINE WAS COMPLETED AND READY FOR THE CLINICAL TRIAL. THIS PHASE II CLINICAL TRIAL ULTIMATELY SCREENED APPROXIMATELY 1,051 CHILDREN FOR THE TRIAL WITH MULTI-ARM END-POINTS. A TOTAL OF 949 INFANTS COMPLETED THE STUDY AND PURSUANT TO THE TRIAL DESIGN WERE FOLLOWED FOR ONE-YEAR TO MONITOR FOR ANY SAFETY ISSUES. THE LAST INFANT FOLLOW-UP VISIT WAS COMPLETED IN EARLY DECEMBER 2010. AFTER A YEAR OF FOLLOWING THE INFANTS, THERE WAS THEN A DATA LOCK ON THE CLINICAL TRIAL INFORMATION IN JUNE OF 2011 FOLLOWED BY THE FINAL CLINICAL STUDY REPORT IN DECEMBER OF 2011. NEO-NATAL DOSING: A KEY ASPECT OF INTL-MEDICA DEVELOPMENT OF ROTASHIELD WAS THE CHANGE OF DOSING FOR ROTAVIRUS VACCINES TO A NEONATAL DOSING SCHEDULE, IE PROVIDING THE FIRST DOSE WITHIN THE FIRST 29 DAYS BIRTHED LIFE AND A SECOND DOSE BEFORE 60 DAYS OF AGE. THE VACCINE WAS ORIGINALLY DEVELOPED WHERE THE FIRST DOSE WOULD BE ADMINISTERED TO INFANTS AT 2 MONTHS OF AGE, IN A THREE DOSE REGIMEN. TO INCREASE THE EFFECTIVENESS OF THE VACCINE WITH FEWER DOSES, AND TO INCREASE THE LIKELIHOOD OF ACCESS OF CHILDREN TO HEALTH PROFESSIONALS IN THE DEVELOPING WORLD, INTERNATIONAL MEDICA DID EXTENSIVE REVIEW INTO THE PREVIOUS DATA AND ESTABLISHED A PROTOCOL TO DETERMINE THE EFFECTIVENESS OF ROTASHIELD WHEN GIVEN IN THIS TWO-DOSE, NEONATAL DELIVERY REGIME. NEONATAL DOSING HAS BECOME A PRACTICE OF GREAT INTEREST IN THE PEDIATRIC VACCINE FIELDS SINCE A SIGNIFICANT NUMBER OF INFANTS DIE FROM VACCINE PREVENTABLE DISEASES WITHIN THE FIRST FEW MONTHS OF LIFE; AND IN THE DEVELOPING WORLD, MOST INFANTS COME IN CONTACT WITH MEDICAL/HEALTH WORKERS DURING THE NEONATAL PERIOD.FURTHER, AS ALL ROTAVIRUS VACCINES HAVE SOME CONCERN OF CORRELATION WITH INTUSSUSCEPTION AFTER RECEIVING THE VACCINE, PROVIDING THE VACCINE PRIOR TO THE AGE WHERE INTUSSUSCEPTION IS TO OCCUR COULD MINIMIZE IF NOT ELIMINATE THE RISK OF INTUSSUSCEPTION. THIS COULD LEAD TO ROTASHIELD ACTUALLY BEING THE SAFEST ROTAVIRUS VACCINE ON THE MARKET.NEW RIGHTS: CONSISTENT WITH OUR NEONATAL DELIVERY STRATEGY, INTL-MEDICA, WORKING WITH THE NIH, AMENDED OUR LICENSE TO ADD THE INTELLECTUAL PROPERTY THAT THE NIH HAS DEVELOPED CONCERNING NEO-NATAL DELIVERY OF ROTASHIELD. IN ESSENCE, THE CLINICAL TRIAL CONDUCTED BY INTL-MEDICA PROVED THE PATENTED IDEAS OF THE NIH OF NEONATAL DOSING.PHASE II TRIAL CONCLUSION: INTL-MEDICA WORKING WITH KENDLE RESEARCH INC. (NOW INC RESEARCH), WENT THROUGH A DETAILED ANALYSIS OF THE VOLUMINOUS DATA GENERATED BY THIS TRIAL AND CHARACTERIZED THE DATA INTO WORKABLE FORMATS. THIS INVOLVED ANALYZING THE DATA AND PUTTING MUCH OF THE DATA INTO READABLE TABLES. THE FINAL CLINICAL STUDY REPORT WAS FINALIZED IN DECEMBER OF 2011. BASED ON A REVIEW BY EXPERTS IN THE ROTAVIRUS FIELD, THE RESULTS OF THE TRIAL