| Category | Amount | Net Investment Income | Adjusted Net Income | Disbursements for Charitable Purposes |
|---|---|---|---|---|
| ACCOUNTING | 4,850 | 970 | 0 | 3,880 |
| Description of Property | Date Acquired | Cost or Other Basis | Prior Years' Depreciation | Computation Method | Rate / Life (# of years) |
Current Year's Depreciation Expense | Net Investment Income | Adjusted Net Income | Cost of Goods Sold Not Included |
|---|---|---|---|---|---|---|---|---|---|
| SONY COMPUTER | 2010-09-20 | 1,126 | 1,126 | 200DB | 3.000000000000 | 0 | 0 | 0 | |
| LENOVO COMPUTER | 2012-12-26 | 1,990 | 1,842 | 200DB | 3.000000000000 | 148 | 0 | 0 |
| Identifier | Return Reference | Explanation |
|---|---|---|
| FORM 990-PF, PART IX-A, #1-SUMMARY OF DIRECT CHARITABLE ACTIVITIES | CONTINUATION OF DIRECT CHARITABLE ACTIVITY #1: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: OVERVIEW: 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.SPECIFICS: 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: AS MENTIONED ABOVE, A KEY ASPECT OF INTL-MEDICA'S DEVELOPMENT OF ROTASHIELD WAS THE CHANGE OF DOSING FOR ROTAVIRUS VACCINES TO A NEONATAL DOSING SCHEDULE, I.E. PROVIDING THE FIRST DOSE WITHIN THE FIRST 29 DAYS OF 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 PRIMARILY DURING THE NEONATAL PERIOD.FURTHER, AS ALL ROTAVIRUS VACCINES HAVE AN INCREASED RISK OF VACCINE-ASSOCIATED INTUSSUSCEPTION AFTER RECEIVING THE VACCINE, PROVIDING THE VACCINE PRIOR TO THE AGE WHERE INTUSSUSCEPTION IS TO OCCUR (NEONATAL PERIOD) 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 WORLD'S LEADING EXPERTS IN THE FIELD OF ROTAVIRUS DISEASE AND VACCINATIONS TO WRITE A MANUSCRIPT FOR PUBLICATION OF THE RESULTS OF THE CLINICAL TRIAL IN GHANA. THIS WAS PUBLISHED IN AUGUST OF 2013 IN THE JOURNAL OF INFECTIOUS DISEASES (JID 2013;208:423-31), AND WAS TITLED: EFFICACY, IMMUNOGENICITY, AND SAFETY OF TWO DOSES OF A TETRAVALENT ROTAVIRUS VACCINE RRV-TV IN GHANA WITH THE FIRST DOSE ADMINISTERED DURING THE NEONATAL PERIOD. THIS PUBLICATION RECEIVED PRESS SUPPORT FROM THE MAYO CLINIC IN THE FORM OF A PRESS RELEASE AND VIDEO INTERVIEW WITH DR. ROBERT JACOBSON, ONE OF THE CO-AUTHORS. WHILE OUR STUDY WAS TOO SMALL TO ADDRESS THE ISSUE OF INTUSSUSCEPTION, IT DID PROVE THAT EFFICACY AGAINST ROTAVIRUS GASTROENTERITIS COULD BE ACHIEVED IN VERY YOUNG INFANTS WHICH COULD LEAD TO MINIMIZING OR ELIMINATING THE INCREASED RISK OF VACCINE ASSOCIATED INTUSSUSCEPTION.FY DECEMBER 2015-NOVEMBER 2016 UPDATE: INTL-MEDICA DID NOT HAVE THE RESOURCES TO CONDUCT THE