ARE IMPRESSIVE. ROTASHIELD, WITH ONLY TWO DOSES APPEARS TO HAVE PRODUCED EFFICACY RESULTS APPROXIMATELY EQUIVALENT TO THREE DOSES OF A ROTAVIRUS VACCINE CURRENTLY ON THE MARKET AND PROVIDED PROTECTION SEVERAL MONTHS EARLIER IN LIFE THAN THE EXISTING VACCINE DID IN A PREVIOUS (SEPARATE) STUDY IN GHANA.CLINICAL TRIAL RESULTS/ PUBLICATION: INTL-MEDICA ASSEMBLED A TEAM OF THE WORLDS LEADING EXPERTS IN THE FIELD OF ROTAVIRUS DISEASE AND VACCINATIONS TO WRITE A MANUSCRIPT FOR PUBLICATION OF THE RESULTS. THE MANUSCRIPT HAS BEEN ACCEPTED FOR PUBLICATION IN A MAJOR SCIENTIFIC JOURNAL IN THE JULY 2013 ISSUE.PHASE III CLINICAL TRIAL PLANNING / EMA: BASED ON THE POSITIVE PHASE II CLINICAL TRIAL RESULTS, INTL-MEDICA HAS DEVELOPED A STRATEGIC PLAN FOR A PHASE III CLINICAL TRIAL FOR ROTASHIELD, AND THE FOUNDATION BEGAN PREPARING FOR A SCIENTIFIC ADVICE MEETING WITH THE EUROPEAN MEDICINES AGENCY (EMA) TO CONDUCT A PHASE III TRIAL WITH PARTS OF THE TRIAL TO BE CONDUCTED IN THE EU AND OTHER PORTIONS IN VARIOUS REGIONS AROUND THE WORLD. THE FOUNDATION WORKING WITH QUINTILES (A CONTRACT RESEARCH ORGANIZATION) DRAFTED A VOLUMINOUS SUBMISSION CONCERNING PRIMARILY THE SIZE OF THE TRIAL NEEDED TO INDICATE EFFICACY AND SAFETY OF ROTASHIELD. A PRELIMINARY MEETING WITH THE EMA OCCURRED IN NOVEMBER OF 2012 IN LONDON AND THE FINAL MEETING OCCURRED IN JANUARY 2013 AGAIN IN LONDON. A DETERMINATION BY THE EMA WILL BE RECEIVED BY THE FOUNDATION IN 1ST QTR OF 2013.SUMMARY: CONCLUDING THIS LARGE PHASE II CLINICAL TRIAL WAS A MAJOR ACHIEVEMENT FOR INTL-MEDICA, ESPECIALLY CONSIDERING THAT THIS WAS A MAJOR UNDERTAKING FOR A FOUNDATION CONSIDERING ITS SMALL SIZE. THE PUBLICATION CONCERNING THE RESULTS OF OUR TRIAL WILL ALSO BE OF GREAT IMPORTANCE TO THE FOUNDATION IN THE NEXT FISCAL YEAR AS WILL BE THE REPORT OF THE EMA ON THE FOUNDATIONS STRATEGY FOR CONDUCTING A PHASE III CLINICAL TRIAL.","expense":497136},{"description":"INTERNATIONAL MEDICA HAS BEEN WORKING WITH THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) NATIONAL INSTITUTES OF HEALTH (NIH), AND IDT BIOLOGIKA GMBH, ITS VACCINE MANUFACTURER IN GERMANY, ON A NEW, PROPRIETARY, LIQUID, HEAT-STABLE FORMULATION OF ROTASHIELD.A MAJOR CONSTRAINT IN ACHIEVING HIGH IMMUNIZATION RATES IN LESS-DEVELOPED COUNTRIES IS THE REQUIREMENT FOR A COLD CHAIN -- MAINTAINING PROPER REFRIGERATION OF THE VACCINE PRODUCT TO ENSURE ITS EFFECTIVENESS. THIS NEW ROTASHIELD LIQUID FORMULATION HAS THE POTENTIAL TO ELIMINATE THE NEED FOR A COLD CHAIN, WHICH WOULD SIGNIFICANTLY REDUCE THE DISTRIBUTION AND STORAGE COSTS OF THE VACCINE. ALL OF THE CURRENTLY MARKETED ROTAVIRUS VACCINES REQUIRE REFRIGERATION. ELIMINATION OF THE NEED FOR THE COLD-CHAIN FOR VACCINES IS ALSO OF GREAT INTEREST TO THE VACCINE COMMUNITY WORLDWIDE, ESPECIALLY IN THE DEVELOPING WORLD.A TYPICAL LIQUID ROTAVIRUS SUSPENSION WOULD GENERALLY LOSE ITS EFFECTIVENESS AFTER APPROXIMATELY ONE WEEK OF STORAGE AT 37 DEGREES CELSIUS (98.6 DEGREES FAHRENHEIT), WHEREAS THE NEW ROTASHIELD LIQUID FORMULATION HAS SHOWN STABILITY FOR 6 MONTHS AT THIS TEMPERATURE EVEN WHEN AN ANTACID IS PRESENT. THIS SAME PROPRIETARY TECHNOLOGY MAY BE ADAPTABLE FOR USE WITH OTHER ORAL VACCINES. THE FOUNDATION HAS BEEN ACTIVELY SEEKING INTELLECTUAL PROPERTY PROTECTION OF ITS ADVANCED FORMULATION.INTL-MEDICA EXPANDED ITS PATENT PROTECTION OF ITS NEW FORMULATION AND FILED FOR EXTENSIVE WORLD-WIDE PATENT PROTECTION OF ITS FORMULATION. THE FOUNDATION ALSO BEGAN DISCUSSIONS WITH NUMEROUS GROUPS WHO ARE INTERESTED IN A LICENSE OF THIS TECHNOLOGY TO ULTIMATELY UTILIZE THIS TECHNOLOGY IN VACCINE DELIVERY.","expense":108087},{"description":"THE FOUNDATION HAS CONTINUED TO ENGAGE IN DISCUSSIONS WITH RESEARCHERS AT THE NATIONAL INSTITUTE OF HEALTH (NIH) IN BETHESDA, MARYLAND, THE INFECTIOUS DISEASE RESEARCH INSTITUTE (IDRI) IN SEATTLE, WASHINGTON AND THE MAYO CLINIC IN ROCHESTER, MINNESOTA, WITH REGARD TO POTENTIAL VACCINES TO BE DEVELOPED AND OTHER POSSIBLE GLOBAL DISEASE ISSUES TO BE ADDRESSED. THE FOUNDATION IS ACTIVELY EXAMINING THE POSSIBILITIES OF LICENSING AND DEVELOPING A VACCINE FOR DENGUE.","expense":21617}],"functional_expense_allocations":{"current_officers_directors":{"program_services":336000,"management_and_general":69000,"total":405000},"other_employee_benefits":{"program_services":35872,"management_and_general":7295,"total":43167},"payroll_taxes":{"program_services":16135,"management_and_general":3390,"total":19525},"legal_fees":{"program_services":17124,"management_and_general":2748,"total":19872},"accounting_fees":{"management_and_general":6382,"total":6382},"other_service_fees":{"program_services":25000,"total":25000},"office_expenses":{"program_services":4072,"management_and_general":4072,"total":8144},"occupancy":{"program_services":7032,"total":7032},"travel":{"program_services":19462,"management_and_general":2051,"total":21513},"conferences_meetings":{"management_and_general":35,"total":35},"depreciation_depletion":{"management_and_general":497,"total":497},"insurance":{"management_and_general":2226,"total":2226}},"tax_and_disclosure_flags":{"activities_conducted_through_partnership":false,"foreign_financial_account":false,"employment_tax_returns_filed":true,"lobbying_activities":false,"deductible_non_cash_contributions":false,"deductible_contributions_of_art":false,"method_of_accounting_accrual":true,"schedule_o_part_iii":true,"schedule_o_part_vi":true},"principal_officer_detail":{"person_name":"DR 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