NEXT PHASE OF DEVELOPMENT IN THE LONG PROCESS OF GETTING A VACCINE INTO THE WORLD MARKETS. THEREFORE, INTL-MEDICA SOUGHT OUT PARTNERS WITH THE RESOURCES TO CONTINUE THE DEVELOPMENT AND ULTIMATELY REACHED AN AGREEMENT WITH A COMPANY IN CHINA WHO WOULD CONTINUE THE DEVELOPMENT. NOT ONLY DOES CHINA HAVE A SIGNIFICANT ROTAVIRUS PROBLEM, BUT THIS COMPANY IS INTERESTED IN THE WORLD MARKET INCLUDING THOSE COUNTRIES UNDER GAVI (A GLOBAL VACCINE ALLIANCE PROGRAM FOR CHILDREN LIVING IN THE WORLD'S POOREST COUNTRIES). INTL-MEDICA ALSO RETAINED RIGHTS FOR THE NEGLECTED POPULATIONS OF THE WORLD, FOR THOSE AREAS NOT COVERED BY GAVI.INTL-MEDICA HAS STRONGLY SUPPORTED AND DILIGENTLY ASSISTED OUR PARTNER IN THEIR QUEST TO: RECEIVE REGULATORY APPROVAL IN CHINA, AS WELL AS BEGINNING THE REGULATORY PROCESS THROUGHOUT THE WORLD; ENHANCING THEIR FUTURE PRODUCT (SECOND GENERATION ROTASHIELD) WITH THE ADDITIONS OF ADDITIONAL STRAIN(S) OF ROTAVIRUS AS WELL AS LOOKING AT ALTERNATE FORMULATIONS; TO ESTABLISH THEIR MANUFACTURING CAPABILITIES; AND TO EXPAND THEIR RELATIONSHIPS IN THE WORLD VACCINE COMMUNITY. SPECIFICALLY: REGULATORY ADVANCEMENTS: THE FOUNDATION HAS SUPPORTED OUR PARTNER IN DEVELOPING THEIR REGULATORY PROFILE FOR SUBMISSIONS FOR VARIOUS REGULATORY BODIES. FURTHER THE FOUNDATION HAS SUPPORTED OUR PARTNER IN DEVELOPING THEIR MANUFACTURING CAPABILITIES AND REGULATORY APPROVAL OF THEIR MANUFACTURING SITES.EXPANDING CONTACTS IN THE WORLD VACCINE COMMUNITY: IN JUNE 2016, THE BRAVOVAX TEAM VISITED THE NIH FOR A MEETING ORGANIZED BY INTL-MEDICA TO UPDATE THE NIH ON THE DEVELOPMENT OF OUR VACCINE PRODUCT AS WELL AS STRENGTHEN THE RELATIONSHIP AS THE PROCESS GOES FORWARD. ALSO, THROUGHOUT THE YEAR THE FOUNDATION SUPPORTED OUR PARTNER IN VARIOUS MEETINGS WITH WORLD-RENOWNED NGOS. INTL-MEDICA HELPED ESTABLISH AND ADVANCE THESE MEETINGS. ENHANCEMENT OF THEIR PRODUCT: WITH THE SUPPORT FROM INTL-MEDICA AND THE SIGNIFICANT EFFORTS OF THE NIH/TTO, BRAVOVAX HAS RECEIVED A SIGNIFICANT PORTION OF THE REMAINING ROTAVIRUS SAMPLES. THESE ARE SUPPLEMENTARY MATERIAL TO PREVIOUSLY PROVIDED MATERIALS AND NECESSARY FOR QUALITY CONTROL AND INDUSTRIAL PRODUCTION FOR RRV-BV. OUR PARTNER IS ALSO EXAMINING THE DEVELOPMENT OF A NEW LIQUID FORM OF THE VACCINE. A LIQUID, READY TO ADMINISTER VACCINE, WOULD HAVE SOME MARKETING ADVANTAGES BUT WOULD PROBABLY NEED REFRIGERATION. THE FOUNDATION ASSISTED OUR PARTNER IN ADVANCING A NEW FORMULATION AS THEY CONTINUE IN-HOUSE RESEARCH, COLLABORATIONS, AS WELL AS GRANT FUNDING TO ADVANCE THIS DEVELOPMENT.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 WAS ALSO A MAJOR MILESTONE FOR THE FOUNDATION. AND FINALLY, WORKING WITH A PARTNER IN CHINA TO CONTINUE THE ADVANCEMENT OR ROTASHIELD WILL ALLOW THE FOUNDATION TO CONTINUE ITS MISSION OF ULTIMATELY PROVIDING A SAFE AND EFFECTIVE VACCINE FOR ROTAVIRUS THAT CAN SIGNIFICANTLY DECREASE THE MORBIDITY AND MORTALITY CAUSED BY ROTAVIRUS AROUND THE WORLD, ESPECIALLY TO THE NEGLECTED POPULATIONS OF THE WORLD. | |
| FORM 990-PF, PART IX-A, #2-SUMMARY OF DIRECT CHARITABLE ACTIVITIES | CONTINUATION OF SUMMARY OF DIRECT CHARITABLE ACTIVITY #2:A TYPICAL LIQUID ROTAVIRUS SUSPENSION WOULD GENERALLY LOSE ITS EFFECTIVENESS AFTER APPROXIMATELY ONE WEEK OF STORAGE AT 37 C (98.6 F), 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. WE ALSO SIGNED A LICENSE FOR OUR "ELIMINATION OF THE REFRIGERATION (COLD CHAIN) REQUIREMENTS" TECHNOLOGY WITH A COMPANY THAT IS COMPRISED OF EXPERTS IN VACCINES, INCLUDING THE DELIVERY OF VACCINES. THIS COMPANY, WITH OUR SUPPORT, IS ACTIVELY DEVELOPING THAT TECHNOLOGY PLATFORM. FY DECEMBER 2015-NOVEMBER 2016 UPDATE: INTL-MEDIA CONTINUES TO PROVIDE A STRONG LEADERSHIP ROLE IN THE FORMULATION DEVELOPMENT. ONGOING RESEARCH TO DEAL WITH COMPLEX MANUFACTURING ISSUES E.G. LYOPHILIZATION AND PRODUCING MINIMIZE PARTICLE SIZES AND MINIMIZING MOISTURE IS ONGOING. WE CONTINUE TO ACTIVELY PROSECUTE OUR PATENT PROTECTION FOR THIS TECHNOLOGY AROUND THE WORLD. |
| Category / Item | Cost / Other Basis | Accumulated Depreciation | Book Value | End of Year Fair Market Value |
|---|---|---|---|---|
| SONY COMPUTER | 1,126 | 1,126 | 0 | |
| LENOVO COMPUTER | 1,990 | 1,990 | 0 |
| Category | Amount | Net Investment Income | Adjusted Net Income | Disbursements for Charitable Purposes |
|---|---|---|---|---|
| LEGAL SERVICES | 24,910 | 0 | 0 | 24,910 |
| Description | Revenue and Expenses per Books | Net Investment Income | Adjusted Net Income | Disbursements for Charitable Purposes |
|---|---|---|---|---|
| INSURANCE | 3,204 | 641 | 0 | 2,563 |
| OFFICE SUPPLIES AND EXPENSE | 6,943 | 1,384 | 0 | 5,559 |
| INFORMATION TECHNOLOGY | 168 | 34 | 0 | 134 |
| NATIONAL INSTITUTE OF HEALTH (NIH) FEES | 39,071 | 0 | 0 | 39,071 |
| Category | Amount | Net Investment Income | Adjusted Net Income | Disbursements for Charitable Purposes |
|---|---|---|---|---|
| PAYROLL PROCESSING SERVICE | 1,002 | 200 | 0 | 802 |
| Category | Amount | Net Investment Income | Adjusted Net Income | Disbursements for Charitable Purposes |
|---|---|---|---|---|
| INCOME TAXES | 9,579 | 9,579 | 0 | 0 |